Pfizer Inc., and BioNTech SE are into the first phase of a clinical trial for a potential COVIV-19 vaccine, and Michigan is playing a key role.
The two companies announced testing and manufacturing sites for the vaccine, and one of the primary manufacturing sites is Pfizer’s complex in Kalamazoo.
Michigan Gov. Gretchen Whitmer said Pfizer is making additional at-risk investment to “actively scale up their manufacturing capacity” and distribution infrastructure to bring a “promising vaccine candidate” to the world.
The company’s clinical trial supply will be made at sites in Andover, Mass., and Chesterfield, Mo., and the initial manufacturing will be conducted in Kalamazoo.
Whitmer welcomed the news.
“This is great news for our families, our neighbors and those serving on the front lines during this crisis,” Whitmer said. “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, Michigan.”
Pfizer Inc. and BioNTech SE said Tuesday that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19, Phizer announced in a press release on its website.
The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.
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. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age).
The first subjects immunized in Stage 1 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.
Sites currently dosing participants include 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/CEo Albert Bourla said in the release. “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. 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.
“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. “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.”
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 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.
The breadth of this program should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. In addition to the Kalamazoo site, Pfizer-owned sites in Massachusetts and Missouri and in Puurs, Belgium have been identified as manufacturing centers for COVID-19 vaccine production, with more sites to be selected.
“Michigan has a strong history of vaccine development with the polio and anthrax vaccines,” Michigan’s Whitmer said. “Pfizer is a great partner and the State of Michigan and our strong manufacturing roots stand ready to serve.”
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.