Study to Evaluate Safety, Tolerability & Immunogenicity o... | NCT04895982 | Trialant
NCT04895982
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Oct 9, 2024Actual
Enrollment
124Actual
Phase
Phase 2
Conditions
SARS-CoV-2 Infection, COVID19
Interventions
BNT162b2
Countries
United States
Brazil
Germany
Mexico
Protocol Section
Identification Module
NCT ID
NCT04895982
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4591024
Secondary IDs
ID
Type
Description
Link
2021-001290-23
EudraCT Number
Brief Title
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
Official Title
A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 15, 2021Actual
Primary Completion Date
Jul 23, 2023Actual
Completion Date
Jul 23, 2023Actual
First Submitted Date
May 5, 2021
First Submission Date that Met QC Criteria
May 17, 2021
First Posted Date
May 21, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jul 3, 2024
Results First Submitted that Met QC Criteria
Oct 1, 2024
Results First Posted Date
Oct 9, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 1, 2024
Last Update Posted Date
Oct 9, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BioNTech SEINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.
Detailed Description
Not provided
Conditions Module
Conditions
SARS-CoV-2 Infection, COVID19
Keywords
COVID19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
124Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BNT162b2
Experimental
Intramuscular Injection
Biological: BNT162b2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BNT162b2
Biological
Intramuscular Injection
BNT162b2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 Evaluable Immunogenicity population (EIP).
1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1).
Participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1).
Participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period.
Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
Participants who are immunocompromised by virtue of the following:
Having known non-small cell lung cancer (NSCLC) and is ≥18 years of age with at least 1 of the following:
Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or
Receiving checkpoint inhibitor treatment (programmed cell death protein 1 (PD-1)/ programmed death-ligand 1 (PD-L1) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
Receiving targeted drug therapy treatment (epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene tyrosine-protein kinase (ROS1), v-raf murine sarcoma viral oncogene homolog B1 (BRAF),rearranged during transfection (RET),hepatocyte growth factor receptor (MET), neurotrophic tyrosine kinase (NTRK) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
Having known chronic lymphocytic leukemia (CLL) and is ≥18 years of age with at least 1 of the following:
Has asymptomatic disease (eg, Rai stage <3, Binet stage A or B) and is undergoing observation and does not receive any treatment for CLL; or
Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has received at least 3 cycles prior to enrollment; and/or
Receives a Bruton tyrosine kinase (BTK) inhibitor, phosphoinositide 3-kinase (PI3K) inhibitor, or B-cell lymphoma-2 (BCL-2) inhibitor; or
Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or
Is on active immunomodulator therapy (eg, tumor necrosis factor alpha (TNFα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and Crohn's disease) at a stable* dose
*Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to Visit 1; or
Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 1), and is ≥2 to <18 years of age; or
Has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (Visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age
The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).
Exclusion Criteria:
Past clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19, or a past clinical diagnosis of multisystem inflammatory syndrome in children (MIS-C).
Participants with active graft-vs-host disease (GVHD), transplant rejection, or posttransplant lymphoproliferative disorder (PTLD), or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment (Visit 1).
Participants <18 years of age whose weight is less than the 5th percentile of age-adjusted ideal body weight.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Participant who is pregnant or breastfeeding.
Participants who may be ineligible because of the number of phlebotomy assessments during this study, in the opinion of the investigator.
Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
Previous vaccination with any coronavirus vaccine.
Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to Dose 4.
Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
Previous participation in other studies involving study intervention containing lipid nanoparticle (LNPs).
Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ochsner Clinic Foundation
Jefferson
Louisiana
70121
United States
Ochsner Medical Center - Jefferson Highway
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
A total of 124 participants were enrolled in this study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
(Greater Than or Equal to (>=) 2 to Less Than (<) 5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 13, 2023
Jul 2, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
1 Month after Vaccination 4
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
1 Month after Vaccination 4
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
1 Month after Vaccination 4
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP .
1 Month after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Local reactions were collected in an electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (>0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Local reactions collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm), severe(>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis[redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity),Grade 4(ER visit or hospitalization for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate(>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity) and Grade 4(ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 degree C (deg C); categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 de, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Jefferson
Louisiana
70121
United States
Ochsner Clinic Foundation
Kenner
Louisiana
70065
United States
Ochsner Medical Center Kenner
Kenner
Louisiana
70065
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
Ochsner Medical Center - Jefferson Highway
New Orleans
Louisiana
70121
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
Henry Ford Hospital - Research Pharmacy
Detroit
Michigan
48202
United States
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
45206
United States
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
45229
United States
Cincinnati Children's Hospital Vaccine Research Center
Cincinnati
Ohio
45229
United States
Cincinnati Children's Hospital
Cincinnati
Ohio
45229
United States
Texas Children's Hospital
Houston
Texas
77030
United States
Seattle Children's Research Institute: Building Cure
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG003
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG004
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG005
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG006
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG007
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG008
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG009
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG010
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
FG011
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
FG0009 subjects
FG00115 subjects
FG00213 subjects
FG00319 subjects
FG00424 subjects
FG00522 subjects
FG0067 subjects
FG0071 subjects
FG0087 subjects
FG0095 subjects
FG0101 subjects
FG0111 subjects
Dose 1
FG0009 subjects
FG00115 subjects
FG00213 subjects
FG00319 subjects
FG00424 subjects
FG00522 subjects
FG0067 subjects
FG0071 subjects
FG0087 subjects
FG0095 subjects
FG0101 subjects
FG0111 subjects
Dose 2
FG0009 subjects
FG00115 subjects
FG00212 subjects
FG00319 subjects
FG00424 subjects
FG00522 subjects
FG0067 subjects
FG0071 subjects
FG0087 subjects
FG0095 subjects
FG0101 subjects
FG0111 subjects
Dose 3
FG0009 subjects
FG00115 subjects
FG00211 subjects
FG00317 subjects
FG00424 subjects
FG00522 subjects
FG0067 subjects
FG0071 subjects
FG0086 subjects
FG0095 subjects
FG0101 subjects
FG0111 subjects
Dose 4
FG0007 subjects
FG00113 subjects
FG0026 subjects
FG00314 subjects
FG00420 subjects
FG00517 subjects
FG0065 subjects
FG0071 subjects
FG0083 subjects
FG0093 subjects
FG0101 subjects
FG0110 subjects
COMPLETED
FG0007 subjects
FG00112 subjects
FG0026 subjects
FG00316 subjects
FG00420 subjects
FG00518 subjects
FG0065 subjects
FG0070 subjects
FG0083 subjects
FG0093 subjects
FG0101 subjects
FG0110 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0027 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
FG0062 subjects
FG0071 subjects
FG0084 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
Withdrawal by parent/guardian
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Refused further study procedures
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Safety population included all participants who received at least 1 dose of study intervention. To avoid risk of identification of participant, any baseline measure data is not disclosed for reporting arm including (>=18 Years with Non-Small Cell Lung Cancer, >= 18 Years with Haemodialysis) and baseline measure data other than age is not disclosed for reporting arm (>=12 to <18 Years with Solid Organ Transplant) and reported the participant under category- Not Disclosed
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG003
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG004
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG005
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG006
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG007
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG008
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG009
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG010
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
BG011
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG00115
BG00213
BG00319
BG00424
BG00522
BG0067
BG0071
BG0087
BG0095
BG0101
BG0111
BG012124
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Participant in >=18 Years with Non-Small Cell Lung Cancer and >= 18 Years with Haemodialysis is not disclosed to avoid risk of identification and kept under category "Not disclosed".
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Children (2-11 years)
BG0009
BG00115
BG00213
BG003
Sex/Gender, Customized
Participant in 12 to <18 Years with Solid Organ Transplant, >=18 Years with Non-Small Cell Lung Cancer, >= 18 Years with Haemodialysis is not disclosed to avoid risk of identification and kept under category "Not disclosed".
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG001
Race/Ethnicity, Customized
Ethnicity is reported. Participant in 12 to <18 Years with Solid Organ Transplant, >=18 Years with Non-Small Cell Lung Cancer, >= 18 Years with Haemodialysis is not disclosed to avoid risk of identification and kept under category "Not disclosed".
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG001
Race/Ethnicity, Customized
Race is reported. Participant in 12 to <18 Years with Solid Organ Transplant, >=18 Years with Non-Small Cell Lung Cancer, >= 18 Years with Haemodialysis is not disclosed to avoid risk of identification and kept under category "Not disclosed".
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 Evaluable Immunogenicity population (EIP).
Dose 3 EIP= all participants who received 3 doses of vaccine with Dose 2 and Dose 3 within predefined window, had at least 1 valid & determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 3); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 3 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 3 in '>=2 to <5 years with stem cell transplant' arm.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 3
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0016
OG0020
Title
Denominators
Categories
Title
Measurements
OG000600.2(77.8 to 4629.8)
OG001884.7(176.7 to 4430.6)
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Dose 3 EIP= all randomized participants who received 3 doses of vaccine with Dose 2 and Dose 3 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window (28 to 42 days, inclusive, after Dose 3), and had no other important protocol deviations as determined by the clinician.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 3
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Dose 3 EIP= all randomized participants who received 3 doses of vaccine with Dose 2 and Dose 3 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window (28 to 42 days, inclusive, after Dose 3), and had no other important protocol deviations as determined by the clinician.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 3
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Dose 3 EIP= all participants who received 3 doses of vaccine with Dose 2 and Dose 3 within predefined window, had at least 1 valid & determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 3); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 3 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 3 in '>=18 years with non small cell lung cancer' arm.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 3
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Dose 4 EIP= all participants who received 4 doses of vaccine with Dose 2,3&4 within predefined window,had at least 1 valid & determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 4); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 4 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 4 in '>=2 to <5 years with stem cell transplant' arm.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 4
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Dose 4 EIP= all randomized participants who received 4 doses of vaccine with Dose 2, Dose 3 and Dose 4 received within the predefined window, had at least 1 valid and determinate immunogenicity result from the blood sample collected within an appropriate window (28 to 42 days, inclusive, after Dose 4), and had no other important protocol deviations as determined by the clinician.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 4
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Dose 4 EIP=all participants who received 4 doses of vaccine with Dose 2,3&4 within predefined window,had atleast 1 valid&determinate immunogenicity result from sample collected within appropriate window(28-42 days,inclusive,after Dose4);had no other important protocol deviations as determined by clinician.No participants qualified for Dose 4 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose4 in'12 to <18 years with immunomodulatory therapy&stem cell transplant'arm.
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 4
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody [serum] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT [nasal swab] until prior vaccination, and negative NAAT [nasal swab] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP .
Dose 4 EIP=all participants who received 4 doses of vaccine with Dose 2,3&4 within predefined window,had at least 1 valid& determinate immunogenicity result from sample collected within appropriate window (28 to 42 days, inclusive, after Dose 4); had no other important protocol deviations as determined by clinician. No participants qualified for Dose 4 EIP without prior evidence of past SARS-CoV-2 infection up to 1 month after dose 4 in '>=18 years with non-small cell lung cancer&hemodialysis'
Posted
Geometric Mean
95% Confidence Interval
Titers
1 Month after Vaccination 4
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Local reactions were collected in an electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (>0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Local reactions collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm), severe(>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis[redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity),Grade 4(ER visit or hospitalization for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. 'Number Analyzed (n)' signifies participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate(>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity) and Grade 4(ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Data is not reported for ">=18 Years with Non-Small Cell Lung Cancer" arm as e-diary data is not transmitted (i.e. participants had not reported the data for the entire e- diary collection period).
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (> 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Participants of >=18 years haemodialysis: group did not receive Vaccination 4 and therefore were not analyzed for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 degree C (deg C); categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 1
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 2
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Data is not reported for ">=18 Years with Non-Small Cell Lung Cancer" arm as e-diary data is not transmitted (i.e. participants had not reported the data for the entire e- diary collection period).
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 3
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 de, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature >=38.0 deg C; categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Safety population consisted of all participants who received at least 1 dose of study intervention.Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure. Participants of >=18 years Haemodialysis: group did not receive Vaccination 4 and therefore were not analyzed for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after Vaccination 4
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 1 month after Vaccination 2
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 1 month after Vaccination 2
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 1 month after Vaccination 2
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 1 month after Vaccination 2
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 3 to 1 month after Vaccination 3
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=2 to <5 Years With Solid Organ Transplant
Primary
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 3 to 1 month after Vaccination 3
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=5 to <12 Years With Solid Organ Transplant
Primary
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 3 to 1 month after Vaccination 3
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=12 to <18 Years With Solid Organ Transplant
Primary
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 3 to 1 month after Vaccination 3
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 4 to 1 month after Vaccination 4
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=2 to <5 Years With Solid Organ Transplant
Primary
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 4 to 1 month after Vaccination 4
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=5 to <12 Years With Solid Organ Transplant
Primary
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Overall Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 4 to 1 month after Vaccination 4
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=12 to <18 Years With Solid Organ Transplant
Primary
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.Participants of >=18 years with Haemodialysis: group did not receive Vaccination 4 and therefore were not analyzed for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 4 to 1 month after Vaccination 4
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=18 Years With Non-Small Cell Lung Cancer
Primary
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
ID
Title
Description
OG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
ID
Title
Description
OG000
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
ID
Title
Description
OG000
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Primary
Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
ID
Title
Description
OG000
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Time Frame
Local reactions/systemic events (systematic assessment): Day 1 to Day 7 after each dose. Non-systematic assessment: AEs were reported from Day 1 of dose 1 up to 1 month after dose 4 (approximately 9 months). For SAE, from Dose 1 on Day 1 to 6 months after Dose 4 (approximately 14 months).
Description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Some Adverse Events were collected in both systematic and non-systematic assessment methods.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
>=2 to <5 Years With Immunomodulatory Therapy
Participants aged >=2 to <5 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
9
0
9
8
9
EG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
15
8
15
13
15
EG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
13
3
13
10
13
EG003
>=5 to <12 Years With Immunomodulatory Therapy
Participants aged >=5 to <12 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
19
3
19
18
19
EG004
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
24
5
24
23
24
EG005
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
22
3
22
22
22
EG006
>=12 to <18 Years With Immunomodulatory Therapy
Participants aged >=12 to <18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
7
0
7
7
7
EG007
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
1
0
1
1
1
EG008
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
7
0
7
6
7
EG009
>=18 Years With Immunomodulatory Therapy
Participants aged >=18 years received immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
5
1
5
4
5
EG010
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
0
1
0
1
1
1
EG011
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Chest pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Chills
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Chills (CHILLS)
General disorders
MedDRA v26.0
Systematic Assessment
EG0002 events2 affected9 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected13 at risk
EG003
Erythema (REDNESS)
General disorders
MedDRA v26.0
Systematic Assessment
EG0004 events3 affected9 at risk
EG0015 events3 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v26.0
Systematic Assessment
EG0004 events3 affected9 at risk
EG0013 events3 affected15 at risk
EG0023 events3 affected13 at risk
EG003
Injection site bruising
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Injection site erythema
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Injection site pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected15 at risk
EG0022 events1 affected13 at risk
EG003
Injection site pain (PAIN AT INJECTION SITE)
General disorders
MedDRA v26.0
Systematic Assessment
EG0006 events4 affected9 at risk
EG0016 events3 affected15 at risk
EG0024 events4 affected13 at risk
EG003
Medical device site inflammation
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected15 at risk
EG0021 events1 affected13 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v26.0
Systematic Assessment
EG0003 events2 affected9 at risk
EG0011 events1 affected15 at risk
EG0022 events2 affected13 at risk
EG003
Swelling (SWELLING)
General disorders
MedDRA v26.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0012 events1 affected15 at risk
EG0021 events1 affected13 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Breast enlargement
Reproductive system and breast disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected13 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0006
OG0019
OG00211
Title
Denominators
Categories
Title
Measurements
OG000758.4(123.7 to 4650.4)
OG001741.2(150.6 to 3647.0)
OG0024592.3(1989.5 to 10600.4)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0001
OG0011
OG0022
Title
Denominators
Categories
Title
Measurements
OG0007330.0(NA to NA)95% CI could not be calculated as only one participant was analyzed.
OG00143.5(NA to NA)95% CI could not be calculated as only one participant was analyzed.
OG0022368.1(1679.9 to 3338.3)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0002
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG000596.5(0.1 to 3699753.4)
OG002115.0(NA to NA)95% CI could not be calculated as only one participant was analyzed.
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0003
OG0012
OG0020
Title
Denominators
Categories
Title
Measurements
OG000837.5(1.4 to 518774.5)
OG0019576.3(0.0 to 2070132632.7)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0002
OG0014
OG0022
Title
Denominators
Categories
Title
Measurements
OG000754.2(0.0 to 351878145.2)
OG0015335.3(517.0 to 55061.8)
OG0025330.8(0.0 to 113927797661576)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0000
OG0011
OG0020
Title
Denominators
Categories
Title
Measurements
OG0012845.0(NA to NA)95% CI could not be calculated as only one participant was analyzed.
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0001
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG0001474.0(NA to NA)95% CI could not be calculated as only one participant was analyzed.
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00213
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 24.7)
Redness: Mild
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 24.7)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Swelling: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Swelling: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Pain at the injection site: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG00113.3± 1.7(1.7 to 40.5)
OG00223.1± 5.0(5.0 to 53.8)
Pain at the injection site: Mild
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG00113.3± 1.7(1.7 to 40.5)
OG00223.1± 5.0(5.0 to 53.8)
Pain at the injection site: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Pain at the injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Pain at the injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00019
OG00124
OG00222
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0018.3± 1.0(1.0 to 27.0)
OG0029.1± 1.1(1.1 to 29.2)
Redness: Mild
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Swelling: Any
Title
Measurements
OG0005.3± 0.1(0.1 to 26.0)
OG0014.2± 0.1(0.1 to 21.1)
OG00218.2± 5.2(5.2 to 40.3)
Swelling: Mild
Title
Measurements
OG0005.3± 0.1(0.1 to 26.0)
OG0010± 0.0(0.0 to 14.2)
OG00213.6± 2.9(2.9 to 34.9)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Pain at the injection site: Any
Title
Measurements
OG00073.7± 48.8(48.8 to 90.9)
OG00158.3± 36.6(36.6 to 77.9)
OG00254.5± 32.2(32.2 to 75.6)
Pain at the injection site: Mild
Title
Measurements
OG00052.6± 28.9(28.9 to 75.6)
OG00150.0± 29.1(29.1 to 70.9)
OG00245.5± 24.4(24.4 to 67.8)
Pain at the injection site: Moderate
Title
Measurements
OG00021.1± 6.1(6.1 to 45.6)
OG0018.3± 1.0(1.0 to 27.0)
OG0029.1± 1.1(1.1 to 29.2)
Pain at the injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Pain at the injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0027
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
Redness: Mild
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Swelling: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG001100.0± 2.5(2.5 to 100.0)
OG00214.3± 0.4(0.4 to 57.9)
Swelling: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 41.0)
Swelling: Moderate
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Pain at the injection site: Any
Title
Measurements
OG00085.7± 42.1(42.1 to 99.6)
OG001100.0± 2.5(2.5 to 100.0)
OG00257.1± 18.4(18.4 to 90.1)
Pain at the injection site: Mild
Title
Measurements
OG00071.4± 29.0(29.0 to 96.3)
OG001100.0± 2.5(2.5 to 100.0)
OG00228.6± 3.7(3.7 to 71.0)
Pain at the injection site: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00228.6± 3.7(3.7 to 71.0)
Pain at the injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Pain at the injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0011
OG0021
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Any
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Any
Title
Measurements
OG00080.0± 28.4(28.4 to 99.5)
OG001100.0± 2.5(2.5 to 100.0)
OG002100.0± 2.5(2.5 to 100.0)
Pain at injection site: Mild
Title
Measurements
OG00040.0± 5.3(5.3 to 85.3)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Moderate
Title
Measurements
OG00040.0± 5.3(5.3 to 85.3)
OG0010± 0.0(0.0 to 97.5)
OG002100.0± 2.5(2.5 to 100.0)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00211
Title
Denominators
Categories
Redness: Any
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.7(0.2 to 31.9)
OG0020(0.0 to 30.8)
Redness: Mild
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Redness: Moderate
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Redness: Severe
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Redness: Grade 4
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Swelling: Any
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Swelling: Mild
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Swelling: Moderate
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Swelling: Severe
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Swelling: Grade 4
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00210
Title
Measurements
OG000
Pain at injection site: Any
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Pain at injection site: Mild
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Pain at injection site: Moderate
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Pain at injection site: Severe
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Pain at injection site: Grade 4
ParticipantsOG0009
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00019
OG00124
OG00222
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG00112.5± 2.7(2.7 to 32.4)
OG00222.7± 7.8(7.8 to 45.4)
Redness: Mild
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0014.2± 0.1(0.1 to 21.1)
OG00213.6± 2.9(2.9 to 34.9)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0018.3± 1.0(1.0 to 27.0)
OG0029.1± 1.1(1.1 to 29.2)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Swelling: Any
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0018.3± 1.0(1.0 to 27.0)
OG00231.8± 13.9(13.9 to 54.9)
Swelling: Mild
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0014.2± 0.1(0.1 to 21.1)
OG0029.1± 1.1(1.1 to 29.2)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0014.2± 0.1(0.1 to 21.1)
OG00222.7± 7.8(7.8 to 45.4)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Pain at injection site: Any
Title
Measurements
OG00068.4± 43.4(43.4 to 87.4)
OG00162.5± 40.6(40.6 to 81.2)
OG00250.0± 28.2(28.2 to 71.8)
Pain at injection site: Mild
Title
Measurements
OG00052.6± 28.9(28.9 to 75.6)
OG00145.8± 25.6(25.6 to 67.2)
OG00222.7± 7.8(7.8 to 45.4)
Pain at injection site: Moderate
Title
Measurements
OG00015.8± 3.4(3.4 to 39.6)
OG00116.7± 4.7(4.7 to 37.4)
OG00227.3± 10.7(10.7 to 50.2)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0027
Title
Denominators
Categories
Redness: Any
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG00216.7(0.4 to 64.1)
Redness: Mild
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Redness: Moderate
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Redness: Severe
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Redness: Grade 4
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Swelling: Any
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Swelling: Mild
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Swelling: Moderate
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Swelling: Severe
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Swelling: Grade 4
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0026
Title
Measurements
OG000
Pain at injection site: Any
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0027
Title
Measurements
OG000
Pain at injection site: Mild
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0027
Title
Measurements
OG000
Pain at injection site: Moderate
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0027
Title
Measurements
OG000
Pain at injection site: Severe
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0027
Title
Measurements
OG000
Pain at injection site: Grade 4
ParticipantsOG0007
ParticipantsOG0011
ParticipantsOG0027
Title
Measurements
OG000
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0011
OG0021
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Any
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Any
Title
Measurements
OG00080.0± 28.4(28.4 to 99.5)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Mild
Title
Measurements
OG00060.0± 14.7(14.7 to 94.7)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Moderate
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00211
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG00113.3± 1.7(1.7 to 40.5)
OG0020± 0.0(0.0 to 28.5)
Redness: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Redness: Moderate
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Swelling: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Swelling: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Swelling: Moderate
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Pain at injection site: Any
Title
Measurements
OG00022.2± 2.8(2.8 to 60.0)
OG00113.3± 1.7(1.7 to 40.5)
OG0029.1± 0.2(0.2 to 41.3)
Pain at injection site: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG00113.3± 1.7(1.7 to 40.5)
OG0029.1± 0.2(0.2 to 41.3)
Pain at injection site: Moderate
Title
Measurements
OG00022.2± 2.8(2.8 to 60.0)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00017
OG00123
OG00221
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00029.4± 10.3(10.3 to 56.0)
OG0014.3± 0.1(0.1 to 21.9)
OG00214.3± 3.0(3.0 to 36.3)
Redness: Mild
Title
Measurements
OG00017.6± 3.8(3.8 to 43.4)
OG0010± 0.0(0.0 to 14.8)
OG0029.5± 1.2(1.2 to 30.4)
Redness: Moderate
Title
Measurements
OG00011.8± 1.5(1.5 to 36.4)
OG0014.3± 0.1(0.1 to 21.9)
OG0024.8± 0.1(0.1 to 23.8)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 19.5)
OG0010± 0.0(0.0 to 14.8)
OG0020± 0.0(0.0 to 16.1)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 19.5)
OG0010± 0.0(0.0 to 14.8)
OG0020± 0.0(0.0 to 16.1)
Swelling: Any
Title
Measurements
OG00017.6± 3.8(3.8 to 43.4)
OG0018.7± 1.1(1.1 to 28.0)
OG00214.3± 3.0(3.0 to 36.3)
Swelling: Mild
Title
Measurements
OG0005.9± 0.1(0.1 to 28.7)
OG0010± 0.0(0.0 to 14.8)
OG0029.5± 1.2(1.2 to 30.4)
Swelling: Moderate
Title
Measurements
OG00011.8± 1.5(1.5 to 36.4)
OG0018.7± 1.1(1.1 to 28.0)
OG0024.8± 0.1(0.1 to 23.8)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 19.5)
OG0010± 0.0(0.0 to 14.8)
OG0020± 0.0(0.0 to 16.1)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 19.5)
OG0010± 0.0(0.0 to 14.8)
OG0020± 0.0(0.0 to 16.1)
Pain at injection site: Any
Title
Measurements
OG00070.6± 44.0(44.0 to 89.7)
OG00126.1± 10.2(10.2 to 48.4)
OG00257.1± 34.0(34.0 to 78.2)
Pain at injection site: Mild
Title
Measurements
OG00035.3± 14.2(14.2 to 61.7)
OG00121.7± 7.5(7.5 to 43.7)
OG00242.9± 21.8(21.8 to 66.0)
Pain at injection site: Moderate
Title
Measurements
OG00035.3± 14.2(14.2 to 61.7)
OG0014.3± 0.1(0.1 to 21.9)
OG00214.3± 3.0(3.0 to 36.3)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 19.5)
OG0010± 0.0(0.0 to 14.8)
OG0020± 0.0(0.0 to 16.1)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 19.5)
OG0010± 0.0(0.0 to 14.8)
OG0020± 0.0(0.0 to 16.1)
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0026
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Redness: Mild
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Redness: Moderate
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Redness: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Redness: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Swelling: Any
Title
Measurements
OG00028.6(3.7 to 71.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Swelling: Mild
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Swelling: Moderate
Title
Measurements
OG00028.6(3.7 to 71.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Swelling: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Swelling: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Pain at injection site: Any
Title
Measurements
OG00071.4(29.0 to 96.3)
OG001100.0(2.5 to 100.0)
OG00266.7(22.3 to 95.7)
Pain at injection site: Mild
Title
Measurements
OG00028.6(3.7 to 71.0)
OG001100.0(2.5 to 100.0)
OG00233.3(4.3 to 77.7)
Pain at injection site: Moderate
Title
Measurements
OG00042.9(9.9 to 81.6)
OG0010(0.0 to 97.5)
OG00233.3(4.3 to 77.7)
Pain at injection site: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Pain at injection site: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0004
OG0010
OG0021
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00025.0± 0.6(0.6 to 80.6)
OG0020± 0.0(0.0 to 97.5)
Redness: Mild
Title
Measurements
OG00025.0± 0.6(0.6 to 80.6)
OG0020± 0.0(0.0 to 97.5)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Swelling: Any
Title
Measurements
OG00025.0± 0.6(0.6 to 80.6)
OG0020± 0.0(0.0 to 97.5)
Swelling: Mild
Title
Measurements
OG00025.0± 0.6(0.6 to 80.6)
OG0020± 0.0(0.0 to 97.5)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Any
Title
Measurements
OG00075.0± 19.4(19.4 to 99.4)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Mild
Title
Measurements
OG00050.0± 6.8(6.8 to 93.2)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Moderate
Title
Measurements
OG00025.0± 0.6(0.6 to 80.6)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0020± 0.0(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0016
OG0026
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Redness: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Redness: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Swelling: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG00216.7± 0.4(0.4 to 64.1)
Swelling: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG00216.7± 0.4(0.4 to 64.1)
Swelling: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Pain at injection site: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 45.9)
OG00216.7± 0.4(0.4 to 64.1)
Pain at injection site: Mild
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 45.9)
OG00216.7± 0.4(0.4 to 64.1)
Pain at injection site: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00012
OG00119
OG00215
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG00220.0± 4.3(4.3 to 48.1)
Redness: Mild
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0026.7± 0.2(0.2 to 31.9)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG00213.3± 1.7(1.7 to 40.5)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Swelling: Any
Title
Measurements
OG00016.7± 2.1(2.1 to 48.4)
OG0015.3± 0.1(0.1 to 26.0)
OG00220.0± 4.3(4.3 to 48.1)
Swelling: Mild
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG00213.3± 1.7(1.7 to 40.5)
Swelling: Moderate
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0010± 0.0(0.0 to 17.6)
OG0026.7± 0.2(0.2 to 31.9)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Pain at injection site: Any
Title
Measurements
OG00091.7± 61.5(61.5 to 99.8)
OG00142.1± 20.3(20.3 to 66.5)
OG00240.0± 16.3(16.3 to 67.7)
Pain at injection site: Mild
Title
Measurements
OG00041.7± 15.2(15.2 to 72.3)
OG00131.6± 12.6(12.6 to 56.6)
OG00226.7± 7.8(7.8 to 55.1)
Pain at injection site: Moderate
Title
Measurements
OG00050.0± 21.1(21.1 to 78.9)
OG00110.5± 1.3(1.3 to 33.1)
OG00213.3± 1.7(1.7 to 40.5)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0004
OG0011
OG0023
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00075.0(19.4 to 99.4)
OG0010(0.0 to 97.5)
OG00266.7(9.4 to 99.2)
Redness: Mild
Title
Measurements
OG00075.0(19.4 to 99.4)
OG0010(0.0 to 97.5)
OG00266.7(9.4 to 99.2)
Redness: Moderate
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Redness: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Redness: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Swelling: Any
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Swelling: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Swelling: Moderate
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Swelling: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Swelling: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Pain at injection site: Any
Title
Measurements
OG00075.0(19.4 to 99.4)
OG001100.0(2.5 to 100.0)
OG00233.3(0.8 to 90.6)
Pain at injection site: Mild
Title
Measurements
OG00025.0(0.6 to 80.6)
OG001100.0(2.5 to 100.0)
OG0020(0.0 to 70.8)
Pain at injection site: Moderate
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Pain at injection site: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Pain at injection site: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0003
OG0011
OG0020
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Redness: Mild
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Redness: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Redness: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Redness: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Swelling: Any
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Swelling: Mild
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Swelling: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Swelling: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Swelling: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Pain at injection site: Any
Title
Measurements
OG00066.7± 9.4(9.4 to 99.2)
OG001100.0± 2.5(2.5 to 100.0)
Pain at injection site: Mild
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG001100.0± 2.5(2.5 to 100.0)
Pain at injection site: Moderate
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Pain at injection site: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00213
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG00215.4± 1.9(1.9 to 45.4)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0027.7± 0.2(0.2 to 36.0)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0027.7± 0.2(0.2 to 36.0)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Fatigue: Any
Title
Measurements
OG00022.2± 2.8(2.8 to 60.0)
OG0016.7± 0.2(0.2 to 31.9)
OG0027.7± 0.2(0.2 to 36.0)
Fatigue: Mild
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Fatigue: Moderate
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0027.7± 0.2(0.2 to 36.0)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Headache: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Headache: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Headache: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Chills: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0027.7± 0.2(0.2 to 36.0)
Chills: Mild
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Chills: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0027.7± 0.2(0.2 to 36.0)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Vomiting: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG00223.1± 5.0(5.0 to 53.8)
Vomiting: Mild
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0027.7± 0.2(0.2 to 36.0)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG00215.4± 1.9(1.9 to 45.4)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Diarrhea: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG00120.0± 4.3(4.3 to 48.1)
OG0027.7± 0.2(0.2 to 36.0)
Diarrhea: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG00120.0± 4.3(4.3 to 48.1)
OG0020± 0.0(0.0 to 24.7)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0027.7± 0.2(0.2 to 36.0)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened muscle pain: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened muscle pain: Moderate
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened joint pain: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened joint pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened joint pain: Moderate
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 24.7)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00019
OG00124
OG00222
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000(0.0 to 17.6)
OG0014.2(0.1 to 21.1)
OG0020(0.0 to 15.4)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000(0.0 to 17.6)
OG0014.2(0.1 to 21.1)
OG0020(0.0 to 15.4)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Fatigue: Any
Title
Measurements
OG00047.4(24.4 to 71.1)
OG00137.5(18.8 to 59.4)
OG00222.7(7.8 to 45.4)
Fatigue: Mild
Title
Measurements
OG00031.6(12.6 to 56.6)
OG00120.8(7.1 to 42.2)
OG00213.6(2.9 to 34.9)
Fatigue: Moderate
Title
Measurements
OG00015.8(3.4 to 39.6)
OG00116.7(4.7 to 37.4)
OG0029.1(1.1 to 29.2)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Headache: Any
Title
Measurements
OG00042.1(20.3 to 66.5)
OG00112.5(2.7 to 32.4)
OG00222.7(7.8 to 45.4)
Headache: Mild
Title
Measurements
OG00031.6(12.6 to 56.6)
OG00112.5(2.7 to 32.4)
OG0029.1(1.1 to 29.2)
Headache: Moderate
Title
Measurements
OG00010.5(1.3 to 33.1)
OG0010(0.0 to 14.2)
OG00213.6(2.9 to 34.9)
Headache: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Chills: Any
Title
Measurements
OG0005.3(0.1 to 26.0)
OG0010(0.0 to 14.2)
OG0024.5(0.1 to 22.8)
Chills: Mild
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0024.5(0.1 to 22.8)
Chills: Moderate
Title
Measurements
OG0005.3(0.1 to 26.0)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Chills: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Vomiting: Any
Title
Measurements
OG0005.3(0.1 to 26.0)
OG0014.2(0.1 to 21.1)
OG0020(0.0 to 15.4)
Vomiting: Mild
Title
Measurements
OG0005.3(0.1 to 26.0)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 17.6)
OG0014.2(0.1 to 21.1)
OG0020(0.0 to 15.4)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Diarrhea: Any
Title
Measurements
OG00010.5(1.3 to 33.1)
OG0010(0.0 to 14.2)
OG0024.5(0.1 to 22.8)
Diarrhea: Mild
Title
Measurements
OG00010.5(1.3 to 33.1)
OG0010(0.0 to 14.2)
OG0024.5(0.1 to 22.8)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened muscle pain: Any
Title
Measurements
OG0005.3(0.1 to 26.0)
OG0014.2(0.1 to 21.1)
OG0020(0.0 to 15.4)
New or worsened muscle pain: Mild
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened muscle pain: Moderate
Title
Measurements
OG0005.3(0.1 to 26.0)
OG0014.2(0.1 to 21.1)
OG0020(0.0 to 15.4)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened joint pain: Any
Title
Measurements
OG00010.5(1.3 to 33.1)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened joint pain: Moderate
Title
Measurements
OG00010.5(1.3 to 33.1)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 17.6)
OG0010(0.0 to 14.2)
OG0020(0.0 to 15.4)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0027
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Fever: >=38.0 deg C to 38.4 deg C
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Fatigue: Any
Title
Measurements
OG00057.1± 18.4(18.4 to 90.1)
OG0010± 0.0(0.0 to 97.5)
OG00242.9± 9.9(9.9 to 81.6)
Fatigue: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
Fatigue: Moderate
Title
Measurements
OG00057.1± 18.4(18.4 to 90.1)
OG0010± 0.0(0.0 to 97.5)
OG00228.6± 3.7(3.7 to 71.0)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Headache: Any
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG0010± 0.0(0.0 to 97.5)
OG00228.6± 3.7(3.7 to 71.0)
Headache: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
Headache: Moderate
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Chills: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Chills: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Chills: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Vomiting: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Vomiting: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Vomiting: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Diarrhea: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00228.6± 3.7(3.7 to 71.0)
Diarrhea: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00228.6± 3.7(3.7 to 71.0)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened muscle pain: Any
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG0010± 0.0(0.0 to 97.5)
OG00242.9± 9.9(9.9 to 81.6)
New or worsened muscle pain: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00242.9± 9.9(9.9 to 81.6)
New or worsened muscle pain: Moderate
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened joint pain: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened joint pain: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened joint pain: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0011
OG0021
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Fatigue: Any
Title
Measurements
OG00060.0(14.7 to 94.7)
OG001100.0(2.5 to 100.0)
OG002100.0(2.5 to 100.0)
Fatigue: Mild
Title
Measurements
OG00040.0(5.3 to 85.3)
OG001100.0(2.5 to 100.0)
OG0020(0.0 to 97.5)
Fatigue: Moderate
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010(0.0 to 97.5)
OG002100.0(2.5 to 100.0)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Headache: Any
Title
Measurements
OG00040.0(5.3 to 85.3)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Headache: Mild
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Headache: Moderate
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Headache: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Chills: Any
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG002100.0(2.5 to 100.0)
Chills: Mild
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG002100.0(2.5 to 100.0)
Chills: Moderate
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Chills: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Vomiting: Any
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Diarrhea: Any
Title
Measurements
OG00040.0(5.3 to 85.3)
OG001100.0(2.5 to 100.0)
OG0020(0.0 to 97.5)
Diarrhea: Mild
Title
Measurements
OG00040.0(5.3 to 85.3)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 52.2)
OG001100.0(2.5 to 100.0)
OG0020(0.0 to 97.5)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Any
Title
Measurements
OG00020.0(0.5 to 71.6)
OG001100.0(2.5 to 100.0)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Mild
Title
Measurements
OG0000(0.0 to 52.2)
OG001100.0(2.5 to 100.0)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Moderate
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened joint pain: Any
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened joint pain: Moderate
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00210
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fever: >=38.0 deg C to 38.4 deg C
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fatigue: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.7(0.2 to 31.9)
OG00210.0(0.3 to 44.5)
Fatigue: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.7(0.2 to 31.9)
OG00210.0(0.3 to 44.5)
Fatigue: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Headache: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.7(0.2 to 31.9)
OG0020(0.0 to 30.8)
Headache: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.7(0.2 to 31.9)
OG0020(0.0 to 30.8)
Headache: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Headache: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Chills: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Chills: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Chills: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Chills: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Vomiting: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG00113.3(1.7 to 40.5)
OG00210.0(0.3 to 44.5)
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG00113.3(1.7 to 40.5)
OG0020(0.0 to 30.8)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG00210.0(0.3 to 44.5)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Diarrhea: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0016.7(0.2 to 31.9)
OG00210.0(0.3 to 44.5)
Diarrhea: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0016.7(0.2 to 31.9)
OG00210.0(0.3 to 44.5)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened muscle pain: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened muscle pain: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened muscle pain: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened joint pain: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened joint pain: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 21.8)
OG0020(0.0 to 30.8)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00019
OG00124
OG00222
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0005.3± 0.1(0.1 to 26.0)
OG0010± 0.0(0.0 to 14.2)
OG0024.5± 0.1(0.1 to 22.8)
Fever: >=38.0 deg C to 38.4 deg C
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0005.3± 0.1(0.1 to 26.0)
OG0010± 0.0(0.0 to 14.2)
OG0024.5± 0.1(0.1 to 22.8)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Fatigue: Any
Title
Measurements
OG00057.9± 33.5(33.5 to 79.7)
OG00137.5± 18.8(18.8 to 59.4)
OG00245.5± 24.4(24.4 to 67.8)
Fatigue: Mild
Title
Measurements
OG00026.3± 9.1(9.1 to 51.2)
OG00120.8± 7.1(7.1 to 42.2)
OG00213.6± 2.9(2.9 to 34.9)
Fatigue: Moderate
Title
Measurements
OG00031.6± 12.6(12.6 to 56.6)
OG00116.7± 4.7(4.7 to 37.4)
OG00231.8± 13.9(13.9 to 54.9)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Headache: Any
Title
Measurements
OG00036.8± 16.3(16.3 to 61.6)
OG00129.2± 12.6(12.6 to 51.1)
OG00218.2± 5.2(5.2 to 40.3)
Headache: Mild
Title
Measurements
OG00015.8± 3.4(3.4 to 39.6)
OG00112.5± 2.7(2.7 to 32.4)
OG0024.5± 0.1(0.1 to 22.8)
Headache: Moderate
Title
Measurements
OG00021.1± 6.1(6.1 to 45.6)
OG00116.7± 4.7(4.7 to 37.4)
OG00213.6± 2.9(2.9 to 34.9)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Chills: Any
Title
Measurements
OG00021.1± 6.1(6.1 to 45.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
Chills: Mild
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0014.2± 0.1(0.1 to 21.1)
OG0020± 0.0(0.0 to 15.4)
Chills: Moderate
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0010± 0.0(0.0 to 14.2)
OG0024.5± 0.1(0.1 to 22.8)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Vomiting: Any
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG00112.5± 2.7(2.7 to 32.4)
OG0020± 0.0(0.0 to 15.4)
Vomiting: Mild
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG00112.5± 2.7(2.7 to 32.4)
OG0020± 0.0(0.0 to 15.4)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Diarrhea: Any
Title
Measurements
OG0005.3± 0.1(0.1 to 26.0)
OG0018.3± 1.0(1.0 to 27.0)
OG0024.5± 0.1(0.1 to 22.8)
Diarrhea: Mild
Title
Measurements
OG0005.3± 0.1(0.1 to 26.0)
OG0014.2± 0.1(0.1 to 21.1)
OG0020± 0.0(0.0 to 15.4)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
New or worsened muscle pain: Any
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG00112.5± 2.7(2.7 to 32.4)
OG0024.5± 0.1(0.1 to 22.8)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0020± 0.0(0.0 to 15.4)
New or worsened muscle pain: Moderate
Title
Measurements
OG00010.5± 1.3(1.3 to 33.1)
OG0018.3± 1.0(1.0 to 27.0)
OG0024.5± 0.1(0.1 to 22.8)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
New or worsened joint pain: Any
Title
Measurements
OG00015.8± 3.4(3.4 to 39.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
New or worsened joint pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
New or worsened joint pain: Moderate
Title
Measurements
OG00015.8± 3.4(3.4 to 39.6)
OG0014.2± 0.1(0.1 to 21.1)
OG0024.5± 0.1(0.1 to 22.8)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 17.6)
OG0010± 0.0(0.0 to 14.2)
OG0020± 0.0(0.0 to 15.4)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0026
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fever: >=38.0 deg C to 38.4 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fatigue: Any
Title
Measurements
OG00085.7± 42.1(42.1 to 99.6)
OG0010± 0.0(0.0 to 97.5)
OG00233.3± 4.3(4.3 to 77.7)
Fatigue: Mild
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG0010± 0.0(0.0 to 97.5)
OG00233.3± 4.3(4.3 to 77.7)
Fatigue: Moderate
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fatigue: Severe
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Headache: Any
Title
Measurements
OG00071.4± 29.0(29.0 to 96.3)
OG0010± 0.0(0.0 to 97.5)
OG00216.7± 0.4(0.4 to 64.1)
Headache: Mild
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG00216.7± 0.4(0.4 to 64.1)
Headache: Moderate
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Chills: Any
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Chills: Mild
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Chills: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Any
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG001100.0± 2.5(2.5 to 100.0)
OG00216.7± 0.4(0.4 to 64.1)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Moderate
Title
Measurements
OG00042.9± 9.9(9.9 to 81.6)
OG0010± 0.0(0.0 to 97.5)
OG00216.7± 0.4(0.4 to 64.1)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Mild
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 45.9)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0011
OG0021
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fatigue: Any
Title
Measurements
OG00060.0± 14.7(14.7 to 94.7)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Fatigue: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Fatigue: Moderate
Title
Measurements
OG00060.0± 14.7(14.7 to 94.7)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Headache: Any
Title
Measurements
OG00060.0± 14.7(14.7 to 94.7)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Headache: Mild
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Headache: Moderate
Title
Measurements
OG00040.0± 5.3(5.3 to 85.3)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Chills: Any
Title
Measurements
OG00040.0± 5.3(5.3 to 85.3)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Chills: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Chills: Moderate
Title
Measurements
OG00040.0± 5.3(5.3 to 85.3)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Vomiting: Any
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Vomiting: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Diarrhea: Any
Title
Measurements
OG00060.0± 14.7(14.7 to 94.7)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Diarrhea: Mild
Title
Measurements
OG00040.0± 5.3(5.3 to 85.3)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Diarrhea: Moderate
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG001100.0± 2.5(2.5 to 100.0)
OG0020± 0.0(0.0 to 97.5)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened muscle pain: Any
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened muscle pain: Moderate
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened joint pain: Any
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened joint pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened joint pain: Moderate
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00211
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Fever: >=38.0 deg C to 38.4 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Fatigue: Any
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Fatigue: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Fatigue: Moderate
Title
Measurements
OG00011.1± 0.3(0.3 to 48.2)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Headache: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Headache: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Headache: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Chills: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Chills: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Chills: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Vomiting: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Vomiting: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Diarrhea: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Diarrhea: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened muscle pain: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0016.7± 0.2(0.2 to 31.9)
OG0020± 0.0(0.0 to 28.5)
New or worsened muscle pain: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened joint pain: Any
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened joint pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened joint pain: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG0010± 0.0(0.0 to 21.8)
OG0020± 0.0(0.0 to 28.5)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00017
OG00123
OG00221
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00017.6(3.8 to 43.4)
OG0010(0.0 to 14.8)
OG00219.0(5.4 to 41.9)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0010(0.0 to 14.8)
OG00214.3(3.0 to 36.3)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0024.8(0.1 to 23.8)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Fever: Unknown
Title
Measurements
OG0005.9(0.1 to 28.7)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Fatigue: Any
Title
Measurements
OG00047.1(23.0 to 72.2)
OG00134.8(16.4 to 57.3)
OG00252.4(29.8 to 74.3)
Fatigue: Mild
Title
Measurements
OG00035.3(14.2 to 61.7)
OG00113.0(2.8 to 33.6)
OG00223.8(8.2 to 47.2)
Fatigue: Moderate
Title
Measurements
OG00011.8(1.5 to 36.4)
OG00121.7(7.5 to 43.7)
OG00228.6(11.3 to 52.2)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Headache: Any
Title
Measurements
OG00035.3(14.2 to 61.7)
OG0018.7(1.1 to 28.0)
OG00228.6(11.3 to 52.2)
Headache: Mild
Title
Measurements
OG00029.4(10.3 to 56.0)
OG0014.3(0.1 to 21.9)
OG0029.5(1.2 to 30.4)
Headache: Moderate
Title
Measurements
OG0005.9(0.1 to 28.7)
OG0010(0.0 to 14.8)
OG00219.0(5.4 to 41.9)
Headache: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0014.3(0.1 to 21.9)
OG0020(0.0 to 16.1)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Chills: Any
Title
Measurements
OG00017.6(3.8 to 43.4)
OG0014.3(0.1 to 21.9)
OG00214.3(3.0 to 36.3)
Chills: Mild
Title
Measurements
OG0005.9(0.1 to 28.7)
OG0014.3(0.1 to 21.9)
OG0024.8(0.1 to 23.8)
Chills: Moderate
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0010(0.0 to 14.8)
OG0029.5(3.0 to 36.3)
Chills: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Vomiting: Any
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0024.8(0.1 to 23.8)
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0024.8(0.1 to 23.8)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Diarrhea: Any
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0010(0.0 to 14.8)
OG0024.8(0.1 to 23.8)
Diarrhea: Mild
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0010(0.0 to 14.8)
OG0024.8(0.1 to 23.8)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
New or worsened muscle pain: Any
Title
Measurements
OG00029.4(10.3 to 56.0)
OG00113.0(2.8 to 33.6)
OG0024.8(0.1 to 23.8)
New or worsened muscle pain: Mild
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00113.0(2.8 to 33.6)
OG0024.8(0.1 to 23.8)
New or worsened muscle pain: Moderate
Title
Measurements
OG00023.5(6.8 to 49.9)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
New or worsened joint pain: Any
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0014.3(2.8 to 33.6)
OG0024.8(0.1 to 23.8)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 19.5)
OG0014.3(2.8 to 33.6)
OG0024.8(0.1 to 23.8)
New or worsened joint pain: Moderate
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 19.5)
OG0010(0.0 to 14.8)
OG0020(0.0 to 16.1)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0026
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00042.9(9.9 to 81.6)
OG0010(0.0 to 97.5)
OG00233.3(4.3 to 77.7)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG00028.6(3.7 to 71.0)
OG0010(0.0 to 97.5)
OG00233.3(4.3 to 77.7)
Fever: >38.4°C to 38.9 deg C
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Fever: >38.9°C to 40.0 deg C
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Fatigue: Any
Title
Measurements
OG00085.7(42.1 to 99.6)
OG001100.0(2.5 to 100.0)
OG00250.0(11.8 to 88.2)
Fatigue: Mild
Title
Measurements
OG00014.3(0.4 to 57.9)
OG001100.0(2.5 to 100.0)
OG00250.0(11.8 to 88.2)
Fatigue: Moderate
Title
Measurements
OG00071.4(29.0 to 96.3)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Headache: Any
Title
Measurements
OG00085.7(42.1 to 99.6)
OG001100.0(2.5 to 100.0)
OG00266.7(22.3 to 95.7)
Headache: Mild
Title
Measurements
OG00028.6(3.7 to 71.0)
OG001100.0(2.5 to 100.0)
OG00233.3(4.3 to 77.7)
Headache: Moderate
Title
Measurements
OG00057.1(18.4 to 90.1)
OG0010(0.0 to 97.5)
OG00233.3(4.3 to 77.7)
Headache: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Chills: Any
Title
Measurements
OG00071.4(29.0 to 96.3)
OG001100.0(2.5 to 100.0)
OG00216.7(0.4 to 64.1)
Chills: Mild
Title
Measurements
OG00014.3(0.4 to 57.9)
OG001100.0(2.5 to 100.0)
OG00216.7(0.4 to 64.1)
Chills: Moderate
Title
Measurements
OG00057.1(18.4 to 90.1)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Chills: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Vomiting: Any
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Diarrhea: Any
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG00233.3(4.3 to 77.7)
Diarrhea: Mild
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG00233.3(4.3 to 77.7)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened muscle pain: Any
Title
Measurements
OG00028.6(3.7 to 71.0)
OG0010(0.0 to 97.5)
OG00216.7(0.4 to 64.1)
New or worsened muscle pain: Mild
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG00216.7(0.4 to 64.1)
New or worsened muscle pain: Moderate
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened joint pain: Any
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened joint pain: Moderate
Title
Measurements
OG00014.3(0.4 to 57.9)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 41.0)
OG0010(0.0 to 97.5)
OG0020(0.0 to 45.9)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0004
OG0010
OG0021
Title
Denominators
Categories
Fever:Any
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Fatigue: Any
Title
Measurements
OG00075.0(19.4 to 99.4)
OG0020(0.0 to 97.5)
Fatigue: Mild
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
Fatigue: Moderate
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0020(0.0 to 97.5)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Headache: Any
Title
Measurements
OG00075.0(19.4 to 99.4)
OG0020(0.0 to 97.5)
Headache: Mild
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0020(0.0 to 97.5)
Headache: Moderate
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
Headache: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Chills: Any
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
Chills: Mild
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0020(0.0 to 97.5)
Chills: Moderate
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0020(0.0 to 97.5)
Chills: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Vomiting: Any
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Diarrhea: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0020(0.0 to 97.5)
Diarrhea: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Diarrhea: Moderate
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0020(0.0 to 97.5)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Any
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Moderate
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
New or worsened joint pain: Any
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
New or worsened joint pain: Moderate
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0020(0.0 to 97.5)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0020(0.0 to 97.5)
OG001
>=2 to <5 Years With Solid Organ Transplant
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0016
OG0026
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00028.6± 3.7(3.7 to 71.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fatigue: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG00216.7± 0.4(0.4 to 64.1)
Fatigue: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG00216.7± 0.4(0.4 to 64.1)
Fatigue: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Headache: Any
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Headache: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Headache: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Chills: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Chills: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Chills: Moderate
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Any
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Any
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Mild
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Any
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Any
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 45.9)
OG0020± 0.0(0.0 to 45.9)
OG001
>=5 to <12 Years With Solid Organ Transplant
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00012
OG00119
OG00215
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0026.7± 0.2(0.2 to 31.9)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0026.7± 0.2(0.2 to 31.9)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Fatigue: Any
Title
Measurements
OG00050.0± 21.1(21.1 to 78.9)
OG00126.3± 9.1(9.1 to 51.2)
OG00233.3± 11.8(11.8 to 61.6)
Fatigue: Mild
Title
Measurements
OG00033.3± 9.9(9.9 to 65.1)
OG00110.5± 1.3(1.3 to 33.1)
OG00213.3± 1.7(1.7 to 40.5)
Fatigue: Moderate
Title
Measurements
OG00016.7± 2.1(2.1 to 48.4)
OG00115.8± 3.4(3.4 to 39.6)
OG00220.0± 4.3(4.3 to 48.1)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Headache: Any
Title
Measurements
OG00033.3± 9.9(9.9 to 65.1)
OG00121.1± 6.1(6.1 to 45.6)
OG00213.3± 1.7(1.7 to 40.5)
Headache: Mild
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG00115.8± 3.4(3.4 to 39.6)
OG0020± 0.0(0.0 to 21.8)
Headache: Moderate
Title
Measurements
OG00025.0± 5.5(5.5 to 57.2)
OG0015.3± 0.1(0.1 to 26.0)
OG0026.7± 0.2(0.2 to 31.9)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0026.7± 0.2(0.2 to 31.9)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Chills: Any
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG00213.3± 1.7(1.7 to 40.5)
Chills: Mild
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0020± 0.0(0.0 to 21.8)
Chills: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG00213.3± 1.7(1.7 to 40.5)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Vomiting: Any
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0020± 0.0(0.0 to 21.8)
Vomiting: Mild
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0020± 0.0(0.0 to 21.8)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Diarrhea: Any
Title
Measurements
OG00025.0± 5.5(5.5 to 57.2)
OG00115.8± 3.4(3.4 to 39.6)
OG0026.7± 0.2(0.2 to 31.9)
Diarrhea: Mild
Title
Measurements
OG00025.0± 5.5(5.5 to 57.2)
OG00110.5± 1.3(1.3 to 33.1)
OG0026.7± 0.2(0.2 to 31.9)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0015.3± 0.1(0.1 to 26.0)
OG0020± 0.0(0.0 to 21.8)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
New or worsened muscle pain: Any
Title
Measurements
OG00016.7± 2.1(2.1 to 48.4)
OG00115.8± 3.4(3.4 to 39.6)
OG0026.7± 0.2(0.2 to 31.9)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG00115.8± 3.4(3.4 to 39.6)
OG0020± 0.0(0.0 to 21.8)
New or worsened muscle pain: Moderate
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0010± 0.0(0.0 to 17.6)
OG0026.7± 0.2(0.2 to 31.9)
New or worsened muscle pain: Severe
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
New or worsened joint pain: Any
Title
Measurements
OG00025.0± 5.5(5.5 to 57.2)
OG0010± 0.0(0.0 to 17.6)
OG0026.7± 0.2(0.2 to 31.9)
New or worsened joint pain: Mild
Title
Measurements
OG0008.3± 0.2(0.2 to 38.5)
OG0010± 0.0(0.0 to 17.6)
OG0026.7± 0.2(0.2 to 31.9)
New or worsened joint pain: Moderate
Title
Measurements
OG00016.7± 2.1(2.1 to 48.4)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG0010± 0.0(0.0 to 17.6)
OG0020± 0.0(0.0 to 21.8)
OG001
>=12 to <18 Years With Solid Organ Transplant
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0004
OG0011
OG0023
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Fever: >40.0 deg C
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Fatigue: Any
Title
Measurements
OG00050.0(6.8 to 93.2)
OG001100.0(2.5 to 100.0)
OG00266.7(9.4 to 99.2)
Fatigue: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Fatigue: Moderate
Title
Measurements
OG00050.0(6.8 to 93.2)
OG001100.0(2.5 to 100.0)
OG00233.3(0.8 to 90.6)
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Headache: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Headache: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Headache: Moderate
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Headache: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Chills: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Chills: Mild
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Chills: Moderate
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Chills: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Vomiting: Any
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Diarrhea: Any
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Diarrhea: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened muscle pain: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
New or worsened muscle pain: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened muscle pain: Moderate
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010(0.0 to 97.5)
OG00233.3(0.8 to 90.6)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 97.5)
New or worsened joint pain: Any
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened joint pain: Mild
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened joint pain: Moderate
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 97.5)
OG0020(0.0 to 70.8)
OG001
>=18 Years With Non-Small Cell Lung Cancer
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0003
OG0011
OG0020
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Fever: >=38.0 to 38.4 deg C
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Fever: >38.4 to 38.9 deg C
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Fever: >38.9 to 40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Fever: >40.0 deg C
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Fatigue: Any
Title
Measurements
OG00066.7± 9.4(9.4 to 99.2)
OG0010± 0.0(0.0 to 97.5)
Fatigue: Mild
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Fatigue: Moderate
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Fatigue: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Fatigue: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Headache: Any
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Headache: Mild
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Headache: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Headache: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Headache: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Chills: Any
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Chills: Mild
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Chills: Moderate
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
Chills: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Chills: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Vomiting: Any
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Vomiting: Mild
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Vomiting: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Vomiting: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Vomiting: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Diarrhea: Any
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Diarrhea: Mild
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Diarrhea: Moderate
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Diarrhea: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
Diarrhea: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
New or worsened muscle pain: Any
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
New or worsened muscle pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
New or worsened muscle pain: Moderate
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
New or worsened muscle pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
New or worsened joint pain: Any
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
New or worsened joint pain: Mild
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
New or worsened joint pain: Moderate
Title
Measurements
OG00033.3± 0.8(0.8 to 90.6)
OG0010± 0.0(0.0 to 97.5)
New or worsened joint pain: Severe
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG0010± 0.0(0.0 to 97.5)
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00213
Title
Denominators
Categories
Title
Measurements
OG00044.4± 13.7(13.7 to 78.8)
OG00133.3± 11.8(11.8 to 61.6)
OG00238.5± 13.9(13.9 to 68.4)
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00019
OG00124
OG00222
Title
Denominators
Categories
Title
Measurements
OG00036.8(16.3 to 61.6)
OG0018.3(1.0 to 27.0)
OG00227.3(10.7 to 50.2)
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0027
Title
Denominators
Categories
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00214.3± 0.4(0.4 to 57.9)
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0011
OG0021
Title
Denominators
Categories
Title
Measurements
OG00020.0± 0.5(0.5 to 71.6)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00211
Title
Denominators
Categories
Title
Measurements
OG00033.3± 7.5(7.5 to 70.1)
OG00140.0± 16.3(16.3 to 67.7)
OG0020± 0.0(0.0 to 28.5)
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00017
OG00123
OG00222
Title
Denominators
Categories
Title
Measurements
OG00029.4± 10.3(10.3 to 56.0)
OG0018.7± 1.1(1.1 to 28.0)
OG0024.5± 0.1(0.1 to 22.8)
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0026
Title
Denominators
Categories
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG0010± 0.0(0.0 to 97.5)
OG00216.7± 0.4(0.4 to 64.1)
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0005
OG0011
OG0021
Title
Denominators
Categories
Title
Measurements
OG0000± 0.0(0.0 to 52.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 97.5)
Participants aged >=2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG00014.3± 0.4(0.4 to 57.9)
OG00116.7± 0.4(0.4 to 64.1)
OG0020± 0.0(0.0 to 45.9)
Participants aged >=5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00012
OG00119
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000± 0.0(0.0 to 26.5)
OG00136.8± 16.3(16.3 to 61.6)
OG0020± 0.0(0.0 to 21.8)
Participants aged >=12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0004
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG0000± 0.0(0.0 to 60.2)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 70.8)
Participants with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0003
OG0011
OG0020
Title
Denominators
Categories
Title
Measurements
OG0000± 0.0(0.0 to 70.8)
OG001100.0± 2.5(2.5 to 100.0)
OG002
>=2 to <5 Years With Stem Cell Transplant
Participants aged >=2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0009
OG00115
OG00213
Title
Denominators
Categories
Title
Measurements
OG0000± 0.0(0.0 to 33.6)
OG00153.3± 26.6(26.6 to 78.7)
OG00223.1± 5.0(5.0 to 53.8)
OG002
>=5 to <12 Years With Stem Cell Transplant
Participants aged >=5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG00019
OG00124
OG00222
Title
Denominators
Categories
Title
Measurements
OG00015.8± 3.4(3.4 to 39.6)
OG00120.8± 7.1(7.1 to 42.2)
OG00213.6± 2.9(2.9 to 34.9)
OG002
>=12 to <18 Years With Stem Cell Transplant
Participants aged >=12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.
Units
Counts
Participants
OG0007
OG0011
OG0027
Title
Denominators
Categories
Title
Measurements
OG0000± 0.0(0.0 to 41.0)
OG0010± 0.0(0.0 to 97.5)
OG0020± 0.0(0.0 to 41.0)
OG002
>= 18 Years With Haemodialysis
Participants undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was planned to be administered 3 to 6 months after Dose 3.