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Fauci says FDA will review new Merck Covid treatment “ as soon as possible ”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), testifies at Senate hearings on health, education, labor and retirement to study updates from federal officials on efforts to combat COVID-19 at the Dirksen Senate office building on May 11, 2021 in Washington, DC.

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White House chief medical adviser Dr. Anthony Fauci said Friday that the FDA will review data on a new oral antiviral pill, Covid, from Merck and Ridgeback Biotherapeutics “as soon as possible” in hopes of issuing an emergency approval. cases.

The companies said their antiviral treatment, molnupiravir, reduces the risk of hospitalization or death for unvaccinated patients with mild to moderate cases of Covid by about 50%. In the third phase of the clinical trial, which involved 775 participants who took either molnupiravir or placebo, eight people who received the placebo died within 29 days. None of the participants who took molnupiravir died, according to data released Friday.

“You have to make sure you give the FDA time to analyze the data very carefully and make decisions to approve emergency use,” Fauci told CNBC’s Closing Bell. “So I don’t want to get ahead of them. I can’t predict when it will happen, but I can tell you one thing: they will do it as quickly as they can. “

Merck and Ridgeback Biotherapeutics also stated that 7.3% of mollupiravir recipients in their phase 3 study were hospitalized within 29 days, while 14.1% of placebo recipients were hospitalized or died. All participants had at least one medical condition that raised their chances of more severe Covid symptoms.

The FDA Emergency Use Authorization will make molnupiravir the first oral antiviral to fight Covid. The United States agreed to purchase 1.7 million courses of lightnupiravir. White House Coronavirus Response Coordinator Jeff Zientes told reporters at a briefing Friday that the government has the option to buy even more doses if the drug is approved.

Merck predicts that it will have 10 million courses of molnupiravir by the end of 2021.

When asked if lightnupiravir will end up being used exclusively for unvaccinated people, Fauci said he would like to avoid speculation before the FDA makes a final decision. Fully vaccinated people can still get Covid, especially if the vaccine’s effectiveness declines. But they retain a high degree of protection against serious illness and death.

“I shouldn’t get ahead of myself as to why the FDA will permit it,” Fauci said. “But I would suggest that if you are infected, then you are infected. It doesn’t matter if you are vaccinated or not. “


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