WASHINGTON – Biden management plans to pay more than $ 5 billion for stock of Pfizer’s new Covid-19 pill, enough for about 10 million courses of treatment to be delivered in the next 10 months, according to people familiar with the deal .
Senior federal health officials estimate the drug will be a powerful weapon against Covid. If given promptly to trial groups of at-risk unvaccinated people who had developed symptoms of the disease, the drug sharply reduced the risk of hospitalization and death.
Pfizer on Tuesday applied for federal authorization of the drug on an emergency basis. A similar pill developed by Merck and Ridgeback Biotherapeutics could be authorized immediately in early December, meaning pharmacies could have limited supplies for weeks. Pfizer treatment is taken as a 30-pill regimen for five days; Merck’s requires 40 pills for five days.
The antiviral drugs have helped inspire hope among senior administrative officials that the U.S. will be able to curb the devastating number of the Delta variant and its predecessors. Some experts believe the worst of the coronavirus pandemic has passed in the country, in part because more than four out of every five Americans age 12 and older are at least partially vaccinated.
Others say rates of infection have simply soared and could easily rebound, especially with the onset of winter. After declining for more than a month, the daily average of cases began to creep in. Over the past week, an analysis by the New York Times shows, an average of approximately 85,800 coronavirus cases were reported daily in the United States, an increase of 18 percent than two weeks ago. The number of deaths, a late indicator, is declining by 15 percent, to an average of nearly 1,100 deaths a day.
“I do think these new oral antivirals will change the way Covid is administered,” said Dr. David Dowdy, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.
“These will help reduce burden on hospitals and the number of deaths,” he said, but he added that “even without these pills, those numbers are declining.”
The antiviral drugs are a new class of treatment for Covid that ultimately expects far more patients than others have. Monoclonal antibody treatments typically require infusions, usually given in outpatient clinics. Antiviral pills, by comparison, are intended to be taken in pharmacies and taken orally at home.
Their promise depends in part on access to rapid over-the-counter tests, as the pills have been shown to work in five days or less after symptoms develop. While the government has promised $ 3 billion for rapid tests and the Food and Drug Administration has removed a dozen of them, a test usually costs around $ 12 and not everyone can easily get one.
However, one of the newest speed tests costs $ 7, and by the end of the year, the general supply is forecast nearly 10 times than it was in August, federal officials said.
“You do have more availability and more online,” said Dr. Amesh A. Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
“But they are not yet being used to their full potential,” he added, and “rapid testing will be critical for those antivirus tests.”
A much bigger obstacle, at least initially, is likely to be availability. Merck is expected to deliver enough courses to cover just over three million people by February. Pfizer is expected to provide enough to cover about 300,000 people by the end of February, then to sharply increase deliveries.
This means that the drug, which seemed less effective in studies, will initially be more abundant. The Pfizer pill has reduced the risk of hospitalization or death by 89 percent when given within three days of the onset of symptoms. The Merck pill was only about 50 percent effective when given within five days of the onset of symptoms, although the different designs and timing of the clinical trials make comparisons inaccurate.
Both drugs are targeted at people older than 65 or who have diseases that put them at a higher risk of severe Covid. Pfizer presented data showing the effectiveness of the treatment only for unvaccinated people at high risk, although officials said the company could send more data later as clinical trials progress.
Both Pfizer and Merck, who applied for approval of their medication last month, said it would be up to the Food and Drug Administration to decide which groups are eligible to receive the treatments. A panel of experts advising the Food and Drug Administration on antimicrobial medications is scheduled to meet at the end of the month to discuss Merck’s drug.
“I think this is a powerful new tool in terms of keeping people alive and out of the hospital,” Dr. Dowdy said. “But the people who will get these are the people who can be diagnosed quickly and who are at enough risk that someone thinks they might need to go to the hospital.”
Pfizer and Merck plan to increase production over the next year. Pfizer said it expects to be able to produce enough pills to cover more than 21 million people in the first half of next year and 50 million by the end of the year.
Australia and the United Kingdom have already seized some of the supply. Pfizer said on Tuesday it had reached an agreement to allow other manufacturers to make and sell the pills cheaply for use in 95 developing countries.
The U.S. government initially planned to order 1.7 million courses from Pfizer’s healthcare, with an additional option for $ 3.3 million, compared to about $ 700 per course. But under the contract for 10 million treatments, the cost is expected to be significantly lower – perhaps as much as $ 180 less for treatment.
The contract is not yet final, but an announcement is expected this week.