FDA Advisory Panel Narrowly Votes Yes To Recommending COVID-19 Pill
Image via Merck
The Federal Drug Administration’s (FDA) Antimicrobial Drug Advisory Committee has voted in favor of recommending the COVID-19 treatment pill, though only by a narrow margin. The drug, named molunpiravir, has been recommended to receive an emergency use authorization (EUA) in the US till the pandemic dissipates.
Similar to the COVID-19 vaccines, this ruling doesn’t mean the oral antiviral treatment will be authorized for public use right away.
Instead, the recommendation allows for the FDA to come to a final decision on if it would grant the EUA request. Following that, the Centers for Disease Control and Prevention (CDC) will choose to endorse the pill for those who are at higher risk of severe infection from contracting the virus.
According to SlashGear, the advisory committee said yes in a 13 to 10 vote. This paves the way for molnupiravir to potentially become the first oral treatment option for COVID-19.
The drug, which is manufactured by Merck and Ridgeback Biotherapeutics, is to be taken twice a day for five days from the onset of symptoms.
Some of the experts, who voted no, voiced concerns about the pill’s efficacy and side effects, including birth defects in babies. There was also discussion over whether the use of an oral drug could lead to additional virus mutations that would render the existing vaccines less effective. At the moment, Merck told NBC the company has yet to come up with data on if its treatment pill could induce more COVID-19 mutations.
“The risk-benefit assessment of mulnupiravir supports a EUA,” concluded the FDA report.
[via SlashGear, cover image via Merck]
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