Merck’s Covid Treatment Pill Wins FDA Panel Blessing – .

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Merck’s Covid Treatment Pill Wins FDA Panel Blessing – .


In a clinical trial, molnupiravir was found to reduce the risk of hospitalization or death by 30% when given to high-risk, unvaccinated volunteers within five days of onset of symptoms. It appears to be significantly less effective than the Pfizer pill, which has been shown to reduce this risk by 89%. Monoclonal antibody treatments have been shown to reduce the risk of hospitalization or death by at least 70%.

Assuming the FDA clears the use of molnupiravir, supplies will likely be limited at first.

Also, the reduced time to get the pills could be a challenge. Merck treatment is supposed to be given within five days of the onset of symptoms and is taken as 40 tablets 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 packet of pills that can be picked up from a pharmacy. But it often takes days to get results from a PCR test, and in some parts of the country it’s hard to find tests that return results within 15 minutes. In addition, many people do not have a regular doctor to turn to for prescriptions.

The Biden administration has ordered enough treatments from Merck, at around $ 700 per person, for 3.1 million people. Merck is expected to deliver these pills before February. In contrast, Pfizer is only expected to deliver enough of its pills to cover 300,000 people in the United States by the end of February.

One question hanging over the 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 main group that should need the pills – said they would not take FDA-cleared antiviral pills if they fell ill with Covid.

Several committee members raised questions about the safety of the pill. The treatment works by inserting errors into the genes of the virus. Some scientists say there is a theoretical risk that it could also trigger mutations in cells, potentially causing reproductive damage or a long-term risk of cancer.

“The overall risk of mutagenicity in humans is considered low,” FDA chief medical officer Dr. Aimee Hodowanec told the meeting, referring to the drug’s potential to induce mutations in the DNA of people who take it.

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