The US Food and Drug Administration approved Paxlovid, a Pfizer antiviral tablet, to treat Covid-19 on Wednesday.
This is the first antiviral Covid-19 pill that may be taken at home by sick people before they need to be admitted to the hospital.
This treatment is only available to high-risk patients aged 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test. They must be recommended by a doctor.
According to an FDA statement, the pill “should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset.”
Paxlovid is a five-day treatment that combines a novel antiviral medicine called nirmatrelvir with an older one called ritonavir. It is taken as three pills twice a day for five days.
Pfizer revealed new results this week showing that if administered to high-risk patients within a few days after their initial symptoms, the medication reduced the chance of hospitalisation or death by 89 percent. The efficacy was similar when given within the first five days of symptoms: 88 %.
“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. 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,” Pfizer Chairman and CEO Albert Bourla said in a statement. “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.”
The Biden administration said in November that it will spend $5.295 billion on 10 million treatment courses. Pfizer’s “promising findings” encouraged President Biden, who said the medicine will “mark a significant step forward in our path out of the pandemic.”
Paxlovid, he said, is a “potentially powerful tool in our fight against the virus, including the Omicron variant,” but getting vaccinated and getting a booster dose are still “the most important tools we have to save lives.”
Paxlovid is not for Covid-19 pre- or post-exposure prophylaxis, according to the FDA, and “is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
Merck has also filed emergency use authorization for molnupiravir, an antiviral medication. After statistics indicated it reduced the risk of hospitalisation or death by 30% among high-risk adults, FDA experts narrowly approved it in a 13-10 vote at the end of November. This was lower than an earlier estimate that suggested the figure may be near 50%. The FDA has yet to decide whether or not to approve the treatment.
The only antiviral licenced by the FDA for the treatment of Covid-19 is Remdesivir, which is sold under the brand name Veklury. It is administered intravenously rather than as a tablet to be eaten at home.