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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48132
• EU PAS number:
  EUPAS43468
• Study ID:
  48132
• Official title and acronym:
  A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will use a retrospective cohort design of individuals with concurrent unexposed comparators. The study will compare the incidence of safety events among individuals who have received a first, second, or third dose in a primary series of Pfizer-BioNTech COVID-19 Vaccine with that among individuals who have no record of any COVID-19 vaccine in a concurrent time period. Additionally, in individuals aged 5 years and older who have received 2 doses in a primary series of Pfizer-BioNTech COVID-19 Vaccine, the incidence of safety events among individuals who have received a third dose (either as an additional dose in a primary series or as an initial booster dose) of the vaccine more than 2 months after the second dose will be compared with that among individuals who have not received a third dose of any COVID-19 vaccine. Finally, the study will compare the prevalence of birth outcomes (including major congenital malformations and small size for gestational age) in infants born to pregnant women who have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine during an exposure window of interest with that among infants born to pregnant women who have not received any COVID-19 vaccine during the exposure window of interest. The source population for this study will be health plan enrollees from 5 data research partners that contribute data from claims and electronic health records to the Sentinel System: CVS Health/Aetna, HealthCore/Anthem, HealthPartners, Humana, and Optum. Safety events of interest will be identified in claims and electronic health records (where available) using predefined algorithms based on diagnosis codes, with procedure and/or pharmacy dispensing codes as appropriate.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Harvard Pilgrim Health Care Institute

Study timelines

Date when funding contract was signed

Planned: 05/11/2020

Actual: 05/11/2020

Study start date

Planned: 30/06/2022

Actual: 17/06/2022

Date of final study report

Planned: 31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591009_PROTOCOL_19AUG2021 (1)

Updated protocol

C4591009_PROTOCOL AMENDMENT 3_V4_30JUN2023

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)