Washington, D.C. (Agencies) July 10, 2025 — The U.S. Food and Drug Administration (FDA) has officially granted full approval to Moderna’s COVID-19 vaccine, Spikevax, for use in children aged 6 months through 11 years—but with a key limitation: the approval applies only to children who are considered at increased risk for severe COVID-19 illness.
Previously available under Emergency Use Authorization (EUA), Spikevax now transitions to full licensure for pediatric populations with underlying medical conditions such as asthma, diabetes, or immunodeficiency. Moderna stated that the updated vaccine will be available ahead of the 2025–2026 respiratory virus season, with dosing guidelines tailored to age and vaccination history.
Children aged 6 to 23 months who have never received a COVID vaccine will require two doses, spaced one month apart. Those previously vaccinated or older than 2 years will receive a single booster dose.
The FDA’s decision follows a controversial move by Health and Human Services Secretary Robert F. Kennedy Jr., who in May 2025 removed COVID-19 vaccines from the CDC’s recommended immunization schedule for healthy children and pregnant women. That policy shift has drawn criticism from public health experts, who argue that young age alone is a risk factor for severe COVID outcomes.
Moderna CEO Stéphane Bancel welcomed the FDA’s approval, stating, “Vaccination remains a vital tool for protecting our youngest against severe disease and hospitalization”