Whitmer: Pfizer's plan to make Paxlovid in Kalamazoo 'a great source of pride'

PORTAGE – Wearing a "Science Will Win" T-shirt beneath her navy blue blazer, Gov. Gretchen Whitmer hailed the announcement Monday that Pfizer is adding 250 more jobs and will invest $120 million in its Kalamazoo County manufacturing facility as "one more step in our battle to beat back COVID-19 and keep people safe and healthy."

The company's Portage factory will be the only site in the U.S. to manufacture the ingredients it uses to make the COVID-19 antiviral pill Paxlovid.

"The Kalamazoo plant is one of the most advanced manufacturing facilities in the world," Whitmer said at a news event staged in a large white tent outside the Pfizer plant. "Eighteen months ago, it was here that the first doses of the COVID vaccine were manufactured and shipped out.

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"And by the end of this year, Pfizer will ship 4 billion doses of their safe, effective COVID vaccine worldwide. So with today's announcement, Pfizer Kalamazoo will simultaneously produce the vaccine and help manufacture Paxlovid, their COVID pill."

The prescription antiviral drug Paxlovid, when used in the first five days of a mild or moderate coronavirus infection, was shown in clinical trials to be 89% effective in preventing hospitalization and death among people at high risk for severe disease from the virus.

Paxlovid is a protease inhibitor, which stops coronavirus from replicating in the body. It won emergency use authorization from the U.S. Food and Drug Administration in December. Since then, more than 1 million dose packs have been prescribed in the U.S.

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Mike McDermott, Pfizer's chief global supply officer, said this is just one of the company's latest investments in Kalamazoo County.

Since the first doses of its COVID-19 vaccine rolled out on trucks on Dec. 13, 2020, the company invested $350 million in the mRNA vaccine technology at the site. Another $450 million was poured into the facility when the company announced in 2021 that it would expand its Modular Aseptic Processing Facility, for the production of injectable pharmaceuticals.

"There's more. Lo and behold, Pfizer was fortunate enough to bring a protease inhibitor to this COVID challenge," said Mike McDermott,  the company's chief global supply officer. "We were thrilled to have discovered and launch Paxlovid and we needed to expand our production facility.

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"So today, we're absolutely  thrilled to announce an additional $120 million investment at this site and an additional 250 highly talented colleagues to be able to help us with that fight to bring Paxlovid to all of the U.S. and its territories and all over the world."

No tax abatements, exemptions or reductions were tied to this investment in the Kalamazoo facility, a company spokesman told the Free Press.

With this expansion, it will become the company's primary global source of active ingredients for Paxlovid as Pfizer aims to produce 120 million packs this year, McDermott said.

"We've actually already shipped 12 million packs. As we stand today, we have shipped that to 37 countries," he said. About 5 million courses of Paxlovid have been delivered to the U.S. so far, McDermott said.

"We also use a Pfizer site in Ireland to make the active ingredient and then our actual tablet and packaging operations are in Europe — Germany and Italy," he said.

"The incremental investment in Kalamazoo will allow us to expand our capacity and give us more redundancy and capability here in the U.S."

With the addition of 250 new workers — which will include scientists, packaging and logistics experts, active pharmaceutical ingredient operators, engineers, quality assurance personnel and lab assistants — it'll bring the company's total workforce in Portage to about 3,600 people.

"It is a large and vibrant site," McDermott said. "We're going to start production immediately in some of the existing areas using existing capacity."

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New equipment will be in place in 2023 to fully ramp up production.

Michigan's Kalamazoo County facility was picked for a few reasons.

"The site history goes back to 1948 with the Upjohn Company. Since then, it's been engaged in a significant amount of innovation, high-quality products (and) a great workforce," McDermott said.

"It has the capability, the technical expertise to do it. And we have the confidence in them. ... And finally, it's a place that we can find really high-quality talent. The universities and the infrastructure in the area allow us to hire really high-quality colleagues."

Although many hailed Paxlovid as a pandemic game-changer when it first hit the market, the medication does have some limitations.

Paxlovid interacts with several other commonly used medications and can’t be given to anyone who has severe kidney or liver disease. Those who take blood thinners or heart rhythm medication, such as flecainide or amiodarone, shouldn't take Paxlovid.

Cholesterol-lowering drugs also can interact with Paxlovid; people who take those medications may need to talk to their doctors about whether they should go off their cholesterol drugs for a short time to take Paxlovid instead. Paxlovid also is a risk to people who have HIV because it can make the medicines used to treat HIV less effective.

In April, the FDA amended its emergency use authorization for Paxlovid, granting the OK for doctors to prescribe a lower dose to people with moderate kidney impairment.

And in May, the U.S. Centers for Disease Control and Prevention issued a health advisory, warning of the potential for a recurrence of COVID-19 symptoms or a rebound effect, reported by some people after they stopped taking the drug.

Still, the agency continues to recommend Paxlovid for early treatment of mild to moderate COVID-19 among people who are at high risk for severe disease from the virus.

With how rapidly the coronavirus is mutating, some scientists have speculated that Paxlovid could soon be rendered ineffective against it a future variant.

Pfizer isn't concerned about a shifting virus affecting the demand for Paxlovid or the volume of production that will be needed in Kalamazoo, McDermott said.

"We've ... been public in our commitment to being able to pivot to a new variant formulation in 100 days, which is really extraordinary. So I think first and foremost, we want to ensure that patients around the world are fully vaccinated and have access to high-quality vaccines and new variant vaccines if needed. So that's sort of chapter one.

"The second chapter, of course, is having a protease inhibitor (Paxlovid) for the population that needs it and we're incredibly happy so far with the safety, efficacy of that product.

"And the product also ... has had strong coverage against all the variants of concern. So to date, we don't see a need for a new version of Paxlovid. But in the future, we would absolutely pivot to one if needed. And then of course, we would pivot quickly convert over the Kalamazoo site to support that as well."

McDermott said he is "deeply proud" of the Pfizer workers in Kalamazoo.

"They are just so incredibly talented and have stepped up with innovation but always with a focus on quality, high-quality medicines," he said, "and it's wonderful to see our colleagues being recognized for the work that they do.

"It's a stunning example of what U.S. manufacturing can do, of what U.S. citizens — highly trained, highly educated — can do."

Whitmer said Pfizer's investment in Kalamazoo County shows "the world that Michigan is the place to be for companies who want to do big things.

"I'm so grateful to Pfizer for playing on team Michigan, for getting things done here," she said. "We've all been through a lot over the last couple of years. Tough times call for tough people. And those who want to solve problems and that is precisely what we are seeing here at Pfizer and that's precisely why we want to continue to partner to make sure our economy grows, to create good-paying jobs and solve problems together to keep people safe."

Whitmer's appearance comes days after she and hundreds of elected leaders, businesspeople and others attended the Mackinac Policy Conference.

Although U.S. Transportation Secretary Pete Buttigieg announced Monday he tested positive for COVID-19, and conference organizers at the Detroit Regional Chamber said they are aware of at least 15 attendees with positive tests after the event, a Whitmer spokesman said the governor tested negative Monday morning.

Free Press staff writer Dave Boucher contributed to this report.

Contact Kristen Jordan Shamus: kshamus@freepress.com. Follow her on Twitter @kristenshamus. 

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This article originally appeared on Detroit Free Press: Whitmer hails Pfizer's $120M plan to make Paxlovid in Michigan