January 20, 2022

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FDA advisory panel recommends use of Merck’s COVID-19 pill

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The Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted on Tuesday to recommend emergency authorization of molnupiravir, Merck’s oral COVID-19 treatment pill.

It was a narrow vote of 13-10, with many panel members saying that after they weighed the risks and benefits, they felt that there were still too many questions that needed to be answered about the pill’s safety and whether it could enable the virus to mutate into variants that can get around current vaccines, CNBC reports. 

Dr. Michael Green, a pediatric transplant specialist at the University of Pittsburgh School of Medicine Division of Infectious Diseases, voted in favor of the drug, and said he supported emergency authorization because there aren’t many therapies for high-risk individuals with COVID-19. Still, it was “a very difficult decision,” Green said, and he recommends that the pill only be used by unvaccinated people at most risk of severe COVID-19.

Molnupiravir is an antiviral drug that is designed to treat adults with mild to moderate COVID-19 symptoms who are at high risk of severe illness. It would be given to patients at home, in the form of an 800 milligram pill taken every 12 hours for five days following the start of symptoms. On Tuesday, Merck presented new data to the FDA showing that the drug was 30 percent effective in preventing hospitalizations and death from COVID-19. The company also said the drug should not be given to children and pregnant women.

Before the public can use the drug on an emergency basis, final authorization has to come from the FDA and the Centers for Disease Control and Prevention; typically, the FDA follows along with the Antimicrobial Drugs Advisory Committee’s recommendations.

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