FDA Approves First mRNA Flu Vaccine Year After Kennedy
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- HHS under Robert F. Kennedy Jr. killed 22 mRNA vaccine development projects worth roughly $500 million on Aug. 5, 2025, claiming the data showed the platform fails to protect against upper respiratory infections and posed more risks than benefits.
- FDA approved mFlusiva on Wednesday — the first mRNA seasonal influenza vaccine ever licensed in the U.S. — after its advisory committee voted unanimously that benefits outweigh risks in adults 50 to 64 and again for adults 65 and older.
- Moderna's Phase 3 trial of 40,805 adults across 11 countries, reported June 30, 2025 — five weeks before Kennedy's announcement — showed mFlusiva outperformed a standard-dose flu shot by 26.6%, including in patients over 65, directly contradicting the secretary's claim.
- FDA official Vinay Prasad personally refused to review mFlusiva on Feb. 3, objecting to Moderna's use of a standard-dose rather than high-dose comparator — a criterion not in the agency's own influenza guidance — before reversing 15 days later after public outcry.
- Individualized mRNA cancer vaccines cut recurrence/death risk by 49% at five years in high-risk melanoma when combined with pembrolizumab, while a Memorial Sloan Kettering team reported nearly 90% of pancreatic cancer patients who mounted immune responses were alive up to six years post-vaccine, versus ~13% five-year survival baseline.
- The author notes China and private capital are continuing to build on mRNA platforms, leaving the U.S. as 'the only country walking away from' a technology it invented under Operation Warp Speed.
- Congressional action: the author calls on lawmakers to restore the canceled contracts and require any decision to fund or defund an entire medical platform go through scientific review rather than a press release.
Why it matters: Kennedy justified $500 million in mRNA cuts by claiming the platform fails to protect against flu — yet the FDA this week unanimously approved mRNA flu shot mFlusiva after Phase 3 data showed 26.6% better protection than standard vaccines. The U.S. is now the only country walking away from a platform increasingly being built in China.
