FDA Advisers Narrowly Endorse , Merck’s COVID Antiviral Pill.
On Nov.
30, the FDA's Antimicrobial Drugs Advisory Committee voted to endorse Merck's molnupiravir pill for use in treating COVID-19 in high-risk adults.
On Nov.
30, the FDA's Antimicrobial Drugs Advisory Committee voted to endorse Merck's molnupiravir pill for use in treating COVID-19 in high-risk adults.
The vote was 13-10.
The panel's decision could prompt the agency to grant Merck emergency use authorization, which the U.K. has already done.
CBS News reports the Biden administration has already bought about 3.1 million courses of the treatment, which is given to patients over five days.
CBS News reports the Biden administration has already bought about 3.1 million courses of the treatment, which is given to patients over five days.
This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderate symptomatic persons would be available, Dr. W.
David Hardy, a scientist at Charles Drew University School of Medicine and Science and panel member, via CBS News.
Those in opposition debated the rare risk that the drug, which relies on triggering mutations of the virus, might unleash a new variant.
Even if the probability is very low, one in 10,000 to one in 100,000, that this drug would induce an escape mutant for which the vaccines we have do not cover, that would be catastrophic for the whole world actually, Dr. James Hildreth, one of the panel's advisers, via CBS News.
CBS News reports Merck admitted it did not have the data to accurately estimate that risk, but no one who took the pills appeared to be infectious.
Additionally, Merck's most recent trial data revealed a 30% efficacy rate as opposed to its initial claim of reducing the risk of hospitalization or death by 50%.
Additionally, Merck's most recent trial data revealed a 30% efficacy rate as opposed to its initial claim of reducing the risk of hospitalization or death by 50%
