FDA panel recommends molnupiravir, first pill for COVID-19

Pile of molnupiravir pills
Pile of molnupiravir pills

© 2009-2021 Merck Sharp & Dohme Corp

Today the Food and Drug Administration's (FDA's) antimicrobial drugs advisory committee voted to recommend the use of Merck's molnupiravir—the first pill indicated to treat COVID-19 infections and prevent hospitalization and death—13 to 10, concluding that potential benefits outweighed risks to patients who were at risk for developing severe COVID-19.

The pill, if taken within the first 5 days of infection, offers a 30% reduction in the risk of hospitalization and death. During the meeting, advisors discussed using the drug in high-risk patient populations, including pregnant women. Animal studies of the pill showed a potential toxicity for fetuses.

Children and pregnant women have not been included in any trials of molnupiravir.

The advisors also discussed whether treatment with molnupiravir could, in theory, trigger mutations in the cells of recipients, and whether such mutations would have long-term effects on fertility and cancer.

Earlier this month, the United Kingdom authorized use of the pill, excluding pregnant and breastfeeding women.

Several members of the advisory group said the treatment, which consists of 40 pills taken over 5 days, should be used in older patients or those with significant underlying medical conditions that put them at high-risk for COVID-19 complications.

The drug requires final approval from both the FDA and the Centers for Disease Control and Prevention (CDC) before it will be widely available on an emergency use basis. The FDA typically follows the committee's recommendations.

Omicron still not detected in US

Despite extensive genomic sequencing, the CDC and the White House today said the Omicron (B.1.1.529) COVID-19 variant has yet to be detected in the United States.

"This virus is unpredictable, and we must be ready to be proactive," said CDC Director Rochellle Walensky, MD, MPH. Walensky said the nation was in a good position to tackle Omicron, which has several mutations from the original strain of the virus, as well as the Delta (B1617.2) strain.

She said one in seven PCR samples are now being submitted across the country to surveillance labs to undergo sequencing in an effort to detect the new strain, for a total of 80,000 samples per week. And four major US airports—in New York, Atlanta, Newark, and San Francisco—will start enhanced screening of passengers today.

During a press briefing, chief White House medical advisor Anthony Fauci, MD, said it would be at least another 2 weeks before scientists can understand how and if current vaccines offer protection against Omicron.

"We do not know what the degree of diminution of the vaccines will be, we are hoping with good reason there will be some level of protection," Fauci said.

Both Walensky and Fauci urged the 100 million Americans who are currently eligible for booster vaccines to get one as soon as possible. The CDC COVID Data Tracker shows 59.3% of Americans are fully vaccinated against COVID-19, 70.1% have received at least one dose of vaccine, and 20.5% of fully vaccinated Americans have received a booster dose.

Michigan sets hospitalization record

Michigan's number of hospitalized adults with confirmed COVID-19 cases reached a new pandemic high Monday, the Associated Press reports. The total of 4,185 hospitalized patients surpassed the previous record of 4,158.

The Upper Midwest, including Michigan, Minnesota, and Wisconsin, is still the nation's early winter hot spot.

The United States reported 208,745 new COVID-19 cases yesterday, and 1,962 deaths, according to the Johns Hopkins COVID-19 tracker. The 7-day average of new daily cases is 79,249, with 889 deaths, according to the Washington Post tracker.

Other US developments

  • New York City officials said on Monday that they do not immediately plan to reimpose an indoor mask requirement, but are strongly recommending people wear masks in indoor public spaces, according to The Hill.

  • A US district judge has temporarily blocked the federal government from enforcing a COVID-19 vaccine mandate for healthcare workers in Iowa and nine other states, the Des Moines Register reported today.

  • The US Supreme Country has rejected taking up a case from fired Boston healthcare workers challenging the vaccine mandate, according to GBH News.

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