WASHINGTON (AP) — U.S. health regulators on Thursday authorized the second pill against COVID-19, providing another easy-to-use medication to battle the rising tide of omicron infections.

The Food and Drug Administration announcement on Merck’s molnupiravir comes one day after the agency cleared a competing drug from Pfizer.

Pfizer’s pill, Paxlovid, is likely to become the first-choice treatment against the virus, because of its superior benefits and milder side effects.

As a result, Merck’s pill is expected to have a lesser role against the pandemic than predicted just a few weeks ago. Its ability to head off severe COVID-19 is much smaller than initially announced and the drug label will warn of serious safety issues, including the potential for birth defects.

Both treatments will be free to patients in the U.S. after being purchased by the federal government.

The FDA authorized Merck’s drug for adults with a positive COVID-19 test, early symptoms and who face the highest risks of hospitalization, including older people and those with conditions like obesity and heart disease.

The agency said molnupiravir should be considered for patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.” It did not include that restriction for Paxlovid, which was authorized for patients 12 and older.

Molnupiravir, made by Merck and Ridgeback Biotherapeutics, also will carry a warning against use during pregnancy. Women of childbearing age should use birth control during treatment and for a few days after while men should use birth control for at least three months after their final dose, the FDA said. The federal agency also said molnupiravir should not be used in patients under age 18 because it may affect bone growth.

Dr. Nick Kartsonis, Merck’s senior vice president of clinical research, said company scientists are still studying the drug and they hope to eventually get it approved for use in children.

The restrictions were expected after an FDA advisory panel only narrowly endorsed the drug last month, warning that its use would have to be strictly tailored to patients who can benefit the most.

Kartsonis said Merck researchers are “very comfortable” with their drug’s safety profile.

He also noted that molnupiravir has been studied in more than a thousand people, and researches saw side effects like diarrhea and nausea in only a small percentage of patients.

“The drug has actually looked very well tolerated,” he said.

Pfizer’s Paxlovid also comes with limitations. Regulators say doctors have to consider how it will interact with other medicines a patient may be taking, and they’ve noted it shouldn’t be prescribed to patients with severe liver or kidney problems.

Both treatments also should be started within five days of the beginning of symptoms, a deadline that puts pressure on patients to get tested and diagnosed quickly.

The two pills work differently and Pfizer’s doesn’t carry the same risks. Additionally, Pfizer’s drug was roughly three times more effective in testing, reducing hospitalization and death by nearly 90% among high-risk patients, compared with 30% for Merck’s.

Some experts question whether there will be much of a role for the Merck drug in the U.S.

“To the extent that there’s an ample supply of Pfizer’s pill, I think it won’t be used,” said Dr. Gregory Poland of the Mayo Clinic, referring to the Merck drug. “There would be no reason, given it has less efficacy and a higher risk of side effects.”

For now, the FDA decision provides another potential option against the virus that has killed more than 800,000 Americans, even as health officials brace for record-setting cases, hospitalizations and deaths driven by the omicron variant.

The seven-day rolling average for U.S. COVID-19 cases climbed past 160,000 Wednesday, according to data collected by Johns Hopkins University. That’s more than double the average in late November.

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

Researchers have warned that older COVID-19 treatments that are administered by IV are unlikely to work against the new strain.

The FDA based its Merck decision on results showing nearly 7% of patients taking the drug ended up in the hospital and one died at the end of 30 days. That compared with 10% of patients hospitalized who were taking the placebo and nine deaths.

Merck says several hundred thousand treatment courses will be available in the U.S. in the next several days and a million will be available over the next few weeks. The supply of Pfizer’s drug is more limited before ramping up in 2022.

The U.S. will pay about $700 for each course of Merck’s drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King’s College London estimated it costs about $18 to make each 40-pill course of treatment.

Merck’s drug inserts tiny errors into the coronavirus’ genetic code to slow its reproduction. That genetic effect has raised concerns that the drug could cause mutations in human fetuses and even spur more virulent strains of the virus. But FDA scientists said the variant risk is largely theoretical because people take the drug for such a short period of time.

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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. 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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Associated Press writer Tom Murphy contributed to this report.

MATTHEW PERRONE | AP News

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