The western Michigan city where the first US doses of a coronavirus vaccine were manufactured is about to get another leading role in fighting the pandemic.
Pharmaceutical giant Pfizer is to announce Monday that it will add 250 new jobs to its 1,300-acre Portage manufacturing facility as part of a $120 million investment to boost production of its antiviral COVID-19 pill Paxlovid.
The factory, which is in Kalamazoo County, will be the sole US manufacturer of the active ingredients and starting materials Pfizer uses to make Paxlovid, Mike McDermott, the company’s chief global supply officer, told the Free Press in an exclusive interview.
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“Our Kalamazoo, Michigan, site was not only at the center of the production of our vaccine, 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 site to support the effort as well,” McDermott said.
The prescription drug treatment, 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 won emergency use authorization from the US Food and Drug Administration in December. Since then, more than 1 million dose packs have been prescribed in the US
The drug should be taken twice a day for five days and has been authorized for use in people ages 12 and older who weigh at least 88 pounds with COVID-19 who are at high risk for severe disease.
“Our Kalamazoo, Michigan, site is our largest plant globally. It’s also our largest active pharmaceutical ingredient plant globally. We’re really proud of the capability of this site,” McDermott said.
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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 US so far, McDermott said.
“We also use a Pfizer site in Ireland to make the active ingredient and then our actual tablet and 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 US”
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.”
New equipment will be in place in 2023 to fully ramp up production.
“We have a lot of choices on where we can make our product and Paxlovid in particular,” McDermott said of the company’s 40 global manufacturing sites.
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Michigan’s Kalamazoo County facility was picked for a few reasons. The first is its rich history in pharmaceutical production.
“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.”
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 to add about 450 new jobs through 2024, and expand the company’s ability to make sterile injectable drugs.
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.
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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 US 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.
“Pfizer has been very public in our ability to pivot,” he said.
“We’ve also 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 US manufacturing can do, of what US citizens — highly trained, highly educated — can do.”
Contact Kristen Jordan Shamus: email@example.com. Follow her on Twitter @kristenshamus.