US FDA to Review COVID-19 Vaccine Formulas on May 16, 2024

The US Food and Drug Administration (FDA) announced in a post on X that on May 16, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public discussion to recommend the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.

On February 26, 2024, the FDA confirmed that changes to the vaccine composition may be necessary based on the currently circulating strains of the virus that causes COVID-19.

After receiving any recommendations from the VRBPAC regarding the 2024-2025 formula update, the FDA plans to take appropriate regulatory actions on updated COVID-19 vaccines so that manufacturers can make them available by September 2024.

The FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for seasonal influenza vaccines.

Background material and the link to the online teleconference and/or video conference meeting will be available on the Advisory Committee calendar no later than two business days before the VRBPAC meeting.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time. 

Contact Information: Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, FDA, 202-657-8533 or [email protected].