Tuesday, October 19, 2021
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FDA advisory panel scheduled to discuss Merck’s COVID-19 antiviral pill

The Food and Drug Administration (FDA) has scheduled a meeting for the end of next month for its advisory panel to discuss Merck’s antiviral pill designed to treat mild to moderate COVID-19.

The drug could be a game changer in America’s fight against the virus.

The federal agency announced Thursday that the advisory committee will meet on November 30 to review data on molnupiravir. If approved, the oral pill would be administered to adults who have recently tested positive for COVID-19 and are at high risk of serious illness, hospitalization and death.

Merck applied for an emergency use authorization for the drug, developed with Ridgeback Biotherapeutics, earlier this week after trials showed it reduced the risk of hospitalization by 50 percent.

In the results that the maximum expert in infectious diseases Anthony FauciAnthony FauciFeehery: Rebuilding Bipartisan Night Health Care – Presented by National Council on Mental Well-Being – Merck Asks FDA to Authorize Five-Day COVID-19 Treatment AstraZeneca Says COVID-19 Drug Helps Reduce Disease Risk serious and death MORE Called “impressive,” no deaths were reported among patients receiving molnupiravir, while eight people died in the placebo group.

“We believe that, in this case, a public discussion of these data with the agency’s advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating to make a decision on the authorization of this treatment for emergency use. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The five-day oral treatment could be key in bringing the US closer to light at the end of the tunnel in the pandemic, experts have said, along with clearance for the vaccine to be given to younger children.

The US government has agreed to buy 1.7 million doses of Merck’s treatment if the FDA grants it emergency use authorization, although former FDA Commissioner Scott Gottlieb said the amount “is not enough.” .

But White House health officials, including Fauci, have emphasized that COVID-19 vaccines would still be necessary even with Merck’s antiviral pill to prevent infection in the first place.

The FDA advisory panel is considering this week to recommend booster vaccines for Moderna and Johnson & Johnson recipients.

The committee voted unanimously Thursday to recommend a third dose of Moderna for people 65 and older and adults at high risk for severe COVID-19 due to their medical conditions, jobs or life situations.

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