How US FDA Explained The Difference Between Approved And EUA Pfizer/BioNTech COVID-19 Vaccine
When Comirnaty was approved in 2021, the product in the vials was identical, but the agency still had to state that legally they were different without confusing people.
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Woodcock’s willingness to stay on at US FDA for more than a transitional period after Robert Califf’s expected confirmation as commissioner may depend on exactly the type of authority and tasks he’d be willing to delegate to her. Plus, some other agency personnel updates.
Full Approval Without Some Benefits: FDA Cautions Against Off-Label Use Of Pfizer’s COVID-19 Vaccine For Children, Boosters
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.
Vaccines and Related Biological Products Advisory Committee also said that more data is needed to determine the groups that potentially could receive more than one periodic vaccine booster.