FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children

NEW YORK, Oct 22 (Reuters) – Scientists at the U.S. Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer (PFE.N)/BioNTech COVID-19 vaccine to 5 to 11 year olds clearly outweigh the risks of rare cases of heart inflammation.

Earlier on Friday, the vaccine makers said their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old.

The details were in briefing documents published ahead of a meeting of a panel of outside experts scheduled to vote on Tuesday whether to recommend the FDA authorize the shots for the young age group.

If the FDA authorizes the Pfizer/BioNTech immunization for children 5 to 11 years old, it would be the first COVID-19 vaccine for the age group and shots could be available in the United States in early November.

Both the Pfizer/BioNTech and Moderna Inc (MRNA.O) vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.

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Source: Reuters