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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 be given to children ages 6 months through 11 years, but only if they have at least one health issue that increases their COVID risk.
Moderna COVID vaccine gets FDA green light for kids 6 months to 11 years
The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O 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 company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...
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