Merck’s Molnupiravir was approved by the Food and Drug Administration one day after Pfizer cleared another drug.
Because of its superior benefits, Paxlovid by Pfizer is expected to be the first-choice treatment for the virus.
Merck’s pill will likely play a less important role in fighting the pandemic than was predicted just weeks ago. It is less capable of preventing severe COVID-19 than originally announced. The drug label will also warn about serious safety concerns, including the possibility for birth defects.
After being purchased by the federal governments, both treatments will be available to all patients in the United States.
Merck’s drug was approved by the Food and Drug Administration for adults suffering from COVID-19 early symptoms. This includes older people and those with heart disease and obesity. In November, the UK approved the first pill.
Merck will warn against the use of this drug during pregnancy. The FDA advised that women of childbearing years should use birthcontrol during treatment and for a few more days, while men should continue to use birth control for at most three months following their last dose. Molnupiravir should be avoided in patients younger than 18 years of age, as it can affect bone and cartilage growth.
Dr. Nick Kartsonis is Merck’s senior vice-president of clinical research. He said that scientists at the company are still studying the drug, and that they hope to get it approved for children’s use.
These restrictions were expected because the FDA advisory panel that approved the drug only narrowly last month warned that it would be used only by patients who are most likely to benefit from it.
Kartsonis stated that Merck researchers are “very happy” with the drug’s safety profile. He noted that Molnupiravir was studied in over a thousand patients, and only a small number of studies found side effects such as diarrhea and nausea.
He said that the drug had been well tolerated.
Pfizer’s pill is different from Merck’s, and does not carry the same risks. Pfizer’s drug was three times more effective than Merck’s in testing. It reduced hospitalizations and deaths by almost 90% for high-risk patients compared to Merck’s 30%.
Experts are unsure if the Merck drug will play a significant role in the United States.
Dr. Gregory Poland, Mayo Clinic, said that the Merck drug will not be used “to the extent that there is an ample supply Pfizer’s pills.” It has a lower efficacy and higher risk of side effect. There would be no reason to use it.
The FDA decision offers another option for the virus that has already killed over 800,000 Americans. Health officials are preparing for record-setting hospitalizations, deaths, and cases caused by the omicron variant. Merck’s antiviral pills are expected to work against omicron, as they don’t target spike protein, which is where the most worrisome mutations of the variant reside.
FDA’s decision was based on data showing that nearly 7% of patients who took the drug ended in hospital, and one of them died within 30 days. This compares to 10% of patients who were hospitalized for taking the placebo, and nine deaths.
Federal officials have committed to purchasing enough drug to treat 3.1 Million people.
Officials at Merck claim that several hundred thousand treatment programs will be made available in the United States in the coming days, and one million in the coming weeks.
Each course of Merck’s drug will cost the U.S. $700. Patients must take four pills twice daily for five days. According to King’s College London and Harvard University, each 40-pill treatment costs around $18.
Merck’s drug introduces small errors in the genetic code of the coronavirus to slow down its reproduction. This genetic effect has been criticized by some because it could lead to mutations in the human fetus and possibly even more severe strains. FDA scientists say the variant risk is mostly theoretical as people only take the drug for a very short time.
