Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, reported this week (May 5, 2020) that the first participants in a Phase I/II clinical trial for the companies’ vaccine program (BNT162) to prevent COVID-19 have been dosed in the US. The trial is part of a global development program, which involves four mRNA vaccine candidates. The dosing of the first cohort of trial participants was conducted in Germany last week (as reported on April 29, 2020).

Last month (April 2020), Pfizer and BioNTech formed a collaboration, worth up to $748 million ($185 million upfront), to develop vaccine candidates against COVID-19. The BNT162 vaccine program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The design of the trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate.

The Phase I/II study is designed to determine the immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. Sites currently dosing participants include the NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center to begin enrollment shortly.

During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. In anticipation of a successful clinical development program, Pfizer and BioNTech are working to scale up production for global supply. Pfizer plans to activate its manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine to allow production of millions of vaccine doses in 2020 and for increasing to hundreds of millions of vaccine doses in 2021. Pfizer-owned sites in three US states (Massachusetts, Michigan and Missouri) and Puurs, Belgium have been identified as manufacturing centers for production of the COVID-19 vaccine, with more sites to be selected. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity to provide further capacities for a global supply of the potential vaccine.

BioNTech and Pfizer say they will work to commercialize the vaccine worldwide upon regulatory approval (excluding China, where BioNTech has a collaboration with Fosun Pharma, a Shanghai-based pharmaceutical company) for BNT162 for both clinical development and commercialization.

Source: Pfizer and BioNTech