What is the FDA staff's key conclusion about Moderna's mFlusiva flu vaccine for adults 65 and older?

FDA staff stated that immunogenicity data showing a strong immune response to Moderna's mFlusiva may support its effectiveness in adults 65 years and older, though the application relies on comparison to a standard-dose flu vaccine—not the CDC-preferred high-dose vaccine—and is based on limited one-season data, with noted higher short-term side effects and a requirement for postmarket studies.

What are the regulatory pathways Moderna is seeking for mFlusiva in different age groups, and what recent FDA action preceded the current review?

Moderna is seeking traditional approval of mFlusiva for adults 50 to 64 years old and accelerated approval for adults 65 and older; this follows the FDA’s February rejection of Moderna’s initial application—citing patient risk from using a standard-dose (rather than high-dose) comparator in the 65+ trial—which led to an amended application accepted after Moderna agreed to conduct a post-approval study in adults 65 and older.

Moderna Flu Shot Data May Support Use in Older Adults, US FDA Staff Says

Jun 16, 2026

US FDA staff indicated Moderna's mFlusiva flu shot data supports effectiveness in adults 65+. An advisory committee votes June 18 on approval for ages 50+, potentially making it the first mRNA seasonal flu vaccine in the U.S.

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Moderna Flu Shot Data May Support Use in Older Adults, US FDA Staff Says

Moderna Flu Shot Data May Support Use in Older Adults, US FDA Staff Says

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