- Posted by ISPE Boston
- On May 6, 2020
Pfizer and BioNTech have dosed the first participants in the U.S. and Germany in the Phase 1/2 clinical trial for the BNT162 COVID-19 vaccine program. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.
Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The novel 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 in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time.
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 extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible. The breadth of this program should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.
Pfizer-owned sites in Massachusetts, Michigan, Missouri and Belgium have been identified as manufacturing centers for COVID-19 vaccine production, 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 will work jointly to commercialize the vaccine worldwide upon regulatory approval, excluding China where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialization. (Source: Pfizer Website, 05 May, 2020)