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FDA Fully Approves Moderna’s COVID Vaccine for Some Young Kids
The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather than used under emergency authorization, STAT News reported. The vaccine can now to be given to children ages 6 months through 11 years,
Moderna COVID vaccine gets FDA green light for kids 6 months to 11 years
Moderna expects to make its updated vaccine available for eligible U.S. population for the 2025-26 respiratory virus season. Health secretary Robert F. Kennedy Jr. had in May said the U.S. has stopped recommending routine COVID-19 vaccinations for healthy children and healthy pregnant women.
Moderna filed for FDA approval on data from a late-stage trial that showed its vaccine was 83.7% effective at preventing at least two symptoms of RSV, such as cough and fever.
The FDA expanded the approval of the GSK vaccine in June to include adults ages 50 to 59 at risk of RSV-LRTD due to underlying conditions. The Moderna vaccine is approved for people ages ...
The Moderna RSV vaccine, which will be marketed under the name mResvia, was approved for adults 60 and older. It is made using the same messenger RNA platform as Moderna’s other licensed ...
Moderna’s shot is the third RSV vaccine for people 60 and older that’s gotten the green light from the FDA and the first mRNA vaccine among them. It’s the company’s second product to ...
COVID, RSV and the flu on the rise amid declining vaccination rates 01:47. The Food and Drug Administration has approved giving GSK's vaccine for respiratory syncytial virus down to age 50 ...
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the ...
The US Food and Drug Administration has approved another vaccine that can help protect older people from respiratory syncytial virus, known as RSV. The shot, made by Moderna and sold under ...
Moderna’s RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines. Despite availability, RSV ...
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the ...
Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...
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