FDA gives modest backing to Moderna’s flu vaccine, noting efficacy questions but no major concerns

The FDA released briefing documents ahead of an advisory committee meeting on Moderna’s seasonal influenza vaccine.

The agency’s assessment was described as tepid, highlighting some questions about the vaccine’s efficacy, but it did not identify any serious safety or manufacturing issues.

Because no major red flags were raised, the vaccine’s path to potential approval appears unobstructed, though the efficacy concerns may be discussed further at the upcoming meeting.