Merck’s COVID-19 faces panel review as scientists voice concerns


Merck finally gets his chance to participate in the pandemic. The FDA has announcement its group of external experts will meet on November 30 to deliberate on Merck’s pill for COVID-19 infection.

Over the past two years, the life science industry has worked overtime developing tests, vaccines and treatments to detect, prevent and treat the novel coronavirus. Pharmaceutical giant Merck has seen quite a few failures in its efforts, but its latest attempt, molnupiravir, is in its final attempt at approval.

Merck submitted its antiviral drug to the FDA for approval on Oct. 11. The FDA has waived its typical expert advisory committees on all previously approved coronavirus vaccines. This will be the first such meeting for therapy targeting COVID-19.

“We believe that, in this case, a public discussion of this data with the agency’s advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating,” said Dr. Patrizia Cavazzoni, director of the center. pharmaceuticals from the FDA.

The treatments and vaccines developed for this pandemic have garnered more public attention and mistrust than ever before, driven by the highly polarized political scene in the United States. The FDA’s decision to host this panel ahead of its decision reflects its efforts to address public skepticism.

The panel will make its recommendation on the basis of the data available to it. Then the FDA will make a decision. Although the agency follows the recommendation of the committee regarding 80% of the time, It is not mandatory.

While the drug proven itself effective in late-stage trials, halving the risk of serious illness and hospitalization, some questions swirl in the scientific community regarding the drug’s potential effects.

Molnupiravir, whose name was inspired by Thor’s hammer Mjölnir, works by incorporating into the virus’s RNA to cause mutations in the replication process. With a dispersal effect, it adds more and more mutations until the virus genome can no longer make copies, an event called an “error catastrophe”.

Researchers at the University of North Carolina conducted a to study where they exposed hamster cells to the drug for 32 days. At this level of exposure, the drug caused low levels of mutation in the hamster’s DNA.

This raises the question of whether taking Merck’s drug COVID-19 for five days, twice a day, could pose a risk for human DNA mutations. Importantly, Merck said his team conducted their own experiments on lab rats, not isolated cells, and found no evidence of DNA mutations. Scientists at Merck backed down, saying studies of cells in a lab box are irrelevant in determining how an entire human would be affected.

“It’s really an unknown risk,” said Ronald Swanstrom, author of the UNC study, of the mutations. “It’s somewhere between harmless risk and significant risk.”

He agrees, however, that the drug shows promise and believes more research is needed. Until then, the FDA could limit the drug to people who would truly benefit from it – the elderly and immunocompromised most at risk of serious illness and hospitalization. To err on the side of caution, the drug could be avoided in people of childbearing age.

Merck’s trial excluded pregnant and breastfeeding women, as most drug studies do, and those of childbearing potential were asked to use contraception.

Another great repel on Merck’s COVID-19 pill is the cost. While Merck hasn’t done any of the initial research itself, it will charge the US government over $ 700 per five-day treatment. Independent analysis estimates that a sustainable generic price with a built-in 10% profit margin would be $ 20 per spin. Doctors Without Borders hits Merck hard on pricing and licensing deals, only allowing generic manufacturers in India.

At least three other oral COVID-19 pills are sufficiently advanced that clinical data is expected by the end of the year: Atea Pharmaceuticals and Roche, Fujifilm and Dr. Reddy’s Laboratories, and Pfizer.