Post-Approval Observational Cohort Study to Evaluate the Safety of the COMIRNATY 2023-2024 Formula in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/108136
• EU PAS number:
  EUPAS108135
• Study ID:
  108136
• Official title and acronym:
  Post-Approval Observational Cohort Study to Evaluate the Safety of the COMIRNATY 2023-2024 Formula in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to answer the following research question: What is the incidence of pre-specified safety events of interest among individuals who receive the COMIRNATY 2023-2024 Formula in the United States? In Phase 1, the primary objective is to estimate the incidence of pre-specified safety events of interest following vaccination with the COMIRNATY 2023-2024 Formula compared to the incidence of these events during a control window (i.e. expected rates of these events). In Phase 2, the primary objective is to estimate the incidence of pre-specified safety events of interest among individuals who receive the COMIRNATY 2023-2024 Formula compared to individuals with no recorded vaccination with the COMIRNATY 2023-2024 Formula. The secondary objective is to estimate the incidence of pre-specified safety events of interest among individuals who receive the COMIRNATY 2023-2024 Formula compared to individuals with no recorded vaccination with the COMIRNATY 2023-2024 Formula among subgroups of individuals with concomitant administration of a non-COVID-19 vaccine, immunocompromised individuals, individuals with specific comorbidities, individuals with prior SARS-CoV-2 infection, individuals with prior COVID-19 vaccination, pregnant women, pediatric subjects, and the elderly, if sample size permits. This is a non-interventional observational study utilizing an administrative claims database in the US. Phase 1 will utilize a self-controlled risk interval (SCRI) design, and Phase 2 will utilize a matched comparative safety cohort design.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

OptumInsight Life Science, Inc.

Study timelines

Date when funding contract was signed

Planned: 09/11/2023

Actual: 09/11/2023

Study start date

Planned: 15/01/2024

Date of interim report, if expected

Planned: 30/06/2024

Date of final study report

Planned: 30/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591062_PROTOCOL AND STATISTICAL ANALYSIS PLAN_V1.0_12DEC2023

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable