FDA Gears Up for Next COVID Vaccine Formula—Public Weighs In May
Published Date: 4/27/2026
Notice
Summary
The FDA is holding a public meeting on May 28, 2026, to decide the 2026-2027 COVID-19 vaccine formula. Anyone interested can watch online and share their thoughts by May 27, 2026. This affects vaccine makers, healthcare providers, and the public, helping ensure the vaccine stays effective and ready for the year ahead.
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
FDA to select 2026-2027 COVID-19 formula
On May 28, 2026, the FDA's Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss and make recommendations on the selection of the 2026-2027 COVID-19 vaccine formula for use in the United States. This decision process affects vaccine makers, healthcare providers, and the public by guiding which viral strains or composition will be recommended for vaccines for the year ahead.
Public docket open for comments
FDA established docket FDA-2026-N-3962 so anyone can submit comments about the 2026-2027 COVID-19 vaccine formula; the docket closes May 27, 2026, and comments submitted on or before May 21, 2026 will be provided to the Committee. Electronic comments via regulations.gov are accepted until 11:59 p.m. Eastern Time on May 27, 2026.
Meeting will be live-streamed; materials posted
The May 28, 2026 meeting will be held online and live-streamed (YouTube link provided), and FDA intends to post background materials no later than two business days before the meeting. If materials cannot be posted beforehand, they will be made available on FDA's website at the time of the advisory committee meeting.
Public oral presentations rules and deadlines
Oral presentations from the public will be scheduled approximately between 1:00 p.m. and 2:00 p.m. Eastern Time on May 28, 2026. Individuals who want to speak must notify the contact person and submit a brief statement and contact details and requested time by 12 p.m. Eastern Time on May 18, 2026; the contact person will notify speakers by 6 p.m. Eastern Time on May 20, 2026. If requests exceed available time, FDA may conduct a lottery to select speakers.
How to submit confidential comments
If you need to submit confidential information, FDA instructs you to send written/paper submissions with two copies: one copy labeled 'THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION' and one redacted copy for public viewing. Confidential submissions will be reviewed by FDA and the redacted copy posted publicly as described in the notice.
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