Pfizer, BioNTech Get FDA Fast Track Status for COVID-19 Vaccines

July 17, 2020

U.S. Pfizer and Germany’s BioNTech announced Monday that they have received Fast Track designation from the FDA for two COVID-19 vaccine candidates – BNT162b1 and BNT162b2 – part of the companies’ “Project Lightspeed” program. The designation was issued based on promising preliminary data from Phase 1/2 clinical studies. The FDA’s Fast Track designation is intended to get critical new drugs to patients sooner by expediting the regulatory review process.

“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,” said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer.

“Our innovative drug industry is clearly stepping up to beat COVID-19,” said Kelvyn Cullimore, president and CEO of BioUtah. “We see it in key U.S. players, such as Pfizer, and in Utah’s own life sciences community.”

If the Phase 2b/3 clinical trial is successful and the companies get a green light from the FDA, they expect to produce up to 100 million doses by the end of 2020, and possibly more than 1.2 billion doses by the end of 2021.