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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FDA approves Moderna's COVID vaccine for children as young as 6 months old
Younger children will now have access to a COVID-19 vaccine but only if they're considered at higher risk.The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old.The vaccine was previously only available to children through emergency use authorization after approval in Jan. 2022. Approval was expanded to people 12 years and older last year.RELATED STORY | Doctors and public health o…
Moderna gets full U.S. approval for COVID vaccine in children 6 months and older – CLG News
Moderna gets full U.S. approval for COVID vaccine in children 6 months and older | 10 July 2025 | The U.S. Food and Drug Administration has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, the company said on Thursday. The shot was previously available for pediatric populations under emergency use authorization. Moderna said it expects to have …
Moderna gets full FDA approval for kids COVID-19 vaccine
(NewsNation) — Moderna reports it has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, in children six months through 11 years of age, who are at an increased risk of the disease. The company announced the FDA’s full approval in a statement July 10, noting its COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under emergency use authorization. The company noted it…
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