Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente Southern California

Summary

Participation Requirements

Description

The primary objective of this study is to determine the vaccine effectiveness (VE) of 2-doses of Pfizer's BNT162b2 vaccine against COVID-19-associated hospitalization. In addition, VE of 1 dose and at least one dose will be determined. Other outcomes in addition to hospitalization to be assessed inc...

The primary objective of this study is to determine the vaccine effectiveness (VE) of 2-doses of Pfizer's BNT162b2 vaccine against COVID-19-associated hospitalization. In addition, VE of 1 dose and at least one dose will be determined. Other outcomes in addition to hospitalization to be assessed include COVID-19-associated ED admissions, ICU admissions, outpatient visits and death. To assess VE, we propose a large retrospective database study using two parallel study designs: a test-negative case-control design and a retrospective cohort design. The test-negative design (TND) will assess VE against COVID-19 hospitalization (primary endpoint) and emergency department (ED) admission. The retrospective cohort analysis will assess VE against COVID-19 hospitalization (primary), ICU admission, death, ED admission, and outpatient disease (with no subsequent hospitalization within 14 days). We will further conduct exploratory analyses of VE estimates by strain type.

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