The FDA Approved the First mRNA Flu Vaccine

The U.S. Food and Drug Administration approved mFLUSIVA, also called mRNA-1010, on August 5. Moderna makes the vaccine.

It is the first flu vaccine using messenger RNA, or mRNA, to receive FDA approval. It is indicated to prevent influenza A and B in adults age 50 and older.

The FDA gave traditional approval for adults ages 50 to 64. For adults 65 and older, it granted accelerated approval based on immune responses, with a confirmatory study required after approval.

The decision adds another tool for protecting older adults from seasonal influenza while keeping the approval limited to the age groups named by the agency.