FDA Approves Moderna’s COVID-19 Vaccine For At-Risk Children Six Months And Older

July 11, 2025

Reuters (7/10, Satija, Roy) reports Moderna said Thursday that the FDA gave full approval to its “COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease.” The vaccine was “previously available for pediatric populations under emergency use authorization. Moderna expects to make its updated vaccine available for eligible U.S. population for the 2025-26 respiratory virus season.” Although HHS Secretary Robert F. Kennedy Jr. said recently that the US “has stopped recommending routine COVID-19 vaccinations for healthy children and healthy pregnant women,” the CDC “said shots remain an option for healthy children when parents and doctors agree that it is needed. The agency recommended updated COVID vaccines for everyone aged six months and older, following the guidance of its panel of outside experts.”