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US regulatory committee recommends MSD’s coronavirus pill

An advisory committee to the US Food and Drug Administration USA (FDA, in English) recommended this Tuesday the approval for emergency use of the pill against the coronavirus COVID-19 of the American pharmaceutical company Merck, which operates in the rest of the world as MSD.

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After almost eight hours of meeting, the members of the FDA’s so-called Vaccine and Biological Products Advisory Committee gave the green light to the recommendation in a tight vote with 13 votes in favor and 10 against.

Merck noted last week that its pill reduces the risk of death and hospitalization by 30%, a percentage lower than the 50% initially announced, but FDA experts concluded that the results for now are positive and should be authorized for emergency use. .

Specifically, they considered that the pill should be administered to adults who are experiencing mild or moderate symptoms of Covid-19 and who are at higher risk of being hospitalized or dying due to their age or previous illnesses, including asthma and obesity.

However, experts warned that the pill could cause fetal defects if taken during pregnancy, so they asked the FDA to take that factor into account.

The committee’s vote is not binding and, now, it is up to the FDA to evaluate the effectiveness of the pill so that later the Centers for Disease Control and Prevention (CDC, in English) issue what would be the final decision.

If approved, Merck’s pill could become the first drug Americans can take orally at home to treat COVID-19.

That pill known as lagevrio or molnupiravir has already been authorized in the United Kingdom.

One of the most anticipated interventions before the committee was that of the vice president of Merck’s infectious diseases and vaccine research department, Daria Hazuda, who stated that the pill should in principle be equally effective against any new variant of the virus.

Specifically, Hazuda spoke to the committee’s experts to explain exactly how this pill works.

With a few slides, Hazuda detailed how the drug attacks an enzyme that the covid-19 virus uses to make copies of itself, thus preventing its multiplication and keeping the viral load at low levels in the body, thereby reduces the severity of the disease.

In this context, he explained that the pill would have a “similar activity against any new variant” and, based on the available data, he considered that this drug has a “favorable residence profile”, therefore it would continue to reduce the rates of hospital admissions and deaths.

However, the expert did not expressly mention how effective the pill would be against the new omicron variant, detected for the first time in South Africa.

This new variant of covid-19 is characterized by having a high number of mutations that could lead to greater transmissibility; But scientists around the world are still investigating how effective the available vaccines and treatments would be.

In addition to the Merck pill, Pfizer announced earlier this month the creation of another pill that reduces the risk of death from COVID-19 by almost 90% for those infected with comorbidities.

Experts agree that obtaining easy-to-administer treatments for those infected by COVID-19 could be a turning point in the pandemic, which in the US alone has killed 777,000 people since March 2020.



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