CNBC's Meg Tirrell joins Shep Smith to report on questions about the safety of a Merck antiviral pill intended to fight Covid. For access to live and exclusive video from CNBC subscribe to CNBC PRO: [ Ссылка ]

A Food and Drug Administration advisory panel on Tuesday narrowly endorsed the use of Merck and Ridgeback Biotherapeutics’ oral Covid treatment pill, despite questions about the drug’s effectiveness, safety and whether it would help the virus mutate into even more dangerous variants.

The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir, an oral antiviral drug initially hailed as a potential game changer in the battle against Covid since it can be taken at home instead of at a hospital like other treatments. It’s designed to treat adults with mild to moderate symptoms of Covid-19 who are at high risk of severe disease. The 800 milligram pill is taken every 12 hours for five days after symptom onset.

The drug needs final authorization from the FDA and Centers for Disease Control and Prevention before it’s available to the public on an emergency basis. The FDA doesn’t have to take the panel’s advice, but it often does.

Difficult vote

Many members of the advisory committee described the vote as a difficult one, in which they had to carefully weight the risks and benefits of a drug that could help those most at risk but raised many unanswered questions. Several committee members recommended that Merck’s emergency use authorization be revisited and potentially withdrawn if another treatment becomes available later.

“This was clearly a very difficult decision,” said Dr. Michael Green, a pediatric transplant specialist at University of Pittsburgh School of Medicine Division of Infectious Diseases, said in voting for the drug. He said the lack of available therapies to treat high-risk individuals with Covid swayed him to support Merck’s emergency application. He however recommended that the medication be limited to unvaccinated people most at risk for severe Covid.

Dr. Sankar Swaminathan, an infectious disease specialist at the University of Utah School of Medicine, voted against endorsing Merck’s medication because the efficacy was “modest at best.” Swaminathan also said he worried that the drug’s potential affect on human DNA wasn’t adequately understood.

Question on birth defects

“Given the large potential population affected, the risk of widespread effects on potential birth defects, especially delayed effects on the male, has not been adequately studied,” he said.

Merck originally said the drug was more than 50% effective in preventing hospitalizations and death, but a more full set of data presented to the FDA on Tuesday noted the drug is just 30% effective.

The FDA and Merck both recommended against using the drug in kids and pregnant women. Molnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.

Molnupiravir works by prompting the virus that causes Covid to mutate and produce errors inhibiting its ability to replicate and spread. However, some doctors and scientists worried that it could also enable the virus to mutate in a way that makes vaccines and treatments less effective.

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