US Federal Advisory Committee Approves Merck’s COVID-19 Pill

A panel of health experts in the US has voted to recommend using Molnupiravir, a COVID-19 pill manufactured by Merck. Following this approval by the panel set up by the US government, the Food and Drug Administration (FDA) is soon expected to grant it an Emergency Use Authorization (EUA). The final approval will allow pharmacies across the US to stock the pill. 

The decision taken by the panel wasn’t unanimous, though, and barely made it through on a 13-10 vote. Concerns over potential dangers related to the use of the pill and recent speculations over its efficiency were major concerns. 

Sascha Dublin from the Kaiser Permanente Washington Health Research Institute and one of the members on the panel said the decision was a difficult one. Dublin also cautioned that it was essential to strictly monitor the use of the drug and ensure it was only administered to those who suited its uses. 

An infectious disease specialist from the University of Utah, Dr. Sankar Swaminathan, was among those who reluctantly voted in favor of the pill, noting that “although the efficacy of this product is not overwhelmingly good, there was a need for something like this.” 

Molnupiravir has already been authorized by the British government and has been in use in the UK since early November. There, although it is not being administered to pregnant or breastfeeding women, the pill has been reported to influence a drop in the rate of hospitalizations and COVID deaths if administered immediately after infection. The FDA has also recommended that the pill should not be administered to pregnant and lactating women. 

Merck has recently released the complete set of results of its clinical trials with the pill and reported a 30% drop in hospitalization and death. Although still noteworthy, the number is a significant drop from the 50% Merck has quoted earlier. The reports further suggested that the pill was safe for use and did not cause any severe mutations in human cells. The clinical trial was conducted on 1400 patients. 

A similar pill from Pfizer is also set to be approved by FDA soon, and together, the two pills will initiate a new mode of treatment for COVID-19 patients. At the cost of around $700 per person, Merck is scheduled to supply enough pills to treat 3.1 million people. On the other hand, Pfizer’s pill will only cover around 300,000 patients in the first round of supplies that are scheduled for distribution before February ends.

The pills are mostly targeted at the unvaccinated population in the US. But a Morning Consult poll revealed that only half of the polled unvaccinated individuals said they would agree to its use. The other half said they would refrain from using it even if they were affected by COVID or the government approved its use.