FDA Panel Unanimously Recommends Moderna’s First mRNA Flu Vaccine
4 verified8 unconfirmed1 contested
An independent advisory committee for the Food and Drug Administration voted unanimously to recommend approval of Moderna’s mRNA seasonal influenza vaccine for adults aged 50 and older. The vaccine, branded as mFlusiva, is the first flu shot to use the messenger-RNA technology previously employed in COVID-19 vaccines. The vote by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) came after an all-day review of clinical data, with all nine members supporting the vaccine. The recommendation marks the committee’s first vote on a new vaccine application after a multiyear pause. The FDA initially declined to review Moderna’s application but reversed that decision weeks later. No major safety issues were identified during the review, and the FDA’s own scientific staff presented data that was supportive of the vaccine. The development represents a step toward potentially making the vaccine available for the upcoming flu season.
What’s verified
The FDA's VRBPAC voted 9–0 to recommend Moderna's mRNA flu vaccine, mFlusiva, for adults 50 and older.
The vaccine is the first influenza vaccine to use mRNA technology, the same platform used in COVID-19 vaccines.
The FDA initially declined to review Moderna's application but later reversed that decision.
Clinical data reviewed showed no major safety concerns with the vaccine.
Where accounts differ
Sources disagree on the date of the VRBPAC vote. One report states the vote occurred on a Thursday, while another states it occurred on a Friday.
Not yet confirmed
The vote was the VRBPAC's first review of a new vaccine application since 2023, according to a single report.
The vote was the first for a new vaccine under the second Trump administration, according to a single report.
Health and Human Services Secretary Robert F. Kennedy Jr. had previously pulled back nearly $500 million in contracts for mRNA vaccine development, according to a single report.
The meeting lasted six and a half hours, according to a single report.
The vaccine was found to be about 27 percent more effective than a standard flu shot in a Phase 3 trial of over 40,000 adults, according to a single report.
A smaller Phase 3 trial of nearly 3,000 adults aged 65 and older showed stronger immune responses than a high-dose flu vaccine, according to a single report.
The vaccine is also designated as mRNA-1010, according to a single report.
The vaccine could be available for the next flu season, according to a single report.
Misconceptions
Sources address the misconception that mRNA vaccines cause cancer or integrate into human DNA, noting that these claims are not possible and have been disproven. Experts cited in the reports emphasize that over six billion doses of mRNA vaccines have been administered since 2020 with an "incredibly safe safety profile."
Key figures
Dr. Anna Durbin, VRBPAC member and director of the Center for Immunization Research at Johns Hopkins University
Dr. Paul Offit, former VRBPAC member and director of the Vaccine Education Center at the Children's Hospital of Philadelphia
Dr. Jesse Goodman, former director of the FDA's Center for Biologics Evaluation and Research
Dr. Flor Munoz-Rivas, VRBPAC voting member and pediatric infectious disease expert at Baylor College of Medicine
Sources: NPR, Ars Technica
