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Moderna’s Covid Vaccine Gets Full FDA Approval For Use In Children 6 Months And Older

UNITED STATES, JUL 10 – The FDA’s full approval allows Moderna’s vaccine for children at increased risk, covering ages 6 months to 11 years, with 94.1% efficacy shown in adult trials, the company said.

  • In July 2025, the US Food and Drug Administration granted full approval for Moderna's Spikevax in children six months and older at increased risk of COVID-19.
  • Following pediatric trials, the KidCOVE study showed two 25 µg doses of the vaccine were safe and elicited immune responses comparable to young adults.
  • The FDA approved the vaccine for children 6 months and older based on three clinical trials showing safety, immune response, and antibody production, as supported by statement #39.
  • Moderna's shares rose over 3% Thursday morning, reflecting positive market reaction to full FDA approval for pediatric use.
  • Moderna plans to have its updated Spikevax available for the 2025–26 season and is developing mRNA-1283 for adult risk groups.
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biopharmadive.com broke the news in on Thursday, July 10, 2025.
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