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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.

  • On Thursday, the FDA granted full approval for Moderna's Spikevax in children aged six months to 11 years at increased risk.
  • The FDA granted full approval based on data from the KidCOVE trial, which showed that two 25 microgram doses of the vaccine are safe and elicit immune responses comparable to young adults.
  • Following the FDA's full approval, Moderna's shares rose 2% to USD 33.45 in premarket trading, reflecting positive market reaction to the regulatory milestone.
  • Moderna plans to have its updated Spikevax vaccine available for the 2025–26 respiratory season, with ongoing development of mRNA-1283 for high-risk adults, indicating preparations for future protection efforts.
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biopharmadive.com broke the news in on Thursday, July 10, 2025.
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