Non-Interventional Postmarketing Safety Study of the COMIRNATY 2025-2026 Formula (LP.8.1) in the United States

Study identification

• EU PAS number:
  EUPAS1000000932
• Study ID:
  1000000932
• Official title and acronym:
  Non-Interventional Postmarketing Safety Study of the COMIRNATY 2025-2026 Formula (LP.8.1) in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study will be conducted in two phases, each with its own specific objectives.; Phase 1 will be designed to sequentially monitor the occurrence of pre-specified AESIs in near real-time following vaccination.; Primary objective: ; • To estimate the incidence of pre-specified AESIs in a risk window following vaccination with the COMIRNATY 2025-2026 Formula compared to the incidence of these events during a control window (ie, expected rates of these events).; Phase 2 will be designed to compare the incidence of pre-specified AESIs for up to 1 year among individuals who receive the COMIRNATY 2025-2026 Formula to individuals with no recorded coronavirus disease 2019 (COVID-19) vaccination.; Primary objective: ; • To estimate the incidence of pre-specified AESIs among individuals who receive the COMIRNATY 2025-2026 Formula compared to the incidence among individuals with no recorded COVID-19 vaccination.; Secondary objective: ; • To estimate the incidence of pre-specified AESIs among individuals who receive the COMIRNATY 2025-2026 Formula compared to the incidence among individuals with no recorded COVID-19 vaccination within subgroups of individuals with prior SARS-CoV-2 infection; individuals with prior COVID-19 vaccination; individuals with administration of non-COVID-19 vaccines; children 5 through 17 years of age; adults 65 years of age and older; and individuals 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, if sample size permits.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Optum - United States

Study timelines

Date when funding contract was signed

Planned:29/08/2025

Study start date

Planned:02/03/2026

Date of interim report, if expected

Planned:30/06/2026

Date of final study report

Planned:28/02/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable