The use of’shortening’ was narrowly approved by a panel from the Food and Drug Administration on Tuesday. MerckRidgeback Biotherapeutics’ Oral Covid Treatment Pill, in spite of questions over its effectiveness, safety, and whether the drug would allow the virus to mutate further.

FDA’s Antimicrobial Drugs Advisory Committee voted by 13 votes to 10 in favor of emergency authorization for molnupiravir. It was originally hailed as a potentially game-changing drug against Covid. This drug is intended to be used to treat Covid-19-related symptoms in adults who have mild or moderate to severe health problems. It is recommended that the 800mg pill be taken within 12 hours of symptom onset for five consecutive days.

Before the drug is made public, the FDA and Centers for Disease Control and Prevention must approve it. While the FDA is not required to accept advice from the panel, this happens quite often.

Merck initially claimed that the drug prevented more than 50% of deaths and hospitalizations, but more data was presented Tuesday to FDA.

Both Merck and the FDA recommended that this drug not be used in children and pregnant women. Molnupiravir caused birth defects in pregnant rats and was fatal to the embryos. The data also showed that it caused bone defects in young puppies, as well as other anomalies.

Molnupiravir acts by causing the Covid virus mutation and producing errors, which in turn inhibit its replication and spread. Scientists, doctors, and others worry that the drug could cause Covid to become more resistant and make vaccines less effective.

According to Dr. James Hildreth of Meharry Medical College, Nashville, Tenn.

Nicholas Kartsonis is Merck’s senior vice-president of clinical research. He said that the company doesn’t have any data about the possibility for such a mutation to evolve. Kartsonis said that Merck hasn’t seen unusually high rates of spike protein mutations in its clinical trials, as compared to a placebo. Hildreth informed Kartsonis it was up to Merck, in order to determine the possibility of escape mutants.

Kartsonis explained that “we are investigating the feasibility of using publicly available SARS CoV-2 sequencing databases to monitor the emergence of novel variants of the replicase complicated as well as spike proteins.”

Patrick Harrington is the FDA’s Senior Virology Reviewer. He said that it was not clear if changes to the spike protein linked with molnupiravir might have a significant impact on the evolution of this virus.

Harrington stated that in order for molnupiravir’s effect to extend the evolution of SarsCoV-2 beyond an individual who has been treated, variants must be transmissible. At this point, we don’t know if it is feasible.

Merck submitted its applicationThe FDA approved molnupiravir emergency authorization in October. Covid has not been treated with any oral antiviral drugs. Pfizer is similarly seeking approvalIt is its own oral Covid treatment pillThe drug was 89% effective in the prevention of death, hospitalizations and deaths when used with an HIV drug.

Merck presented Tuesday’s FDA advisory committee with its first application. The company stated that the pill is 50% effective in reducing hospitalization and death rates in interim analyses of 762 patients. According to Merck, an analysis of all 1,400 patients revealed a lower 30% efficacy rate.

Post-interim analyses of 646 participants showed that deaths and hospitalization were higher among those taking the pill than in those not using the drug. This was at 6.2% compared to 4.2% in the placebo group.

The FDA committee heard from Kartsonis that there was no drop in death and hospitalizations in the placebo group as compared with those taking molnupirivar.

Kartsonis stated that the second section of the study, which was completed after an interim analysis had enrolled an older population and enrolled more diabetic patients. “One would have thought indeed that would be the case —- that you would see more mortality.”

“However there were more women in this second study and it’s associated with the what we can view with less risk as well as the more patients who had antibodies positive,” he stated.

The trial involved unvaccinated adult participants who were either older than 60 years or suffered from pre-existing medical conditions like diabetes, obesity and heart disease.

The FDA advisory committee was informed by Kartsonis that the interim analysis of 762 patients showed that molnupiravir had significantly decreased the chance of death or hospitalization during clinical trials. Nine out of 10 deaths occurred in the placebo group.

According to Kartsonis, Merck didn’t identify safety issues associated with molnupiravir in the clinical trial. According to Kartsonis, dizziness, diarrhea and nausea were experienced by a few patients.

Kartsonis stated that there are currently more than 50,000 Americans living with the disease in our hospitals. He also said that as the winter season approaches, another spike is likely, possibly in the context of new variants. In outpatient care, Kartsonis said: “We are still in desperate need of novel and effective, well-tolerated, conveniently administered therapies for COVID 19.”

FDA scientists gave a briefing to the committee. They stated in it that studies on animals have shown the drug could cause abnormal bone formation and a decrease in fetal body mass. Merck did not intend for pregnant women using molnupiravir, and they were excluded from the clinical trials.

Mark Seaton was a research officer at the FDA’s section of pharmacology, toxicology, infectious diseases. Seaton said that abnormal cartilage and bone formation in rats isn’t relevant for adult human beings.

Janet Cragin (a medical officer in the CDC’s division for birth defects) stated that while it was not ethical to give molnupiravir as a pregnancy treatment due to the possible side effects, it is problematic to deny the drug to a pregnant women suffering from Covid.

Cragin explained that “I don’t think you can ethically say to a pregnant lady who has Covi-19 she can’t get the drug if that’s her decision,” noting that Cragin’s views are not representative of those at the CDC.

She stated that “pregnancy can be considered as a risk factor to the progression of severe Covid illness.” Covid is a case in point. We all know that the severity of respiratory illness can increase and may become fatal as the pregnancy progresses.

Meharry Medical College CEO Dr. Hildreth was unambiguous in his opposition.

Were we willing to decrease the danger to the mother of 30% while still exposing the embryos and fetuses to greater harm through the use of this drug?” Hildreth replied, “No.” “And in no situation would I advise a pregnant lady to take this drug.”

Robert Heflich was the FDA’s director for genetic and molecular toxology. He stated that the FDA has no plans to alter the human genome in clinical settings by using molnupiravir, as the drug is not known to be mutagenic in rodents. According to Merck, the study did not show an increase in mutations in rodents’ livers or bone marrow.

This study, however, was done as a follow up to an earlier investigation that used rodents and was non-conclusive regarding whether molnupiravir can be mutagenic. Molnupiravir proved to be mutagenic in vitro experiments using bacteria cells and hamster cells.

During the public comments portion of the meeting, there was some disagreement over data about whether molnupiravir can be associated with genetic mutation. Experts and the general public were concerned that only one study could have led to a conclusion regarding human risks. FDA experts believe that there is a low risk of mutation due to the five-day treatment.