Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine

Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine

This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.

. This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.

• The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval.
• There will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. All participants must be allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Brazilian Immunization National Plan.
• For safety analysis , the incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance until 42 days after two-doses immunization schedule.
• The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine.
• Active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the Immunization Program.

Inclusion Criteria:

• Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
• Informed consent form signed by participant.
• Show voluntary intention to participate in the study and availability throughout the study.

Exclusion Criteria:

• History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
• History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
• Be unavailable during the study period.
• Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.