This is the first Covid-19 antiviral pill approved for sick people to take home before they get sick enough to be hospitalized.
High-risk individuals 12 years of age and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test are eligible for this treatment and must have it prescribed by a physician.
Paxlovid combines a new antiviral drug called nirmatrelvir and an older one called ritonavir and is administered as three pills given twice daily for five days.
Last week, Pfizer released updated results showing that treatment reduced the risk of hospitalization or death by 89% if given to high-risk adults within a few days of their first symptoms. If given within the first five days with symptoms, the effect was equal: 88%.
“Today’s approval of PAXLOVID represents yet another tremendous example of how science will help us eventually defeat this pandemic, which, even in two years’ time, continues to disrupt and destroy lives around the world. This groundbreaking therapy, which has been shown to reduce significant hospital admissions and deaths and can be taken home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems, “said Pfizer’s chairman and CEO Albert Bourla in a statement. “Pfizer is ready to begin delivery in the United States immediately to help get PAXLOVID into the hands of suitable patients as soon as possible.”
He called Paxlovid a “potentially powerful tool in our fight against the virus, including the Omicron variant,” but stressed that vaccinating and receiving a booster syringe are still “the most important tools we have to save lives.”
The FDA stressed in a statement that Paxlovid is not for pre- or post-exposure prevention of Covid-19 and “is not a substitute for vaccination in individuals as Covid-19 vaccination and a booster dose are recommended.”
Separately, Merck has requested an emergency use permit for its antiviral pill, molnupiravir. It was strongly recommended by FDA advisors in a 13-10 poll in late November after data showed that it reduced the risk of hospitalization or death by 30% among high-risk adults. This was lower than a previous analysis which indicated that the figure could be around 50%. The FDA has not announced whether they will approve the treatment.
Remdesivir, sold under the brand name Veklury, is the only antiviral drug approved by the FDA for the treatment of Covid-19. It is given intravenously, not as a pill that can be taken at home.