Merck COVID-19 Pill Less Effective Than Expected
Molnupiravir, one of the antiviral pills currently on the market for treatment against COVID-19 from pharmaceutical firm Merck, brought a lot of traction when it was announced as a treatment option for its affordability and the projected reduction rate for hospitalization. At the time of the announcement, initial clinical trials showed it could help reduce hospitalizations up to 80 percent, however it had not received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) yet. It was later approved for EUA in late November.
Uncertainties surrounding the antivirals efficacy and safety arose when the completed results of the study were released. The results from the trial showed a 30 percent decrease in hospitalization — this number is a 50 percent reduction of the projected numbers before the trial result was released.
Medicinal chemist Katherine Seley-Radtke, among many others in the scientific community voiced their dismay at the lackluster results; Merck on the other hand expressed that any amount that will reduce the likelihood of hospitalizations is beneficial, especially to areas that are experiencing the largest surges.
Nicholas Kartsonis, senior vice-president of clinical research at Merck, told the FDA advisory committee in November of last year that there was no explanation for the large difference in effectiveness. Other committee members note that the Delta variant and subsequently the Omicron variant, which are both highly transmissible, were not as dominant globally when the trials first began. Trial group demographics and locations were other possible causes in the decreased effectiveness noted.
In the end, Molnupiravir did receive EUA approval, in a 13–10 decision wherein the panel members debated on whether or not Molnupiravir’s benefits outweighed its risks. This antiviral incorporates itself into the RNA of the virus and creates errors and interrupts the virus’s ability to replicate. Critics say that the problem with this method is that introducing mutations has the possibility of creating an even more dangerous strain of the SARS-CoV-2 that can be even more transmissible.
Merck responded saying that their trials did not show any remaining virus in the participants after the treatment course was completed but the drug was not tested on immunocompromised people, who would have more difficulty clearing the virus. There was also a risk that Molnupiravir could create mutations in human DNA, specifically in cells that reproduce quickly such as blood cells and spermatozoa, though the animal tests showed this to be low. Regardless, experts say it is not ethically sound to say this treatment would be safe in pregnant people or in children.
Monoclonal antibody treatment can reduce the risk of severe COVID-19 infection by up to 85 percent but are very costly and have intravenous administration. The search for a more cost effective, oral antiviral is a high priority, but there is likely still space for this treatment option for many people.
https://www.nature.com/articles/d41586-021-03667-0
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