The Biden administration expects to take a delivery of 4 million courses of COVID-19 treatments by the end of January, including 265,000 courses of Pfizer Inc.’s newly authorized pill, according to officials familiar with the matter — sharply ramping up therapies for the disease as the omicron variant spreads.
Pfizer’s pill was authorized Wednesday by the Food and Drug Administration, and authorization for Merck & Co.’s pill was also expected this week.
The overall group of treatments includes a monoclonal antibody product, pre-exposure preventive drugs for immunocompromised people, and new antiviral pills, the officials said.
The treatments will give doctors a larger arsenal to fight severe coronavirus cases as the U.S. endures another surge of the disease, driven by omicron. Infections are rising nationally, and U.S. President Joe Biden warned Tuesday that while vaccinated Americans might be infected in “large numbers,” they will likely experience only mild cases of the disease while the unvaccinated pay the heaviest price.
The president had given little hint of the coming stockpile of therapies, instead pleading with Americans to get vaccinated in order to all but eliminate the risk of contracting severe COVID-19 in the first place.
“Those who are not vaccinated are causing hospitals to become overrun again,” the president said in a speech warning about the omicron variant. “This is a critical moment. We also have more tools than we’ve ever had before. We’re ready. We’ll get through this.”
Omicron has rapidly become the dominant strain in the U.S., accounting for 73% of new cases the week ending Dec. 18, according to the Centers for Disease Control and Prevention.
The seven-day moving average of U.S. cases is 149,000, more than double that from two weeks earlier, data from the CDC show. New hospital admissions have leveled off, but are rising in New York, which was worst hit early on by omicron. Biden spoke Tuesday with that state’s governor.
Variety of treatments
The administration has sought to buy a variety of FDA-authorized therapeutics to ensure a mix of effective treatments, part of what the administration is calling its “medicine cabinet,” the officials said. They asked not to be identified because the two antiviral pills had not yet been authorized by regulators when they spoke.
The FDA earlier this month authorized AstraZeneca PLC’s Evusheld, a pre-exposure prevention treatment for the immunocompromised and other people who respond poorly to vaccines. The administration believes that all data so far suggests it works against omicron, the officials said.
The administration also expects to allocate about another 300,000 courses of GlaxoSmithKline PLC’s monoclonal antibody treatment by the end of January — the only such drug they think has shown effectiveness against omicron — and is in talks to purchase 600,000 more, the officials said.
The FDA authorized Pfizer Inc.’s Paxlovid on Wednesday, the first such pill to treat COVID-19 cases. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, called it a “major step forward in the fight against this global pandemic.” The FDA is also expected to soon authorize Merck’s molnupiravir.
The authorizations could come with recommendations on which pills are best suited for different populations. Pfizer’s was cleared for use in people age 12 and up who weigh at least 40 kilograms (88 pounds).
The U.S. now has one — and potentially two — COVID-19 antiviral pills, one preventative treatment and one monoclonal antibody treatment that the administration believes are effective against omicron.
“The nation’s medicine cabinet of treatments gives us more options to protect the American people,” Biden’s COVID-19 response coordinator, Jeff Zients, said at a news briefing Wednesday.
4 million courses
The officials said the U.S. should have nearly 400,000 courses of Merck’s pill available upon its authorization and 65,000 courses of Pfizer’s pill. By the end of January, the government expects to have received a total of about 3 million Merck courses — its entire order — and 265,000 Pfizer courses, Zients said. Merck developed molnupiravir with partner Ridgeback Biotherapeutics LP.
The production of Pfizer’s pill is expected to steadily escalate, with the U.S. receiving its full order of 10 million courses by July, the officials said.
And the U.S. expects nearly a half-million more doses of AstraZeneca’s preventative treatment by the end of January, the people said. Zients also said they’re in talks to order more.
The treatments will be made available for free to states on a per-capita basis, the officials said. At first, Pfizer’s pill will most likely be given out by doctors writing a prescription for someone who is in the first three days of symptoms and is high-risk, Anthony Fauci, Biden’s top medical adviser, said Wednesday.
Some treatments will also be sent to federally qualified health centers in an effort to ensure access to treatments isn’t disproportionate by race or ethnicity, the officials said.
Biden’s administration has offered Pfizer the support of the U.S. government if it runs into any production issues with its pill, including use of wartime powers under the Defense Production Act, the officials said. So far, Pfizer hasn’t needed any intervention, and the biggest hurdle is just the pill’s lengthy, intensive manufacturing process.
“We know the Pfizer team is hard at work, ramping up production, and everyone agrees this is a very promising antiviral and therefore we want to make sure production is ramped up as quickly as possible,” Zients said.
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