The Biden Administration is invoking the Defense Production Act (DPA) to increase manufacturing of existing vaccines, a move that could help expand limited supplies and get more vaccinations sites up and running.
But the idea that any company, even another pharmaceutical company, can simply start producing the vaccines is easier than it sounds, according to some experts. Barry Bloom, a leading infectious disease expert at Harvard University, said it’s “one of the delusions I think people have.”
“This is a really complicated business that requires highly skilled people that you can't go by, with a Defense Production Act, to make vaccines tomorrow,” he said.
“This is a really complex business,” Bloom added, in a recent interview.
NYU Langone Health vaccine expert Dr. Arthur Caplan said vaccines are “a pain in the neck” because unlike other pharmaceutical products, they rely on incubating biological ingredients.
“Sometimes what you’re trying to grow in an incubator doesn’t grow well, and you don’t know why. Historically, vaccine rollouts ... have had some delay because the factory gets in trouble,” Caplan said.
Baylor College of Medicine’s Dr. Peter Hotez, another top vaccine expert, said the current demand is pushing the limits of manufacturing a brand new technology, messenger RNA, at scale.
“We knew the mRNA vaccines were not going to be the workhorse of this epidemic. It’s a new technology, it doesn’t have that capacity for scale like other technologies do,” Hotez said.
But some experts point to the ability to tweak mRNA vaccines more quickly, which has less biological-dependent processes — increasingly important as variants spread throughout the country— as a key benefit of the platform.
The White House COVID-19 Response Team’s latest briefing saw officials focus on leveraging the DPA to provide critical components, instead of actual vaccine production.
National supply chain coordinator Tim Manning said Friday the DPA can, through a priority rating, route supplies to a company.
“That means that...a vaccine manufacturer gets first access to the product they need before anyone else,” Manning said.
Pivot to supplies
The team is starting with ensuring supplies and components are manufactured for Pfizer (PFE) to help ramp up production. That includes filling pumps and filtration systems.
The company had previously touted its refusal to accept Operation Warp Speed funding to develop its vaccines, but it did use help from the Trump administration for distribution and supplies.
The DPA was used “in the last days of the Trump administration” to prioritize components for the company’s vaccine production, White House officials said Friday.
This, according to Response Team coordinator Andy Slavitt, is why the company was able to recently announce a ramp up in production.
Pfizer declined multiple requests to comment on the details of the aid from the federal government. Meanwhile, the White House team has only revealed some details.
Caplan said that was one shortfall of the Trump administration, which did not push enough for domestic production of things like glass vials and syringes.
Slavitt also noted that should the U.S. Food and Drug Administration (FDA) authorize Johnson & Johnson’s (JNJ) vaccine, “every option is on the table” to increase production of the one-shot dose.
J&J filed for emergency use authorization Thursday, and a vaccine advisory committee meeting is scheduled for February 26 for independent experts to consider recommending approval or rejection of the application.
But whether the use of the Korean War–era rule will escalate to the point of compelling pharmaceutical competitors to produce vaccines remains unclear.
The administration has also discussed using the DPA to produce accessories like syringes, vials and other needs to support vaccine distribution. The White House COVID-19 Response Team noted FEMA is allocating $1 billion to support states through reimbursements dating back to last year, as well as storage and transportation costs — such as the cost of ultra-cold freezers.
On Friday, White House officials also announced that protective gear, like masks and gloves, will be produced by several contracted manufacturers. The companies contracted to do so have not yet been revealed, but officials said they will be once the contracts are in place.
State by state
For some, the vaccine rollout has led to what some experts are calling a “Darwinian” struggle. Some Americans have taken to staking out pharmacies and grocery stores, while others are confused or left out as appointments have relied heavily on tech-savviness.
“Every state does its own thing, which is crazy. And I don’t know any way to fix it,” Harvard’s Bloom said o the U.S.’s 64 different jurisdictions — states, tribal nations and territories — running the show locally.
Daily reports of missteps— a freezer breakdown leading to a rush to vaccinate before vials expired in Washington and a disproportionate uptake of vaccines in diverse metros like New York City— show just how chaotic the U.S. vaccine rollout has been.
Politico reported that the U.S. is unable to track about 20 million doses, and the Biden administration has been struggling to get a handle on the prior administration’s actions and strategy.
“I think we’re going to be dealing with ... chaotic distribution for a while,” NYU Langone’s Caplan said.
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