The FDA’s Vaccines and Related Biological Products Advisory Committee voted 9-0 Thursday to back mFluvisa, Moderna’s mRNA-based flu vaccine, for adults aged 50 and older — two separate unanimous votes: full approval for the 50-to-64 cohort, accelerated approval for adults 65 and up. A PDUFA decision is due Aug. 5.
Moderna has pegged mFluvisa at a $1 billion revenue opportunity against a $2.8 billion net loss in 2025. Flu revenue is part of the company’s growth targets starting in 2027; the 2028 breakeven plan depends on it landing.
In February, the FDA issued a refusal-to-file letter, dated February 3, at the direction of then-CBER director Vinay Prasad, who argued Moderna’s pivotal study used a comparator that didn’t reflect “best-available standard of care.” The FDA reversed course within days. Prasad departed in April; Commissioner Marty Makary followed.
What the briefing document showed me this week: the FDA’s own reviewers found the submission “met all prespecified sequential success criteria.” That’s the old Prasad position vs. the current career staff position, and the adcomm sided unanimously with career staff. The agency follows those recommendations roughly 84% of the time. Clinical professor Hayley Gans of Stanford Medicine Children’s Health said the platform’s broader potential factored into her vote.
Moderna’s shares rose 28% to $63.96 from the briefing document’s release through Thursday’s close. Worth marking Aug. 5 if you’re tracking Moderna’s 2028 revenue math.
Rebecca Lauren