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On August 22, 2024, we reported on the FDA granting approval and emergency use authorization (EUA) for updated mRNA COVID-19 vaccines for this fall that include a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2.
The decision
The FDA awarded approval for Pfizer’s Comirnaty and Moderna’s Spikevax vaccines (2024-2025 formulations) for individuals 12 years and older and granted EUA for both vaccines for individuals 6 months through 11 years. The updated 2024-2025 vaccine formulation more closely targets currently circulating SARS-CoV-2 variants and provides better protection against the serious consequences related to COVID-19, including hospitalization and death. This update was based on a recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee, which voted unanimously to recommend that composition be included in 2024-2025 vaccines.
FDA comment
“Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
