Supply shortage of new antiviral drug threatens fight against omicron

A new pill from Pfizer to treat COVID-19 has been hailed as a game-changer that can drastically cut down the number of hospitalizations and deaths from the disease. 

But demand for the treatment, known as Paxlovid, is expected to far outrun supply, blunting its ability to help fight what medical professionals say is an oncoming wave of infections from the omicron variant. 

Experts are calling on the Biden administration to take action to help increase manufacturing capacity by enlisting additional companies to help Pfizer make the doses. 

“I think we should be doing everything we can,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center. “This requires a full court press.”

He noted that Merck is helping make the Johnson & Johnson vaccine, a model that could be applied to therapeutics like the Pfizer pill as well. 

But so far, he said, “I have not seen any aggressive push or attempt to access existing manufacturing capacity in the U.S. or globally to date around therapeutics.”

Pfizer says it expects to have 180,000 courses of the treatment available by the end of 2021, with 30 million available globally in the first half of 2022, rising to 80 million by the end of next year. 

But with about 120,000 new COVID-19 cases every day and rising just in the United States, the demand for the antiviral product is spiking sharply. 

“It’s kind of a drop in the bucket in the short term,” said David Boulware, an infectious disease expert at the University of Minnesota. 

“There’s definitely going to be a shortage,” he added. “People have this expectation of ‘Oh yeah, I’m just going to go get this Paxlovid.’ That’s not going to happen [at least in the next few months].”

Experts said the initial authorization could be restricted to the most high-risk groups, like unvaccinated people and the immunocompromised.  

The product from Pfizer has the potential to blunt the damage from the pandemic if it is made widely available. Trial data released by Pfizer earlier this week showed that Paxlovid reduced the risk of hospitalization or death from COVID-19 by 89 percent in high-risk adults. 

The treatment must first be authorized by the Food and Drug Administration before it becomes available, but that could happen soon. 

President Biden released a statement praising the treatment this week after the trial results were published, though he also appeared to reference the need to ramp up supply. 

“If this treatment is indeed authorized — and once the pills are widely available — it will mark a significant step forward in our path out of the pandemic,” Biden said. 

The White House did not have additional comment when asked by The Hill about efforts to increase supply of the pills. 

When asked about the supply of the drug, Pfizer spokeswoman Sharon Castillo said, “We are in discussions with governments around the world regarding supply agreements for PAXLOVID.”

“Pfizer’s goal is to deliver this oral antiviral therapy to patients in need as soon as possible and at an affordable price, subject to country regulatory authorization,” she added. “It is premature to speculate on the specifics of any future agreements as discussions are ongoing.”

The Biden administration in November announced it was buying 10 million courses of the pills, which are to be delivered starting this year and “throughout 2022,” the Department of Health and Human Services said at the time. 

As is still the case with COVID-19 vaccines, supply problems with the Pfizer treatment are likely to be even worse in lower-income countries. 

“Demand is going to be significantly outpacing supply for Paxlovid, even in the U.S., much less the rest of the world,” Udayakumar said.

Peter Maybarduk, access to medicines director at the progressive group Public Citizen, put it more starkly: “We are in for a repeat of the medical apartheid that characterized the vaccine rollout, now for treatments,” he said.  

Pfizer has entered into an agreement with a United Nations-backed organization called the Medicines Patent Pool to grant licenses to allow its COVID-19 treatment to be supplied to 95 lower-income countries, a move that was praised by experts and advocates as an important step. 

But the limitation of that agreement is that it could take several months for production to actually begin, experts said. Udayakumar said he had heard “unofficially” that it could be the second half of 2022 before there is any production from the Medicine Patents Pool agreements.  

The expert added that the U.S. could do more to help stand up manufacturing capacity for the treatment in other countries. 

The bright side is that pills like Paxlovid are easier to produce than the complex mRNA vaccines, which experts said should make efforts to boost manufacturing more feasible. 

A complication, though, is that the Pfizer treatment is intended to be started within five days of the onset of symptoms. That means it will be key to have enough tests and fast turnaround times to allow people to know they have COVID-19 so that they can set up treatment.  

Not everyone who gets the virus will need the treatment. Experts say that young, healthy people will likely be able to get by on their own with generally mild cases. But if supply ramps up enough, there could be a large market, experts said, moving beyond the unvaccinated and the immunocompromised to large groups like the elderly. 

“To treat with these oral therapeutics requires adequate testing, and that’s a place where we’re really falling down almost everywhere in the world, including the U.S.,” Udayakumar said. 

If the treatment becomes widespread, though, it could have a major impact. 

“If you have an oral antiviral that can keep people out of the hospital, and keep them from dying, that’s a major path-breaking advance,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “It’s evidence of the fact that we are going to get to a point where this virus becomes tame.”

But for now, he said, “it is going to be something that’s probably going to be supply constrained in the very beginning.” 

“And that’s going to blunt the impact that it has early on,” he added. “But hopefully they’ll be able to start to meet demand to be able to have it become ubiquitous.”