FDA grants fast track designation to Pfizer & Biontech’s Covid-19 vaccine candidates

Global Phase 2b/3 trials to as early as July 2020

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Pfizer and Biontech announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes Covid-19), received fast track designation from the US Food and Drug Administration (FDA). 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.

Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions that can 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 and animal immunogenicity studies. The companies released early data from the ongoing U.S. Phase 1/2 study for the product candidate BNT162b1 on 1 July 2020. The manuscript is available on the online preprint server medRxiv and is concurrently undergoing scientific peer-review for potential publication. 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 developing 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. According to the press statement, the BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

Pfizer and BioNTech are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of both companies’ decision-making. 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.

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