Pfizer adds 250 jobs at Kalamazoo site, where it will manufacture Paxlovid

The western Michigan town where the first US doses of a coronavirus vaccine were made is set to play another prominent role in the fight against the pandemic.

Pharmaceutical giant Pfizer is due to announce Monday that it will add 250 new jobs at its 1,300-acre Portage manufacturing plant as part of a $120 million investment to boost production of its COVID-19 antiviral pill. Paxlovid.

The plant, which is in Kalamazoo County, will be the sole U.S. manufacturer of the active ingredients and raw materials that Pfizer uses to make Paxlovid, Mike McDermott, the company’s director of global sourcing, told the Free Press. in an exclusive interview.

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“Our Kalamazoo, Michigan site was not only the center of our vaccine production, producing (nearly) a billion doses…serving virtually every US citizen but also many countries around the world. , but now with Paxlovid, we also have the opportunity for our Kalamazoo location to support this effort as well,” McDermott said.

Prescription drug treatment, when used within the first five days of mild or moderate coronavirus infection, has been demonstrated in clinical trials be 89% effective in preventing hospitalizations and deaths in people at high risk of serious illness from the virus.

Paxlovid received emergency use authorization from the US Food and Drug Administration in December. For more than 1 million doses have been prescribed in the United States

The drug must be taken twice a day for five days and has been authorized for use in people aged 12 and over weighing at least 88 pounds with COVID-19 who are at high risk of serious illness.

“Our location in Kalamazoo, Michigan is our largest plant in the world. It is also our largest active pharmaceutical ingredient plant in the world. We’re really proud of the capability of this site,” McDermott said.

A lab technician examines samples of Paxlovid tablets to check for irregularities.  It's one of hundreds of quality controls that Pflizer has in place for the production of Paxlovid, its COVID-19 antiviral drug.

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

“We’ve actually shipped 12 million packs already. As it stands, we’ve shipped that to 37 countries,” he said.

About 5 million courses of Paxlovid have been delivered in the United States so far, McDermott said.

“We also use a Pfizer site in Ireland to manufacture the active ingredient, and then our actual tablet and packaging operations are in Europe – in Germany and Italy,” he said.

“The additional investment in Kalamazoo will allow us to expand our capacity and give us more redundancy and capacity here in the United States”

With the addition of 250 new workers – which will include scientists, packaging and logistics experts, active pharmaceutical ingredient operators, engineers, quality assurance staff and laboratory assistants – this will bring the workforce company’s total at Portage to about 3,600 people.

“It’s a large and dynamic site,” McDermott said. “We will start production immediately in some of the existing areas using existing capacity.”

New equipment will be put in place in 2023 to completely accelerate production.

“We have a lot of choice about where we can manufacture our product and Paxlovid in particular,” McDermott said of the company’s 40 global manufacturing sites.

Mike McDermott, Global Chief Procurement Officer of Pfizer.

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The Kalamazoo County facility in Michigan was chosen for several reasons. The first is its rich history in pharmaceutical production.

“The site’s history dates back to 1948 with the Upjohn company. Since then, it has been committed to a significant amount of innovation, high quality products (and) excellent workmanship,” said said McDermott.

“He has the capacity, the technical expertise to do it. And we have confidence in them. … And finally, it’s a place where we can find really high quality talent. The universities and the infrastructure of the region allow us to hire really high quality colleagues.”

The announcement comes about 15 months after Pfizer announced it would invest $1.1 billion to expand its modular aseptic processing facility at the Portage site, which was expected to create about 450 new jobs through 2024 and expand the company’s ability to manufacture sterile injectable drugs.

Although many hailed Paxlovid as a pandemic game changer when it first hit the market, the drug has some limitations.

Paxlovid interacts with several other commonly used medications and should not be given to anyone with severe kidney or liver disease. Those taking blood thinners or heart rhythm medications, such as flecainide or amiodarone, should not take Paxlovid.

This image, provided by Pfizer in October 2021, shows the company's Paxlovid COVID-19 pill.  US health regulators on Wednesday, Dec. 22, 2021, authorized the first COVID-19 pill, a Pfizer drug that Americans can take at home to avoid the worst effects of the virus.

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Cholesterol lowering drugs may also interact with Paxlovid; people taking these medications may need to talk to their doctor about whether they should stop their cholesterol medications for a short time and take Paxlovid instead. Paxlovid also poses a risk to people living with HIV because it can make medicines used to treat HIV less effective.

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

And in May, the United States Centers for Disease Control and Prevention issued a health advisorywarning of the possibility of a recurrence of COVID-19 symptoms or a rebound effect, reported by some people after stopping the drug.

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

With the rapidity with which the coronavirus mutates, some scientists have speculated that Paxlovid may soon be rendered ineffective against a future variant.

Pfizer is not concerned about a changing virus affecting demand for Paxlovid or the volume of production that will be needed at Kalamazoo, McDermott said.

Pfizer Global Supply in Kalamazoo, Michigan on Dec. 10, 2020.

“Pfizer has been very public in our ability to pivot,” he said.

“We’ve also made public our commitment to be able to transition to a new variant formulation in 100 days, which is really extraordinary. So I think first and foremost we want to make sure that patients around the world are fully vaccinated and have the access to high-quality vaccines and new vaccine variants 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’ve been incredibly happy with the safety and effectiveness of this product so far.

“And the product too…has had strong coverage against all variants of concern. So at this time we don’t see the need for a new version of Paxlovid. But in the future we would absolutely upgrade to a if necessary. . And then, of course, we would quickly pivot the conversion to the Kalamazoo site to support that as well.”

McDermott said he was “deeply proud” of Pfizer workers in Kalamazoo.

“They’re so incredibly talented and have stepped up innovation, but always with a focus on high quality medicines,” he said, “and it’s wonderful to see our colleagues being recognized for the work that they make.

“It’s an amazing example of what American manufacturing can do, what American citizens – highly skilled, highly educated – can do.”

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

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