US FDA will Decide “within weeks” on Merck’s “molnupiravir” COVID-19 Pill Authorization

FDA to decide whether to recommend Emergency-Use-Authorization (EUA) for molnupiravir pill to treat early-stage coronavirus disease.

US FDA will Decide “within weeks” on Merck’s “molnupiravir” COVID-19 Pill Authorization

A team of infectious disease advisers to the U.S. Food and Drug Administration (FDA) will look at outcomes of Merck and Ridgeback Biotherapeutics’ clinical trial and decide whether to recommend Emergency-Use-Authorization (EUA) for molnupiravir pill to treat early-stage coronavirus disease in a meeting on Tuesday, 30 November 2021.

According to the October news release from Merck & Co., the results, which have yet to be revised by the US federal health agency FDA or released in a medical journal, are pretty stunning; the oral antiviral pill decreased hospital admissions and fatalities by nearly 50 percent.

An infectious disease professional at “Vanderbilt University Medical Center,” Dr. Mark Denison, said that he’s wanted to yell from the rooftops regarding molnupiravir – an antiviral medication that prevents the replication of specific RNA viruses and is used to treat coronavirus disease in those infected by SARS-CoV-2 – so that is like sending their baby off to college. Nevertheless, it isn’t apparent what sort of report card that baby would get.

Molnupiravir performs in a somewhat unusual way, and there’re also concerns it could be risky for developing fetuses. Although, the firm’s clinical trials didn’t include pregnant women, Daria Hazuda, Ph.D. – who leads Merck & Co.’s antiviral pill research – says the federal health agency might restrict its use in pregnant women.

Moreover, there’re worries that the tablet could lead to the development of jab-resistant COVID transformations. However, Hazuda says Merck’s study found that the drug doesn’t lead to such tensions.

America to Require Vaccination for All Border Crossers

Adjunct Professor of Immunology & Infectious Diseases at “Harvard T.H. Chan School of Public Health,” Dr. Eric Rubin, said that they should concern about the perils to pregnant women and the menaces of developing resistance. But if they’ve a drug that works, they want that medication. They just have to determine how best to use it, given its confines.

Joe Biden, the US President, will require essential, non-resident visitors crossing American land borders, such as truckers, government officials, and emergency response officers, to be fully inoculated starting from 22nd January, the Biden administration planned to declare.

US FDA will Decide “within weeks” on Merck’s “molnupiravir” COVID-19 Pill Authorization
US FDA will Decide “within weeks” on Merck’s “molnupiravir” COVID-19 Pill Authorization
Source: Web

A senior government official said the requirement, which the White House preliminary viewed in October, brings the restrictions for essential visitors in line with those that took effect earlier in November for leisure visitors, when America reopened its borders to fully inoculated people.

According to the data from the U.S. CDC, nearly 47M American adults remain uninoculated.

Read Also: Kamala Harris Announces 1.5 Billion Dollars Investment in Healthcare For Undeserved Community