Two experimental coronavirus vaccines being developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer have received the US Food and Drug Administration’s ‘fast track’ designation. The vaccines, BNT162b1 and BNT162b2, are the two most advanced of the four vaccines being developed by the companies. These two vaccines are currently being evaluated in ongoing Phase 1/2 clinical studies in the US and Germany.
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.
Pfizer said the fast-track status 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.
Early data from the German trial of BNT162b1 are expected to be released in July.
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 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.”
“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.
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.
US President Donald Trump’s Warp Speed program has backed efforts at a number of companies, including Johnson & Johnson, Novavax Inc, Merck & Co., Pfizer Inc., Moderna Inc., and AstraZeneca Plc, to get doses as early as possible.
Operation Warp Speed seeks to compress a process that is typically years-long into a matter of months.
Drug companies and university researchers are investigating more than 140 experimental inoculations, according to the World Health Organization.
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