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
What to know about BA.2 – the newest Covid Omicron variant
It's called the "stealth" variant, but there's nothing particularly stealthy about it. Researchers are working to parse whether it is a new threat. As coronavirus case numbers in the U.S. show early signs of [...]
New, better coronavirus rapid test
Researchers at the Paul Scherrer Institute PSI and the University of Basel have developed a rapid test for COVID-19. Its novel functional principle promises reliable and quantifiable results concerning a patient's COVID-19 disease and [...]
Bio-Inspired Nanocoating Improves NIR and Biomedical Properties of Titanium Alloy
A group of researchers proposed an optimized electroforming strategy to achieve a bioinspired nano-holed TiO2 coated Ti6Al4V alloy, according to a study published in the journal ACS Applied Material Interfaces. Near-infrared (NIR) energy plays a critical part [...]
Seeking a hydrophilic nanoparticle solution to antibiotic resistance
The Centers for Disease Control and Prevention estimates that more than 2.8 million Americans experience antibiotic-resistant infections each year; more than 35,000 die from those infections. To address this critical and worldwide public health [...]
Nano-sized vesicles with ACE2 receptor could prevent, treat infection of SARS-CoV-2
Scientists at The University of Texas MD Anderson Cancer Center and Northwestern Medicine have identified natural extracellular vesicles containing the ACE2 protein (evACE2) in the blood of COVID-19 patients that can block infection from [...]
‘Superpower’ nano bubbles could treat, prevent current and future strains of SARS-CoV-2
Scientists at Northwestern Medicine and The University of Texas MD Anderson Cancer Center have identified natural nano-bubbles containing the ACE2 protein (evACE2) in the blood of COVID-19 patients and discovered these nano-sized particles can [...]
Groundbreaking AI Technology Diagnoses COVID-19 In Minutes
Pioneering Artificial Intelligence (AI) technology, developed by experts at University of the West of Scotland (UWS), is capable of accurately diagnosing Covid-19 in just a few minutes. The groundbreaking program is able to detect [...]
Antimicrobial resistance now a leading cause of death worldwide, study finds
Antimicrobial resistance poses a significant threat to humanity, health leaders have warned, as a study reveals it has become a leading cause of death worldwide and is killing about 3,500 people every day. More [...]
Evaluating Antiviral Activities of Nanoparticles Could Help Prevent Future Pandemics
The Necessity of Novel Antiviral Materials With the severe acute respiratory coronavirus 2 (SARS-CoV-2) being highly infectious and transmissible, the need for novel antiviral materials that can decrease viral activities has become paramount. Preparation procedures [...]
Nanocarrier therapy offers new hope for the treatment of Type 1 diabetes
Individuals living with Type 1 diabetes must carefully follow prescribed insulin regimens every day, receiving injections of the hormone via syringe, insulin pump or some other device. And without viable long-term treatments, this course [...]
Nanobubbles provide pathway to build better medical devices
Researchers from the University of Sydney Nano Institute and School of Chemistry have revealed that tiny gas bubbles – nanobubbles just 100 billionths of a metre high – form on surfaces in unexpected situations, [...]
Nanocomposite Hydrogel Improves Bone Repair Treatment
Innovative researchers have investigated the potential of incorporating a gelatin methacryloyl hydrogel functionalized with synthetic nanoclay laponite to improve the delivery of osteoblast derived extracellular vesicles for increased bone repair. This research has been [...]
Bioengineered nanoparticles show promise for fibrinogen manufacture
A couple of essential biomolecules play a key role in the process of blood clotting. One of these is a protein called fibrinogen. It is often given to those who have experienced heavy bleeding, [...]
Applying Nanoemulsions to the Food Sector
Nanoemulsions are a relatively new technology that has found significant use for delivering functional chemicals such as micronutrients, flavorings, bioactive molecules, and antimicrobial agents into food and beverage products. This article focuses on applying [...]
Researchers develop new method to increase effectiveness of nanomedicines
Researchers at Penn Medicine have discovered a new, more effective method of preventing the body's own proteins from treating nanomedicines like foreign invaders, by covering the nanoparticles with a coating to suppress the immune [...]
Researchers Create Nanobombs Capable of Attacking Only the Cancer Cells
Bioinspired by tunicates and mussels, a Korean research team has created a “bomb-like” anticancer therapeutic agent that only destroys cancer cells. Schematic diagram of the mechanism of action of photoactivatable adhesive nanobombs made with [...]
