Despite Safety Concerns, FDA Approves Moderna’s mRNA Flu Shot
On Aug. 5, 2026, the U.S. Food and Drug Administration (FDA) approved Moderna’s seasonal flu shot, mFLUSIVA (mRNA-1010), making it the first messenger RNA platform for seasonal influenza in the United States. The decision permits health care providers to use mRNA technology for annual influenza vaccination in eligible age groups.1 FDA regulators approved mFLUSIVA to […]
FDA Panel Backs mFlusiva mRNA Flu Shot for Elderly
Despite a number of significant limitations in the available safety and efficacy data for licensure review of Moderna, Inc.’s new mRNA influenza biologic mFlusiva, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee ((VRBPAC) voted on June 18, 2026 to recommend fast-tracked licensure of the first mRNA product to target […]
FDA Set to Review Moderna’s mFlusiva mRNA Flu Shot
An mRNA (messenger ribonucleic acid) influenza biologic developed by Moderna, Inc. is scheduled to be reviewed today by a U.S. Food and Drug Administration (FDA) advisory panel. The Vaccines and Related Biological Products Advisory Committee ((VRBPAC) will evaluate data on Moderna’s mFlusiva (formerly known as mRNA-1010) to determine if the product provides superior relative vaccine […]