Pfizer Inc. (New York, NY) and BioNTech SE announced that two of the companies’ four investigational vaccine candidates from their mRNA-based vaccine program being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).
The two vaccine candidates are currently being evaluated in ongoing Phase 1/2 clinical studies in the U.S. and Germany. 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.
This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies.
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.