Moderna flu shot outperforms marketed vaccines in large late-stage trial

BioPharma Dive June 30, 2025
Jonathan Gardner

The mRNA drug developer said it will begin discussing approval with an FDA that has adopted stricter vaccine review standards.

Dive Brief:

Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of influenza-like illness in people 50 years and older by 27% compared with those given a marketed shot targeting three or four strains of the virus, the company said Monday.
The COVID-19 vaccine pioneer said it will begin discussing an approval submission with the Food and Drug Adminstration, aiming to launch what would be the first messenger RNA-based influenza vaccine in the U.S. as early as the 2026-2027 flu season.
FDA submission of the flu vaccine data could also pave...

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