Moderna Shares Surge After FDA Gives Green Light to Flu Vaccine Review

Moderna (NASDAQ: MRNA) shares jumped more than 11% on Tuesday, hitting a new 52-week high of $62.30, after the US Food and Drug Administration (FDA) published broadly favourable briefing documents for the company’s mRNA-based influenza vaccine candidate, mFlusiva (mRNA-1010).

The documents, released ahead of a critical FDA advisory committee meeting scheduled for Wednesday, found no major deficiencies in Moderna’s regulatory filing — a far more constructive outcome than investors had anticipated, and enough to spark one of the stock’s biggest single-day moves of the year.

The relief rally was amplified by a turbulent regulatory backstory. In February, the FDA stunned markets by issuing a rare “refuse-to-file” letter, citing concerns over Moderna’s trial design in older adults. The agency subsequently reversed course, and Moderna revised its strategy to seek traditional approval for adults aged 50–64 and accelerated approval for those aged 65 and over, based on immunogenicity data.

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Wednesday’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel vote is now seen as a key stepping stone toward the FDA’s official target action date of August 5, 2026.

The stakes extend beyond mFlusiva itself. A successful approval could smooth the path for mCombriax, Moderna’s combination flu and COVID vaccine already approved in the EU, and bolster the company’s broader ambition to diversify its revenue well beyond its COVID-19 franchise.

Moderna shares are now up approximately 88% year-to-date.