[ad_1]
WASHINGTON — According to people familiar with the deal, the Biden administration plans to pay more than $5 billion for Pfizer’s stock of new Covid-19 pills, enough for nearly 10 million treatment courses over the next 10 months, according to people familiar with the deal.
Senior federal health officials trust the drug will be a powerful weapon against Covid. When the drug was given promptly to trial groups of high-risk unvaccinated people who developed symptoms of the disease, it significantly reduced the risk of hospitalization and death.
On Tuesday, Pfizer applied for urgent federal authorization of the drug. A similar pill Biotherapeutics developed by Merck and Ridgeback could be licensed as early as December, meaning pharmacies could have limited supply within weeks. Pfizer treatment is taken as a 30-pill regimen for five days; Merck’s requires 40 pills for five days.
Antiviral drugs have sparked hope among senior management officials that the United States can lessen the devastating toll from the Delta variant and its predecessors. Some experts believe the worst of the coronavirus pandemic is over in the country, partly because more than four in five Americans aged 12 and older are at least partially vaccinated.
Others say infection rates have only remained stable and can easily recover, especially with the onset of winter. After falling for more than a month, average daily cases began to creep up.
Associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “I think these new oral antivirals will change the way Covid is managed,” said David Dowdy.
“These will help reduce the burden on hospitals and the death toll,” he said, but added that “even without these pills, those numbers would drop.”
Antiviral drugs are a new class of treatment for Covid that is expected to eventually reach far more patients than any other. Monoclonal antibody treatments typically require infusions, which are usually given in outpatient clinics. In contrast, antiviral pills are intended to be bought from pharmacies and taken orally at home.
Their promise is due, in part, to access to rapid over-the-counter testing, because the pills have been proven to work in five days or less after symptoms develop. While the government has committed $3 billion to rapid tests and the Food and Drug Administration has approved a dozen of them, a test usually costs around $12 and not everyone can easily get one.
Federal officials estimate that one of the newest rapid tests will cost $7 and total supply by the end of the year will be about 10 times what it was in August.
A senior scientist at the Johns Hopkins Center for Health Security, Dr. “You have more accessibility and more onlineness,” said Amesh A. Adalja.
“But they’re still not used to their full potential,” he added, adding that “rapid testing will be critical for these antiviral tests.”
A much bigger hurdle is likely to be usability, at least initially. By March, most of the government’s supply of antiviral pills is expected to come from Merck. there is government ordered nearly three million treatment courses from the company, with two million more options, about $700 per person.
While Pfizer says it expects to produce enough pills for more than 180,000 people by the end of the year, the vast majority of the treatments it will provide to the federal government are expected from March to September.
This means that the drug, which appears to be less effective in studies, will be more abundant at first. The Pfizer pill reduces the risk of hospitalization or death by 89 percent when given within three days of the onset of symptoms. The Merck pill was only 50 percent effective when given within five days of the onset of symptoms, but the different designs and timing of clinical trials did not conclusive the comparisons.
Both drugs are intended for people who are older than 65 or have medical conditions that put them at serious risk of Covid. Pfizer has only shown the treatment’s effectiveness in high-risk unvaccinated people, although officials say the company may provide more data later as clinical trials progress. A company spokesperson, Kit Longley, said that demand could be expanded at a later time, depending on what clinical trials show. It is up to the Food and Drug Administration to decide which groups are eligible to take the pill.
Merck, which applied for a license for the drug Last month, he said the agency would decide whether to authorize the unvaccinated as well as the vaccinated. A panel of experts who advise the Food and Drug Administration on antimicrobial drugs meeting is scheduled See you at the end of the month to discuss Merck’s medicine.
Dr. “I think it’s a powerful new tool for keeping people alive and out of the hospital,” Dowdy said. “But the people who will get these are people who can be diagnosed quickly and are at enough risk for someone to think they might need to go to the hospital.”
Pfizer and Merck plan to increase production next year. Pfizer said it expects 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 UK have already snatched some of the supply. Pfizer said on Tuesday had an agreement Allowing other manufacturers to make and sell the pills cheaply for use in 95 developing countries.
The US government had originally planned to order 1.7 million Pfizer treatment courses with an additional 3.3 million options for approximately $700 per course. But with the contract for 10 million treatments, the cost is expected to be significantly lower—perhaps $180 less per treatment.
The contract is yet to be finalized, but an announcement is expected this week.
[ad_2]
Source link