PORTAGE — Southwest Michigan could become one of three production sites in the U.S. for a potential vaccine for COVID-19 that Pfizer Inc. and Mainz, Germany-based BioNTech SE are developing.
The first participants in a clinical trial for four vaccine candidates have already been dosed, Pfizer and BioNTech said today. If the clinical trials proves the vaccine candidate successful, Pfizer and BioNTech plan to produce the vaccine at its Kalamazoo-area facility in Portage, as well as in St. Louis, Mo. and Andover, Mass., plus Puurs, Belgium.
“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 for those most in need around the world,” Pfizer and BioNTech said today in a joint statement. “The breadth of this program should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.”
Pfizer has a long history in the Kalamazoo area, where it employs thousands of people at production facilities. Pfizer in 2018 decided to invest $465 million into a two-story, 400,000-square-foot building at its Portage campus for a sterile drug manufacturing facility.
“COVID-19 has shown how vulnerable our country is when it comes to supply chain and much of the lifesaving materials we need are manufactured out of the country. That’s why we are so proud that one of the largest pharmaceutical manufacturing facilities in the world is the Pfizer site right here in Kalamazoo,” Gov. Gretchen Whitmer said in a statement. “In fact, Michigan has a strong history of vaccine development with the polio and anthrax vaccines. Pfizer is a great partner and the State of Michigan and our strong manufacturing roots stand ready to serve.”
The clinical trial is to determine the safety, immunogenicity and optimal dose level of four vaccine candidates. The trial to determine proper dosing will enroll up to 360 healthy participants in the U.S. in two cohorts, ages 18-55 and 65-85, at four locations: 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.
“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,” Pfizer Chairman and CEO Albert Bourla said. “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.”