FDA advisory panel endorses Merck’s COVID-19 pill for high-risk adults

According to NBC News, it was a tight vote of 13 to 10 by the FDA's Antimicrobial Drugs Advisory Committee to approve Merck's product.

Their reporting stresses that the committee's approval in itself doesn't mean the agency will agree with that in their final ruling.

Members had questions about Molnupiravir, a drug from the Merck and Ridgeback Biotherapeutics' pharmaceutical company that is said to reduce the risk of hospitalization and death from COVID-19 by 30 percent.

Despite monoclonal antibody treatments reducing severe COVID risks by 70 percent, pills are seen as the next frontier of pandemic treatment for the leading drug companies. Pfizer is ramping up their production of competing product Paxlovid, for instance.

Tuesday's presentation to the advisory committee comes on the heels of the Omicron COVID-19 variant being identified in South Africa. Merck's scientists believe their drug will still be effective against that particular strain of the disease (but stress the need for further testing).

The dilemma as explained by CBS is that Merck reported early results showcasing a 50 percent drop in severe COVID-19 symptoms.

It was only through later data that the company had to temper their expectations down to that 30 percent number.

The way Merck's pill works, however, is by creating mutations into COVID-19 to make it more difficult to replicate itself.

A source of concern for many committee members was that this drug could speed up the evolution process of the virus. To combat that, Merck's senior vice president for global regulatory affairs and clinical safety recommended that patients simply take the full prescription of the pill, to ensure complete eradication.

Another heated debate for the FDA's Antimicrobial Drugs Advisory Committee was whether or not pregnant women could take Merck’s drug. They were completely left out of the company's study.

Outstanding concerns over the issue left one committee member outraged. "What it comes down to for me is, do we want to reduce the risk for the mother by 30 percent of harm by exposing the embryo and the fetus to a much higher risk of harm by this drug? And my answer is no," remarked Dr. James Hildreth of the Meharry Medical College in Tennessee.

Cancer risks from the mutation of DNA are also mentioned.

Regulators in the United Kingdom approved Molnupiravir for use in COVID-19 patients at the beginning of November.

It was around this same timeframe that the Biden administration bought another $1 billion USD of Merck's COVID-19 pill, bringing their total stock pile up to 3.1 million doses and $2.2 billion worth of the drug.