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 U.S. Food and Drug Administration authorized Pfizer’s drug for people age 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 such as obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems. Children must weigh at least 88 pounds to be eligible for the drug.
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 Paxlovid 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 areas. Pfizer said the small supply is due to the time it takes to manufacture the pills — about nine months. It’s working on halving that.
The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer said it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.
President Biden said the pill marks a “significant step forward in our path out of the pandemic.”
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 infection surges. The U.S. is now reporting more than 140,000 new COVID-19 infections daily and federal officials warn that the omicron variant could send case counts soaring.