FDA Grants Full Approval to Moderna COVID Vaccine for At-Risk Children

The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna's COVID-19 vaccine Spikevax for children aged 6 months through 11 years who are at increased risk of severe disease. Previously available under emergency use authorization, Moderna expects to offer an updated vaccine formulation for the 2025-2026 respiratory virus season. This approval comes amid ongoing controversy led by Health and Human Services Secretary Robert F. Kennedy Jr., who has ceased recommending routine COVID-19 vaccinations for healthy children and pregnant women, and replaced the CDC's Advisory Committee on Immunization Practices with members questioning vaccine efficacy and safety. Despite these policy shifts and legal challenges from medical organizations, the CDC maintains that COVID-19 vaccination remains an option for healthy children through shared clinical decision-making. Moderna's stock rose modestly following the approval announcement, reflecting market confidence in the vaccine's regulatory progress.