Merck’s COVID-19 pill could lead to serious safety concerns, scientists warn – .

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Merck is new COVID-19[feminine[feminine The pill, known as molnupiravir, slated for FDA review for emergency clearance, could potentially lead to serious safety concerns related to the method used to kill the virus, scientists have warned, according to a report.

The oral antiviral drug becomes part of the genetic makeup of the virus, causing a large number of mutations to destroy the virus. However, some lab tests have indicated the drug’s ability to cause mutations in the genetic material of mammalian cells, theoretically causing cancer or birth defects, Barron reported.

However, a spokesperson for Merck told Fox News that animal testing indicates otherwise: “The totality of the data from these studies indicate that molnupiravir is not mutagenic or genotoxic in mammalian systems in vivo,” partly indicates a press release.

MERCK REQUESTS EMERGENCY APPROVAL FOR COVID-19 ANTIVIRAL PILL

Dr Raymond Schinazi, professor of pediatrics and director of the division of biochemical pharmacology at Emory University School of Medicine, warned of NHC, the compound that molnupiravir turns into after being ingested. He advised caution with widespread use until more data are available, because of its potential harm to young people of childbearing age or those who are pregnant. The Merck trial currently excluded pregnant women.

An interim analysis published last week following the global phase 3 MOVe-OUT trial indicated that the investigational antiviral drug reduced the risk of hospitalization or death by almost 50% compared to placebo for adult patients with Mild to moderate COVID-19.

Only 7.3% of patients who received the investigational drug were hospitalized or subsequently died, compared to 14.1% of patients randomized to receive placebo on day 29 of treatment. to study.

Each patient had at least one risk factor for poor outcome and symptoms within five days of starting the study. The aim of the study was to examine whether the oral drug could reduce hospitalizations or deaths.

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Merck last week announced plans to seek emergency clearance from the Food and Drug Administration (FDA) as soon as possible. The company also has an agreement to provide 1.7 million antiviral treatments to the US government upon authorization or approval.

Dr. Antoine Fauci, Chief Medical Advisor to President Biden, told a White House October 1 briefing that “Merck’s data is impressive,” while noting that no deaths have occurred in the treatment group , compared with eight deaths in the placebo group.

Jeff Zients, White House COVID-19 response coordinator, also weighed in, adding, “This is a potential additional tool in our toolkit to protect people from the worst consequences of COVID,” but said noted that vaccination remains the most effective tool against COVID-19, including the prevention of infections.

“We want to prevent infections, not just wait to treat them once they happen,” Zients said.

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Because Tamiflu can prevent complications in patients diagnosed with influenza, Merck’s drugs have similar potential to prevent hospitalization and death after being diagnosed with COVID-19.

The The FDA will be tasked with reviewing the data for an emergency clearance recommendation, according to Merck’s announcement last week of its intention to seek EUA soon. While a precise timeline is uncertain, if approved, it could prevent more patients with mild to moderate COVID-19 from being hospitalized or dying from the infectious disease.

Kayla Rivas of Fox News contributed to this report.

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