Merck’s Covid Treatment Pill Wins Blessing From FDA Panel

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In a clinical study, molnupiravir was shown to reduce the risk of hospitalization or death by 30 percent when given to high-risk unvaccinated volunteers within five days of showing symptoms. It turns out to be significantly less effective than Pfizer’s Pill, which reduced that risk by 89 percent. Monoclonal antibody treatments have been shown to reduce the risk of hospitalization or death by at least 70 percent.

Assuming the FDA approves the use of molnupiravir, stocks will likely be limited to begin with.

In addition, the compressed time frame of getting the pills can be challenging. Merck’s treatment should be given within five days of the onset of symptoms and taken as 40 pills over five days.

Patients will most likely need to test positive for the coronavirus and see a doctor, who will write a prescription for a pack of pills that can be picked up from a pharmacy. But it often takes days to get the results of a PCR test, and in some parts of the country it’s hard to find tests that give results within 15 minutes. In addition, many people do not have a regular doctor to whom they can go for prescriptions.

The Biden administration has ordered enough courses of Merck’s treatment, at about $700 per person, for 3.1 million people. Merck is expected to ship those pills before February. In contrast, Pfizer is expected to supply only enough of its pills to supply 300,000 people in the United States before the end of February.

One question hanging over treatment is how many eligible Americans will refuse to take the new pills. In a Morning Consult poll released this week, about half of unvaccinated adults — the primary group expected to need the pills — said they wouldn’t take FDA-approved antiviral pills if they got sick. from Covid.

A number of committee members had questions about the safety of the pill. The treatment works by inserting errors into the virus’s genes. Some scientists say there is a theoretical risk that it could also cause mutations in cells, potentially causing reproductive harm or a long-term risk of cancer.

“The overall risk of mutagenicity in humans is considered low,” said Dr. Aimee Hodowanec, a senior medical officer at the FDA, at the meeting, citing the drug’s potential to cause mutations in the DNA of people who use it.

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