The FDA Has Authorized The First Covid-19 Pill For Adults & Children 12 & Up
“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.”
The federal Food and Drug Administration (FDA) authorized the first Covid-19 antiviral pill for prescribed use in adults and children ages 12 and up on Wednesday. The regulatory body has granted an emergency use authorization for Pfizer’s Paxlovid, an orally injected pill used to prevent the progression of serious illness in those with mild to moderate cases of Covid-19.
“Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,” Pfizer Chairman and CEO Albert Bourla said in a statement celebrating the FDA’s authorization. “Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible.”
According to the pharmaceutical company, Paxlovid has been authorized for the treatment of mild to moderate Covid-19 in adults and children 12 years of age or older who weigh at least 88 pounds. The antiviral will only be available via prescription and is not authorized for use as a pre-or-post-exposure prevention strategy. Instead, the drug is intended only for those with a positive Covid-19 test who are at risk of seeing their illness progress to more a serious stage that could require hospitalization or even lead to death.
“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,” Bourla said.
Early studies showed Paxlovid, which works to block activity from the main protease enzyme coronavirus uses to replicate, reduced the risk of hospitalization or death by 89%. What’s more, early studies reported no deaths through 28 days of monitoring in patients who were given Paxlovid compared to 19 deaths in patients that were not treated with the antiviral.
But the FDA has stressed that Paxlovid is not meant to serve as a substitution for Covid-19 vaccines, which can help prevent infection. “Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended,” the agency noted when announcing its authorization of the antiviral. “The FDA urges the public to get vaccinated and receive a booster if eligible.”
Still, the FDA has hailed Paxlovid as “a major step forward in the fight against this global pandemic. “This authorization provides a new tool to combat Covid-19 at a crucial time in the pandemic as new variants emerge,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement issued by the agency Wednesday. “And [it] promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe Covid-19.”