A drug maker in the region, in partnership with an immunotherapy company, dosed the first U.S. patients in a clinical trial for a COVID-19 vaccine.
New York-based Pfizer, which has its largest production facility in Kalamazoo, and Mainz, Germany-based BioNTech, on Tuesday said that they have dosed the first participants in the U.S. in a trial of the BNT162 vaccine program to prevent COVID-19.
Sites currently dosing participants include New York University 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 beginning enrollment shortly.
The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.
The phase I/II study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.
The dose level escalation portion (stage one) of the phase I/II trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts, 18-55 and 65-85 years old. The first subjects immunized in stage one of the study will be healthy adults 18-55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity.
“With our unique and robust clinical study program underway, starting in Europe and now the U.S., 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,” said Albert Bourla, chair and CEO of Pfizer.
“The short, less than four-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.”
Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen, to facilitate the sharing of data with regulatory authorities in real time.
“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 program in such a short period,” said Ugur Sahin, CEO and co-founder of BioNTech.
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 outcome, Pfizer and BioNTech are working to scale up production for global supply. Pfizer plans to activate its manufacturing network and invest at-risk to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world.
The breadth of this program “should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021,” the partners said.
Pfizer-owned sites in three U.S. states — Massachusetts, Michigan and Missouri — as well as a facility in Puurs, Belgium, were identified as manufacturing centers for COVID-19 vaccine production with more sites to be selected in the future.
BioNTech is preparing to ramp up its production capacity at its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, as well.
BioNTech and Pfizer will work jointly to commercialize the vaccine worldwide upon regulatory approval, excluding in China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for clinical development and commercialization.