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

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

Assuming the FDA allows the use of molnupiravir, supplies are likely to be limited at first.

Additionally, the compressed time frame of taking the pills can pose a challenge. Merck’s treatment is supposed to be given within five days of the onset of symptoms and taken as 40 pills for five days.

Patients will most likely need to test positive for coronavirus and see a doctor who will write a prescription for a pack of pills available at the pharmacy. However, it often takes days to get results from a PCR test, and it is difficult to find tests that give results within 15 minutes in some parts of the country. Also, many people do not have a regular doctor they can turn to for a prescription.

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

One question about treatment is how many eligible Americans will refuse to take the new pills. In a Morning Consultation survey 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 with Covid.

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

A senior paramedic at the FDA, Dr. “The overall risk of mutagenicity in humans is thought to be low,” Aimee Hodowanec said at the meeting, referring to the drug’s potential to induce mutations in the DNA of people who take it.

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