The US Food and Drug Administration (FDA) on Thursday authorized Merck’s Covid pill for high risk adults amid a winter surge of cases driven by the highly infectious Omicron variant.
The decision to grant an emergency use authorization came a day after the agency gave a green light to a similar but more effective pill developed by Pfizer.
“Today’s authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally,” said FDA scientist Patrizia Cavazzoni.
The pill developed by Merck, which is known as MSD outside the US and Canada, is taken within five days of symptom onset and was shown in a trial of 1,400 participants to reduce Covid hospitalizations and deaths by 30 percent among at-risk people.
Pfizer’s pill reduced the same outcomes by almost 90 percent.
While vaccines and boosters remain the foremost tools in the fight against the virus, experts have welcomed the addition of new oral treatments, which should eventually be easy to access at pharmacies following a prescription.
Until now, the main treatments have been synthetic antibodies or Gilead’s antiviral remdesivir, which are administered by infusion.
Because neither Pfizer nor Merck’s treatments target the ever-mutating spike protein that dots the surface of the virus, they should be more able to withstand new variants, such as Omicron.
Both companies have said early lab testing has borne out this hypothesis.
While both treatments were found to be generally safe in clinical trials, more potential concerns have been raised about Merck’s pill, called molnupiravir.
Safety concerns
The FDA has not authorized Merck’s pill for people under 18 because it may affect bone and cartilage growth.
It is not recommended for use in pregnant women because of the potential fetal harm which was identified in animal testing, but doctors can still decide if the benefits outweigh the risks in individual cases.
Independent experts convened by the FDA narrowly voted in favor of authorizing molnupiravir in early December. Several who voted “no” highlighted the potential risks.
Preliminary data about its efficacy was more encouraging, suggesting a 50 percent reduction in severe Covid, but this was later downgraded to 30 percent after the final analysis included more cases.
The FDA did not convene a panel of experts to discuss Pfizer’s pill, instead opting to authorize it without seeking their advice.
Eight capsules of molnupiravir are taken orally for five days, for a total of 40 capsules.
The US has paid for 3.1 million courses of Merck’s treatment, for about $2.2 billion, and 10 million courses of Pfizer’s for $5.3 billion.
Molnupiravir works by incorporating itself into the genome of the virus, causing mutations that prevent viral replication.
The drug has previously been authorized in Britain and Denmark.
News
Scientists Discover Why Some COVID Survivors Still Can’t Taste Food Years Later
A new study provides the first direct biological evidence explaining why some people continue to experience taste loss long after recovering from COVID-19. Researchers have uncovered specific biological changes in taste buds that could help [...]
Catching COVID significantly raises the risk of developing kidney disease, researchers find
Catching Covid significantly raises the risk of developing deadly kidney disease, research has shown. The virus was found to increase the chances that patients will develop the incurable condition by around 50 per cent. [...]
New Toothpaste Stops Gum Disease Without Harming Healthy Bacteria
Researchers have developed a targeted approach to combat periodontitis without disrupting the natural balance of the oral microbiome. The innovation could reshape how gum disease is treated while preserving beneficial bacteria. The human mouth [...]
Plastic Without End: Are We Polluting the Planet for Eternity?
The Kunming Montreal Global Biodiversity Framework calls for the elimination of plastic pollution by 2030. If that goal has been clearly set, why have meaningful measures that create real change still not been implemented? [...]
Scientists Rewire Natural Killer Cells To Attack Cancer Faster and Harder
Researchers tested new CAR designs in NK-92 cells and found the modified cells killed tumor cells more effectively, showing stronger anti-cancer activity. Researchers at the Ribeirão Preto Blood Center and the Center for Cell-Based [...]
New “Cellular” Target Could Transform How We Treat Alzheimer’s Disease
A new study from researchers highlights an unexpected player in Alzheimer’s disease: aging astrocytes. Senescent astrocytes have been identified as a major contributor to Alzheimer’s progression. The cells lose protective functions and fuel inflammation, particularly in [...]
Treating a Common Dental Infection… Effects That Extend Far Beyond the Mouth
Successful root canal treatment may help lower inflammation associated with heart disease and improve blood sugar and cholesterol levels. Treating an infected tooth with a successful root canal procedure may do more than relieve [...]
Microplastics found in prostate tumors in small study
In a new study, researchers found microplastics deep inside prostate cancer tumors, raising more questions about the role the ubiquitous pollutants play in public health. The findings — which come from a small study of 10 [...]
All blue-eyed people have this one thing in common
All Blue-Eyed People Have This One Thing In Common Blue Eyes Aren’t Random—Research Traces Them Back to One Prehistoric Human It sounds like a myth at first — something you’d hear in a folklore [...]
Scientists reveal how exercise protects the brain from Alzheimer’s
Researchers at UC San Francisco have identified a biological process that may explain why exercise sharpens thinking and memory. Their findings suggest that physical activity strengthens the brain's built in defense system, helping protect [...]
NanoMedical Brain/Cloud Interface – Explorations and Implications. A new book from Frank Boehm
New book from Frank Boehm, NanoappsMedical Inc Founder: This book explores the future hypothetical possibility that the cerebral cortex of the human brain might be seamlessly, safely, and securely connected with the Cloud via [...]
Deadly Pancreatic Cancer Found To “Wire Itself” Into the Body’s Nerves
A newly discovered link between pancreatic cancer and neural signaling reveals a promising drug target that slows tumor growth by blocking glutamate uptake. Pancreatic cancer is among the most deadly cancers, and scientists are [...]
This Simple Brain Exercise May Protect Against Dementia for 20 Years
A long-running study following thousands of older adults suggests that a relatively brief period of targeted brain training may have effects that last decades. Starting in the late 1990s, close to 3,000 older adults [...]
Scientists Crack a 50-Year Tissue Mystery With Major Cancer Implications
Researchers have resolved a 50-year-old scientific mystery by identifying the molecular mechanism that allows tissues to regenerate after severe damage. The discovery could help guide future treatments aimed at reducing the risk of cancer [...]
This New Blood Test Can Detect Cancer Before Tumors Appear
A new CRISPR-powered light sensor can detect the faintest whispers of cancer in a single drop of blood. Scientists have created an advanced light-based sensor capable of identifying extremely small amounts of cancer biomarkers [...]
Blindness Breakthrough? This Snail Regrows Eyes in 30 Days
A snail that regrows its eyes may hold the genetic clues to restoring human sight. Human eyes are intricate organs that cannot regrow once damaged. Surprisingly, they share key structural features with the eyes [...]
