FDA Grants Full Approval to Moderna COVID Vaccine for At-Risk Children
First non-emergency authorized shot for kids aged 6 months to 11 years now limited to those with underlying conditions.
WASHINGTON — The U.S. Food and Drug Administration (FDA) on Thursday granted full approval to Moderna’s COVID-19 vaccine for children aged 6 months to 11 years, marking the first coronavirus vaccine for that age group to move beyond emergency use. However, eligibility is restricted to children with at least one underlying medical condition that puts them at high risk of severe illness, following a policy shift by Health and Human Services Secretary Robert F. Kennedy Jr.
Moderna’s CEO, Stéphane Bancel, emphasized the continued threat of COVID-19 to vulnerable children and the importance of vaccination in preventing severe outcomes. The company expects its updated vaccine to be available for the 2025–2026 respiratory season.
The decision comes after Kennedy’s broader rollback of federal vaccine recommendations, including for pregnant women and children. The CDC now advises parents to consult with their pediatrician to determine need. Medical groups, including the American Academy of Pediatrics, have filed suit against Kennedy over the new restrictions.
Previously, UOJ reported that the U.S. Department of Health and Human Services (HHS) announced that Secretary Robert F. Kennedy Jr. had issued a letter urging health care providers and medical boards to revise treatment protocols for youth diagnosed with gender dysphoria.
