Easy-to-take antiviral pills, authorized just before Christmas, were hailed as a potential turning point in the fight against the coronavirus because of the medicines’ ability to keep high-risk people out of the hospital.
“I don’t think they’ll end up being the game changers we want them to be,” because of scant supply, said Shelley Schmidt, a critical care physician and pulmonologist in Grand Rapids, Mich., who doesn’t expect to have access to the antiviral pills until mid-January.
President Biden acknowledged the drugs’ scarcity in his remarks on the omicron surge Tuesday, but said the government was doubling its order of Pfizer’s antiviral to 20 million treatment courses this year, which would be distributed as the drug is manufactured.
“Due to the complex chemistry . . .to make the pill, it takes months literally to make a pill, " he said. But he stressed the medication is “already saving lives.”
That impact hasn’t been felt yet in Grand Rapids. Schmidt said hospital admissions for covid-19 are mounting in Spectrum Health’s Blodgett and Butterworth hospitals, where she treats patients — with the unvaccinated accounting for most of the severe infections. She worries that the efficacy of the antiviral pills may also be limited by the narrow window for their use. Many people don’t seek treatment until they are experiencing severe symptoms, she said, and by that time it is often too late to prescribe the antivirals, which must be taken within a few days of the first symptoms.
“We’re seeing our patients really gasping their last breaths of life,” Schmidt said. “These are healthy people in their 30s, 40s and 50s. We are in the room when they are on their FaceTime phone call with their spouse, telling them that they’re the love of their life and apologizing.”
She added that physicians are “always happy for any help we can get, but it’s very hard to get these early therapies into the regular population.”
In late December, the Food and Drug Administration granted emergency use authorization for the two antiviral drugs — Pfizer’s Paxlovid and Merck and Ridgeback Biotherapeutics’s molnupiravir — as omicron began to overtake delta as the most prominent variant of the novel coronavirus in many parts of the country. The antiviral pills, alongside the monoclonal antibody sotrovimab, are among the few outpatient treatments shown to be effective against the omicron variant.
Although the government has already purchased 10 million courses of Paxlovid and 3 million of molnupiravir — and has distributed 365,000 so far — the national supply of the antiviral pills will be low for several weeks as the drug companies ramp up production.
About 65,000 courses of Paxlovid, which reduced hospitalizations and death for high-risk people with covid-19 by nearly 90 percent in clinical trials, have been distributed to states on the basis of a population formula.
Populous states such as California, Texas and Florida received thousands of courses, and many less-populous states, such as Wyoming and Vermont, received proportionally fewer, in some cases fewer than 150 units. Each treatment course contains 30 tablets to be taken over five days.
Distribution of molnupiravir has been similarly limited, with about 300,000 courses being split among states according to population. The FDA authorized molnupiravir as another at-home treatment option for high-risk patients if alternatives are unavailable. Molnupiravir works by causing mutations to the virus, sparking concerns the drug could trigger the creation of new variants or potentially cause mutations in the cells of people who take it. In addition, the results from a clinical trial fell short of expectations. Still, the drug reduced hospitalizations and deaths by about 30 percent when given within five days of symptom onset.
Ralph Rogers, an infectious-disease physician in Rhode Island who specializes in the care of immunocompromised patients, is among the lucky doctors who managed to get access to the new drugs.
Rogers’s patients, many of whom have received organ transplants and take medications to suppress their immune systems, have a much higher risk of developing severe covid-19 that could result in hospitalization or death. He said he has prescribed Pfizer’s Paxlovid to several of them.
But the supply of the pills cannot keep up with demand. When Rogers tried to place an order for Paxlovid on Monday morning, the pharmacies that had been dispensing the drug last week were out of stock.
Senate Majority Leader Charles E. Schumer (D-N.Y.) on Sunday urged the federal government to prioritize states that are experiencing sharp increases in coronavirus infections and hospitalizations rather than distributing the pills according to population formulas.
“Right now, New York will not have enough of these pills to meet the health demand,” Schumer said at a news conference. “The pills should go where the surges are.”
The federal government distributed the antiviral medications on a pro rata basis to “simplify distribution and provide baseline coverage nationwide,” a spokeswoman for the U.S. Department of Health and Human Services said in an email. The agency also provided the drugs to 200 federally funded community health centers to ensure some supply reaches people in the most vulnerable communities in all 50 states. Officials will continue to evaluate those plans, she said.
Given the limited supply, Rogers said doctors must decide who stands to benefit the most from the pills, which must be given within five days of the onset of symptoms.
Patients over 65, those with underlying conditions such as obesity, and those who are immunocompromised are obvious candidates, he said. But some otherwise healthy people — especially those who are unvaccinated — also may develop severe infections.
“It’d be great if we could wait and see and if they get worse,” Rogers said, “but the treatment is really most effective when it’s given early.”
State health departments determine where to allocate their share of the pills — with most opting to make the drugs available through select pharmacies by prescription.
In Ohio, any physician can order the drugs for a high-risk patient and the medication will be dispensed through the same network of providers that handles monoclonal antibodies, a spokeswoman said in an email. New York will ship pills to community pharmacies, including a single location in New York City that will deliver the medication to patients’ homes in all five of the city’s boroughs.
But Maryland health officials said on Monday that because of shipping delays, they have received only a small portion of their allotment so far.
“Stretching out the supply is less of a problem than getting the products on the shelves of pharmacies,” said health department spokesman Andy Owen.
Pfizer spokesman Kit Longley said the company expected to produce more than 180,000 courses of Paxlovid by the end of last year and up to 120 million courses by the end of 2022. Pfizer must complete a multistep process of five to six months’ duration to produce the active pharmaceutical ingredient in its pills.
The first packs of Paxlovid were shipped from Pfizer’s distribution center in Memphis beginning on Dec. 23, shortly after the FDA authorized the drug. Hundreds of thousands of packs will be shipped in early 2022, Longley said.
Merck provided hundreds of thousands of molnupiravir courses to the federal government in the last days of 2021, said company spokeswoman Melissa Moody. Production will ramp up to make 1 million courses over the next few weeks, she added.
Public health experts have continued to emphasize that coronavirus vaccines and booster shots remain the most effective way to prevent severe infection and death in most people.
“We shouldn’t lose sight of the fact that covid vaccines are readily accessible and available,” said Alex Varkey, the director of pharmacy services at Houston Methodist in Texas. “Vaccination is effective at preventing severe illness and death, and we are still seeing that, even with the omicron variant.”
The new antiviral pills are not the only prevention and early treatment options for people at a heightened risk of developing severe covid-19, but they are the only therapy that can be taken at home.
This week, the federal government also is providing about 50,000 courses of AstraZeneca’s monoclonal antibody Evusheld, which was authorized by the FDA last month for prevention of covid-19 in immunocompromised individuals who have had bad reactions to vaccines or cannot mount a response from vaccination. Nearly 50,000 units of GlaxoSmithKline’s monoclonal antibody sotrovimab will be made available to states this week.
In places where omicron has not fully overtaken delta, the federal government is still shipping Regeneron and Eli Lilly’s monoclonal antibodies, which are effective against other virus variants. All of those monoclonal antibodies are given intravenously in a hospital setting.
Another option is Remdesivir, which has been used for inpatient treatment and recently has shown promise in preventing hospitalizations if given shortly after symptoms develop, but the drug must be administered in a clinical setting.
If those treatment options, including the antiviral pills, become more readily available in coming weeks, some places may be able to stave off the worst effects of the winter surge. Although omicron has caused up to 88 percent of cases in parts of the northeast, according to data tracked by the Centers for Disease Control and Prevention, the delta variant still accounts for more cases in other areas of the country
“For parts of the country that have not seen a surge yet, [the antiviral drugs] could really, really blunt the impact,” said Nicole Iovine, an infectious-disease physician and chief epidemiologist for University of Florida Health in Gainesville. “And that’s really important, because we want to keep people from getting into the hospital.”
She said that she and her colleagues could not yet prescribe the antiviral pills but that she expected doctors to get access to them within days.
“They can’t come soon enough,” Iovine said. “It’s just a matter of if we can get these drugs out and to people in time, before omicron really takes over the entire country.”
Yasmeen Abutaleb contributed to this report.
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