The Food and Drug Administration on Wednesday issued an emergency use authorization for Pfizer’s COVID-19 pill, Paxlovid.
The pill was authorized to treat mild-to-moderate COVID-19 in people aged 12 and older who have tested positive for the viral infection and who are at high risk of severe disease from the virus.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Wednesday in a statement. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
FDA issued an EUA for Paxlovid for the treatment of mild-to-moderate #COVID19 in adults & pediatric patients (age 12 & older weighing at least 40 kg) w/ positive results of direct SARS-CoV-2 testing, and at high risk for progression to severe #COVID19. https://t.co/HVmpdFDJ7r pic.twitter.com/JjqHaKjORY
— U.S. FDA (@US_FDA) December 22, 2021
Pfizer last month announced it was seeking emergency use authorization of Paxlovid, which the company said has been shown to reduce hospitalizations or deaths from COVID-19 by up to 89% among high-risk patients.
>> Related: Pfizer asks FDA for emergency authorization of COVID-19 pill
Officials with Merck have also asked the FDA to authorize emergency use of its antiviral COVID-19 pill, called molnupiravir.
In a statement, officials with the FDA emphasized that the pill “is not a substitute for vaccination.”
“The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death,” officials said. “The FDA urges the public to get vaccinated and receive a booster if eligible.”
>> Related: FDA panel endorses Merck’s COVID-19 pill, molnupiravir
As of Tuesday morning, more than 72% of the U.S. population – 241.1 million people – has gotten at least one dose of any of the available COVID-19 vaccines, according to the Centers for Disease Control and Prevention. Over 61% of Americans, or 204.5 million people, have been fully vaccinated, and more than 30% of those who have been fully vaccinated have gotten booster shots, CDC data shows.
Since the start of the pandemic, officials have reported 51.3 million cases of COVID-19 nationwide, resulting in more than 810,000 deaths, according to a tally from Johns Hopkins University. Globally, 276.4 million cases have been reported, resulting in 5.3 million deaths, according to the university.
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