FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

Key Points:

• The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (9–0) to support approval of Moderna’s seasonal mRNA flu vaccine, mRNA-1010 (mFlusiva), after reviewing strong efficacy and safety data from Phase 3 trials in adults 50 and older.
• The mRNA flu vaccine showed approximately 27% greater effectiveness than standard flu shots and elicited stronger immune responses than high-dose vaccines in adults 65 and older, with experts praising the agile mRNA platform for its potential in rapid vaccine development and pandemic preparedness.
• The unanimous vote contrasts with a prior decision by former Trump appointee Vinay Prasad, who initially blocked the vaccine’s review due to trial design concerns, a move later reversed after backlash; Prasad was subsequently removed from the FDA amid multiple controversial decisions.
• Moderna expressed satisfaction with the advisory committee’s recommendation and aims to release the vaccine later this year, pending FDA approval expected by August 5, followed by a recommendation process from the CDC’s Advisory Committee on Immunization Practices (ACIP).
• The ACIP’s functionality is currently hindered by a court injunction blocking the appointment of members installed by Health Secretary Robert F. Kennedy Jr., many of whom hold anti-vaccine views; the Department of Health and Human Services is appealing the injunction, with the legal process extending into July.