Pfizer Inc. and BioNTech SE announced that two of the companies’ four investigational vaccine candidates from their combined Project Lightspeed vaccine program to help protect against SARS-CoV-2, the virus that causes COVID-19, have received Fast Track designation from the U.S. Food and Drug Administration (FDA). The Project Lightspeed vaccine development program is grounded on Germany-based BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The two vaccines approved—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 U.S. and Germany.
Fast Track is an FDA 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 the Phase 1/2 studies. “The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, Pfizer’s senior vice president for Global Regulatory Affairs, said in a press release.
The initial clinical supply of the BNT162 vaccines are being made in Germany, but Pfizer and BioNTech plan to scale up production in the U.S., with initial U.S. manufacturing taking place at Pfizer’s manufacturing plant in Kalamazoo County.
Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month with the anticipated enrollment of up to 30,000 subjects. 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.