The US Food and Drug Administration on Thursday authorized Merck’s antiviral pill, molnupiravir, to treat Covid-19 “for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
This is the second Covid-19 antiviral pill that may be taken at home by sick people before they need to be admitted to the hospital jobs. Following this license, Merck has an agreement with the US government to supply 3.1 million courses of molnupiravir.
Molnupiravir was barely approved by the FDA’s advisers in a 13-10 vote at the end of November after evidence indicated it reduced the risk of hospitalization or death in high-risk people by 30%. This was lower than an earlier estimate that suggested the figure maybe around 50%.
Dr. Eliav Barr, Merck’s senior vice president of global medical affairs, told CNN earlier this month that he believes the medication will be effective against the Omicron variant.
“The Omicron variant is primarily different from the other types of Covid at the spike protein. Our drug works in completely different parts of the virus. So we’re very optimistic that the drug will continue to be effective against Omicron, and we’re studying that right now.”
The FDA approved Pfizer’s antiviral pill, Paxlovid, to treat Covid-19 on Wednesday, making it the first antiviral Covid-19 medication approved in the US for sick people to take at home before being 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.
The pill “should be initiated as soon as possible after a diagnosis of Covid-19 and within five days of symptom onset,” according to an FDA statement.
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.
Last week, Pfizer released updated results that showed the treatment cut 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 of symptoms, the efficacy was similar: 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, hospital systems and warehouse jobs,” 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.”
In November, the Biden administration announced that it would purchase 10 million treatment courses for $5.295 billion. President Biden said he was encouraged by the “promising data” from Pfizer and said the drug would “mark a significant step forward in our path out of the pandemic.”
He called Paxlovid a “potentially powerful tool in our fight against the virus, including the Omicron variant,” but stressed that getting vaccinated and receiving a booster shot remained “the most important tools we have to save lives.”
The FDA emphasized in a statement that Paxlovid is not for the pre-or post-exposure prevention of Covid-19 and “is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”