FDA Approves COVID-19 Treatment Pill for Home Use
FOR IMMEDIATE RELEASE:
Dec. 22, 2021
COLUMBIA, S.C. – Today the Food & Drug Administration (FDA) authorized the first orally administered antiviral pill from Pfizer for home use to treat the effects of COVID-19 infections.
The drug, called Paxlovid, was authorized under an Emergency Use Authorization (EUA). Clinical trials showed the pill results in a 90 percent reduction in hospitalizations and deaths among patients most at-risk for severe infections and side effects of Paxlovid are generally mild.
Early supplies are expected to be limited, with only a reported 180,000 treatment courses available worldwide and approximately 60,000 to 70,000 allocated to the United States. The U.S. government already has committed to purchasing enough Pfizer pills to treat 10 million Americans.
An oral medication from Merck is still awaiting FDA authorization, with the government having committed to purchasing enough of it, once approved, to treat three million people. Both pills are expected to be effective against the new omicron variant.
Paxlovid is authorized for use in adults and children ages 12 and over who have a positive COVID-19 test result, early symptoms and face the highest risks of hospitalization. The treatment is meant as a less-expensive alternative to existing biotech drugs such as monoclonal antibodies that are costly, difficult to mass produce and must be administered in a professional healthcare setting.
The best possible method to reduce the risk of contracting COVID-19 or have an infection that results in hospitalization or death is to get fully vaccinated, get a booster shot and practice measures proven to be effective such as social distancing and wearing a mask when indoors in public places.