Posted by: News_Desk on 11/21/2020 03:03 PM
Updated by: thepinetree on 11/21/2020 11:43 PM
Expires: 01/01/2025 12:00 AM
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Pfizer and Biontech to Submit Emergency Use Authorization Request Yesterday to the U.S. FDA for COVID-19 Vaccine
New York & Mainz, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201120005370/en/
In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world
Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization
BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date
The submission is based on a vaccine efficacy rate of 95% (p
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