The Food and Drug Administration determined in an extensive analysis of the first-ever COVID-19 vaccine candidate for U.S. distribution has officially “met the prescribed success criteria” in a clinical study, according to an initial report from The Wall Street Journal — which means the agency is closer now than ever to green-lighting the world-historic product.
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FDA said Pfizer/BioNTech Vaccine ‘met success criteria’
The agency released two different analyses on Tuesday — one from its staff scientists and another from the manufacturers of the vaccine, Pfizer Inc. and its German partner BioNTech SE.
The new FDA analysis emphasized several “known benefits” from the vaccine — including “reduction in risk of confirmed COVID-19 occurring at least seven days after Dose 2.” Notably, Pfizer’s vaccine needs two doses for full immunization to COVID-19 in humans.
This is breaking news about the forthcoming Pfizer/BioNTech vaccine against the global pandemic caused by the COVID-19 illness, so be sure to check-in with us for the latest updates.
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