The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.
Moderna’s flu vaccine will face an FDA advisory committee this week as the mRNA company continues to walk a tumultuous path toward approval. But the initial documents are out, and the regulator and biotech appear to have reached alignment.
In February, the FDA shocked the biopharma world by issuing a refusal to file letter to Moderna for the seasonal mRNA flu shot mRNA-1010, now known as mFLUSIVA. At the time, then–Center for Biologics Evaluation and Research (CBER) director Vinay Prasad intervened in the application and said the company failed to support the case for approval with an adequate and well-controlled trial. In particular, the FDA took issue with the fact that Moderna initially did not use a high-dose vaccine as a comparator for the older populations, which is standard of care.
Days later, the FDA reversed course and allowed the application to proceed, setting a decision date for August. The approval request was narrowed to focus on specific age groups. The agency later set a meeting of the Vaccines and Related Biological Products Advisory Committee for June 18 to discuss the shot.
The documents for that meeting are now available, and Jefferies told investors that the regulator appears to have softened its stance toward Moderna’s application.
Moderna is seeking full approval for the shot’s use in adults ages 50–64 and an accelerated approval for adults 65 and older. For the latter indication, Moderna will have to conduct a post-marketing study to secure a full approval at a later date.
The FDA seems to have determined that the immunogenicity data submitted support the efficacy of mRNA-1010 in people over 65, according to Jefferies. The regulator noted no major safety issues or imbalances in adverse events or deaths between groups that received treatment versus placebo. The shot also showed superior relative vaccine efficacy as compared to the standard dose vaccine comparator in patients 50 to 64 years old.
To sum up, the FDA said no major efficacy deficiencies were identified, with the studies showing that mRNA-1010 “met all prespecified sequential success criteria,” according to the FDA document.
But the FDA flagged for the adcomm to review a few uncertainties, including evidence gaps as the data available are only from one flu season. Efficacy has also not yet been established in immunocompromised individuals and very frail older adults, the agency added.
On safety, the FDA flagged the relatively short dataset—just six months of follow-up—which may not reveal any rare adverse events like myocarditis or neurologic events that have been tied to Moderna’s original mRNA-based COVID-19 vaccine Spikevax. In terms of other adverse events, including anemia and urinary tract infections, people who took Moderna’s shot showed a higher rate than controls.
To address these concerns, Moderna recommended the bifurcated approach to the approval—with a promised confirmatory study to verify benefit in the older population.
The adcomm will vote on two questions: whether the benefits of mFlusiva outweigh its risks for the prevention of influenza disease in the two different age groups: adults 50 through 64 years and adults 65 and older.
FDA advisory committee recommendations are non-binding, but the agency typically follows the advice of these outside experts. Under the Trump administration, fewer adcomms have been held, but since a recent leadership shakeup that saw Commissioner Marty Makary depart, more have been scheduled.
Moderna preps for launch
The stakes are high for Moderna, which has an ambitious plan to market more than seven products by 2027–2028 across respiratory, oncology and rare disease. The company, which has repeatedly reported negative earnings, is looking to improve revenue by 10% year-over-year for $1.9 billion in 2026, Jefferies said.
The FDA’s refusal-to-file letter threatened to blow open Moderna’s plans to breakeven by 2028, with mRNA-1010 representing a potential $1 billion revenue opportunity.
But the company seems to be more upbeat, revealing on Tuesday a shake-up in the C-suite. President Stephen Hoge’s role was expanded to include oversight of leadership across R&D, manufacturing and commercial operations. Moderna has also hired Ester Banque as chief commercial officer, as the company prepares for three product launches next year and in 2028.
The CCO role has been filled by CEO Stephan Bancel since the 2023 departure of Arpa Garay.
