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Pfizer, BioNTech get FDA’s support for potential first emergency use authorization for COVID-19 vaccine in the U.S.

Pfizer and BioNTech said that the FDA is expected to make a decision on Emergency Use Authorization in the coming days after giving a positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data, which would make BNT162b2 the first COVID-19 vaccine available in the U.S.

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Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose, said Pfizer and BioNTech.

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