FDA Grants Full Approval for Spikevax in Children at Increased Risk of Disease

The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna’s Spikevax (mRNA-1273) COVID vaccine in children 6 months through 11 years who are at an increased risk of the disease. Moderna expects to make its updated vaccine available for eligible U.S. population for the 2025-26 respiratory virus season.

Spikevax first received full FDA approval in January 2022 in adults after being available on an emergency use basis earlier in the pandemic. Last year, FDA expanded the approval to people 12 years and older.