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Pfizer and BioNTech to Submit EUA for COVID-19 Vaccine

Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.

By: Contract Pharma

Contract Pharma Staff

Pfizer and BioNTech have announced they will submit a request today to the U.S. FDA for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.    The submission is based on a vaccine efficacy rate of 95% demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective)...

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