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.
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Not only should children age 12 to 15 get a booster, but 16- and 17-year-olds who previously 'may' get a booster, now also 'should' get one, the CDC advisory committee said.
Decision to allow boosters for 12- to 15-year-old recipients of the Pfizer/BioNTech vaccine will go before CDC's ACIP, but like several other recent changes for COVID vaccines, the US FDA opted to skip its advisory committee.
Along with the pandemic, user fees, IT upgrades and nutrition issues should be at the top of the list, the acting commissioner said.