TLDR
- Moderna stock jumped as much as 9.1% after FDA briefing documents showed no “major deficiencies” in its mFlusiva mRNA flu vaccine
- The FDA’s advisory committee (VRBPAC) is set to vote on June 18 on whether mFlusiva’s benefits outweigh its risks for adults 50 and older
- If approved, mFlusiva would be the first mRNA-based seasonal flu vaccine in the U.S., with a final FDA decision expected by August 5
- Moderna is seeking traditional approval for adults 50–64 and accelerated approval for adults 65 and older
- Moderna also announced a leadership restructure, naming Ester Banque as Chief Commercial Officer ahead of up to three new product launches in 2027–2028
Moderna (MRNA) stock climbed as much as 9.1% on Tuesday after FDA staff reviewers published briefing documents saying data on its mFlusiva flu vaccine may support effectiveness in adults 65 and older. The stock was trading near $56.12, close to its 52-week high of $57.80.
The documents were released ahead of a Thursday meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which will vote on whether the benefits of mFlusiva outweigh its risks for adults aged 50 and older.
Crucially, the FDA staff found no “major deficiencies” in the application. That was the green light investors had been waiting for.
The path here has been bumpy. In February, the FDA issued a “refuse-to-file” letter, citing concerns about the trial design, specifically that the control arm for adults 65 and older used a standard-dose flu vaccine rather than the higher-dose shot preferred by the CDC for that age group. The FDA reversed course days later after Moderna agreed to amend its application.
That back-and-forth rattled the market. Tuesday’s briefing documents marked a clear change in tone.
Jefferies analyst Andrew Tsai called the assessment favorable, projecting $750 million in combined U.S. flu and COVID-flu combo vaccine sales by 2030.
What the FDA Staff Actually Said
FDA reviewers noted that mFlusiva showed superior relative vaccine efficacy versus a standard-dose flu vaccine in adults aged 50 to 64. For the 65 and older group, the application leans on immunogenicity data rather than direct efficacy data against a high-dose comparator.
Staff flagged some limitations. The vaccine has only been studied during one flu season, and immunocompromised people and very frail older adults were excluded from the trials, leaving questions about effectiveness in those groups.
Moderna has agreed to run an additional study and submit more data for the 65-plus age group if it receives accelerated approval for that cohort.
The company is seeking traditional approval for adults 50 to 64 and accelerated approval for adults 65 and older. A final FDA decision is expected by August 5.
If approved, mFlusiva would be the first mRNA-based seasonal flu vaccine in the United States.
Moderna Reshuffles Leadership Ahead of Pipeline Push
On the same day, Moderna announced an internal reorganization. The company appointed Ester Banque as Chief Commercial Officer, a move aimed at preparing the business for up to three product launches — including a flu/COVID combination vaccine and a norovirus vaccine — targeted for 2027 and 2028.
The combination of a cleaner regulatory picture and a concrete commercial roadmap gave investors enough reason to push the stock higher.
Moderna is up 81.8% year-to-date. Despite that run, investors who put $1,000 into MRNA five years ago would be sitting on just $283.65 today.
The VRBPAC vote is scheduled for June 18.
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