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  3. Us Fda Approves Modernas Covid 19 Vaccine Spikevax In Children Aged 6 Months Through 11 Years
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  • 14 Jul 2025
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US FDA approves Moderna’s Covid-19 vaccine, Spikevax in children aged 6 months through 11 years

Overview

Moderna, Inc., a leader in the creation of the field of mRNA medicine, announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax, the company's Covid-19 vaccine, in children 6 months through 11 years of age who are at increased risk for Covid-19 disease. The company's Covid-19 vaccine, mRNA-1273, was previously available for paediatric populations under Emergency Use Authorization (EUA).

Statement from Stéphane Bancel: CEO, Moderna

""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, chief executive officer of Moderna. ""We appreciate the FDA's diligent scientific review and approval of Spikevax for paediatric populations at increased risk for Covid-19 disease.""

Moderna to Launch Updated Spikevax for 2025-2026 Season

  • Moderna expects to have its updated Spikevax vaccine available for eligible populations in the US for the 2025-2026 respiratory virus season.
  • Moderna- Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how it treat and prevent disease for everyone.

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