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Full Approval Without Some Benefits: FDA Cautions Against Off-Label Use Of Pfizer’s COVID-19 Vaccine For Children, Boosters

Executive Summary

Unique nature of COVID-19 vaccine distribution in the US rules out off-label prescribing for Pfizer and BioNTech’s fully approved shot, and FDA isn’t on board with it for children under 12 and boosters yet. The need to better understand dosing and myocarditis risk in young children appears to be a key motivating factor for discouraging unauthorized and unapproved use. FDA handed Pfizer six post-market requirements related to better characterizing the myocarditis risk with its vaccine and one post-market commitment.

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