FDA to review Merck Covid treatment “as quickly as possible”

White House Chief Medical Advisor Dr Anthony Fauci said on Friday the Food and Drug Administration would review data on Merck and Ridgeback Biotherapeutics’ new oral antiviral Covid “as quickly as possible” in hopes of delivering an emergency use authorization.

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

“You need to make sure you give the FDA time to very carefully review the data and make the type of determinations for emergency use clearance,” Fauci told CNBC’s “Closing Bell”. “So I don’t want to get ahead of them. I can’t predict when it will be, but I can tell you one thing: they will do it as fast as they can.”

Merck and Ridgeback Biotherapeutics also reported that 7.3% of molnupiravir recipients in their phase three study were hospitalized within 29 days, while 14.1% of placebo recipients were hospitalized or died. All of the participants had at least one health condition that increased their chances of developing more severe symptoms of Covid.

Emergency use clearance from the FDA would make molnupiravir the first oral antiviral to fight Covid. The United States has agreed to purchase 1.7 million courses of molnupiravir. White House coronavirus response coordinator Jeff Zients told reporters in a briefing Friday that the government has the option of purchasing even more doses if the drug is approved.

Merck plans to have 10 million courses of molnupiravir available by the end of 2021.

When asked if molnupiravir would ultimately be reserved exclusively for unvaccinated people, Fauci said he wanted to avoid speculating until the FDA made its final decision. Fully vaccinated people can still contract Covid, especially when the vaccine’s effectiveness wanes, but they retain a high degree of protection against serious illness and death.

“I shouldn’t get ahead of what the FDA will allow,” Fauci said. “But I guess if you’re infected, you’re infected. It doesn’t matter if you were vaccinated or not.”