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The U.S. Food and Drug Administration (FDA) has granted full approval to Moderna’s COVID-19 vaccine, Spikevax, for use in children aged 6 months through 11 years who are at increased risk for COVID-19 disease. This marks a significant milestone, as the vaccine was previously available to this age group only under Emergency Use Authorization (EUA).
Spikevax is now fully approved for:
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All adults aged 65 years and older
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Individuals aged 6 months through 64 years who are at increased risk for COVID-19 disease
Moderna’s CEO, Stéphane Bancel, emphasized the ongoing threat that COVID-19 poses to children, particularly those with underlying medical conditions. He stated, “Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization. We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease”.
The company plans to make an updated version of the Spikevax vaccine available to eligible groups in the U.S. ahead of the 2025-2026 respiratory virus season.
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” said Stéphane Bancel, CEO of Moderna.
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This article is based on information available as of July 11, 2025. The approval applies specifically to children aged 6 months through 11 years who are at increased risk for COVID-19 disease. For specific medical advice, eligibility, and vaccination recommendations, consult healthcare professionals or official public health sources.
