US well being panel endorses Merck’s COVID-19 tablet | Coronavirus pandemic Information
A panel of U.S. health professionals has voted to recommend Merck’s antiviral pill for the treatment of COVID-19.
The independent scientists appointed by the Food and Drug Administration (FDA) voted 13 in favor and 10 against approval on Tuesday.
A close win reflected some concerns about a recent downgrade in treatment efficacy results, as well as concerns about possible side effects.
“I see this as an incredibly difficult decision with a lot more questions than answers,” said jury chairwoman Dr. Lindsey Baden of Harvard Medical School, who voted for the drug.
He said the FDA must carefully tailor use of the drug to the patients who would benefit most from it.
If the FDA approves the drug, it would be the first home treatment for the virus almost two years after the pandemic started.
Approval would likely be limited to patients at high risk of developing serious illness, although the exact population would be determined by the agency.
Molnupiravir, already approved in the UK, has been shown to reduce hospital admissions and death rates in people at high risk for developing severe COVID-19 when taken within five days of symptoms appearing.
Clinical study results
The FDA is expected to issue an Emergency Authorization (EUA) for the treatment, which means millions of courses will soon be in stock in pharmacies.
Last week, Merck, known as MSD outside of the US and Canada, released the full results of a clinical study involving 1,400 people.
It was found safe in its clinical study, with non-serious side effects such as diarrhea and dizziness occurring roughly equally in the placebo and drug groups.
Research showed the pill reduced the risk of hospitalizations and death by 30 percent, a significant finding, albeit more modest than a previously announced 50 percent figure based on an analysis of half of the patients.
The COVID-19 treatment pill molnupiravir has a tight approval from scientists [File: Reuters]
Merck has not specifically tested its drug against the new variant, but said it should have some effectiveness due to its effectiveness against other strains of coronavirus.
This uncertainty frustrated many panelists as they debated whether to support the treatment of millions of Americans.
“Since there is no data that says it will work with new variants, we have to be really careful when we say this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted for Medicines.
Briefing documents uploaded by the FDA in advance of the meeting illustrated the risk-benefit ratio for the experts to assess.
In Tuesday’s vote, the drug was specifically endorsed for adults with mild to moderate COVID-19 who are at the greatest risk, including the elderly and those with conditions such as obesity and asthma.
Studies in rats and rabbits identified potentially harmful effects on fetal development, and Merck said it would not recommend molnupiravir for use in pregnant women.
Most experts also said the drug shouldn’t be used in vaccinated people who weren’t part of Merck’s research and haven’t shown any benefit.
The company didn’t file for approval in children, and the FDA said it did not plan to conduct pediatric studies until it was determined to be safe in juvenile rats for bone formation-related concerns.
Currently, the most effective treatment for COVID-19 is monoclonal antibodies that are administered via a drip and have been shown to reduce the risk of severe cases in high-risk patients by up to 70 percent.
However, pills have the advantage that they are much easier to use and, unlike antibodies, do not require a visit to an infusion site.
Molnupiravir, developed in collaboration with Ridgeback Biotherapeutics, works by introducing mutations into the genetic material of the coronavirus and inhibiting its ability to replicate.
The treatment is taken as four capsules twice a day for five days in a total of 40 tablets.
It’s believed to be more variant-safe than monoclonal antibodies or vaccines because, unlike them, it doesn’t look for the constantly mutating spike proteins that puncture the surface of the virus.
The US government has pledged to buy 3.1 million molnupiravir courses for approximately $ 2.2 billion, with the option to buy more.