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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS41392 | Other Identifier | EU PAS Register Number |
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The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a: Pre-COVID | All participants meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019 | ||
| Cohort 1b: Pre-COVID | All participants with evidence of an influenza vaccination and meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019 | ||
| Cohort 2: Active-COVID | All participants meeting eligibility criteria in the Active-COVID-19 period, Pre-Emergency Use Authorization (EUA) period (following the emergence of COVID-19 but before the first COVID-19 vaccine EUA) (Time Period 2) from 01 December 2019 to 10 December 2020 (1 day prior to first United States SARS-CoV-2 vaccine EUA) | ||
| Cohort 3: Post-EUA | All mRNA-1273 vaccinated participants meeting eligibility criteria in the Post-EUA period (Time Period 3) from date of first United States SARS-CoV-2 vaccine EUA to 31 December 2022 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Special Interests (AESIs) | Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database) |
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Inclusion Criteria:
Exclusion Criteria:
None
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The study population will be selected from HealthVerity's aggregated medical and pharmacy claims database that represents healthcare utilization for over 140 million participants between 01 December 2017 and the end of the study period (31 December 2022).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aetion Inc. | New York | New York | 10001 | United States |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D007239 | Infections |
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| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |