The Food and Drug Administration authorized Pfizer's antiviral Covid-19 pill Wednesday for individuals 12 years of age and older who test positive and are at high risk of developing a severe case of the virus.
The announcement marks a significant development in the pandemic response, allowing Americans who contract Covid-19 to take a pill at home to prevent hospitalization and death.
The pill, called Paxlovid, will provide the U.S. with another tool to help fight the virus as the more infectious Omicron variant surges, now accounting for more than 70 percent of all infections in the country, according to data collected by the Centers for Disease Control and Prevention. Top Biden health officials warned this week that infections and hospitalizations are set to rise significantly in January.
“Those who are not vaccinated are causing hospitals to become overrun again,” President Joe Biden said in a speech Tuesday. “This is a critical moment. We also have more tools than we’ve ever had before. We’re ready.”
In clinical trials, Pfizer’s treatment reduced the risk of hospitalization and death by 89 percent when taken three days after the onset of symptoms. Individuals eligible for the pill need a prescription and should begin taking the treatment as soon as possible within five days of the onset of symptoms, the FDA said in a statement Wednesday. The FDA said the Pfizer pill is not a substitute for vaccination in individuals who are eligible for Covid-19 shots and boosters.
“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 Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat Covid-19 at a crucial time in the pandemic as new variants emerge."
The federal government has already purchased 10 million doses of Pfizer’s pill and will begin delivering them over the next several months.
Five major groups representing pharmacists criticized the FDA for authorizing the pill but preventing them from writing prescriptions for it, saying the federal government previously authorized pharmacists to order and dispense oral therapeutics under the Public Readiness and Emergency Preparedness Act.
The FDA is also considering authorizing an antiviral pill from Merck called molnupiravir, which clinical trials showed reduces the risk of hospitalization and death from the virus by 30 percent. That authorization could come through as soon as Wednesday afternoon. If approved, the federal government will soon begin distributing the more than 3.1 million doses it already purchased from Merck.