As the administration and Pfizer on Tuesday hammered out the final details, the company asked federal regulators to authorize the five-day antiviral pill regimen called Paxlovid. The medication is the second easy-to-take treatment aimed at keeping newly infected people out of the hospital to go before the Food and Drug Administration. The other is by Merck and Ridgeback Biotherapeutics.
Biden aides see both treatments as potential game-changers to help restore a sense of normalcy heading toward the pandemic’s second anniversary and are eager to add them to a still-small collection of treatments for Americans who contract the coronavirus, according to officials who spoke on the condition of anonymity because they were not authorized to discuss the deal. With breakthrough cases rising and 30 percent of adults not fully vaccinated, health officials say the pills will help tame the pandemic by thwarting the virus’s most pernicious effects.
In another important development, Pfizer has agreed to a license-sharing deal that would allow the pill to be manufactured around the globe and sold at lower prices in poor countries. It’s an agreement the company says could give more than half of the world’s population access to the treatment, even as Pfizer rebuffs calls to grant poorer countries access to its coronavirus vaccine formula.
“This license is so important because, if authorized or approved, this oral drug is particularly well suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” said Charles Gore, executive director of Medicines Patent Pool, the nonprofit group backed by the United Nations to facilitate global access to lifesaving medicines.
Pfizer announced this month that Paxlovid, when given to people at high risk of severe illness within three days of symptom onset, reduced the rate of death and hospitalization by 89 percent. The clinical trial for the treatment was halted early because of overwhelming evidence that the medication worked.
Pfizer is asking the FDA to authorize the treatment for people who are at increased risk of hospitalization because of age or underlying medical conditions, and the submission will add to a busy holiday season for regulators. The clinical trial did not include people who fell sick after being vaccinated, but the FDA will decide on who is eligible for the drug and how it should be used.
Pfizer is already making the therapy, which, if cleared by the FDA, could be available right away in limited quantities. Pfizer has said it may have enough treatments to cover between 100,000 to 200,000 people by the end of the year and millions more in the first half of next year.
The White House declined to comment. Pfizer said it would not comment on a potential agreement that has not been finalized.
The treatment advances come as coronavirus cases are increasing in many parts of the United States, raising fears among public health officials that the nation could be in for a rough winter. The seven-day rolling average of daily new cases per 100,000 residents rose 18 percent for the week ending Nov. 15, according to The Washington Post’s covid-19 tracker.
The federal government already has committed to buy about 3.1 million courses of the Merck antiviral pill for approximately $2.2 billion, assuming the FDA authorizes the drug, the company has said. That comes to about $700 for each course of treatment. The government also has the option to buy an additional 2 million courses under that contract. An FDA advisory committee is scheduled to meet Nov. 30 to discuss the safety and effectiveness of molnupiravir.
Merck announced in October that its pill reduced the risk of hospitalization and death by nearly half among higher-risk people diagnosed with mild or moderate illness. Some scientists have raised questions about the safety of the Merck product because it inserts errors into the virus’s genetic code to prevent it from replicating. The concerns center on whether that could encourage mutations.
Pfizer’s pill uses a different mechanism — an experimental molecule to block an enzyme that the coronavirus needs to make copies of itself. The Pfizer molecule must be given in combination with ritonavir, an antiviral drug used to treat HIV that helps slow the molecule’s breakdown.
The price for the Pfizer drug will be less than for the Merck pill — closer to $500 per treatment, said a federal official familiar with the negotiations, who spoke on the condition of anonymity because he was not authorized to discuss the issue. However, the details are not finalized, officials said. Originally, the administration planned to buy as many as 5 million courses of the Pfizer treatment but doubled the order when the clinical trial data looked so promising, the official said.
The company has begun manufacturing and packaging the drug in factories in Ireland, Germany and Italy and has projected having 180,000 pill packs available by the end of the year and 50 million in 2022.
Health experts welcomed the new treatments, while emphasizing that vaccination remains the most effective way to curb the pandemic. Vaccines prevent illness, not just treat it, they noted.
On the international front, Pfizer and the Medicines Patent Pool said in a joint statement that the licensing agreement would allow manufacturers to supply countries with about half of the world’s population — and the company would offer tiered pricing based on a country’s ability to pay. Lower-income countries would pay a not-for-profit price.
The fact that a second covid-19 treatment could see wider use through such an agreement is “very good news,” said Ellen ‘t Hoen, director of the research group Medicines Law & Policy.
“This is setting the precedent that if you have a covid-19 countermeasure, you license for wider use,” said ‘t Hoen, who is also a member of an MPP expert advisory group.
Pfizer will also forgo royalties in low-income countries and waive them in others, so long as covid-19 remains an international public health emergency, the statement said.
“Oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” Albert Bourla, Pfizer’s chairman and chief executive, said in a statement.
“We must work to ensure that all people — regardless of where they live or their circumstances — have access to these breakthroughs,” he added.
But experts say that companies such as Pfizer should license their intellectual property on vaccines and provide know-how to countries in the developing world.
Bourla, however, has been a vocal critic of those urging Pfizer to share its vaccine formula, which the company developed with the German firm BioNTech.
Pfizer spokesman Kit Longley defended the company’s approach in a statement this week and raised concerns about the ability of organizations “without a proven track record” to manufacture high-quality vaccines.
“While we pursue our current strategy, we will continue to evaluate whether and where other options may be appropriate,” he said.
While the treatments by Pfizer and Merck are not designed to prevent coronavirus infection, as pill-based drugs, they have certain advantages: They are easier to store and administer than vaccines. They also do not rely on the complicated messenger RNA technology that powers the Pfizer-BioNTech shot.
Both drugs have been studied for use specifically in high-risk individuals. And Britain recently authorized molnupiravir only for patients who are 60 or older or have at least one underlying condition that puts them at risk of developing severe illness from covid-19.
Having a combination of pills available could help prevent the coronavirus from developing a resistance to treatment, said Katherine Seley-Radtke, a chemistry professor at the University of Maryland at Baltimore County.
“If you can stop the replication at several steps or with multiple drugs, you exponentially decrease your chance of the virus developing resistance,” she said.