WASHINGTON (AP) — As more doctors prescribe Pfizer’s powerful COVID-19 pill, new questions are emerging about its performance, including why a small number of patients appear to relapse after taking the drug.

Paxlovid has become the go-to option against COVID-19 because of its at-home convenience and impressive results in heading off severe disease. The U.S. government has spent more than $10 billion to purchase enough pills to treat 20 million people.

But experts say there is still much to be learned about the drug, which was authorized in December for adults at high risk of severe COVID-19 based on a study in which 1,000 adults received the medication.

WHY DO SOME PATIENTS SEEM TO RELAPSE?

Doctors have started reporting rare cases of patients whose symptoms return several days after completing Paxlovid’s five-day regimen of pills. That’s prompted questions about whether those patients are still contagious and should receive a second course of Paxlovid.

Last week, the Food and Drug Administration weighed in. It advised against a second round because there’s little risk of severe disease or hospitalization among patients who relapse.

Dr. Michael Charness reported last month on a 71-year-old vaccinated patient who saw his symptoms subside but then return, along with a spike in virus levels nine days into his illness.

Charness says Paxlovid remains a highly effective drug, but he wonders if it might be less potent against the current omicron variant. The $500 drug treatment was tested and OK’d based on its performance against the delta version of the coronavirus.

“The ability to clear the virus after it’s suppressed may be different from omicron to delta, especially for vaccinated people,” said Charness, who works for Boston’s VA health system.

Could some people just be susceptible to a relapse? Both the FDA and Pfizer point out that 1% to 2% of people in Pfizer’s original study saw their virus levels rebound after 10 days. The rate was about the same among people taking the drug or dummy pills, “so it is unclear at this point that this is related to drug treatment,” the FDA stated.

Some experts point to another possibility: The Paxlovid dose isn’t strong enough to fully suppress the virus. Andy Pekosz of Johns Hopkins University worries that could spur mutations that are resistant to the drug.

“We should really make sure we’re dosing Paxlovid appropriately because I would hate to lose it right now,” said Pekosz, a virologist. “This is one of the essential tools we have to help us turn the corner on the pandemic.”

HOW WELL DOES PAXLOVID WORK IN VACCINATED PEOPLE?

Pfizer tested Paxlovid in the highest-risk patients: unvaccinated adults with no prior COVID-19 infection and other health problems, such as heart disease and diabetes. The drug reduced their risk of hospitalization and death from 7% to 1%.

But that doesn’t reflect the vast majority of Americans today, where 89% of adults have had at least one shot. And roughly 60% of Americans have been infected with the virus at some point.

“That’s the population I care about in 2022 because that’s who we’re seeing — vaccinated people with COVID — so do they benefit?” asked Dr. David Boulware, a University of Minnesota researcher and physician.

There’s no clear answer yet for vaccinated Americans, who already have a hospitalization rate far below 1%.

That may come from a large, ongoing Pfizer study that includes high-risk vaccinated people. No results have been published; the study is expected to wrap up in the fall.

Pfizer said last year that initial results showed Paxlovid failed to meet the study’s goals of significantly resolving symptoms and reducing hospitalizations. It recently stopped enrolling anyone who’s received a vaccination or booster in the past year, a change Boulware says suggests those patients aren’t benefitting.

At a minimum, the preliminary data should be released to federal officials, Boulware said. “If the U.S. government is spending billions of dollars on this medicine, what’s the obligation to release that data so that they can formulate a good policy?”

CAN PAXLOVID BE USED TO HELP PREVENT COVID-19 INFECTION?

Pfizer recently reported that proactively giving Paxlovid to family members of people infected with COVID-19 didn’t significantly reduce their chances of catching it. But that’s not the end of the story. Pfizer is studying several other potential benefits of early use, including whether Paxlovid reduces the length and severity of COVID-19 among households.

“It’s a high bar to protect against infection but I’d love to see data on how Paxlovid did against severe disease because it may be more effective there,” said Pekosz.

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WASHINGTON (AP) — U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus.

The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”

The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).

The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. The company said it expects to have 250,000 available in the U.S. by the end of January.

Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.

The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.

President Joe Biden said the pill marks a “significant step forward in our path out of the pandemic” and said his administration will work with states to ensure equitable distribution.

Health experts agree that vaccination remains the best way to protect against COVID-19. But with roughly 40 million American adults still unvaccinated, effective drugs will be critical to blunting the current and future waves of infection.

The U.S. is now reporting more than 140,000 new infections daily and federal officials warn that the omicron variant could send case counts soaring. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.

Against that backdrop, experts warn that Paxlovid’s initial impact could be limited.

For more than a year, biotech-engineered antibody drugs have been the go-to treatments for COVID-19. But they are expensive, hard to produce and require an injection or infusion, typically given at a hospital or clinic. Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.

Pfizer’s pill comes with its own challenges.

Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only proven effective if given within five days of symptoms appearing. With testing supplies stretched, experts worry it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription within that narrow window.

“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.

The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.

The U.S. will pay about $500 for each course of Pfizer’s treatment, which consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.

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