Posted by Michael Wonder on 21 Nov 2020
Pfizer and BioNTech to submit emergency use authorisation request today to the U.S. FDA for COVID-19 vaccine
20 November 2020 - 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.
Pfizer and BioNTech announced they will submit a request today to the U.S. FDA for emergency use authorisation 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.
