- Advertisement -

Merck’s new COVID-19 According to a report, scientists have warned that the pill called mollupiravir, which was headed for FDA review for emergency authorization, could potentially carry serious safety issues arising from the method used to kill the virus. May go.

Oral antiviral medication is integrated into the genetic makeup of the virus, causing a large number of mutations to destroy the virus. However, some laboratory tests indicated the drug’s ability to cause mutations in the genetic material of mammalian cells, theoretically causing cancer or birth defects, Barron’s said. informed of.


However, Merck told the outlet that testing in animals indicates this is not an issue: “The totality of the data from these studies indicates that mollupiravir is not mutagenic or genotoxic in in-vivo mammalian systems,” said a Merck spokesperson. he said.

Merck to request emergency approval for COVID-19 antiviral pill

- Advertisement -

Granthshala News has requested comment from Merck.

Professor of Pediatrics and Director of the Department of Biochemical Pharmacology at Emory University School of Medicine, Dr. Raymond Shinazzi warns on NHC, which turns up after swallowing the compound mollupiravir. They advised caution with widespread use until more data are available because of its potential harm to young people of reproductive age or pregnant. The Merck trial currently excludes pregnant women.

An interim analysis released last week stemming from the MOVe-OUT global phase 3 trial indicated that the investigational antiviral drug reduced the risk of hospitalization or death by about 50% compared to placebo for adult patients with mild to moderate COVID-19. % has been reduced.

Only 7.3% of patients receiving the experimental drug were hospitalized or subsequently died compared to 14.1% of patients randomized to receive placebo by day 29. Study.

Each patient had at least one risk factor for poor outcome and symptoms within five days of starting the study. The goal of the study was to investigate whether oral medication could reduce hospitalization or death.

Click here for full coronavirus coverage

Merck said last week that it plans to obtain emergency approval from the Food and Drug Administration (FDA) as soon as possible. The company also has an agreement to supply 1.7 million courses of antivirals to the US government after authorization or approval.

Doctor. Anthony Fauci, President Biden’s chief medical adviser told an October 1 White House briefing that Merck’s “data is impressive” that there were no deaths in the treatment group, compared with eight deaths in the placebo group.

White House COVID-19 Response Coordinator Jeff Ziants also weighed in, saying: “It’s a potential additional tool in our toolbox to protect people from the worst consequences of COVID,” but noted that vaccination is the best vaccine against COVID. The effective tool is 19, including preventing infection.

“We want to prevent infections, not wait to treat them after they occur,” Ziants said.

Click here for full coronavirus coverage

Just as Tamiflu can prevent complications for patients diagnosed with influenza, Merck’s drug has the same potential to prevent hospitalization and death after a diagnosis of COVID-19.

NS The FDA will be tasked with examining the data for emergency authorization recommendation, according to Merck’s announcement it plans to request the EUA soon. Although a specific timeline is uncertain, if approved it has the potential to prevent hospitalization of more patients with mild to moderate COVID-19 or death due to infectious disease.

Granthshala News’ Kayla Rivas contributed to this report.