Pfizer and BioNTech power on with vaccine by submitting EUA to FDA

US pharma giant Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) have wasted no time following the announcement of positive preliminary Phase III data on their COVID-19.

They have announced that on Friday they will submit a request to the US 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 USA by the middle to end of December.

"We now have a more complete picture of both the efficacy and safety profile of our vaccine"The submission is based on data including a vaccine efficacy rate of 95% demonstrated in the companies’ Phase III study in participants without prior SARS-CoV-2 infection, the trial’s first primary objective, and also in participants with and without prior SARS-CoV-2 infection in each case measured from seven days after the second dose.