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Pfizer, BioNTech To Submit Emergency Use Authorization Request To FDA For COVID-19 Vaccine

Pharmaceutical giant Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) said they will submit a request Friday to the U.S. Food and Drug Administration or FDA for Emergency Use Authorization (EUA) of their mRNA-based coronavirus vaccine candidate, BNT162b2.

The companies noted that the EUA will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

"Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," said Dr. Albert Bourla, Pfizer Chairman and CEO.

The EUA submission to the FDA is based on a vaccine efficacy rate of 95 percent demonstrated in the companies' Phase 3 clinical study in participants without prior SARS-CoV-2 infection, the first primary objective, and also in participants with and without prior SARS-CoV-2 infection, the second primary objective, in each case measured from 7 days after the second dose.

The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission is supported by solicited safety data from a randomized subset of about 8,000 participants 18 years of age, as well as unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate.

The companies have already initiated rolling submissions with several regulatory agencies around the world. These include the EMA and the Medicines & Healthcare Products Regulatory Agency or MHRA in the United Kingdom. The companies also intend to submit applications to other regulatory agencies worldwide in the coming days.

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