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Pfizer, BioNTech Granted FDA Fast Track Designation For Two COVID-19 Vaccine Candidates

Drug major Pfizer Inc. (PFE) and Germany's Biopharmaceutical New Technologies or BioNTech SE (BNTX) announced Monday that the U.S. Food and Drug Administration has granted Fast Track Designation for two of their Investigational mRNA-based vaccine candidates against SARS-CoV-2, the virus that causes COVID-19.

These two are among the four investigational vaccine candidates from their BNT162 mRNA-based vaccine program being developed to help protect against SARS-CoV-2.

BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.

If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

FDA's Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need.

The designation was granted based on preliminary data from the ongoing Phase 1/2 studies. The companies released early data from the ongoing U.S. Phase 1/2 study for the product candidate BNT162b1 on July 1, 2020. Early data from the German trial of BNT162b1 are expected to be released in July.

The Project Lightspeed vaccine development program is based on BioNTech's proprietary mRNA-based technology platforms and supported by Pfizer's global vaccine development capabilities.

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