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Pfizer, BioNTech Received Fast Track Status from FDA

Pfizer and BioNTech have received fast track designation from the US Food Drug and Administration for two of their four potential COVID-19 vaccines.

BNT162b1 and BNT162b2, the two potential vaccines, are part of the companies’ BNT162 mRNA-based vaccine program. The candidates are currently in ongoing Phase I/II clinical trials in the US and Germany.

According to Senior VP Global Regulatory Affairs of Pfizer, Peter Honig, “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.”

“We look forward to continuing to work closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates,” he added.

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 United States and Germany as well as animal immunogenicity studies. The companies released early data from the ongoing U.S. Phase 1/2 study for the product candidate BNT162b1 on July 1, 2020.

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” said Özlem Türeci, Chief Medical Officer at BioNTech.

If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by the end of 2021.

The companies expect to begin a large trial with up to 30,000 participants as soon as later this month if they receive regulatory approval.