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FDA Grants Full Approval of Moderna’s COVID-19 Vaccine for High-Risk Children Aged 6 Months to 11 Years

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Moderna’s Spikevax receives full FDA approval for use in children at increased risk for COVID-19, expanding protection ahead of the 2025–2026 virus season.

©desertsands/AdobeStock

©desertsands/AdobeStock

The US FDA has granted full approval for Moderna’s COVID-19 vaccine, mRNA-1273 (Spikevax), for use in children aged 6 months through 11 years who are at increased risk for COVID-19 disease, according to a company announcement today. The approval expands the vaccine's indication beyond emergency use in pediatric populations and solidifies its role in protecting medically vulnerable children.

With this approval, mRNA-1273 is now fully licensed for use in older adults aged 65 years and older and for those aged 6 months through 64 years who are at increased risk for severe outcomes from COVID-19. Moderna stated that the updated vaccine is expected to be available for eligible populations during the 2025–2026 respiratory virus season.

Children with underlying medical conditions remain at elevated risk for severe COVID-19 outcomes, including hospitalization. The FDA’s decision was based on a scientific review of data supporting vaccine safety and efficacy in this younger population, although specific clinical data supporting the approval were not detailed in the company’s press release.

Moderna's COVID-19 vaccine was previously authorized for pediatric populations under Emergency Use Authorization. The move to full approval in high-risk children reflects continued regulatory confidence in mRNA-based vaccine platforms for preventing COVID-19 in vulnerable groups.

The full licensure of Spikevax in this demographic aligns with ongoing public health efforts to reduce COVID-19 morbidity in pediatric populations with chronic health conditions. The vaccine remains a critical option for physicians managing preventive care in children with comorbidities.

Moderna confirmed that the updated formulation of Spikevax will be available for the coming respiratory virus season, although no details were provided regarding specific variant coverage or formulation updates.

Spikevax is indicated for individuals aged 65 years and older, and those aged 6 months through 64 years at high risk for severe COVID-19. As with other COVID-19 vaccines, immunization may not confer protection to all recipients.


Source: Moderna receives full U.S. FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease. News release. Moderna. July 10, 2025. Accessed July 10, 2025. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx

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