FDA to Hold Review Meeting for Moderna's Flu Vaccine
By Dean Seal
The Federal Drug Administration has called for a public meeting of independent scientific and public-health experts to review Moderna's experimental influenza vaccine, Mflusiva.
A notice released Thursday shows the agency is convening the Vaccines and Related Biological Products Advisory Committee on June 18 to examine the safety and effectiveness of the proposed vaccine.
Moderna has been waiting for the agency to approve its standalone flu shot later this August.
An initial application for Mflusiva was rejected in February at the behest of Vinay Prasad, the FDA's vaccines chief at the time, despite objections from the agency's career staff. After meeting with the company, the agency pivoted a week later and said it would review the shot.
The company has been looking for a way to reignite growth. Its stock has tumbled from pandemic-era highs amid falling demand for Spikevax, its Covid-19 vaccine.
Moderna's shot would be the first flu vaccine to be made with mRNA technology, which has been criticized by Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
May 21, 2026 14:16 ET (18:16 GMT)
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