U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

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U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children
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An expert panel will weigh authorization of Pfizer Inc and BioNTech's COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

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