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.
You may also be interested in...
Two GOP governors are talking about using COVID products in ways not authorized by the US government. But the different paths they are taking could lead to different enforcement approaches by the feds – as well as different political outcomes for the governors.
Moderna fell behind Pfizer after receiving EUA for Spikevax, as it took three months longer to file its BLA and had an extra two months of FDA review for full approval. Novavax files request for FDA emergency use authorization of its vaccine.
Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review
Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.