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RaDonda Vaught: Victim, felon, or both?

Article Type
Changed
Wed, 04/27/2022 - 14:23

For 4 and a half years, I have followed the RaDonda Vaught medication error that led to the unfortunate death of a human being. I am not alone. Nurses across the country have followed the case with anxiety and fear, knowing a guilty verdict might have the potential to challenge basic tenets of care.

According to Kaiser Health News, nurses are “raging and quitting” following the announcement of a guilty verdict for two felonies: criminally negligent homicide and gross neglect of an impaired adult.

Thousands of nurses have claimed they could arrive in Nashville, Tenn., on May 13, the day Ms. Vaught is to be sentenced, to protest the conviction. Others have stated they believe justice is being conducted, as their sympathies lie with the victim, Charlene Murphey, who died 12 hours after being unable to draw breath, paralyzed from the inadvertent dose of vecuronium given intravenously by her nurse.

How should we feel as clinicians? What does this guilty verdict mean for nurses across the country as Ms. Vaught waits to receive a sentence that could imprison her for up to 8 years, according to sentencing guidelines?

My belief is that it is understandable to feel passionately about this case, including what it could mean to an era of “just culture” that nursing organizations have promoted. The concept of just culture looks at medication/nursing errors as opportunities for growth to avoid future errors, not as scenarios for punitive action. With the guilty verdict in Ms. Vaught’s case, nurses (and facilities) fear that nurses will avoid coming forward after mistakes, leading to cover-ups and a culture perspective.

Will nurses be hesitant to report errors (especially significant errors) that lead to patient harm? Will we fear retribution and reprisal for being truthful?

I believe that Ms. Vaught’s criminal case has changed little in the political landscape of caregiving. Before you let loose with a loud expletive (or two), hear me out.

When a patient dies from unintentional harm, someone must be held accountable. Society needs a scapegoat, and unfortunately, excrement slides downhill to the lowest common denominator, which may be the nurse. Initially, Ms. Vaught was contacted by her state licensing board (Tennessee) and informed there would be no professional repercussions for her mistake. That decision did not hold. She was later indicted criminally for the death of her patient. She also had her nursing license revoked.

Why? The hospital where she worked was threatened with Medicare reprisal if systemic issues were not addressed following the incident; for example, a bar-coding device was not available for Ms. Vaught to use prior to administering the vecuronium, and paralytic agents were stored unsafely in a Pyxis MedStation, readily available for any nurse to obtain via override.

In fact, the number of overrides performed by all nurses caring for Ms. Murphey in the days leading to her death was alarming, leading reviewers to assume that time to acquire medication for inpatients was a problem.

Ms. Vaught herself, stating the obvious on talk shows, said she should not have performed an override, that the situation was “not an emergency” and she should have taken time to check that Versed (midazolam) was available by the generic name and not the “VE” she entered as a search mechanism into the machine. She also stated she was “distracted” by a trainee assigned to her at the time.

We have all been there, feeling rushed to perform a task under stressful situations, skipping safety guidelines to sedate a patient while radiology is waiting. Someone is always on our a**, waiting to get to the next task, the next patient, the next admission, the next pseudo-emergency called nursing workload.

It never ends.

Which is why I wish to emphasize what the Ms. Vaught guilty verdict really means for nurses.

It means we must never forget that our actions have the potential to harm, even kill, our patients.

We must never forget that repercussions and reprisal may occur, whether personal guilt that may prove more damaging than the prison sentence Ms. Vaught might receive, or problems that could result if nurses attempt to hide or subvert medication issues.

In Ms. Vaught’s case, she did not document the medication that had been given to Ms. Murphey, facts the prosecution seized on to proclaim her guilt. Why? We can only guess at this point. But her claims of truthfulness need to be balanced by what occurred, and the facts are that she did not document the error after administering vecuronium that night.

When reflecting on this verdict, we need to remember a patient died, and she did so horribly, being unable to draw breath. This should never happen during our watch, ever, and as clinicians, we need to be vigilant.

In summary, protest if you believe justice has been too harsh or unfair, and that nurses may be fearful as a result. But please spare a moment to realize that someone should protest for Ms. Murphey as well. We cannot bring her back, nor can we right the system issues that may have led to her death.

But we should protest for safer systems, for improved staffing, for a need to catch our collective breaths, and a day to work and nurture patients when someone is not constantly on our a**. Only then will nurses be protected from unjust reprisal, from needing to be the lowest common denominator of guilt.

Ms. Goodman is a researcher and consultant in Libertyville, Ill. She disclosed no conflicts of interest.

A version of this article first appeared on Medscape.com.

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For 4 and a half years, I have followed the RaDonda Vaught medication error that led to the unfortunate death of a human being. I am not alone. Nurses across the country have followed the case with anxiety and fear, knowing a guilty verdict might have the potential to challenge basic tenets of care.

According to Kaiser Health News, nurses are “raging and quitting” following the announcement of a guilty verdict for two felonies: criminally negligent homicide and gross neglect of an impaired adult.

Thousands of nurses have claimed they could arrive in Nashville, Tenn., on May 13, the day Ms. Vaught is to be sentenced, to protest the conviction. Others have stated they believe justice is being conducted, as their sympathies lie with the victim, Charlene Murphey, who died 12 hours after being unable to draw breath, paralyzed from the inadvertent dose of vecuronium given intravenously by her nurse.

How should we feel as clinicians? What does this guilty verdict mean for nurses across the country as Ms. Vaught waits to receive a sentence that could imprison her for up to 8 years, according to sentencing guidelines?

My belief is that it is understandable to feel passionately about this case, including what it could mean to an era of “just culture” that nursing organizations have promoted. The concept of just culture looks at medication/nursing errors as opportunities for growth to avoid future errors, not as scenarios for punitive action. With the guilty verdict in Ms. Vaught’s case, nurses (and facilities) fear that nurses will avoid coming forward after mistakes, leading to cover-ups and a culture perspective.

Will nurses be hesitant to report errors (especially significant errors) that lead to patient harm? Will we fear retribution and reprisal for being truthful?

I believe that Ms. Vaught’s criminal case has changed little in the political landscape of caregiving. Before you let loose with a loud expletive (or two), hear me out.

When a patient dies from unintentional harm, someone must be held accountable. Society needs a scapegoat, and unfortunately, excrement slides downhill to the lowest common denominator, which may be the nurse. Initially, Ms. Vaught was contacted by her state licensing board (Tennessee) and informed there would be no professional repercussions for her mistake. That decision did not hold. She was later indicted criminally for the death of her patient. She also had her nursing license revoked.

Why? The hospital where she worked was threatened with Medicare reprisal if systemic issues were not addressed following the incident; for example, a bar-coding device was not available for Ms. Vaught to use prior to administering the vecuronium, and paralytic agents were stored unsafely in a Pyxis MedStation, readily available for any nurse to obtain via override.

In fact, the number of overrides performed by all nurses caring for Ms. Murphey in the days leading to her death was alarming, leading reviewers to assume that time to acquire medication for inpatients was a problem.

Ms. Vaught herself, stating the obvious on talk shows, said she should not have performed an override, that the situation was “not an emergency” and she should have taken time to check that Versed (midazolam) was available by the generic name and not the “VE” she entered as a search mechanism into the machine. She also stated she was “distracted” by a trainee assigned to her at the time.

We have all been there, feeling rushed to perform a task under stressful situations, skipping safety guidelines to sedate a patient while radiology is waiting. Someone is always on our a**, waiting to get to the next task, the next patient, the next admission, the next pseudo-emergency called nursing workload.

It never ends.

Which is why I wish to emphasize what the Ms. Vaught guilty verdict really means for nurses.

It means we must never forget that our actions have the potential to harm, even kill, our patients.

We must never forget that repercussions and reprisal may occur, whether personal guilt that may prove more damaging than the prison sentence Ms. Vaught might receive, or problems that could result if nurses attempt to hide or subvert medication issues.

In Ms. Vaught’s case, she did not document the medication that had been given to Ms. Murphey, facts the prosecution seized on to proclaim her guilt. Why? We can only guess at this point. But her claims of truthfulness need to be balanced by what occurred, and the facts are that she did not document the error after administering vecuronium that night.

When reflecting on this verdict, we need to remember a patient died, and she did so horribly, being unable to draw breath. This should never happen during our watch, ever, and as clinicians, we need to be vigilant.

In summary, protest if you believe justice has been too harsh or unfair, and that nurses may be fearful as a result. But please spare a moment to realize that someone should protest for Ms. Murphey as well. We cannot bring her back, nor can we right the system issues that may have led to her death.

But we should protest for safer systems, for improved staffing, for a need to catch our collective breaths, and a day to work and nurture patients when someone is not constantly on our a**. Only then will nurses be protected from unjust reprisal, from needing to be the lowest common denominator of guilt.

Ms. Goodman is a researcher and consultant in Libertyville, Ill. She disclosed no conflicts of interest.

A version of this article first appeared on Medscape.com.

For 4 and a half years, I have followed the RaDonda Vaught medication error that led to the unfortunate death of a human being. I am not alone. Nurses across the country have followed the case with anxiety and fear, knowing a guilty verdict might have the potential to challenge basic tenets of care.

According to Kaiser Health News, nurses are “raging and quitting” following the announcement of a guilty verdict for two felonies: criminally negligent homicide and gross neglect of an impaired adult.

Thousands of nurses have claimed they could arrive in Nashville, Tenn., on May 13, the day Ms. Vaught is to be sentenced, to protest the conviction. Others have stated they believe justice is being conducted, as their sympathies lie with the victim, Charlene Murphey, who died 12 hours after being unable to draw breath, paralyzed from the inadvertent dose of vecuronium given intravenously by her nurse.

How should we feel as clinicians? What does this guilty verdict mean for nurses across the country as Ms. Vaught waits to receive a sentence that could imprison her for up to 8 years, according to sentencing guidelines?

My belief is that it is understandable to feel passionately about this case, including what it could mean to an era of “just culture” that nursing organizations have promoted. The concept of just culture looks at medication/nursing errors as opportunities for growth to avoid future errors, not as scenarios for punitive action. With the guilty verdict in Ms. Vaught’s case, nurses (and facilities) fear that nurses will avoid coming forward after mistakes, leading to cover-ups and a culture perspective.

Will nurses be hesitant to report errors (especially significant errors) that lead to patient harm? Will we fear retribution and reprisal for being truthful?

I believe that Ms. Vaught’s criminal case has changed little in the political landscape of caregiving. Before you let loose with a loud expletive (or two), hear me out.

When a patient dies from unintentional harm, someone must be held accountable. Society needs a scapegoat, and unfortunately, excrement slides downhill to the lowest common denominator, which may be the nurse. Initially, Ms. Vaught was contacted by her state licensing board (Tennessee) and informed there would be no professional repercussions for her mistake. That decision did not hold. She was later indicted criminally for the death of her patient. She also had her nursing license revoked.

Why? The hospital where she worked was threatened with Medicare reprisal if systemic issues were not addressed following the incident; for example, a bar-coding device was not available for Ms. Vaught to use prior to administering the vecuronium, and paralytic agents were stored unsafely in a Pyxis MedStation, readily available for any nurse to obtain via override.

In fact, the number of overrides performed by all nurses caring for Ms. Murphey in the days leading to her death was alarming, leading reviewers to assume that time to acquire medication for inpatients was a problem.

Ms. Vaught herself, stating the obvious on talk shows, said she should not have performed an override, that the situation was “not an emergency” and she should have taken time to check that Versed (midazolam) was available by the generic name and not the “VE” she entered as a search mechanism into the machine. She also stated she was “distracted” by a trainee assigned to her at the time.

We have all been there, feeling rushed to perform a task under stressful situations, skipping safety guidelines to sedate a patient while radiology is waiting. Someone is always on our a**, waiting to get to the next task, the next patient, the next admission, the next pseudo-emergency called nursing workload.

It never ends.

Which is why I wish to emphasize what the Ms. Vaught guilty verdict really means for nurses.

It means we must never forget that our actions have the potential to harm, even kill, our patients.

We must never forget that repercussions and reprisal may occur, whether personal guilt that may prove more damaging than the prison sentence Ms. Vaught might receive, or problems that could result if nurses attempt to hide or subvert medication issues.

In Ms. Vaught’s case, she did not document the medication that had been given to Ms. Murphey, facts the prosecution seized on to proclaim her guilt. Why? We can only guess at this point. But her claims of truthfulness need to be balanced by what occurred, and the facts are that she did not document the error after administering vecuronium that night.

When reflecting on this verdict, we need to remember a patient died, and she did so horribly, being unable to draw breath. This should never happen during our watch, ever, and as clinicians, we need to be vigilant.

In summary, protest if you believe justice has been too harsh or unfair, and that nurses may be fearful as a result. But please spare a moment to realize that someone should protest for Ms. Murphey as well. We cannot bring her back, nor can we right the system issues that may have led to her death.

But we should protest for safer systems, for improved staffing, for a need to catch our collective breaths, and a day to work and nurture patients when someone is not constantly on our a**. Only then will nurses be protected from unjust reprisal, from needing to be the lowest common denominator of guilt.

Ms. Goodman is a researcher and consultant in Libertyville, Ill. She disclosed no conflicts of interest.

A version of this article first appeared on Medscape.com.

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The Empire strikes out against one physician’s homemade star fighter

Article Type
Changed
Thu, 04/21/2022 - 09:15

 

The force is with Ukraine, always

Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?

A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”

Richard Franki/MDedge

It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.

Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
 

I’m a doctor, not a hologram

Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.

Thomas Pesquet/ESA

The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.

“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.

They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”

Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
 

 

 

Add electricity for umami

Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.

OpenClipart-Vectors/Pixabay

Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.

In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.

The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.

Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.

The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
 

Pet poop works in mysterious ways

We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.

PxHere

Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”

Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.

“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.

So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.

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The force is with Ukraine, always

Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?

A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”

Richard Franki/MDedge

It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.

Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
 

I’m a doctor, not a hologram

Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.

Thomas Pesquet/ESA

The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.

“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.

They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”

Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
 

 

 

Add electricity for umami

Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.

OpenClipart-Vectors/Pixabay

Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.

In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.

The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.

Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.

The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
 

Pet poop works in mysterious ways

We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.

PxHere

Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”

Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.

“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.

So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.

 

The force is with Ukraine, always

Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?

A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”

Richard Franki/MDedge

It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.

Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
 

I’m a doctor, not a hologram

Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.

Thomas Pesquet/ESA

The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.

“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.

They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”

Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
 

 

 

Add electricity for umami

Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.

OpenClipart-Vectors/Pixabay

Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.

In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.

The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.

Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.

The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
 

Pet poop works in mysterious ways

We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.

PxHere

Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”

Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.

“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.

So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.

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Peripheral muscle fatigue limits post-COVID exercise

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Thu, 04/21/2022 - 14:48

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

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Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

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FROM ESC PREVENTIVE CARDIOLOGY 2022

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Children and COVID: Decline in new cases comes to an end

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Wed, 04/20/2022 - 10:41

It was a good run while it lasted.

New COVID-19 cases in U.S. children had dropped for 11 consecutive weeks, but that streak has come to an end, as cases increased 28% during the week of April 8-14, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The number of reported pediatric cases for the week was 33,146, and the actual increase from the previous week was just 7,231 cases, the AAP and CHA said, but some reports suggest that the new COVID variants and subvariants are starting to have an effect on incidence in some areas while mask mandates continue to fall.

Data from the Centers for Disease Control and Prevention show that, over the last week or two, the 7-day average for percentage of emergency department visits with diagnosed COVID has risen from 0.5% to 0.6% in children aged 0-11 years, from 0.3% to 0.5% among 12- to 15-year-olds, and from 0.3% to 0.4% in 16- and 17-year-olds. Small increases, to be sure, but increases nonetheless.

A somewhat similar scenario is playing out for new admissions of children aged 0-17, which have leveled out after dropping from a high of 1.25 per 100,000 population in mid-January to 0.13 per 100,000 in early April. Over the last 2 weeks, the rate has been alternating between 0.13 and 0.14 per 100,000, the CDC said on its COVID Data Tracker.

The latest news on the vaccination front came from Pfizer and BIoNTech, which announced that a third dose of its COVID-19 vaccine boosted immune protection in children aged 5-11 years in a phase 2/3 trial. Protection against the Omicron strain was 36 times higher than the two previous doses, the companies said, adding that they plan to submit a request for emergency use authorization of a booster dose in the near future.

The ongoing vaccination effort, however, produced mixed results in the last week. Initial vaccinations among children aged 5-11 years fell 14.5% to another new low while initial doses were up 9.3% for those aged 12-17, the AAP said. Overall, just 28.2% of the country’s 5- to 11-year-olds are fully vaccinated, compared with 58.7% of those aged 12-17, the CDC reported.

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It was a good run while it lasted.

New COVID-19 cases in U.S. children had dropped for 11 consecutive weeks, but that streak has come to an end, as cases increased 28% during the week of April 8-14, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The number of reported pediatric cases for the week was 33,146, and the actual increase from the previous week was just 7,231 cases, the AAP and CHA said, but some reports suggest that the new COVID variants and subvariants are starting to have an effect on incidence in some areas while mask mandates continue to fall.

Data from the Centers for Disease Control and Prevention show that, over the last week or two, the 7-day average for percentage of emergency department visits with diagnosed COVID has risen from 0.5% to 0.6% in children aged 0-11 years, from 0.3% to 0.5% among 12- to 15-year-olds, and from 0.3% to 0.4% in 16- and 17-year-olds. Small increases, to be sure, but increases nonetheless.

A somewhat similar scenario is playing out for new admissions of children aged 0-17, which have leveled out after dropping from a high of 1.25 per 100,000 population in mid-January to 0.13 per 100,000 in early April. Over the last 2 weeks, the rate has been alternating between 0.13 and 0.14 per 100,000, the CDC said on its COVID Data Tracker.

The latest news on the vaccination front came from Pfizer and BIoNTech, which announced that a third dose of its COVID-19 vaccine boosted immune protection in children aged 5-11 years in a phase 2/3 trial. Protection against the Omicron strain was 36 times higher than the two previous doses, the companies said, adding that they plan to submit a request for emergency use authorization of a booster dose in the near future.

The ongoing vaccination effort, however, produced mixed results in the last week. Initial vaccinations among children aged 5-11 years fell 14.5% to another new low while initial doses were up 9.3% for those aged 12-17, the AAP said. Overall, just 28.2% of the country’s 5- to 11-year-olds are fully vaccinated, compared with 58.7% of those aged 12-17, the CDC reported.

It was a good run while it lasted.

New COVID-19 cases in U.S. children had dropped for 11 consecutive weeks, but that streak has come to an end, as cases increased 28% during the week of April 8-14, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The number of reported pediatric cases for the week was 33,146, and the actual increase from the previous week was just 7,231 cases, the AAP and CHA said, but some reports suggest that the new COVID variants and subvariants are starting to have an effect on incidence in some areas while mask mandates continue to fall.

Data from the Centers for Disease Control and Prevention show that, over the last week or two, the 7-day average for percentage of emergency department visits with diagnosed COVID has risen from 0.5% to 0.6% in children aged 0-11 years, from 0.3% to 0.5% among 12- to 15-year-olds, and from 0.3% to 0.4% in 16- and 17-year-olds. Small increases, to be sure, but increases nonetheless.

A somewhat similar scenario is playing out for new admissions of children aged 0-17, which have leveled out after dropping from a high of 1.25 per 100,000 population in mid-January to 0.13 per 100,000 in early April. Over the last 2 weeks, the rate has been alternating between 0.13 and 0.14 per 100,000, the CDC said on its COVID Data Tracker.

The latest news on the vaccination front came from Pfizer and BIoNTech, which announced that a third dose of its COVID-19 vaccine boosted immune protection in children aged 5-11 years in a phase 2/3 trial. Protection against the Omicron strain was 36 times higher than the two previous doses, the companies said, adding that they plan to submit a request for emergency use authorization of a booster dose in the near future.

The ongoing vaccination effort, however, produced mixed results in the last week. Initial vaccinations among children aged 5-11 years fell 14.5% to another new low while initial doses were up 9.3% for those aged 12-17, the AAP said. Overall, just 28.2% of the country’s 5- to 11-year-olds are fully vaccinated, compared with 58.7% of those aged 12-17, the CDC reported.

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Real-world data suggest coprescribing PDE5 inhibitors and nitrates may be safe

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Thu, 04/21/2022 - 09:00

As coprescribing drugs for erectile dysfunction and oral organic nitrates for ischemic heart disease (IHD) surged, cardiovascular adverse events did not significantly increase, a new study finds.

The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.

“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”

But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.

To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.

Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
 

Lead author speculates on reasons for findings

“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”

Dr. Holt went on to suggest a novel clinical approach based on the new findings.

“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”

A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
 

 

 

Findings call for a reassessment of whether the contraindication is warranted

Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.

But now, considering these new findings, Dr. Kloner is offering a fresh perspective.

“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”

He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.

“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”

Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.

There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.

The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.

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As coprescribing drugs for erectile dysfunction and oral organic nitrates for ischemic heart disease (IHD) surged, cardiovascular adverse events did not significantly increase, a new study finds.

The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.

“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”

But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.

To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.

Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
 

Lead author speculates on reasons for findings

“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”

Dr. Holt went on to suggest a novel clinical approach based on the new findings.

“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”

A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
 

 

 

Findings call for a reassessment of whether the contraindication is warranted

Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.

But now, considering these new findings, Dr. Kloner is offering a fresh perspective.

“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”

He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.

“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”

Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.

There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.

The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.

As coprescribing drugs for erectile dysfunction and oral organic nitrates for ischemic heart disease (IHD) surged, cardiovascular adverse events did not significantly increase, a new study finds.

The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.

“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”

But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.

To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.

Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
 

Lead author speculates on reasons for findings

“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”

Dr. Holt went on to suggest a novel clinical approach based on the new findings.

“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”

A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
 

 

 

Findings call for a reassessment of whether the contraindication is warranted

Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.

But now, considering these new findings, Dr. Kloner is offering a fresh perspective.

“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”

He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.

“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”

Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.

There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.

The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.

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Age and ferritin levels may predict MIS-C severity

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Tue, 04/19/2022 - 16:48

Older age and higher ferritin levels at hospital admission predict severe illness in COVID-related multisystem inflammatory syndrome in children (MIS-C), according to a Canadian multicenter cohort study.

The adjusted absolute risk for admission to an intensive care unit was 43.6% among children aged 6 years and older and 46.2% in children aged 13 to 17 years, compared with 18.4% in children aged 5 years or younger.

“We do not understand why teens get more severe MIS-C than younger children,” senior author Joan Robinson, MD, of the University of Alberta, Edmonton, told this news organization. “It is possible that more exposures to other coronaviruses in the past result in them having a more robust immune response to SARS-CoV-2, which results in more inflammation.”

The data were published  in the Canadian Medical Association Journal.
 

A multinational study

The study included data on 232 children admitted with probable or confirmed MIS-C at 15 hospitals in Canada, Iran, and Costa Rica between March 1, 2020, and March 7, 2021. The median age of the children was 5.8 years, 56.0% were boys, and 21.6% had comorbidities.

Although cardiac involvement was common (58.6%), and almost one-third of the cohort (31.5%) was admitted to an ICU, “recovery was typically rapid, with 85% of patients discharged within 10 days,” said Dr. Robinson, for the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC).
 

Older age as a risk

The results suggest that older age is associated with increased risk of severe MIS-C. “However, one would then predict that adults would be at even higher risk than teens, whereas the same syndrome in adults (MIS-A) is very, very rare,” said Dr. Robinson.

The study also found that children admitted with ferritin levels greater than 500 μg/L, signaling greater inflammation, also had an increased risk for ICU admission, compared with those with lower levels (adjusted risk difference, 18.4%; relative risk, 1.69). “This is presumably because the more inflammation that the child has, the more likely they are to have inflammation of the heart, which can lead to low blood pressure,” said Dr. Robinson.
 

Features of MIS-C

Among all patients with MIS-C, gastrointestinal involvement was common (89.2%), as were mucocutaneous findings (84.5%). Children with MIS-C had fever for a median duration of 6 days. “Clinicians who see children in their practice commonly have to determine why a child is febrile. Our study shows that one mainly has to consider MIS-C if febrile children have a rash and one or more of vomiting, diarrhea, or abdominal pain,” said Dr. Robinson. 

The study also found that patients with MIS-C who were admitted to the hospital in the latter part of the study period (Nov. 1, 2020, to March 7, 2021) were slightly more likely to require ICU admission, compared with those admitted between March 1 and Oct. 31, 2020. “We cannot provide a clear explanation [for this],” the authors noted. “The features of severe MIS-C were widely publicized by May 2020, so it seems unlikely that severe cases were missed early in the study period. SARS-CoV-2 variants of concern have replaced the wild-type virus. It is possible that the immune response to circulating variants alters the severity of COVID-19 and MIS-C, when compared with wild-type virus.”

Despite initial concerns that pediatric COVID-19 vaccines might cause MIS-C, Dr. Robinson says data suggest this is rarely, if ever, the case, and that vaccines actually prevent the syndrome. She says further studies will be needed to assess MIS-C risk following reinfection with SARS-CoV-2. “I am an optimistic person, and it is my hope that MIS-C following reinfection is rare,” she said. “If this is the case, perhaps we will see very few cases once almost all children have been immunized and/or had SARS-CoV-2 infection.”  
 

 

 

‘Differences across countries’

Adrienne Randolph, MD, a pediatrician at Harvard Medical School, Boston, and senior author of a large case series of patients with MIS-C, said that the Canadian study is valuable because it includes children from three countries. “It’s very interesting that there are differences across countries,” she said. “The patients in Iran had the highest percentage (58.7%) going into the ICU, whereas Costa Rica had the lowest percentage (9.2%), and the percentage going to the ICU in Canada (34.7%) was less than the percentages we see in the U.S. – which is pretty consistently about 60% to 70% of MIS-C patients going into the ICU.” Dr. Randolph was not involved in the current study.

Reasons for differences in the rates of ICU visits will be important to explore in the effort to standardize diagnostic criteria, stratification of severity, and recommendations for treatment of MIS-C, said Dr. Randolph.

“What is consistent is that the younger kids, zero to 5 years, in general are less ill,” she said. “That’s been consistent across multiple countries.” It’s unclear whether the cause of this difference is that parents observe younger patients more closely than they do teenagers, or whether other aspects of adolescence, such as prevalence of obesity and attendant inflammation, are at work, said Dr. Randolph.

What is also unclear is why hospitalized patients with MIS-C had higher percentages of ICU admission in the latter part of the study period, compared with the earlier period. “Did the patients change, or did practice change as we got to understand the disease process?” asked Dr. Randolph. “It could be that they got better at the diagnosis and were weeding out some of the patients who they realized didn’t need to be hospitalized. At the very beginning, we had a very low threshold to admit patients, because we didn’t know, and then, over time, people understood what was going on and felt more comfortable monitoring them as outpatients.”

This study was partially funded by a Janeway Foundation Research Grant to support data collection. Dr. Robinson disclosed no conflicts of interest. Dr. Randolph reported receiving royalties from UpToDate and personal fees from the La Jolla Pharmaceutical Company.

A version of this article first appeared on Medscape.com.

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Older age and higher ferritin levels at hospital admission predict severe illness in COVID-related multisystem inflammatory syndrome in children (MIS-C), according to a Canadian multicenter cohort study.

The adjusted absolute risk for admission to an intensive care unit was 43.6% among children aged 6 years and older and 46.2% in children aged 13 to 17 years, compared with 18.4% in children aged 5 years or younger.

“We do not understand why teens get more severe MIS-C than younger children,” senior author Joan Robinson, MD, of the University of Alberta, Edmonton, told this news organization. “It is possible that more exposures to other coronaviruses in the past result in them having a more robust immune response to SARS-CoV-2, which results in more inflammation.”

The data were published  in the Canadian Medical Association Journal.
 

A multinational study

The study included data on 232 children admitted with probable or confirmed MIS-C at 15 hospitals in Canada, Iran, and Costa Rica between March 1, 2020, and March 7, 2021. The median age of the children was 5.8 years, 56.0% were boys, and 21.6% had comorbidities.

Although cardiac involvement was common (58.6%), and almost one-third of the cohort (31.5%) was admitted to an ICU, “recovery was typically rapid, with 85% of patients discharged within 10 days,” said Dr. Robinson, for the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC).
 

Older age as a risk

The results suggest that older age is associated with increased risk of severe MIS-C. “However, one would then predict that adults would be at even higher risk than teens, whereas the same syndrome in adults (MIS-A) is very, very rare,” said Dr. Robinson.

The study also found that children admitted with ferritin levels greater than 500 μg/L, signaling greater inflammation, also had an increased risk for ICU admission, compared with those with lower levels (adjusted risk difference, 18.4%; relative risk, 1.69). “This is presumably because the more inflammation that the child has, the more likely they are to have inflammation of the heart, which can lead to low blood pressure,” said Dr. Robinson.
 

Features of MIS-C

Among all patients with MIS-C, gastrointestinal involvement was common (89.2%), as were mucocutaneous findings (84.5%). Children with MIS-C had fever for a median duration of 6 days. “Clinicians who see children in their practice commonly have to determine why a child is febrile. Our study shows that one mainly has to consider MIS-C if febrile children have a rash and one or more of vomiting, diarrhea, or abdominal pain,” said Dr. Robinson. 

The study also found that patients with MIS-C who were admitted to the hospital in the latter part of the study period (Nov. 1, 2020, to March 7, 2021) were slightly more likely to require ICU admission, compared with those admitted between March 1 and Oct. 31, 2020. “We cannot provide a clear explanation [for this],” the authors noted. “The features of severe MIS-C were widely publicized by May 2020, so it seems unlikely that severe cases were missed early in the study period. SARS-CoV-2 variants of concern have replaced the wild-type virus. It is possible that the immune response to circulating variants alters the severity of COVID-19 and MIS-C, when compared with wild-type virus.”

Despite initial concerns that pediatric COVID-19 vaccines might cause MIS-C, Dr. Robinson says data suggest this is rarely, if ever, the case, and that vaccines actually prevent the syndrome. She says further studies will be needed to assess MIS-C risk following reinfection with SARS-CoV-2. “I am an optimistic person, and it is my hope that MIS-C following reinfection is rare,” she said. “If this is the case, perhaps we will see very few cases once almost all children have been immunized and/or had SARS-CoV-2 infection.”  
 

 

 

‘Differences across countries’

Adrienne Randolph, MD, a pediatrician at Harvard Medical School, Boston, and senior author of a large case series of patients with MIS-C, said that the Canadian study is valuable because it includes children from three countries. “It’s very interesting that there are differences across countries,” she said. “The patients in Iran had the highest percentage (58.7%) going into the ICU, whereas Costa Rica had the lowest percentage (9.2%), and the percentage going to the ICU in Canada (34.7%) was less than the percentages we see in the U.S. – which is pretty consistently about 60% to 70% of MIS-C patients going into the ICU.” Dr. Randolph was not involved in the current study.

Reasons for differences in the rates of ICU visits will be important to explore in the effort to standardize diagnostic criteria, stratification of severity, and recommendations for treatment of MIS-C, said Dr. Randolph.

“What is consistent is that the younger kids, zero to 5 years, in general are less ill,” she said. “That’s been consistent across multiple countries.” It’s unclear whether the cause of this difference is that parents observe younger patients more closely than they do teenagers, or whether other aspects of adolescence, such as prevalence of obesity and attendant inflammation, are at work, said Dr. Randolph.

What is also unclear is why hospitalized patients with MIS-C had higher percentages of ICU admission in the latter part of the study period, compared with the earlier period. “Did the patients change, or did practice change as we got to understand the disease process?” asked Dr. Randolph. “It could be that they got better at the diagnosis and were weeding out some of the patients who they realized didn’t need to be hospitalized. At the very beginning, we had a very low threshold to admit patients, because we didn’t know, and then, over time, people understood what was going on and felt more comfortable monitoring them as outpatients.”

This study was partially funded by a Janeway Foundation Research Grant to support data collection. Dr. Robinson disclosed no conflicts of interest. Dr. Randolph reported receiving royalties from UpToDate and personal fees from the La Jolla Pharmaceutical Company.

A version of this article first appeared on Medscape.com.

Older age and higher ferritin levels at hospital admission predict severe illness in COVID-related multisystem inflammatory syndrome in children (MIS-C), according to a Canadian multicenter cohort study.

The adjusted absolute risk for admission to an intensive care unit was 43.6% among children aged 6 years and older and 46.2% in children aged 13 to 17 years, compared with 18.4% in children aged 5 years or younger.

“We do not understand why teens get more severe MIS-C than younger children,” senior author Joan Robinson, MD, of the University of Alberta, Edmonton, told this news organization. “It is possible that more exposures to other coronaviruses in the past result in them having a more robust immune response to SARS-CoV-2, which results in more inflammation.”

The data were published  in the Canadian Medical Association Journal.
 

A multinational study

The study included data on 232 children admitted with probable or confirmed MIS-C at 15 hospitals in Canada, Iran, and Costa Rica between March 1, 2020, and March 7, 2021. The median age of the children was 5.8 years, 56.0% were boys, and 21.6% had comorbidities.

Although cardiac involvement was common (58.6%), and almost one-third of the cohort (31.5%) was admitted to an ICU, “recovery was typically rapid, with 85% of patients discharged within 10 days,” said Dr. Robinson, for the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC).
 

Older age as a risk

The results suggest that older age is associated with increased risk of severe MIS-C. “However, one would then predict that adults would be at even higher risk than teens, whereas the same syndrome in adults (MIS-A) is very, very rare,” said Dr. Robinson.

The study also found that children admitted with ferritin levels greater than 500 μg/L, signaling greater inflammation, also had an increased risk for ICU admission, compared with those with lower levels (adjusted risk difference, 18.4%; relative risk, 1.69). “This is presumably because the more inflammation that the child has, the more likely they are to have inflammation of the heart, which can lead to low blood pressure,” said Dr. Robinson.
 

Features of MIS-C

Among all patients with MIS-C, gastrointestinal involvement was common (89.2%), as were mucocutaneous findings (84.5%). Children with MIS-C had fever for a median duration of 6 days. “Clinicians who see children in their practice commonly have to determine why a child is febrile. Our study shows that one mainly has to consider MIS-C if febrile children have a rash and one or more of vomiting, diarrhea, or abdominal pain,” said Dr. Robinson. 

The study also found that patients with MIS-C who were admitted to the hospital in the latter part of the study period (Nov. 1, 2020, to March 7, 2021) were slightly more likely to require ICU admission, compared with those admitted between March 1 and Oct. 31, 2020. “We cannot provide a clear explanation [for this],” the authors noted. “The features of severe MIS-C were widely publicized by May 2020, so it seems unlikely that severe cases were missed early in the study period. SARS-CoV-2 variants of concern have replaced the wild-type virus. It is possible that the immune response to circulating variants alters the severity of COVID-19 and MIS-C, when compared with wild-type virus.”

Despite initial concerns that pediatric COVID-19 vaccines might cause MIS-C, Dr. Robinson says data suggest this is rarely, if ever, the case, and that vaccines actually prevent the syndrome. She says further studies will be needed to assess MIS-C risk following reinfection with SARS-CoV-2. “I am an optimistic person, and it is my hope that MIS-C following reinfection is rare,” she said. “If this is the case, perhaps we will see very few cases once almost all children have been immunized and/or had SARS-CoV-2 infection.”  
 

 

 

‘Differences across countries’

Adrienne Randolph, MD, a pediatrician at Harvard Medical School, Boston, and senior author of a large case series of patients with MIS-C, said that the Canadian study is valuable because it includes children from three countries. “It’s very interesting that there are differences across countries,” she said. “The patients in Iran had the highest percentage (58.7%) going into the ICU, whereas Costa Rica had the lowest percentage (9.2%), and the percentage going to the ICU in Canada (34.7%) was less than the percentages we see in the U.S. – which is pretty consistently about 60% to 70% of MIS-C patients going into the ICU.” Dr. Randolph was not involved in the current study.

Reasons for differences in the rates of ICU visits will be important to explore in the effort to standardize diagnostic criteria, stratification of severity, and recommendations for treatment of MIS-C, said Dr. Randolph.

“What is consistent is that the younger kids, zero to 5 years, in general are less ill,” she said. “That’s been consistent across multiple countries.” It’s unclear whether the cause of this difference is that parents observe younger patients more closely than they do teenagers, or whether other aspects of adolescence, such as prevalence of obesity and attendant inflammation, are at work, said Dr. Randolph.

What is also unclear is why hospitalized patients with MIS-C had higher percentages of ICU admission in the latter part of the study period, compared with the earlier period. “Did the patients change, or did practice change as we got to understand the disease process?” asked Dr. Randolph. “It could be that they got better at the diagnosis and were weeding out some of the patients who they realized didn’t need to be hospitalized. At the very beginning, we had a very low threshold to admit patients, because we didn’t know, and then, over time, people understood what was going on and felt more comfortable monitoring them as outpatients.”

This study was partially funded by a Janeway Foundation Research Grant to support data collection. Dr. Robinson disclosed no conflicts of interest. Dr. Randolph reported receiving royalties from UpToDate and personal fees from the La Jolla Pharmaceutical Company.

A version of this article first appeared on Medscape.com.

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Judge strikes down Biden mask mandate for planes, transit

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Mon, 04/18/2022 - 15:06

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

A version of this article first appeared on WebMD.com.

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A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

A version of this article first appeared on WebMD.com.

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

A version of this article first appeared on WebMD.com.

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Pediatric hepatitis cases may be linked to adenovirus, CDC says

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Fri, 04/22/2022 - 15:52

The U.S. Centers for Disease Control and Prevention has issued a health alert regarding severe hepatitis in young children after several cases have been reported in Alabama. Public health officials in the United Kingdom are also investigating more than 100 cases. While the source of the infections is unknown, “a possible association between pediatric hepatitis and adenovirus infection is currently under investigation,” according to the CDC alert.

Internationally, 108 cases have been reported in the United Kingdom, with 79 cases occurring in England. There are three documented cases in Spain, and similar cases are being reported in Denmark and the Netherlands, according to an article in Science. In the United Kingdom, cases have been reported in children up to 16 years old, but most affected children are between 2 and 5 years old. Eight children in the United Kingdom have required liver transplants.

On April 14, the CDC said that nine cases have been recorded in Alabama since the fall of 2021. All of these cases have been in children between 1 and 6 years old, and two children have needed liver transplants. Two additional cases have been reported in North Carolina, according to Stat News, and both children have since recovered.

Hepatitis A, B, C, D, and E viruses—common causes of hepatitis—have been ruled out in the U.K. and Spanish cases. More than three-fourths (77%) of the children sickened in the United Kingdom and all nine cases in Alabama have tested positive for a form of the adenovirus. While adenovirus can cause hepatitis in children, it is usually in those who are immunocompromised.

The CDC health alert advises clinicians who have cases of unexplained hepatitis in children to test for adenovirus and report these cases to the CDC as well as state public health authorities. The agency recommends nucleic acid amplification testing to detect adenovirus using respiratory swabs, stool samples or rectal swabs, or blood.

Officials are exploring whether these cases are linked to a version of the virus called adenovirus 41, which is associated with gut inflammation. The most recent case in Alabama was reported in February, and five of the nine children in the state with these puzzling cases of hepatitis have tested positive for adenovirus 41.

There have yet to be any links among the cases in Alabama or North Carolina, and investigators in the United Kingdom have also not found any connections in their cases, STAT News reports.

“CDC is working with state health departments to see if there are additional U.S. cases and what may be causing these cases,” said Kristen Nordlund, a CDC spokesperson, in a statement to STAT News. “At this time, adenovirus may be the cause for these, but investigators are still learning more – including ruling out the more common causes of hepatitis.”

Looking for other explanations

None of the children in the United States with hepatitis had COVID-19, but a few children in the United Kingdom have tested positive for the virus; none of these children have received the COVID-19 vaccine.

While the U.K. Health Security Agency says their investigation “continues to point toward a link to adenovirus infection,” they are also considering other contributing factors such as an environmental cause or COVID-19.

“COVID has been consistently shown to increase liver test numbers,” Nancy Reau, MD, the section chief of hepatology at Rush University in Chicago, said in an interview with this news organization. “It has been shown to cause other organ involvement besides just pulmonary symptoms and respiratory failure. As this virus evolves, it might be that in children, it is more able to present as hepatitis.”
 

A version of this article first appeared on Medscape.com.

This article was updated 4/22/22.

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The U.S. Centers for Disease Control and Prevention has issued a health alert regarding severe hepatitis in young children after several cases have been reported in Alabama. Public health officials in the United Kingdom are also investigating more than 100 cases. While the source of the infections is unknown, “a possible association between pediatric hepatitis and adenovirus infection is currently under investigation,” according to the CDC alert.

Internationally, 108 cases have been reported in the United Kingdom, with 79 cases occurring in England. There are three documented cases in Spain, and similar cases are being reported in Denmark and the Netherlands, according to an article in Science. In the United Kingdom, cases have been reported in children up to 16 years old, but most affected children are between 2 and 5 years old. Eight children in the United Kingdom have required liver transplants.

On April 14, the CDC said that nine cases have been recorded in Alabama since the fall of 2021. All of these cases have been in children between 1 and 6 years old, and two children have needed liver transplants. Two additional cases have been reported in North Carolina, according to Stat News, and both children have since recovered.

Hepatitis A, B, C, D, and E viruses—common causes of hepatitis—have been ruled out in the U.K. and Spanish cases. More than three-fourths (77%) of the children sickened in the United Kingdom and all nine cases in Alabama have tested positive for a form of the adenovirus. While adenovirus can cause hepatitis in children, it is usually in those who are immunocompromised.

The CDC health alert advises clinicians who have cases of unexplained hepatitis in children to test for adenovirus and report these cases to the CDC as well as state public health authorities. The agency recommends nucleic acid amplification testing to detect adenovirus using respiratory swabs, stool samples or rectal swabs, or blood.

Officials are exploring whether these cases are linked to a version of the virus called adenovirus 41, which is associated with gut inflammation. The most recent case in Alabama was reported in February, and five of the nine children in the state with these puzzling cases of hepatitis have tested positive for adenovirus 41.

There have yet to be any links among the cases in Alabama or North Carolina, and investigators in the United Kingdom have also not found any connections in their cases, STAT News reports.

“CDC is working with state health departments to see if there are additional U.S. cases and what may be causing these cases,” said Kristen Nordlund, a CDC spokesperson, in a statement to STAT News. “At this time, adenovirus may be the cause for these, but investigators are still learning more – including ruling out the more common causes of hepatitis.”

Looking for other explanations

None of the children in the United States with hepatitis had COVID-19, but a few children in the United Kingdom have tested positive for the virus; none of these children have received the COVID-19 vaccine.

While the U.K. Health Security Agency says their investigation “continues to point toward a link to adenovirus infection,” they are also considering other contributing factors such as an environmental cause or COVID-19.

“COVID has been consistently shown to increase liver test numbers,” Nancy Reau, MD, the section chief of hepatology at Rush University in Chicago, said in an interview with this news organization. “It has been shown to cause other organ involvement besides just pulmonary symptoms and respiratory failure. As this virus evolves, it might be that in children, it is more able to present as hepatitis.”
 

A version of this article first appeared on Medscape.com.

This article was updated 4/22/22.

The U.S. Centers for Disease Control and Prevention has issued a health alert regarding severe hepatitis in young children after several cases have been reported in Alabama. Public health officials in the United Kingdom are also investigating more than 100 cases. While the source of the infections is unknown, “a possible association between pediatric hepatitis and adenovirus infection is currently under investigation,” according to the CDC alert.

Internationally, 108 cases have been reported in the United Kingdom, with 79 cases occurring in England. There are three documented cases in Spain, and similar cases are being reported in Denmark and the Netherlands, according to an article in Science. In the United Kingdom, cases have been reported in children up to 16 years old, but most affected children are between 2 and 5 years old. Eight children in the United Kingdom have required liver transplants.

On April 14, the CDC said that nine cases have been recorded in Alabama since the fall of 2021. All of these cases have been in children between 1 and 6 years old, and two children have needed liver transplants. Two additional cases have been reported in North Carolina, according to Stat News, and both children have since recovered.

Hepatitis A, B, C, D, and E viruses—common causes of hepatitis—have been ruled out in the U.K. and Spanish cases. More than three-fourths (77%) of the children sickened in the United Kingdom and all nine cases in Alabama have tested positive for a form of the adenovirus. While adenovirus can cause hepatitis in children, it is usually in those who are immunocompromised.

The CDC health alert advises clinicians who have cases of unexplained hepatitis in children to test for adenovirus and report these cases to the CDC as well as state public health authorities. The agency recommends nucleic acid amplification testing to detect adenovirus using respiratory swabs, stool samples or rectal swabs, or blood.

Officials are exploring whether these cases are linked to a version of the virus called adenovirus 41, which is associated with gut inflammation. The most recent case in Alabama was reported in February, and five of the nine children in the state with these puzzling cases of hepatitis have tested positive for adenovirus 41.

There have yet to be any links among the cases in Alabama or North Carolina, and investigators in the United Kingdom have also not found any connections in their cases, STAT News reports.

“CDC is working with state health departments to see if there are additional U.S. cases and what may be causing these cases,” said Kristen Nordlund, a CDC spokesperson, in a statement to STAT News. “At this time, adenovirus may be the cause for these, but investigators are still learning more – including ruling out the more common causes of hepatitis.”

Looking for other explanations

None of the children in the United States with hepatitis had COVID-19, but a few children in the United Kingdom have tested positive for the virus; none of these children have received the COVID-19 vaccine.

While the U.K. Health Security Agency says their investigation “continues to point toward a link to adenovirus infection,” they are also considering other contributing factors such as an environmental cause or COVID-19.

“COVID has been consistently shown to increase liver test numbers,” Nancy Reau, MD, the section chief of hepatology at Rush University in Chicago, said in an interview with this news organization. “It has been shown to cause other organ involvement besides just pulmonary symptoms and respiratory failure. As this virus evolves, it might be that in children, it is more able to present as hepatitis.”
 

A version of this article first appeared on Medscape.com.

This article was updated 4/22/22.

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Who doesn’t text in 2022? Most state Medicaid programs

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Mon, 04/18/2022 - 11:07

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Omicron BA.2: What do we know so far?

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Tue, 04/19/2022 - 16:31

Since November 2021, the Omicron variant of SARS-CoV-2 has quickly become the most dominant variant worldwide. Early sequencing of Omicron in South Africa alerted researchers to the possibility that Omicron could be a cause for concern because of extensive mutations of the spike protein. Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).

Omicron’s functional characteristics

Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.

As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
 

Omicron BA.2 evolves

Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.

From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
 

Omicron BA.2 and reinfection

BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.

BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
 

Omicron, BA.2, and vaccination

The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.

These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).

To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?

A version of this article was originally published in Italian on Univadis.

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Since November 2021, the Omicron variant of SARS-CoV-2 has quickly become the most dominant variant worldwide. Early sequencing of Omicron in South Africa alerted researchers to the possibility that Omicron could be a cause for concern because of extensive mutations of the spike protein. Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).

Omicron’s functional characteristics

Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.

As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
 

Omicron BA.2 evolves

Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.

From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
 

Omicron BA.2 and reinfection

BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.

BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
 

Omicron, BA.2, and vaccination

The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.

These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).

To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?

A version of this article was originally published in Italian on Univadis.

Since November 2021, the Omicron variant of SARS-CoV-2 has quickly become the most dominant variant worldwide. Early sequencing of Omicron in South Africa alerted researchers to the possibility that Omicron could be a cause for concern because of extensive mutations of the spike protein. Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).

Omicron’s functional characteristics

Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.

As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
 

Omicron BA.2 evolves

Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.

From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
 

Omicron BA.2 and reinfection

BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.

BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
 

Omicron, BA.2, and vaccination

The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.

These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).

To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?

A version of this article was originally published in Italian on Univadis.

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