WASHINGTON (dpa-AFX) - Moderna has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, in children aged 6 months to 11 years who are considered at heightened risk of severe illness.
Previously authorized for emergency use, the vaccine is now fully licensed for use in this age group under a supplemental Biologics License Application.
The FDA's approval applies specifically to children with underlying medical conditions such as chronic respiratory issues or immunocompromised status that make them more vulnerable to COVID-19 complications. Unvaccinated infants aged 6 to 23 months will require two doses spaced one month apart, while older or previously vaccinated children will need just one shot.
'This approval marks an important step in protecting our youngest and most vulnerable populations from severe disease and hospitalization,' said Moderna CEO Stéphane Bancel. He added that the company expects to have updated doses available for the 2025-2026 respiratory virus season.
The decision comes amid shifting federal guidance on pediatric vaccination. Health Secretary Robert F. Kennedy Jr. recently announced that healthy children and pregnant individuals would no longer be recommended for COVID-19 vaccination a move that drew criticism from health experts.
Former CDC medical epidemiologist Dr. Fiona Havers noted that children under age 2 are especially at risk and often require hospitalization despite having no underlying conditions.
Critics argue that the FDA's narrow approval may limit access for concerned parents who wish to vaccinate healthy infants, placing added pressure on physicians navigating off-label use.
With full licensure in place, Spikevax now becomes a critical tool for protecting at-risk children, even as national policy debates over pediatric vaccination continue.
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
