Story Originally Published by Crains here.
As the U.S. stands on the verge of having a vaccine for COVID-19 approved for widespread use, the city of Portage in Kalamazoo County stands at the center of the “historic” moment.
The Kalamazoo suburb boasts having the largest facility in the manufacturing network of global pharmaceutical company Pfizer Inc. The New York City-based company (NYSE: PFE) is one of just two drug makers set to deploy a highly effective vaccine that will be used in the coming days to begin inoculating health care workers in the U.S. against the deadly virus. The vaccine, reported to be 95 percent effective, was co-developed with German firm BioNTech SE.
A U.S. government panel signed off on use of Pfizer’s vaccine on Thursday and it’s widely expected that the U.S. Food and Drug Administration will do the same at any time, clearing the way for the first doses to be distributed from the Portage facility, as well as Pfizer’s other manufacturing sites around the globe.
“I think this is of historic proportions,” Stephen Rapundalo, president and CEO of Ann Arbor-based biotechnology trade group MichBio, said of the pending approval of the Pfizer vaccine. “There’s never really been a such an integrated effort put on such a fast track. And one that has really succeeded by all appearances completely along the way.”
Vaccines normally take years to develop, test and produce. Companies like Pfizer have now done it in months.
“This is unprecedented for us,” Chaz Calitri, vice president of operations for injectables and Pfizer’s interim site lead in Portage, told Crain’s in May as work was beginning. “The project is called Lightspeed — it’s called that for a reason.”
Once the FDA grants the Pfizer vaccine the emergency use authorization, the company will begin shipping the doses from Kalamazoo, as well from an existing distribution center in Pleasant Prairie, Wis.
“Our distribution is built on a flexible, just-in-time system, which will ship the frozen vials direct to the point of vaccination,” Pfizer said in a fact sheet on its U.S. distribution plans.
Pfizer’s Portage facility is located at the southern edge of the Kalamazoo-Battle Creek International Airport. But despite the close proximity to the airport as a point of distribution, it’s unclear whether the company plans to fly the doses in and out of the regional airport.
Airport Director Craig Williams told Crain’s on Friday that his questions over whether the airport could serve as a distribution hub have gone unanswered.
Pfizer has not made any executives available for comment in recent weeks, and spokespeople on Friday directed Crain’s to the company’s fact sheets.
Once approved, within a matter of days Michigan hospitals and health care agencies are expected to receive about 84,000 doses of the Pfizer vaccine to begin vaccinating front-line workers. The state is also expected to get about 173,000 doses of the vaccine developed by Massachusetts drug company Moderna Inc.
Both the Pfizer and Moderna vaccine require two doses spread out over a one-month period.
Rapundalo, himself a former Pfizer employee, said that he’ll be closely monitoring how supply chains hold up as vaccine makers quickly work to ramp up production and distribution of doses to further vaccinate citizens around the country and world.
“The sheer scale of this, I can’t begin to imagine the many, many, many different things that have to be thought about, just from a supply chain standpoint,” said Rapundalo. “Ensuring that sufficient raw resources, just simply glass vials or rubber for caps. And just on and on and on.”
While the start of vaccinations is undoubtedly a positive step, the pandemic remains far from over, notes Rapundalo.
“We’re barely scratching the surface in terms of who’s going to get vaccinated over the next couple months,” he said, adding that months of work still sit in front of companies like Pfizer. “I think Pfizer is going to stay laser-focused on just cranking out as much as the market is telling them is needed.”