This is the second Covid-19 antiviral pill allowed for sick people to take at home, before they become so sick that they need to be hospitalized. Merck has an agreement with the US government for the company to supply 3.1 million courses of molnupiravir under this authorization.
Molnupiravir was recommended by FDA advisors in an October 13 vote in late November after data showed it reduced the risk of hospitalization or death in high-risk adults by 30%. This is lower than an earlier analysis that suggested it could be around 50%.
Dr. Eliav Barr, Merck’s senior vice president of global health, told CNN this month that he’s optimistic that the treatment will work with the Omicron variant.
“The Omicron variant is mainly different from other Covids in the mutant protein. Our drug works on a completely different part of the virus. So we are very optimistic that this drug will continue to be effective. against Omicron and we’re working on that right now.”
Paxlovid combines a new antiviral drug called nirmatrelvir and an older one called ritonavir and is taken as three pills, twice a day for five days.
Last week, Pfizer released updated results showing that the treatment reduced the risk of hospitalization or death by 89% if applied to high-risk adults within days of their symptoms. Firstly. If injected within the first five days of symptoms, the same effect: 88%.
“Today’s authorization from PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic that, even two years later, continues to disrupt and wreak havoc on life across the globe.” This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be sent home, will change the way we treat COVID-19 and hopefully will helps relieve some of the significant pressures on our healthcare systems and hospitals,” Pfizer President and CEO Albert Bourla said in a statement. “Pfizer is ready to begin shipping in the United States immediately to help get PAXLOVID into the hands of the right patients as quickly as possible.”
He called Paxlovid a “potentially powerful tool in the fight against viruses, including the Omicron variant”, but stressed that vaccinations and boosters remained “the most important tools we have to have.” there to save lives.”
The FDA stressed in a statement that Paxlovid is not for prevention before or after exposure to Covid-19 and “is not a substitute for vaccination in individuals for whom the COVID-19 vaccine and booster dose is recommended. “
Separately, Merck requested an emergency use authorization for its antiviral pill, molnupiravir. It was recommended by FDA advisors in a 13-10 vote in late November after data showed it reduced the risk of hospitalization or death in high-risk adults by 30 percent. . This is lower than a previous analysis that suggested it could be around 50%. The FDA has not announced whether it will authorize the treatment.
Remdesivir, sold under the brand name Veklury, is the only antiviral drug approved by the FDA to treat Covid-19. It is injected into a vein, not a pill that can be taken at home.