Health officials give their opinions on the the first COVID-19 antiviral pill
On Tuesday, November 30, the FDA panel of health advisors, after a day-long meeting with many expressed concerns, narrowly voted to back the Merck COVID-19 pill for emergency use authorization. Molnupiravir, according to Merck’s official website, is an “investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.” In other words, the oral drug inserts small mutations into the virus’s genetic code, preventing the virus from duplicating.
As of right now, the drug is experimental and has only been tested on unvaccinated people. It also—according to the Associated Press—hasn’t yet been tested against the new Omicron variant. The uncertainty of the pill’s effectiveness caused many to question its authorization during Tuesday’s meeting.
Dr. Lindsey Baden, the chair of the Antimicrobial Drugs Advisory Committee (AMDAC), ultimately voted in favor of the drug, but could see where both sides were coming from. “I see this as an incredibly difficult decision and there are many, many more questions than answers,” he stated.
According to NBC News, “Those who voted in favor, Baden said, thought the drug’s efficacy was ‘apparent, albeit with issues that have to be weighed.’ Those who voted against the recommendation, he summarized, weren’t convinced by the data and cited concerns about potential risks, including potential harm to fetuses and DNA damage.”
Dr. Sankar Swaminathan of the University of Utah School of Medicine, who voted against the pill, thought the amount of research completed was not enough to guarantee the drug’s efficacy. “Given the large potential population affected, the risk of widespread effects on potential birth defects has not been adequately studied,” he asserted.
Roblena Walker, the CEO of Mableton, Georgia, based public health mentoring group EMAGAHA Inc, also saw the risk of potential birth defects as a major constraint, saying “I don’t think I would want to take this drug, not knowing the effects it would have on my unborn child.”
The FDA itself acknowledged the risk of molnupiravir resulting in “fetal harm when administered to pregnant individuals” and is considering restricting the drug for pregnant women. Some supporters of the pill, like Dr. Janet Cragan, a medical officer at the CDC’s birth defects branch, didn’t see the restriction as morally right.
“I don’t think you can ethically say it’s okay to give this drug in pregnancy, obviously,” she began. “But at the same time, I’m not sure you can ethically tell a pregnant woman who has Covid-19 that she can’t have the drug if she’s decided that’s what she needs. I think the final decision has to come down to the individual woman and her provider.”
In addition to potential birth defects, another major piece of data also stirred up feelings of doubt in many voting members. In a statement released October 1 on Merck’s website, the company had initially announced a 50% reduction of hospitalization and death in “patients with mild or moderate COVID-19” compared to those taking a placebo. However, the Associated Press revealed that these statistics were recently updated, bringing that number significantly down.
“Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results,” the website revealed.
However, like Stat News says, “In the end, panelists narrowly voted that the benefits of having an oral Covid treatment to keep people out of the hospital outweighed their questions and concerns.”
Ultimately, the results of the panel were very close, with a 13-10 voting in favor of the drug. “The FDA is not required to follow the advisory committee’s guidance,” NBC News reveals, “but it usually does. A final ruling by the agency could come in a matter of days.”
As the Associated Press said,“The drug could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.”