US Food and Drug Administration panel backs Merck & Co's COVID-19 pill Molnupiravir

On Tuesday, a panel of US health advisors narrowly backed Merck & Co's COVID-19 pill, paving the way for the first coronavirus drug that Americans can take at home. According to AP, the Food and Drug Administration (FDA) panel voted 13-10 that the benefits of COVID-19 pill outweigh its risks. 

The risks include the possibility of birth defects if taken during pregnancy. After hours of debate over the drug's modest benefits and potential safety concerns, the recommendation was made. Most proponents of the treatment stressed that it should not be used by anyone who is pregnant, and called on the FDA to recommend additional precautions before prescribing the drug, such as precautionary pregnancy tests for women.

Dr. Lindsey Baden of Harvard Medical School, who voted in favour of the drug, told AP, "I see this as an incredibly difficult decision with many more questions than answers."

According to him, the FDA would need to carefully tailor the drug's use for the patients who would benefit the most. The drug was specifically approved for adults with mild-to-moderate COVID symptoms who face the greatest risks, such as the elderly and those with obesity or asthma. Most experts also agreed that the drug shouldn't be used by people who have already been vaccinated and haven't shown signs of benefitting from Merck's research.

The FDA is not obligated to follow the panel's recommendation and is expected to make its own decision before the end of the year. The antiviral drug has already been approved in the United Kingdom. As colder weather pushes case counts higher and US officials prepare for the arrival of the new Omicron variant, the Molnupiravir drug could prove to be a much-needed weapon against the virus.

Merck & Co hasn't tested its drug against the new variant, but based on its effectiveness against other coronavirus strains, it should be effective, according to the experts. Many panellists were frustrated by this uncertainty as they debated whether or not to support the treatment for millions of Americans, AP reported.

Molnupiravir may cause fetal harm

Merck & Co. released updated data on Friday that paints a less rosy picture of the drug's efficacy than it did just a few weeks ago. When Molnupiravir was compared to a placebo, it reduced hospitalisation and death by 30% in adults infected with the coronavirus, according to Merck's findings.

This was smaller than the 50% reduction it had initially predicted based on incomplete data. For many panelists, the drug's minor effect wasn't enough to outweigh its risk of harming human foetuses. FDA scientists told panelists earlier on Tuesday that the drug caused birth defects in rats when given at very high doses. "Data suggests that molnupiravir may cause fetal harm when administered to pregnant individuals," FDA officials concluded, according to AP.

The FDA is considering imposing a blanket ban on the drug's use in pregnant women or allowing doctors to use it in exceptional circumstances. Some panelists believe that option should be kept open for pregnant mothers with high-risk COVID-19, who may have few other options for treatment.

According to AP, Dr. Janet Cragan, a proponent of the drug, said that even if restrictions were imposed, some pregnant women would inevitably take the antiviral drug. To combat COVID-19, Merck's drug takes a novel approach. It prevents the coronavirus from reproducing itself by inserting small errors into its genetic code. The drug's genetic effect has sparked fears that it could lead to more virulent strains of the virus. Although FDA officials said on Tuesday that the risk is hypothetical, many panelists said that it should be closely monitored in follow-up studies.

(With inputs from AP)

Image: AP