The authorization of Molnupiravir (its brand name) is more limited than that obtained on Wednesday the 22nd by the Pfizer pill. The FDA cleared Merck’s pill for high-risk adults “for whom FDA-cleared alternative treatment options for COVID-19 are not accessible or clinically appropriate.”
Like Pfizer’s oral drug, Merck’s drug is not a substitute for COVID vaccination, which remains crucial to ending the pandemic.
Molnupiravir is a drug that works by introducing errors in the genetic code of the SARS-CoV-2 virus, which prevents the virus from replicating further. It is given in four 200-milligram capsules by mouth every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorized for use for more than five consecutive days.
The FDA authorized the emergency use of a pill to treat COVID-19 symptoms, which will be available to people 12 years of age and older who are at high risk for severe COVID.
Developed by the Pfizer laboratory, Paxlovid (its brand name) is a combination of two drugs that will be sold by prescription only and that aims to prevent hospitalizations and deaths from COVID-19.
“Today’s authorization presents the first treatment for COVID-19 that is in the form of a pill that is taken orally, a great step forward in the fight against this pandemic,” said Dr. Patrizia Cavazzoni, director of the Center for Evaluation and FDA Drug Research.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge; and it promises to make antiviral treatment more accessible for patients who are at high risk of developing a severe form of COVID-19, “he added.
Paxlovid combines a new antiviral drug called nirmatrelvir and an older one called ritonavir. The week of December 20, Pfizer released updated results showing that the treatment reduced the risk of hospitalization or death by 89% if given to high-risk adults within days of their first symptoms.
The FDA recommends consulting with a healthcare provider before starting treatment after a positive result, as this medication is not recommended for certain patients, such as those with kidney and liver problems.
The Biden administration said it will order enough Paxlovid stock to treat at least 10 million people.
The Merck laboratory said it will have a supply of more than 10 million Molnupiravir pills in its first stage of distribution.