FDA Grants Full Approval to Moderna's COVID-19 Vaccine for Certain Young Children

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 to 11 years who have specific medical conditions that heighten the risk of severe illness from COVID-19. This milestone marks a significant step, as it makes Spikevax the first COVID-19 vaccine for children in the U.S. to receive full approval, transitioning from emergency use authorization to standard approval.

The vaccine is now authorized for children in this age group only if they have at least one health issue increasing their vulnerability to COVID-19. Infants aged 6 to 23 months who have never been vaccinated are advised to receive two doses, spaced a month apart. For children over 2 years or those who have already been vaccinated, one dose is recommended.

According to Moderna CEO Stéphane Bancel, the approval reflects ongoing efforts to protect vulnerable children, emphasizing that COVID-19 remains a serious threat to young populations, especially those with pre-existing conditions. Moderna is also preparing an updated version of Spikevax for the upcoming 2025-26 virus season.

The decision follows recent debates and policy changes, including statements from U.S. Health Secretary Robert F. Kennedy Jr., who indicated that the government would no longer promote COVID vaccination for healthy children and pregnant women. This stance has been controversial, with some experts voicing concerns over the potential impact on vaccination coverage.

Medical experts, including Dr. Fiona Havers, highlight the heightened risk of severe COVID-19 in very young children. Data shows that more than half of pediatric hospitalizations for COVID involve children under 2, many without underlying health issues. Babies under 6 months old face the highest hospitalization rates, despite being ineligible for vaccination. Havers notes that the recent FDA approval could influence parental decisions and vaccination practices, especially amid political and policy shifts.

Overall, this approval signifies a cautious but crucial step toward protecting some of the most vulnerable young children from severe COVID-19, though ongoing debates and regulatory changes continue to shape the landscape of pediatric vaccination.

Source: https://medicalxpress.com/news/2025-07-fda-fully-moderna-covid-vaccine.html