FDA Panel to Review Merck’s COVID Pill, Question Use in Pregnant Women, Vaxxed Patients

The Food and Drug Administration will create a panel to investigate the effectiveness of Merck’s molnupiravir COVID-19 treatment, reported the Associated Press.

If approved, the new drug will be the first COVID-19 treatment that can be taken from home in capsule form. However, new information has been released questioning its effectiveness. The FDA’s new panel will analyze claims that Merck’s pill is less effective than promised and could cause birth defects in pregnant women.

The FDA tested the drug against rats and found a less-than-satisfactory conclusion. Scientists affiliated with the FDA claim that birth defects were found in the skeleton, eyes and kidneys of newborn rats, raising the question of whether or not pregnant women would be safe taking the pill. Merck has already begun putting advisories in its presentations discouraging such women from consuming molnupiravir.

Merck’s molnupiravir pill is significant for many reasons, most prominently its approach to fighting off COVID-19. According to the Associated Press, the pill is expected to insert “tiny errors into the coronavirus’ genetic code to stop it from reproducing.” Merck scientists say that the pill has already been tested against COVID-19 variants, including delta. However, the company hasn’t tested the drug against those who have already been vaccinated. The FDA hopes to determine if the pill is effective for vaccinated individuals.

Merck has not commented on the FDA’s review panel. A vote on whether to approve the drug is expected to take place on Tuesday.

For more reporting from The Associated Press, see below.

An experimental COVID-19 drug that could soon become the first U.S.-authorized pill to treat the coronavirus faces one final hurdle Tuesday: A panel of government experts will scrutinize data on the medication from drugmaker Merck. Above, this undated file image provided by Merck & Co. shows their new antiviral medication molnupiravir.
Merck & Co. via AP, File

The panel’s recommendations aren’t binding but often guide FDA decisions.

The meeting comes as U.S. infections are rising again and health authorities worldwide size up the threat posed by the new omicron variant.

If authorized, Merck’s pill would be the first that doctors could prescribe for patients to take on their own to ease symptoms and speed recovery, a major step toward reducing hospital caseloads and deaths. The drug, molnupiravir, is already authorized for emergency use in the U.K.

Given the ongoing threat, the FDA is widely expected to approve emergency use of Merck’s pill. But new data released last week painted a less compelling picture than when the company first publicized its early results in October.

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30 percent among adults infected with the coronavirus when compared with adults taking a placebo. That effect was significantly less than the 50 percent reduction it first announced based on incomplete results.

FDA scientists said Tuesday the reasons for the difference were unclear but appeared to be due to higher-than-expected hospitalizations among patients taking the drug during the second half of the study.

Merck scientists said they believe their drug will be effective against the new omicron variant.

Data from a handful of patients with prior infections suggested the drug had little benefit. Still, it may be impractical for doctors to screen out those patients. The Merck drug works best when given within five days of first COVID-19 symptoms, underscoring the need for speedy treatment.

Merck tested the drug in adults with mild-to-moderate COVID-19 who were considered higher risk due to health problems like obesity, diabetes or heart disease. That’s the same group that currently receives antibody drugs, which help the immune system fight the virus. The FDA has authorized three antibody drugs for COVID-19 but all have to be given by IV or injection at hospitals or clinics.

Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug from Pfizer is close behind and is also under review.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug.

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations.

Merck Sign
The FDA’s new panel will analyze claims that Merck’s pill is less effective than promised and could cause birth defects in pregnant women. Close-up of cast metal sign for the pharmaceutical company Merck in the Mission Bay neighborhood of San Francisco, California, November 13, 2018.
Photo by Smith Collection/Gado/Getty Images