FDA Panel Unanimously Backs Moderna's mRNA Flu Vaccine
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- VRBPAC voted unanimously that the benefits of Moderna's mRNA flu vaccine outweigh its risks for adults ages 50 to 64 and for those 65 and older
- The vaccine became controversial earlier this year when a top FDA official briefly refused to even consider accepting it for review
- FDA staff presentations during the meeting suggested the agency views the vaccine as eligible for traditional licensure in the 50-to-64 group and an accelerated pathway for those 65 and older
- Wellington Sun, a former FDA employee who later worked for Moderna but is no longer with the company, noted in public comment that multiple currently marketed flu vaccines were first licensed using an accelerated pathway
- The FDA's final decision on the vaccine remains pending following the advisory committee vote
Why it matters: VRBPAC's unanimous endorsement gives Moderna's mRNA flu vaccine a clear path forward after a top FDA official's earlier refusal to even review the application — a notable reversal. FDA staff's indication that the shot could use a traditional pathway for adults 50-64 and an accelerated pathway for seniors 65-plus gives Moderna a viable route to its first flu product, though the FDA's final ruling is still pending.
