FDA advisory panel backs Moderna seasonal mRNA flu vaccine after earlier controversy

A Food and Drug Administration advisory committee unanimously endorsed Moderna’s seasonal mRNA flu vaccine on Thursday, after the product became the focus of controversy earlier this year when a senior agency official briefly refused to consider it for review.

The Vaccines and Related Biological Products Advisory Committee concluded that the vaccine’s benefits outweigh the risks for adults aged 50 to 64 and for those 65 and older.

The FDA has not yet issued a final decision, but staff presentations indicated the vaccine appears to have met the criteria for a traditional licensure pathway for the younger age group and an accelerated pathway for the older group.

The endorsement follows a pattern where many flu vaccines have been approved using accelerated pathways, highlighting the agency’s willingness to consider novel platforms for seasonal influenza protection.