firstwordpharmaJuly 12, 2021
Tag: Pfizer , COVID-19 vaccine , FDA
Pfizer said Sunday that it will meet with representatives of the FDA as soon as Monday to discuss the need for a booster dose of its COVID-19 vaccine as it prepares to seek authorization, as reported in Investing.com.
The meeting comes days after the drugmaker and its partner BioNTech announced plans to seek US and European regulatory approval for a third dose of their COVID-19 shot amid the spread of variants.
They also cited data indicating a heightened risk of infection six months after initial inoculation.
However, that announcement prompted a quick joint response from the FDA and the Centers for Disease Control and Prevention, saying Americans do not need a booster right now.
Anthony Fauci, who directs the National Institute of Allergy and Infectious Diseases, said Sunday that US health officials were not dismissing the possible future need for boosters, but that more data is needed for any formal recommendation.
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