Following review of pre-clinical and phase 1/2 clinical trial data, Pfizer Inc. and BioNTech SE have selected a single mRNA vaccine candidate from the BNT162 program for use against SARS-CoV-2 — the virus that causes COVID-19 — in a global phase 2/3 safety and efficacy trial.
Investigators have one primary goal: to investigate whether BNT162b2 is capable of preventing COVID-19. China will be excluded from the trial, but otherwise, trial candidates will include regions across the world with significant expected transmission of SARS-CoV-2. Twin doses will be applied to participants at a 30 µg dose level.
“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine,” Dr. Kathrin Jansen, senior vice president and head of Vaccine Research & Development at Pfizer, said. “The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies.”
In pre-clinical studies, the BNT162b2 candidate showed favorable responses, including production of high levels of neutralizing antibodies in animals. Preliminary clinical phase 1/2 data, pulled from nearly 120 patients, showed similarly favorable results. While side effects such as fever, fatigue and chills did occur, it was determined to provide favorable overall tolerability, owing to its mild to moderate effects.
Advancement of BNT162b2 was chosen after consultation with the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research and other global regulators. It has already received FDA Fast Track designation. The candidate works by encoding an optimized SARS-CoV-2 full length spike glycoprotein, the target of antibodies that could neutralize the virus.
“We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said. “This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio.”
Up to 30,000 participants ranging anywhere from 18 to 85 years old will be able to participate in the trial. In all, approximately 120 sites will be included in the study, both in the U.S. and abroad. If success is seen, the companies intend to press for regulatory review as early as October 2020, then push up to 100 million doses for distribution by the end of 2020. The pair anticipate they could produce approximately 1.3 billion doses by the end of 2021.