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

Scientists at the U.S. Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer/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 vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.

The FDA staff said that, assuming the number of myocarditis cases observed in the younger age group would be similar to that seen in 12 to 15 year olds, the number of COVID-19 related hospitalizations prevented would outnumber myocarditis-related hospitalizations in most scenarios analyzed.

Pfizer suggested in its own briefing documents that the rate of myocarditis in the age group was likely to be lower than observed in vaccinated 12 to 15 year olds, in part because the younger children were given a lower dose.

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