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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.
- The FDA granted full approval for Moderna’s Spikevax in children aged 6 months to 11 years at increased risk this week.
- The KidCOVE trial showed two 25 µg doses of Moderna's vaccine were safe and elicited immune responses noninferior to young adults, supporting full pediatric approval.
- The FDA approved the vaccine based on clinical trial data showing safety and efficacy, including over 30,000 adults with 94.1% efficacy; pediatric immune responses are similar.
- Moderna's shares rose 3.6% to $33.97 premarket after FDA approval, reflecting market confidence in the vaccine's expanded pediatric use.
- Moderna plans to have Spikevax available for the 2025–26 season, with mRNA-1283 already FDA approved for older adults and at-risk populations.
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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…
FDA gives full approval to Moderna COVID shot for at-risk kids
The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is no longer administered under an emergency authorization. Infants younger than 6 months old are too young to be vaccinated. But the…
FDA Approves Moderna’s Covid Shot for “At-risk” Children as Young as 6 Months
The FDA has granted full approval of Spikevax for children aged 6 months through 11 years who are considered at increased risk for Covid-19. ... The post FDA Approves Moderna’s Covid Shot for “At-risk” Children as Young as 6 Months appeared first on The New American.
Moderna gets full US approval for COVID shot in at-risk children 6 months and older
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.
FDA Grants Complete Approval To Moderna's COVID-19 Vaccine For Children As Young As 6 Months - Moderna (NASDAQ:MRNA)
Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 vaccine patent dispute.
Moderna’s COVID-19 Vaccine Spikevax Receives Full FDA Approval for Children Aged 6 Months to 11 Years at "Increased Risk" Despite Mounting Safety Concerns and Public Distrust | The Gateway Pundit | by Jim Hᴏft
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