The Food and Drug Administration authorized an antiviral drug that has shown to be highly effective at preventing hospitalizations due to COVID-19, making it a powerful tool that could bolster the shaky medical system facing an omicron wave.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The pill from Pfizer, marketed under the name Paxlovid, showed an 89% reduction in hospitalization for patients who received the medicine within three days of symptom onset compared with those who received a placebo. People who took the drug within five days of experiencing symptoms were also 88% less likely to be hospitalized or die due to COVID-19. The drug was tested in adults who are at high risk of severe disease, including seniors and people with underlying health conditions.


The authorization of Paxlovid this late in the year suggests that the Biden administration is racing to forestall a fifth wave that could decimate hospitals already strapped for employees. The federal government preemptively purchased enough courses of the Pfizer medication to treat 10 million patients. A single course of the treatment consists of three pills taken twice daily for five days.

“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19 and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” Pfizer CEO Albert Bourla said Wednesday.

President Joe Biden, facing an exhausted public as the country nears the pandemic’s two-year anniversary, called Wednesday's authorization “a significant step forward in our path out of the pandemic."


Pfizer said Wednesday it is prepared to ship out medications immediately, but supply will be low at first while manufacturing scales up.

"Recognizing that this pill takes time to make given the complex scientific process, production will ramp up in the months ahead," Biden said. "We will have over 250,000 treatment courses available to us in January, and we will be working with states to ensure those are being distributed equitably and fairly and that our hardest-hit communities are reached."

The pharmaceutical company Merck has also asked for emergency use authorization for its antiviral drug, which reduced the risk of hospitalization by 30%. The drug was recommended for authorization by a panel of advisers to the FDA late last month. While the agency has not come out with a decision yet, the drug has been authorized for use in the United Kingdom.

A widely accessible series of pills to be taken at home will be a boon to strained hospitals still dealing with the delta variant. Early signs that omicron causes less severe illness due to either populationwide immunity or lower intrinsic severity have provided the United States with hope. But even mild illness could cause massive disruption to the medical system.

Biden announced a contingency plan on Tuesday to stave off catastrophic damage to the healthcare system in the event that omicron proves as destructive as feared. The White House said it will deploy more than 1,000 military service members to hospitals to help with growing case counts, in addition to the deployment of six emergency response teams to Michigan, Indiana, Wisconsin, Arizona, New Hampshire, and Vermont.