FDA Expects ‘Timely Availability’ of Covid Shots as Advisors Update Formula Recommendation
The FDA expects Covid-19 shots to be available in a timely manner after its advisory committee updated recommendations on the formula for the 2025-2026 season.5
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22, 2025, to discuss and recommend the updated strain composition for the next round of Covid-19 vaccines.34
The committee reviewed the latest data on circulating SARS-CoV-2 variants, vaccine effectiveness, and nonclinical immunogenicity studies to guide its recommendation.34
Recent FDA policy changes mean updated Covid-19 vaccines will primarily be recommended for adults aged 65 and older and those at high risk for severe disease, with new clinical trials required for healthy children and adults under 65.21
The updated vaccine composition continues to prioritize strains from the JN.1 lineage, with previous recommendations having focused on the KP.2 strain if feasible for the 2024-2025 formula.3
Sources:
1. https://www.cbsnews.com/news/covid-vaccine-2025-fda-seniors-clinical-trials/
2. https://www.cidrap.umn.edu/covid-19/fda-significantly-limits-covid-19-vaccine-recommendations
3. https://www.fda.gov/media/186567/download
4. https://www.fda.gov/media/186565/download
5. https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/