Protocol

A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States

October 19, 2021
Authors:

Harvard Pilgrim Health Care Institute, RTI Health Solutions, CVS Health, Carelon Research, HealthPartners Institute, Humana HealthCare Research, Optum Epidemiology, Pfizer, Inc.

Capability:
Pregnancy & Mother-Infant Linked Studies
Validation Studies & Algorithm Development
Multi-Site Methods & Coordination
Expertise:
Regulatory Research & Support
RWE Research & Consulting
View the public protocol

Pfizer Inc, Harvard Pilgrim Health Care Institute, RTI Health Solutions, CVS Health, Carelon Research, HealthPartners Institute, Humana HealthCare Research, Optum Epidemiology. A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States (EUPAS43468; Study ID 48132). Amsterdam: European Medicines Agency (EMA); 2021 Oct 19. Available from: https://catalogues.ema.europa.eu/node/3232/administrative-details