India, July 10 -- Moderna has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, in children aged 6 months to 11 years who are considered at heightened risk of severe illness.
Previously authorized for emergency use, the vaccine is now fully licensed for use in this age group under a supplemental Biologics License Application.
The FDA's approval applies specifically to children with underlying medical conditions such as chronic respiratory issues or immunocompromised status that make them more vulnerable to COVID-19 complications. Unvaccinated infants aged 6 to 23 months will require two doses spaced one month apart, while older or previously vaccinated children will need just one shot.
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