FDA Roundup: June 7, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses. This action is based on the totality of the evidence and input from Wednesday’s Vaccines and Related Biological Products Advisory Committee, which unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations ...