BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with […]

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2.

If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within hours of FDA authorization. The companies expect to produce up to 50 million doses worldwide in 2020, with 1.3 billion doses produced by the end of 2021.

The Phase 3 clinical study of the Pfizer and BioNTech vaccine found a 95% efficacy rate — in line with the preliminary results from rival COVID-19 vaccine developer Moderna (NSDQ:MRNA). Pfizer’s BNT162b2 vaccine candidate also appears to have a lower adverse event rate than Moderna’s mRNA-1273 vaccine.

Moderna seems to have the upper hand in terms of its vaccines’ storage requirements, however. The vaccine candidate is stable for 30 days between 2° and 8° C. Pfizer currently specifies that its vaccine candidate should be stored at –70° C.

“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,” Pfizer CEO Albert Bourla said in a news release.

Next up is an upcoming Vaccines and Related Biological Products Advisory Committee discussion about the vaccine candidate.

Pfizer and BioNTech have also initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency (EMA) and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. They plan regulatory submissions to other agencies worldwide in coming days.

“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally,” said BioNTech CEO Dr. Ugur Sahin. “As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

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