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
Mystery Solved: Scientists Find Cause for Unexplained, Deadly Diseases
A study reveals that a protein called RPA is essential for maintaining chromosome stability by stimulating telomerase. New findings from the University of Wisconsin-Madison suggest that problems with a key protein that helps preserve chromosome stability [...]
Nanotech Blocks Infection and Speed Up Chronic Wound Recovery
A new nanotech-based formulation using quercetin and omega-3 fatty acids shows promise in halting bacterial biofilms and boosting skin cell repair. Scientists have developed a nanotechnology-based treatment to fight bacterial biofilms in wound infections. The [...]
Researchers propose five key questions for effective adoption of AI in clinical practice
While Artificial Intelligence (AI) can be a powerful tool that physicians can use to help diagnose their patients and has great potential to improve accuracy, efficiency and patient safety, it has its drawbacks. It [...]
Advancements and clinical translation of intelligent nanodrugs for breast cancer treatment
A comprehensive review in "Biofunct. Mater." meticulously details the most recent advancements and clinical translation of intelligent nanodrugs for breast cancer treatment. This paper presents an exhaustive overview of subtype-specific nanostrategies, the clinical benefits [...]
It’s Not “All in Your Head”: Scientists Develop Revolutionary Blood Test for Chronic Fatigue Syndrome
A 96% accurate blood test for ME/CFS could transform diagnosis and pave the way for future long COVID detection. Researchers from the University of East Anglia and Oxford Biodynamics have created a highly accurate [...]
How Far Can the Body Go? Scientists Find the Ultimate Limit of Human Endurance
Even the most elite endurance athletes can’t outrun biology. A new study finds that humans hit a metabolic ceiling at about 2.5 times their resting energy burn. When ultra-runners take on races that last [...]
World’s Rivers “Overdosing” on Human Antibiotics, Study Finds
Researchers estimate that approximately 8,500 tons of antibiotics enter river systems each year after passing through the human body and wastewater treatment processes. Rivers spanning millions of kilometers across the globe are contaminated with [...]
Yale Scientists Solve a Century-Old Brain Wave Mystery
Yale scientists traced gamma brain waves to thalamus-cortex interactions. The discovery could reveal how brain rhythms shape perception and disease. For more than a century, scientists have observed rhythmic waves of synchronized neuronal activity [...]
Can introducing peanuts early prevent allergies? Real-world data confirms it helps
New evidence from a large U.S. primary care network shows that early peanut introduction, endorsed in 2015 and 2017 guidelines, was followed by a marked decline in clinician-diagnosed peanut and overall food allergies among [...]
Nanoparticle blueprints reveal path to smarter medicines
Lipid nanoparticles (LNPs) are the delivery vehicles of modern medicine, carrying cancer drugs, gene therapies and vaccines into cells. Until recently, many scientists assumed that all LNPs followed more or less the same blueprint, [...]
How nanomedicine and AI are teaming up to tackle neurodegenerative diseases
When I first realized the scale of the challenge posed by neurodegenerative diseases, such as Alzheimer's, Parkinson's disease and amyotrophic lateral sclerosis (ALS), I felt simultaneously humbled and motivated. These disorders are not caused [...]
Self-Organizing Light Could Transform Computing and Communications
USC engineers have demonstrated a new kind of optical device that lets light organize its own route using the principles of thermodynamics. Instead of relying on switches or digital control, the light finds its own [...]
Groundbreaking New Way of Measuring Blood Pressure Could Save Thousands of Lives
A new method that improves the accuracy of interpreting blood pressure measurements taken at the ankle could be vital for individuals who are unable to have their blood pressure measured on the arm. A newly developed [...]
Scientist tackles key roadblock for AI in drug discovery
The drug development pipeline is a costly and lengthy process. Identifying high-quality "hit" compounds—those with high potency, selectivity, and favorable metabolic properties—at the earliest stages is important for reducing cost and accelerating the path [...]
Nanoplastics with environmental coatings can sneak past the skin’s defenses
Plastic is ubiquitous in the modern world, and it's notorious for taking a long time to completely break down in the environment - if it ever does. But even without breaking down completely, plastic [...]
Chernobyl scientists discover black fungus feeding on deadly radiation
It looks pretty sinister, but it might actually be incredibly helpful When reactor number four in Chernobyl exploded, it triggered the worst nuclear disaster in history, one which the surrounding area still has not [...]
