The U.S. Food and Drug Administration on Wednesday authorized Pfizer's oral antiviral tablets for the treatment of mild-to-moderate COVID-19, the first pill approved for COVID-19 treatment in the country.
The pill, called Paxlovid, is authorized to use in adults and pediatric patients 12 years of age and older with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, according to the FDA.
Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset, according to the FDA.
The pill is administered as three tablets, two tablets of nirmatrelvir and one tablet of ritonavir, taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.
Data from clinical trials suggest Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88 percent compared to placebo among patients treated within five days of symptom onset, and who did not receive COVID-19 therapeutic monoclonal antibody treatment, according to the FDA.
Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches.
The FDA's decision came as a winter surge in COVID-19 cases, hospitalizations and deaths has been reported nationwide.
"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," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research.
The pill is seen as a major step forward in the fight against the virus.
But health experts are warning that supply will be constrained in the short term, and they called on the Biden administration to take actions such as enlisting other manufacturers to help make it.
The United States is now averaging nearly 150,000 new COVID-19 cases and 1,200 new deaths each day. U.S. hospitals are back at breaking points as the new Omicron variant fuels a new wave.
The surge has strained testing facilities ahead of holidays. People are waiting in long lines to get COVID-19 tests. The Biden administration has launched new COVID-19 test sites to ease growing demand.
The Omicron variant has already taken the hold to become the dominant variant in the United States as more people are traveling and gathering for holidays.
The new variant accounted for 73.2 percent of all COVID-19 cases in the country in the week ending Dec. 18, and has already been found in at least 48 U.S. states, according to the U.S. Centers for Disease Control and Prevention.