The western city of Michigan, where the first US doses of a coronavirus vaccine were produced, is about to take on another leading role in the fight against the pandemic.
Pharmaceutical giant Pfizer announced on Monday that it will add 250 new jobs to its 1,300-acre Portage production facility as part of a $ 120 million investment to increase production of its antiviral COVID-19 pill Paxlovid.
The plant, located in Kalamazoo County, will be the only U.S. manufacturer of the active ingredients and starting materials Pfizer uses to make Paxlovid, Mike McDermott, the company̵[ads1]7;s global supply manager, told Free Press in an exclusive interview.
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“Our site in Kalamazoo, Michigan, was not only at the center of the production of our vaccine, producing (almost) a billion doses … serving virtually all American citizens, 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, “said McDermott.
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 serious disease from the virus.
Paxlovid won an emergency use permit from the US Food and Drug Administration in December. Since then, more than 1 million dose packs have been prescribed in the United States
The drug should be taken twice a day for five days and has been approved for use in people aged 12 and older who weigh at least 88 pounds with COVID-19 who are at high risk for serious illness.
“Our site in Kalamazoo, Michigan, is our largest plant globally. It is also our largest plant for active pharmaceutical ingredients globally. We are truly proud of the capacity of this site,” said McDermott.
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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 packages this year, McDermott said.
“In fact, we have already sent 12 million packages. As we stand today, we have sent it to 37 countries,” he said.
About 5 million courses with Paxlovid have been delivered to the United States so far, McDermott said.
“We also use a Pfizer site in Ireland to make the active ingredient, and so is our actual tablet and packaging business 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 capacity here in the United States.”
With the addition of 250 new workers – which will include researchers, packaging and logistics experts, active pharmaceutical ingredients operators, engineers, quality assurance staff and laboratory assistants – it will bring the company’s total workforce in Portage to around 3,600 people.
“It’s a big, vibrant place,” McDermott said. “We will start production immediately in some of the existing areas using existing capacity.”
New equipment will be in place in 2023 to fully increase production.
“We have many choices for 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 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 engaged in a significant amount of innovation, high quality products (and) a large workforce,” said McDermott.
“It has the ability, the technical expertise to do it. And we trust them. … And finally, it’s a place where we can find really high quality talent. The universities and infrastructure in the area allow us to hire colleagues of really high quality. “
The announcement comes about 15 months after Pfizer announced it would invest $ 1.1 billion to expand its Modular Aseptic Processing Facility in the Portage area, which would add around 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 drug has some limitations.
Paxlovid interacts with several other commonly used medicines and cannot 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.
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Cholesterol-lowering drugs may also interact with Paxlovid; People taking these medications may need to talk to their doctors about whether they should stop taking the cholesterol medications for a short while to take Paxlovid instead. Paxlovid is also a risk for people with HIV because it can make the medicines used to treat HIV less effective.
In April, the FDA amended its emergency use permit for Paxlovid, allowing doctors to prescribe a lower dose to people with moderate renal impairment.
And in May, the US Centers for Disease Control and Prevention issued a health advice warning about the potential for recurrence of COVID-19 symptoms or a rebound effect, reported by some people after they stopped taking the drug.
Nevertheless, the agency continues to recommend Paxlovid for early treatment of mild to moderate COVID-19 among people at high risk for serious disease from the virus.
With how fast the coronavirus mutates, some researchers have speculated that Paxlovid may soon be rendered ineffective against a future variant.
Pfizer is not worried about a shifting virus affecting Paxlovid demand or the production volume that will be needed in Kalamazoo, McDermott said.
“Pfizer has been very public in our ability to swing,” he said.
“We have also been public in our commitment to be able to swing to a new variant formulation within 100 days, which is really extraordinary. So I think first and foremost that we want to ensure that patients around the world are fully vaccinated and has access to high-quality vaccines and new varieties of vaccines if necessary, so it’s like chapter one.
“The second chapter is of course to have a protease inhibitor (Paxlovid) for the population that needs it, and we are incredibly happy so far with the safety and efficacy of that product.
“And the product has also … had strong coverage against all variants of concern. So to date we do not see the need for a new version of Paxlovid. But in the future we will definitely switch to one if necessary. And then of course we would Swipe quickly across the Kalamazoo site to support it as well. “
McDermott said he was “deeply proud” of the Pfizer workers at Kalamazoo.
“They are just so incredibly talented and have stepped up with innovation, but always with a focus on high quality quality medicines,” he said, “and it’s fantastic to see our colleagues being recognized for the work they do.
“It’s a great example of what American manufacturing can do, of what American citizens – highly educated, highly educated – can do.”
Contact Kristen Jordan Shamus: email@example.com. Follow her on Twitter @kristenshamus.