FDA advisors unanimously vote to approve Moderna's mRNA flu vaccine after agency drama
Independent FDA advisors voted 9-0 in favor of approving Moderna's seasonal mRNA flu vaccine, following a controversial initial rejection by a Trump appointee. The vaccine, mRNA-1010 (mFlusiva), was shown in a Phase 3 trial to be 27% more effective than a standard flu shot.
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (9-0) on Friday to recommend approval of Moderna's seasonal mRNA flu vaccine.
Vaccine data
A Phase 3 trial involving over 40,000 adults aged 50 and older found the mRNA vaccine to be about 27% more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial with nearly 3,000 people aged 65 and older showed the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for that age group. The safety profile was generally good.
Agency drama
The outcome contrasts sharply with events in February, when Trump official Vinay Prasad refused to even review Moderna's submission. Prasad claimed the large trial was not “adequate and well-controlled” because it did not compare efficacy to a high-dose vaccine in people 65 and older. Moderna was blindsided, and the FDA reversed the decision a week later following public outcry. Prasad was pushed out of the FDA at the end of April after a series of controversial decisions.
Next steps
While the unanimous advisory vote is a positive sign, the FDA makes the final decision, with a deadline of August 5. Moderna aims to release the vaccine later this year. Another hurdle will be securing a recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP). However, ACIP is effectively defunct after a federal judge issued a temporary injunction blocking most of Health Secretary Robert F. Kennedy Jr.'s anti-vaccine appointees. The HHS is appealing the injunction on an expedited schedule.
