Pfizer, BioNTech again seek U.S. nod for COVID-19 vaccine boosters in all adults -Breaking
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© Reuters. FILE PHOTO : Nurses fill up syringes as patients receive coronavirus disease booster shots (COVID-19). This was done at a Pfizer BioNTech vaccine clinic in Southfield Michigan. It took place September 29th, 2021. REUTERS/Emily Elconin(Reuters). Pfizer Inc (NYSE: ) and BioNTech again asked the U.S. Food and Drug Administration Tuesday for authorization of booster doses their COVID-19 vaccines for all adults.
In September, Pfizer received FDA approval for its boosters. This was after an FDA panel of experts had rejected Pfizer’s request to authorize the booster for all people 16 years and older.
According to the panel, the evidence that supports broad approval is not sufficient. They want more safety data especially regarding heart inflammation, especially in younger patients after vaccination.
Moderna (NASDAQ:)’s booster doses have since been cleared for use in similar group of patients, and a booster shot of Johnson & Johnson (NYSE:)’s COVID-19 vaccine has been authorized for use as well. As of Monday, approximately 25 million Americans were receiving a booster.
Pfizer, U.S. Health officials and others have stated that the boosters can prevent deaths from hospitalizations or other serious complications and that new data suggests that mild infections may be slowened by them.
The August announcement by President Joe Biden that he would start distributing booster doses of medication to adults was made before FDA advisors suggested a restricted authorization.
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