Biden hopes Defense Production Act can aid vaccine production. Experts say it will take time.

Elizabeth Weise, USA TODAY
·5 min read

On his second day in office, President Biden said he would invoke the Defense Production Act to speed up COVID-19 vaccine production. Whether that can rapidly increase output is an open question, experts say.

The administration's 198-page COVID-19 strategy plan says it will use the production act to strengthen the supply chain for the raw materials needed to make vaccines and support expanding capacity to make lipid nanoparticles, a crucial and complex part of both the Pfizer and Moderna vaccines.

Much depends on where current vaccine bottlenecks are, which is unclear as little information is available from both the vaccine companies and Operation Warp Speed, the Trump administration's vaccine production effort.

Ensuring manufacturing plants have enough raw materials to make the vaccines is something the Defense Production Act could help with, experts say. If the issue is a lack of production capacity requiring building new plants or re-tooling existing ones to fix, it will take time.

“It means a couple of weeks or months, it can’t be done in a week’s time,” said Prashant Yadav,a medical supply chain expert and senior fellow with the Center for Global Development, an international development think tank based in Washington, D.C., and London.

There are several potential ways production could be increased — but all require trade-offs.

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The two current U.S. COVID-19 vaccines, from Pfizer and Moderna, both rely on relatively new mRNA technology. Both companies say their U.S. plants are operating at full capacity, so the government can’t simply tell them to simply drastically increase output.

Pfizer said it anticipates no interruptions in shipments from its U.S. facility and plans to scale up worldwide production from 1.5 billion doses to 2 billion by the end of 2021.

The vaccines require specialized manufacturing procedures and must be made in sophisticated facilities governed by strict Food and Drug Administration regulations to ensure safety and efficacy. Ramping up production is neither simple nor cheap.

Most of the companies with the capability to manufacture them that aren’t already in use are outside of the United States, so there’s little the U.S. government can do to gain more access to facilities.

“The Defense Production Act will have no effect on them,” said Dr. Drew Weissman, a professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, who did foundational research on the mRNA vaccines.

The lipid nanoparticles that surround the active portion of the vaccine and allow it to enter cells without the mRNA being destroyed by the body are difficult to make. Prior to the pandemic, they had mostly been used in oncology drugs, manufactured in much smaller amounts than the hundreds of millions of doses of COVID-19 vaccine the United States needs.

“mRNA vaccines on this scale are new. We’ve never had to make a billion doses before,” said Weissman.

Another option to increase capacity would be for vaccine manufacturers to take down some vaccine production lines so that they can be re-built to be more efficient and higher producing.

This wouldn’t necessarily be something that the Defense Production Act would be used for, but it could increase production from existing facilities. However it carries significant trade-offs.

In Europe, Pfizer plants producing COVID-19 vaccine for that market are being upgraded to increase production but it’s meant diminished output for now. That's caused a backlash.

“It’s a challenge to say, ‘We’ll forgo some throughput in the next three weeks in the hope we can get better production four weeks from now,” said Yadav.

It’s also a medical question. If vaccine availability dips in the midst of a surge in cases, infection rates will go up and more people will die.

“It’s both a political and an epidemiological challenge,” he said.

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Another way to increase production would be to commandeer other vaccine manufacturing plants or the fill and finish plants that put bulk vaccine into the tiny vials that it’s shipped in. There’s some excess capacity for this in the United States but re-tooling a plant takes time.

It also carries risk because some of that manufacturing space will hopefully soon be put to use making the next round of COVID-19 vaccines.

“We may have a Johnson & Johnson’s vaccine in a month and a half, in which case we don’t want to delay its production,” said Yadav.

One of the biggest frustrations for those with expertise in vaccine manufacturing is that there’s so little transparency around production that it's difficult to know what's necessary to fix it.

Under the Trump administration, no information was available on how much vaccine was being produced, if there were production delays or why the number of doses released to states fluctuated so wildly each week.

“I can understand from a manufacturer's point of view that this is proprietary information, but we're in a pandemic," said Norman Baylor, President and CEO, Biologics Consulting and the former director of FDA’s Office of Vaccines Research and Review, said Thursday.

"There are public funds going to this endeavor. I think the public deserves to know what is coming out of your factory every week. Not what's projected —what's coming out,” he said on a media briefing call Thursday held by the COVID-19 Vaccine Analysis Team, a group of vaccine experts.

Dr. Luciana Borio, vice president In-Q-Tel, said she was hopeful that the Biden administration would bring more transparency to the process.

“I think it will get better,” said Borio, who is the former director for Medical and Biodefense Preparedness at the National Security Council. “But I think we’ve got a few bumpy weeks ahead.”

Contact Elizabeth Weise at eweise@usatoday.com

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This article originally appeared on USA TODAY: COVID vaccine: Biden use of Defense Production Act is not a quick fix