UPDATED 11/20/20 1:40 p.m. ET: Pfizer announced the submission of an EUA request to the FDA on Friday:
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.
Rolling submissions have also been initiated in other regions including Australia, Canada, Europe, Japan, and the U.K.
See original story from 11/18/20 below.
Pfizer, clearly not in the business of fucking around, said on Wednesday that the plan is now to submit a request to the FDA "within days" for an Emergency Use Authorization of its mRNA-based COVID-19 vaccine candidate BNT162b2.
The vaccine candidate, developed in collaboration with BioNTech, was reported earlier this month to have shown to have an efficacy rate of more than 90 percent based on early analysis. Now, with the conclusion of final efficacy analysis in the Phase 3 study, the vaccine candidate has shown an efficacy rate of 95 percent in participants without prior infection, the first primary objective. The second primary objective, i.e. the same efficacy rate in participants with and without prior infection, was also met by way of each case measured from seven days after the second dose.
"These achievements highlight the potential of mRNA as a new drug class," Ugur Sahin, M.D.—CEO and co-founder of BioNTech—said Wednesday. "Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities."
Current expectations are for both companies, Pfizer and BioNTech, to have produced as many as 50 million doses worldwide in 2020. By the end of 2021, that number is expected to be as high as 1.3 billion.
Also this month, Moderna shared an update on the also-promising efficacy rate of its COVID-19 vaccine candidate mRNA-1273.