FDA authorizes Pfizer-BioNTech booster shot for elderly, people at high risk of severe Covid-19
The move aligns with the recommendation the agency’s independent vaccine advisers made Friday.
The Food and Drug Administration authorized a booster dose Wednesday of Pfizer and BioNTech’s Covid-19 vaccine for people 65 and older and for certain high-risk adult populations.
The move aligns with the recommendation the agency’s independent vaccine advisers made Friday when they endorsed offering boosters to people at high risk of severe disease as well as those 65 and older at least six months after completion of the primary two-dose series.
The FDA authorization permits Pfizer boosters for anyone between the ages of 18 and 64 “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”
It notably excludes 16- and 17-year-olds — who Pfizer had included in its booster application to the agency — in an apparent nod to the lack of data on the safety of an additional dose for younger people. Pfizer’s and Moderna’s messenger RNA vaccines have been associated with rare cases of myocarditis, an inflammation of the heart muscle, after vaccination. The side effect typically occurs in males 30 and younger.
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