First participants receive trial COVID-19 vaccine
The single, continuous study is designed to look at the safety, immunogenicity and optimal dose of four mRNA vaccine candidates. Stage 1 of the Phase 1/2 study is a dose level escalation portion that will enrol up to 360 healthy subjects into one of two age cohorts—18 to 55 and 65 to 85.
Sites currently dosing or will begin dosing participants shortly include NYU Grossman School of Medicine, University of Maryland School of Medicine, University of Rochester Medical Center/Rochester Regional Health, and Cincinnati Children’s Hospital Medical Center. Initially, the first patients to be vaccinated will be the younger 18- to 55-year age cohort. The older cohort will only be vaccinated with a dose level of a vaccine candidate, once testing of that vaccine candidate and its dose level in the younger patients has provided initial evidence of safety and immunogenicity.
Pfizer Inc. Chairman and Chief Executive Officer (CEO) Albert Bourla said: “With our unique and robust clinical study programme underway, starting in Europe and now the US, we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most. The short, less than 4-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19.”
Ugur Sahin, CEO and cofounder of BioNTech, also voiced his confidence in the vaccines, saying: “It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine programme in such a short period. We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19.”
About the trial and vaccines
Pfizer and BioNTech’s development programme includes four vaccine candidates, each with different combinations of mRNA format and target antigen. The trial’s novel design will enable researchers to evaluate the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, and in a manner that will facilitate the sharing of data with regulatory authorities in real time.
During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. Both Pfizer and BioNTech anticipate the clinical development programme to be successful and, thus, are working to scale up production for global supply. BioNTech and Pfizer will work jointly to commercialize the vaccine worldwide upon regulatory approval with the exclusion of China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization.