FDA to convene panel next month on Moderna flu vaccine review
FDA will send Moderna’s mRNA flu shot to advisers on June 18, a key test after a rare filing rejection and a trial that cut flu illness to 2.0%.
An outside FDA panel will weigh Moderna’s experimental flu vaccine on June 18, a pivotal review that could decide whether the company can turn its COVID-era mRNA platform into a second commercial franchise. The Vaccines and Related Biological Products Advisory Committee is set to meet from 8:30 a.m. to 4:00 p.m. Eastern Time, and its vote will help shape a final agency decision due by August 5.
The review comes after an unusual regulatory detour. The FDA initially rejected Moderna’s application, issuing a rare refusal-to-file letter that centered on the choice of flu shot used in the comparison group for adults 65 and older. After talks with the company, the agency accepted an amended application and allowed Moderna to proceed with a plan for an additional study in older adults after approval. In the revised filing, Moderna is seeking full approval for adults ages 50 to 64 and accelerated approval for adults 65 and older.
The stakes are high because no mRNA-based flu vaccine has been approved anywhere in the world. Moderna is trying to show that the technology that made it a major force during the coronavirus pandemic can also compete in one of the most crowded parts of the vaccine market, where effectiveness, safety and production scale all matter. A yes from regulators would not just validate the science. It would also give Moderna a product that could matter financially beyond COVID and potentially reach the market in time for the 2026-2027 flu season.
Moderna’s case rests on a late-stage trial of more than 40,000 adults ages 50 and older at 301 sites across 11 countries, including the United States. The study found the mRNA shot was about 27% more effective than standard flu vaccines, with illness in about 2.0% of the mRNA group versus 2.8% in the standard-shot group. Side effects such as fatigue, headache and arm pain were more common, but they were generally mild and short-lived.
The review also lands in a politically charged climate for mRNA science. Health Secretary Robert F. Kennedy Jr. has been a prominent critic of the technology, and under his leadership the Department of Health and Human Services has cut $500 million in mRNA contracts. Moderna’s shares rose 6% after the company said the FDA would consider the vaccine after resolving the filing dispute, a sign that investors still see a path to approval. For public health officials, the bigger question is whether the agency sees enough evidence to back a new flu option for older adults, or whether remaining doubts about the trial design will slow mRNA’s next act.
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