Pfizer and BioNtech Are Granted FDA Fast Track Designation for SARS-COV-2 Vaccine Candidates

Pharmaceutical giant Pfizer Inc. and BionTech SE made an exciting joint announcement on Monday that may help to relieve some of the anxiety over coronavirus.

Two of the company’s four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) that are 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).

According to the press release, 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.

The designation from the FDA 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.

The press release explains that the “BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA (mRNA) format and target antigen. BNT162b1 and BNT162b2 are both nucleoside modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.”

“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.

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

“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.

The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for
distribution anywhere in the world. Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and could enroll up to 30,000 subjects.

The press release notes that “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.”

Disclaimer: We have no position in Pfizer Inc. (NYSE: PFE) and have not been compensated for this article.