Pfizer to manufacture some of COVID-19 trial vaccine in Kalamazoo
The drug company Pfizer plans to perform initial manufacturing of a clinical trial COVID-19 vaccine in Kalamazoo, the company announced Tuesday, but it won't be producing most of the clinical supply.
The initial clinical supply of the BNT 162 vaccine will come from BioNTech facilities in Europe, but Pfizer and BioNTech plan to scale up production in the United States for global supply on the expectation that the clinical trial will work.
Initial U.S. manufacturing will take place in Kalamazoo, and the overall supply will be made in Andover, Massachusetts and Chesterfield, Missouri. In America, about 360 healthy volunteers will be enrolled in the trial, the companies said.
Gov. Gretchen Whitmer said in a Tuesday statement that the new drug was “great news” for front line workers and that plans to manufacture the drug in the United States would help to ensure an accessible supply chain.
“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,” Whitmer said in a statement. “In fact, Michigan has a strong history of vaccine development with the polio and anthrax vaccines.”
U.S. Rep. Fred Upton, R-St. Joseph, said he was "delighted" by the development and the recognition of Kalamazoo's facility and workforce, which is in his congressional district.
"We know that a vaccine is the only true way for us to get back to normal and begin on our road to recovery," Upton said in a statement. "That recovery begins with Pfizer’s exciting developments here in Kalamazoo.”
A coronavirus vaccine would help "to restore a sense of normalcy and hope for the future," said Sen. Sean McCann, D-Kalamazoo.
"Pfizer is delivering on that front, and the fact that we could possibly manufacture a cure in our own backyard says volumes about the quality industry and community we have here," McCann said. "Kalamazoo County has a long, proud tradition of innovation in life sciences dating back to W.E. Upjohn and Homer Stryker, and it is only fitting that we should lead the way today in the fight against COVID-19.”
Roughly 100 research groups are attempting to develop vaccines and eight to 11 are in the early stages of testing in the United States, Britain, Germany and China, according to The Associated Press.
Initial test vaccine programs in March have been expanded in China, the U.S. and Europe, but the next phase will include testing the vaccine among more people in locations where the virus is active.
Stay-home orders make it difficult to assess the effectiveness of the vaccine, though, as individuals are less likely to be exposed to the virus.
The federal government has been attempting to remove obstacles that would normally delay similar clinical trials, but Dr. Anthony Fauci has said it could take 12 to 18 months to develop a vaccine even with fewer barriers.
Despite Fauci's best-case timeline, production at Pfizer’s U.S. sites is expected to yield millions of vaccine doses this year and hundreds of millions in 2021, according to a statement from Pfizer and BioNTech SE.
The companies announced Tuesday that the first U.S. participants in the clinical trial had received doses of the vaccine at New York University Grossman Schools of Medicine and the University of Maryland School of Medicine. The companies dosed the first participants in Germany last week and plan to expand to other sites across the United States later this year.
"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 CEO Albert Bourla said in a Tuesday statement.
The clinical trial individuals will come from two age brackets, with those between 18 and 55 years of age being tested first and those between 65 and 85 years old being tested when the tests among younger individuals are found to safe, Pfizer and BioNTech said in a statement.
Four vaccine candidates will be administered to individuals to assess the efficacy of each combination of mRNA and target antigen. The current phase of the study will assess the dose level, safety and immunogenicity of the vaccine, Pfizer and BioNTech said in a statement.
"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,” BioNTech CEO Ugur Sahin said in a statement.
The Associated Press contributed.