FDA Advisory Meeting on Moderna's MFLUSIVA mRNA Influenza Vaccine
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The FDA is opening a public comment docket and holding a public advisory committee meeting on the safety and effectiveness of Moderna's MFLUSIVA, an mRNA influenza vaccine. The meeting is scheduled for June 18, 2026, and will be held online with public access through a video conference link. Pharmaceutical companies, healthcare professionals, researchers, patient groups, and members of the public can submit comments under docket FDA-2026-N-4162. Comments are due by June 17, 2026, but submissions received by June 12 will be shared with the advisory committee before the meeting.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- FDA will hold a public advisory committee meeting on Moderna's MFLUSIVA mRNA influenza vaccine.
- A public comment docket has been opened under FDA-2026-N-4162.
- Comments are due by June 17, 2026, with June 12 as the cutoff for comments shared with the committee before the meeting.
Obligations
What this law requires
Submit electronic comments on docket FDA-2026-N-4162 through Regulations.gov by 11:59 p.m. Eastern Time on June 17, 2026; late comments will not be considered.
Submit written or paper comments on docket FDA-2026-N-4162 by mail, hand delivery, or courier so that FDA receives them on or before June 17, 2026.
Submit comments on or before June 12, 2026, if the commenter wants the comments provided to the Vaccines and Related Biological Products Advisory Committee before the June 18, 2026 meeting.