On Tuesday, a federal advisory group agreed to propose that the government permit the use of an antiviral medication to counteract the severe effects of Covid-19, marking the first time the government has done so.
The drug from Merck was approved by the advisory group by a surprise thin margin of 13 to 10, as public health experts throughout the globe scrambled to beef up their defences against the newly emerged Omicron strain of the coronavirus.
There has been some evidence that the Merck therapy, known as molnupiravir, may help to minimise the risk of hospitalisation and mortality associated with Covid. In the United States, the tablet might be approved for usage in a matter of days and made accessible to patients in a matter of weeks.
The Food and Drug Administration (FDA) may also accept an identical drug from Pfizer in the coming weeks, which seems to be considerably more successful than Merck’s. The introduction of the two simple-to-use medications may offer a buffer against the resurgence of the virus when used together.
The Food and Drug Administration’s advisory council, which is comprised of antimicrobial drug specialists, recommended that Merck’s medication be approved for those who have Covid and are at high risk of getting very sick. Tens of millions of Americans who are over the age of 65 or who have medical issues like as obesity, diabetes, or heart disease would most likely be covered under this provision.
The committee’s tight decision, on the other hand, indicated worries about the pill’s efficacy as well as fears that it may be harmful to reproductive health.
In addition to voting against approval, several members of the committee said that more studies on the drug’s safety were required. In a statement, Dr. Sankar Swaminathan, an infectious disease expert at the University of Utah, said, “The possibility of broad impacts on possible birth abnormalities, particularly delayed effects on the male, has not been fully researched.” Dr. Swaminathan is a specialist in infectious diseases.
The tablets, which will be prescribed by physicians and given by pharmacists, are significantly more convenient than the monoclonal antibody therapies that have traditionally been used to help high-risk Covid patients and are likely to reach a much larger number of individuals. Antibody therapies are costly, and they are normally administered intravenously in hospitals or clinics only.
The Biden administration has been hopeful that the introduction of antiviral medications from Merck and Pfizer would aid in the abolition of the pandemic’s most acute phase since its inception. The United States government has invested billions of dollars to ensure that millions of treatment courses of the new medicines are made available to the public.
Participants in Merck’s clinical studies were mostly infected with the Delta, Mu, and Gamma strains of the coronavirus, according to the company. Scientists have not yet conducted trials to determine how efficiently the tablets inhibit the replication of Omicron viruses. However, there are grounds to believe that they would continue to be beneficial even if the variation is able to elude vaccinations and monoclonal antibodies in certain cases.