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

 
• By Sarah Karlin-Smith

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.

children waiting for train
Full approval still leaves young children waiting for COVID-19 vaccines. • Source: Alamy

The US Food and Drug Administration granted full approval to Pfizer Inc. and BioNTech SE’s COVID-19 vaccine 23 August, giving the companies the distinction of having the first vaccine for SARS-CoV-2 to transition from the more preliminary emergency use authorization to the gold-standard FDA clearance. But the much coveted designation lacks one element normally permitted by agency approval: off-label use.

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