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Two experimental coronavirus vaccines by German biotech firm BioNTech (BNTX.O) and U.S. pharmaceutical giant Pfizer have received the U.S. Food and Drug Administration’s ‘fast track’ designation, the companies said on Monday.
The vaccines, BNT162b1 and BNT162b2, are the two most advanced of the four vaccines being developed by the companies.
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 and 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 and 2 study for the product candidate BNT162b1 on July 1.
The BNT162 program is evaluating at least four experimental vaccines, each of which represents 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 Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities.
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 are anticipating enrolling 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.