On Thursday, the United States Food & Drug Administration (FDA) approved molnupiravir, Merck’s antiviral, to treat mild-to-moderate Coronavirus disease in adults with positive results of direct SARS-CoV-2 viral testing and others who are at high risk of severe illness, hospitalization, or death. It is the second Coronavirus antiviral pill approved for people affected by the virus to take at home before they get ill enough to be hospitalized.
Merck hit a deal with the federal government to deliver around 3.1 million drug courses of molnupiravir upon this approval. The FDA’s panel of advisers narrowly recommended Molnupiravir with a 13-10 vote at the November end after statistics revealed that it decreases the risk of severe illness or death by thirty percent among high-risk adult patients. However, it was less than a prior evaluation suggesting that the number might be around fifty percent.
NEW: FDA authorizes second pill to treat Covid-19: Merck’s antiviral pill, molnupiravir, “for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults…and who are at high risk for progression to severe COVID-19, including hospitalization or death…”
— Ana Cabrera (@AnaCabrera) December 23, 2021
A senior vice president of global medical affairs at Merck, Dr. Eliav Barr, told CNN News that he was hopeful that this pill treatment would work efficiently against the highly contagious Omicron variant. Further, he added that the new variant is quite different from the other kinds of Coronavirus at the spike protein. Barr said that their antiviral pill acts effectively in a completely different part of the virus.
The FDA Authorized Pfizer’s Antiviral Pill
On Wednesday, the Food and Drug Administration approved Pfizer’s antiviral pill, PAXLOVID, to treat Coronavirus – the first antiviral Coronavirus pill approved in the United States for ill people to take at home, before their hospitalization. High-risk people aged twelve and older with a weight of at least eighty-eight pounds and who have a positive COVID-19 test are eligible for the treatment.
According to the latest statement from the FDA, the pill should administered as early as possible after the Coronavirus diagnosis or within five days of COVID symptom onset. Now, PAXLOVID combined with a new drug named nirmatrelvir with the previous one called ritonavir and administered as three pills given two times a day for five days.
Pfizer released updated results of the drug uses last week. It showed that the treatment lessens the risk of hospitalization or death by around eighty-nine percent if administered to high-risk adults within some days of their initial symptoms. If given with starting five days of symptoms, the drug’s efficacy was similar, such as eighty-eight percent.
CEO and Chairman of Pfizer, Albert Bourla, stated that the approval of Pfizer’s PAXLOVID represents another remarkable example of how science will help the country finally defeat the deadly pandemic. Moreover, the breakthrough treatment will significantly cut hospitalizations and deaths, and a patient can take the drug at home. In short, it will change the way health experts are treating Coronavirus and hopefully help cut some of the significant pressures of healthcare and the hospital system.
The U.S. Government will Purchase Ten Million Treatment Courses
In November, the Biden government announced that it would acquire ten million treatment courses of Pfizer for around $5.295 billion. Joe Biden, the President of the United States, expressed that the promising data from Pfizer encouraged him. He hoped that the pill would mark a substantial move in the path out of the Coronavirus. Furthermore, Biden called PAXLOVID a possibly effective tool in the fight against the pandemic, especially the highly contagious Omicron variant. However, he emphasized that getting inoculated and receiving an additional dose remained the most crucial factors to save lives.
The FDA stressed that PAXLOVID is not for the pre-or post-exposure prevention of Coronavirus and is not an alternative for vaccination in people for whom the health officials recommended COVID vaccination and a booster shot. On the other hand, Merck requested emergency use authorization (EUA) for its antiviral drug, molnupiravir.
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