On Tuesday, experts panel to the United States Food and Drug Administration (FDA) narrowly voted to recommend the drug agency approve Merck & Co’s antiviral coronavirus pill. Furthermore, if the agency authorizes the medication, it would be the first at-home treatment for the COVID-19 approximately two years into the deadly pandemic. The panel approved the pill for only patients at high risk of growing severe disease, although the agency would define the population.
Last week Merck published the statistics to suggest the drug was significantly less effective than earlier projected, cutting severe illness, hospitalizations, and deaths in its clinical trial at high-risk people by about thirty percent. Committee member Dr. David Hardy, who votes yes, said that coronavirus is still an emergency. Nevertheless, there is a need for something like this, and it is the first occasion that an oral outpatient drug for mildly symptomatic to comparatively symptomatic individuals would be available. However, he does have questions regarding its overall longer-term efficacy.
BREAKING: A FDA advisory panel just voted 13-10 to recommend Merck’s experimental antiviral pill to treat Covid-19 for emergency use, paving the way for the agency to clear the first oral drug for the disease.
— Berkeley Lovelace (@BerkeleyJr) November 30, 2021
The panel voted 13-10 that the benefits of the antiviral pill outweigh its risks, including possible congenital disabilities if used during pregnancy. Furthermore, the recommendations came after some hours of debate about the potential safety issues and modest benefits of the drug. Most health experts supporting the COVID-19 treatment stressed that any pregnant woman should not be used and asked the FDA to recommend additional precautions before the pill is prescribed, like pregnancy tests for women of child-bearing age.
The oral treatment of Merck called molnupiravir, developed with Ridgeback Biotherapeutics, targets part of the coronavirus called the RNA polymerase that remained unchanged by mutations in the Omicron variant. On the other hand, Pfizer also developed a likely more likely drug that could become even more crucial if vaccine-induced and the variant threatened natural immunity.
Ridgeback Biotherapeutics and Merck developed the drug molnupiravir as a five-day regimen taken at home within five days of starting COVID-19 symptoms. However, the FDA is not bound by 13-10 votes but usually follows the recommendations of its external advisers. In addition, the drug could have an abrupt impact on the coronavirus pandemic if approved – just as the Omicron variant emerged, shaking the world with the prospect of a longer and more complicated outbreak.
Merck vowed to manufacture treatment courses for ten million patients by the year-end, and the U.S. preordered enough drugs to treat 3.1 million people. Moreover, another treatment, monoclonal antibodies, is difficult to administer but is more effective, leading health experts to discuss the drawbacks and benefits of an easy-to-use medicine that would offer an extra tool to cut the strain on hospitals as a possible winter surge emerge.
In early October, Merck released the preliminary statistics of the molnupiravir, and it appeared to decrease the risk of hospitalization and death in half. The finding was so influential that the drug company halted the trial at its midpoint. However, after a continuous follow-up of patients, the pill appeared less impressive, with risks of hospitalization and death cut by thirty percent – an unexplained loss that was another issue in the hesitancy of some committee members to endorse the treatment.
What are the concerns of potential unintended consequences?
There are two significant concerns about the possible unintentional consequences:
First, that Molnupiravir could cause issues in the genome in the own cells of patients, causing congenital disabilities, genetic diseases, or cancer. Additionally, the company requested approval for adults. But on the other hand, Merck’s document filed with the FDA for approval, saying that they didn’t recommend the pill for pregnant or breastfeeding patients. Similarly, it said people of reproductive age should use contraception during pill treatment.
The gold standard laboratory test in rats and the short duration of treatment designed to flag drugs that have the risk for mutagenesis (the process of genetic change) suggested there was no significant risk for adult patients. However, the second concern is that the pill might stimulate genetic modifications to the virus, leading to new and more threatening variants. FDA reviewers shared statistics revealed that seven people treated with the drug, scientists took their viral samples after treatments included worrying mutations, though the patients cleared the virus.
The director of the Division of Genetic and Molecular Toxicology at the National Center for Toxicological Research of the FDA, Robert H. Heflich, said that even if the chance is meager, one ten thousand or one in one hundred thousand, that this pill would produce an escape mutant for which the coronavirus vaccines the FDA don’t cover, that would be disastrous for the whole world. However, FDA reviewers expressed those mutations also emerge naturally.
Is the pill work effective against the delta variant?
The drug did not appear to work in individuals with type 2 diabetes and was also less effective against the most contagious delta variant. There are three legal treatments, monoclonal antibodies, practicing in the U.S. to help keep high-risk individuals from hospitalization. In addition, monoclonal antibodies are unwieldy to administer, and their approval usually has been uneven. Monoclonals administered through prolonged infusions or injections that are less appropriate – new COVID-19 variants can threaten their use.
Molnupiravir would be the first antiviral drug in pill form. Health officials authorized an intravenous medication, remdesivir, for hospitalized patients. But its benefits are debatable, with one review finding that it has no or little effect on deaths among hospitalized coronavirus patients. Merck’s drug uses a new approach to fight coronavirus: it includes minor errors in the genetic code of the COVID-19 to stop it from reproducing. Moreover, that genetic effect raised concerns that the drug could fuel more potent strains of the coronavirus.
On Tuesday, the FDA regulators said that risk is theoretical, but several panelists said it should be carefully pursued in follow-up studies. Merck and its ally Ridgeback Biotherapeutics were the primary ones to submit their coronavirus spill to the FDA. On the other hand, Pfizer, its rival drugmaker, is close behind its own antiviral pill under review. Last week, Pfizer said that its pill is also effective against the mutations of the omicron variant.
Both companies’ COVID pills require patients to take several pills two times a day for five days. The United States government announced to acquire ten million treatment courses of Pfizer’s pill after its approval. So, it is more than three times the Biden administrations’ purchase with Merck for 3.1 million molnupiravir courses.