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A Cold War-era law and vaccines

Coronavirus Daily
Bloomberg

A Cold War-era law and vaccines

Throughout 2020, White House officials made frequent references to the Defense Production Act as a not-so-veiled threat to pharmaceutical manufacturers and others in their supply chains, urging them to speed development of Covid-19 vaccines. President Donald Trump has said he's invoked the act "over a hundred times." President-elect Joe Biden said he would invoke the act soon after taking office to compel private companies to make materials needed for the vaccines.

The Cold War-era law grants the president authority to influence private, domestic industry to prioritize and meet the needs of national defense. But it's not typically used in the health and life sciences sector. Most recently, the act became a focus as the U.S. and Pfizer Inc. negotiated over supply of another 100 million doses of vaccine developed with BioNTech SE.

Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, said the drug giant realized it wouldn't be able to provide the U.S. with that large quantity of doses within the second quarter of 2021 without getting priority access to certain raw materials. Though Pfizer had previously rejected the government's aid with R&D and manufacturing, it asked Warp Speed officials to trigger the DPA. Ultimately a deal was clinched, and both parties suggest the distribution objective will be met.

Vials of the Pfizer-BioNTech Covid-19 vaccine

Photographer: Liesa Johannssen-Koppitz/Bloomberg

MilliporeSigma, a life sciences business with a portfolio of 300,000 products, has been tasked by the U.S. government with prioritizing production of supplies and materials for Covid-19 vaccines. The Burlington, Massachusetts-based unit of German Merck KGaA has been a critical part of the global pandemic response, providing filtration devices, custom lipids, and other tools for 50 vaccines and 20 therapeutics geared to tackle the pandemic, while meeting the needs of its customary clients.

And it's got a 20-year-history making products for mRNA-based technologies -- like the Pfizer-BioNTech and Moderna shots. The Trump administration has triggered the DPA to ensure that MilliporeSigma prioritizes materials for Warp Speed-tapped vaccine makers.

"It's not a threat and it's not imposed upon us as a punitive measure," said Chris Ross, the interim Chief Executive Officer of MilliporeSigma, in an interview. "It's an expected outcome here that we and the U.S. government want in order to absolutely make sure that everything that can be done is being done.''

MilliporeSigma works with directly with officials from Warp Speed and the Biomedical Advanced Research and Development Authority to field what are called "government-rated orders," Ross said. His staff is in near-daily communication with "colonels and majors," the pharmaceutical companies and their contract manufacturers to fulfill those orders.

It's an onerous process, and one that can leave them resource-strapped. "You have to start making trade-offs when you've got limited supply and limited capacity to focus on the need of the moment,'' Ross said. MilliporeSigma has been hit with "off-the-charts'' demand for filtration devices and single-use assemblies, which are used extensively for the Covid-19 vaccines, he said.

Industry now faces a delicate dance in fulfilling orders, allocating materials, and balancing government demands with those of its everyday business. "We support, of course, Covid-19 vaccines, but we also support other life-saving therapy products," Ross said. "We're at an unprecedented inflection point."--Riley Griffin

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