WASHINGTON — US health regulators authorize 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 US 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, cheaper 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,” says 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 authorizes 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. 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.