Drug manufacturer Pfizer on Friday applied to United States’ health regulators for emergency use authorisation of its potential coronavirus...
Drug manufacturer Pfizer on Friday applied to United States’ health regulators for emergency use authorisation of its potential coronavirus vaccine – one that it is developing with BioNTech. The company’s Chief Executive Officer Albert Bourla confirmed about the application in a video posted on Pfizer’s official Twitter handle.
“...Our request for emergency use authorisation for our Covid-19 vaccine is now in the FDA’s [Food and Drug Administration] hands,” Bourla said.
He said that it took Pfizer and BioNtech 248 days from announcing their collaboration to submitting their application and termed the occasion as “a historic day”.
UPDATE: Pfizer and @BioNTech_Group have submitted an #EUA request to the @US_FDA for our #COVID19 vaccine candidate.
— Pfizer Inc. (@pfizer) November 20, 2020
Watch @AlbertBourla's reaction to a moment 248 days in the making. #ScienceWillWin pic.twitter.com/NCGTOCt5Nz
Bourla expressed confidence that the company would produce 50 million doses of the vaccine by the end of this year, and 1.3 billion of them by the end of 2021.
The Food and Drug Administration said on Friday that it would hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine, Reuters reported. The agency declined to predict how long its review would take, although both Pfizer and US Health Secretary Alex Azar have said the FDA could authorise the...