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Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA announced that on May 16, 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to publicly discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.
The FDA anticipates that changes to the vaccine composition may need to be made based on the currently circulating strains of the virus that causes COVID-19. As the agency has previously stated, barring any new major changes to circulating virus, the FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
Following any potential recommendations to update the 2024-2025 formula, the FDA anticipates that, subject to appropriate regulatory actions, manufacturers will be able to make updated COVID-19 vaccines available in advance of the fall/winter respiratory virus season.
- On Monday, the FDA announced the upcoming Medical Device Sterilization Town Hall: FDA Modifications (Mods) Guidances and the Use of Device Master Files in Reviews that will be held on Thursday, February 29, from 1-2 p.m. ET.
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