U.S. FDA Authorizes Merck’s COVID-19 Pill, Despite Experts Questioning Its Value

On Thursday, U.S. Health regulators approved the second dose of COVID-19. This medication provides an easy way to fight the increasing tide of Omicron Infections.

This authorization by the Food and Drug Administration comes just one day after Pfizer cleared another drug. This pill will likely be the first choice treatment for the virus because of its milder side effects and superior benefits.

As a result, Merck’s pill is expected to have a smaller role against the pandemic than predicted just a few weeks ago. The drug label will alert of potential birth defects and warn about the limitations it has in preventing severe COVID-19.
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The Food and Drug Administration authorized Merck’s drug for adults with early symptoms of COVID-19 who face the highest risks of hospitalization, including older people and those with conditions like obesity and heart disease. It was first approved by the U.K. in November.

Molnupiravir was the name of this Merck drug. It is not recommended for use during pregnancy.

After an FDA advisory panel narrowly supported the drug’s use last month, the FDA warned that it would need to be tailored for patients who could benefit most from the drug.

The Pfizer pill works differently and doesn’t carry the same risks. Additionally, Pfizer’s drug was roughly three times more effective in testing, reducing hospitalization and death by nearly 90% among high-risk patients, compared with 30% for Merck’s.

Experts are unsure if the Merck drug will play a significant role in America.

“To the extent that there’s an ample supply of Pfizer’s pill, I think it won’t be used,” said Dr. Gregory Poland of the Mayo Clinic, referring to the Merck drug. “There would be no reason, given it has less efficacy and a higher risk of side effects.”

At the moment, FDA has offered another possible option to the virus that has claimed the lives of more than 800,000. Officials are also preparing for record-setting hospitalizations, deaths, and cases caused by the Omicron variant. Antiviral pills, including Merck’s, are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

FDA’s decision was based on data showing that nearly 7 percent of the patients who took the drug were admitted to the hospital, and only one of them died within 30 days. That compares with the 10% of placebo-treated patients who ended up in hospital and nine deaths.

Federal officials agreed to buy enough drug for 3.1 million patients.

The U.S. will pay about $700 for each course of Merck’s drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King’s College London estimated it costs about $18 to make each 40-pill course of treatment.

Merck’s drug inserts tiny errors into the coronavirus’ genetic code to slow its reproduction. This genetic effect raised concern that it could lead to mutations in the coronavirus’ gene code and possibly even more severe strains. FDA scientists claim that the variant risk from the drug is mostly theoretical, as people only take it for short periods of time.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. All content remains the responsibility of the Associated Press.


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