NEJM November 19, 2025
David Fitz-Patrick, M.D., Donald S. McVinnie, M.D., Lisa A. Jackson, M.D., M.P.H. https://orcid.org/0000-0002-1785-0218, Graham Crowther, Ph.D., Anita Geevarughese, M.D., M.P.H., Kevin D. Cannon, M.D., Lazaro M. Garcia, M.D., Yanely Pineiro Puebla, M.D., Zhuobiao Yi, Ph.D., Luke Cunliffe, B.Sc., Alok Maniar, M.D., M.P.H., Agnieszka M. Zareba, M.D., Ph.D., Claudia Ana Ianos, M.D., Emily Gomme, Ph.D., Kenneth Koury, Ph.D., Pirada Suphaphiphat Allen, Ph.D., Annaliesa S. Anderson, Ph.D., Alejandra Gurtman, M.D., and Kelly Lindert, M.D., for the Pfizer C4781004 Trial Investigators

Abstract

Background

Influenza remains a major health burden despite the use of licensed vaccines. Nucleoside-modified messenger RNA (modRNA) influenza vaccines have shown promising immunogenicity against influenza and an acceptable safety profile in a phase 1–2 trial.

Methods

In this phase 3 trial, we randomly assigned healthy adults between the ages of 18 and 64 years to receive either a quadrivalent modRNA influenza vaccine (modRNA group) or a licensed inactivated quadrivalent influenza vaccine (control group) during the 2022–2023 influenza season in the United States, South Africa, and the Philippines. The primary end point was relative efficacy, defined by the reduction in the percentage of participants with laboratory-confirmed influenza associated with influenza-like illness at least...

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Topics: Biotechnology, Healthcare System, Pharma / Biotech, Public Health / COVID
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