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People infected multiple times with COVID-19 are more likely to develop long COVID, and most never fully recover from the condition. Those are two of the most striking findings of a comprehensive new research study of 138,000 veterans.

Lead researcher Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, spoke with this news organization about his team’s findings, what we know – and don’t – about long COVID, and what it means for physicians treating patients with the condition.

Excerpts of the interview follow.

Your research concluded that for those infected early in the pandemic, some long COVID symptoms declined over 2 years, but some did not. You have also concluded that long COVID is a chronic disease. Why?

We’ve been in this journey a little bit more than three and a half years. Some patients do experience some recovery. But that’s not the norm. Most people do not really fully recover. The health trajectory for people with long COVID is really very heterogeneous. There is no one-size-fits-all. There’s really no one line that I could give you that could cover all your patients. But it is very, very, very clear that a bunch of them experienced long COVID for sure; that’s really happening.

It happened in the pre-Delta era and in the Delta era, and with Omicron subvariants, even now. There are people who think, “This is a nothing-burger anymore,” or “It’s not an issue anymore.” It’s still happening with the current variants. Vaccines do reduce risk for long COVID, but do not completely eliminate the risk for long COVID.

You work with patients with long COVID in the clinic and also analyze data from thousands more. If long COVID does not go away, what should doctors look for in everyday practice that will help them recognize and help patients with long COVID?

Long COVID is not uncommon. We see it in the clinic in large numbers. Whatever clinic you’re running – if you’re running a cardiology clinic, or a nephrology clinic, or diabetes, or primary care – probably some of your people have it. You may not know about it. They may not tell you about it. You may not recognize it.

Not all long COVID is the same, and that’s really what makes it complex and makes it really hard to deal with in the clinic. But that’s the reality that we’re all dealing with. And it’s multisystemic; it’s not like it affects the heart only, the brain only, or the autonomic nervous system only. It does not behave in the same way in different individuals – they may have different manifestations, various health trajectories, and different outcomes. It’s important for doctors to get up to speed on long COVID as a multisystem illness.

Management at this point is really managing the symptoms. We don’t have a treatment for it; we don’t have a cure for it.

Some patients experience what you’ve described as partial recovery. What does that look like?

Some individuals do experience some recovery over time, but for most individuals, the recovery is long and arduous. Long COVID can last with them for many years. Some people may come back to the clinic and say, “I’m doing better,” but if you really flesh it out and dig deeper, they didn’t do better; they adjusted to a new baseline. They used to walk the dog three to four blocks, and now they walk the dog only half a block. They used to do an activity with their partner every Saturday or Sunday, and now they do half of that.

If you’re a physician, a primary care provider, or any other provider who is dealing with a patient with long COVID, know that this is really happening. It can happen even in vaccinated individuals. The presentation is heterogeneous. Some people may present to you with and say. “Well, before I had COVID I was mentally sharp and now having I’m having difficulty with memory, etc.” It can sometimes present as fatigue or postexertional malaise.

In some instances, it can present as sleep problems. It can present as what we call postural orthostatic tachycardia syndrome (POTS). Those people get a significant increase in heart rate with postural changes.

What the most important thing we can we learn from the emergence of long COVID?

This whole thing taught us that infections can cause chronic disease. That’s really the No. 1 lesson that I take from this pandemic – that infections can cause chronic disease.

Looking at only acute illness from COVID is really only looking at the tip of the iceberg. Beneath that tip of the iceberg lies this hidden toll of disease that we don’t really talk about that much.

This pandemic shone a very, very good light on the idea that there is really an intimate connection between infections and chronic disease. It was really hardwired into our medical training as doctors that most infections, when people get over the hump of the acute phase of the disease, it’s all behind them. I think long COVID has humbled us in many, many ways, but chief among those is the realization – the stark realization – that infections can cause chronic disease.

That’s really going back to your [first] question: What does it mean that some people are not recovering? They actually have chronic illness. I’m hoping that we will find a treatment, that we’ll start finding things that would help them get back to baseline. But at this point in time, what we’re dealing with is people with chronic illness or chronic disease that may continue to affect them for many years to come in the absence of a treatment or a cure.

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

People infected multiple times with COVID-19 are more likely to develop long COVID, and most never fully recover from the condition. Those are two of the most striking findings of a comprehensive new research study of 138,000 veterans.

Lead researcher Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, spoke with this news organization about his team’s findings, what we know – and don’t – about long COVID, and what it means for physicians treating patients with the condition.

Excerpts of the interview follow.

Your research concluded that for those infected early in the pandemic, some long COVID symptoms declined over 2 years, but some did not. You have also concluded that long COVID is a chronic disease. Why?

We’ve been in this journey a little bit more than three and a half years. Some patients do experience some recovery. But that’s not the norm. Most people do not really fully recover. The health trajectory for people with long COVID is really very heterogeneous. There is no one-size-fits-all. There’s really no one line that I could give you that could cover all your patients. But it is very, very, very clear that a bunch of them experienced long COVID for sure; that’s really happening.

It happened in the pre-Delta era and in the Delta era, and with Omicron subvariants, even now. There are people who think, “This is a nothing-burger anymore,” or “It’s not an issue anymore.” It’s still happening with the current variants. Vaccines do reduce risk for long COVID, but do not completely eliminate the risk for long COVID.

You work with patients with long COVID in the clinic and also analyze data from thousands more. If long COVID does not go away, what should doctors look for in everyday practice that will help them recognize and help patients with long COVID?

Long COVID is not uncommon. We see it in the clinic in large numbers. Whatever clinic you’re running – if you’re running a cardiology clinic, or a nephrology clinic, or diabetes, or primary care – probably some of your people have it. You may not know about it. They may not tell you about it. You may not recognize it.

Not all long COVID is the same, and that’s really what makes it complex and makes it really hard to deal with in the clinic. But that’s the reality that we’re all dealing with. And it’s multisystemic; it’s not like it affects the heart only, the brain only, or the autonomic nervous system only. It does not behave in the same way in different individuals – they may have different manifestations, various health trajectories, and different outcomes. It’s important for doctors to get up to speed on long COVID as a multisystem illness.

Management at this point is really managing the symptoms. We don’t have a treatment for it; we don’t have a cure for it.

Some patients experience what you’ve described as partial recovery. What does that look like?

Some individuals do experience some recovery over time, but for most individuals, the recovery is long and arduous. Long COVID can last with them for many years. Some people may come back to the clinic and say, “I’m doing better,” but if you really flesh it out and dig deeper, they didn’t do better; they adjusted to a new baseline. They used to walk the dog three to four blocks, and now they walk the dog only half a block. They used to do an activity with their partner every Saturday or Sunday, and now they do half of that.

If you’re a physician, a primary care provider, or any other provider who is dealing with a patient with long COVID, know that this is really happening. It can happen even in vaccinated individuals. The presentation is heterogeneous. Some people may present to you with and say. “Well, before I had COVID I was mentally sharp and now having I’m having difficulty with memory, etc.” It can sometimes present as fatigue or postexertional malaise.

In some instances, it can present as sleep problems. It can present as what we call postural orthostatic tachycardia syndrome (POTS). Those people get a significant increase in heart rate with postural changes.

What the most important thing we can we learn from the emergence of long COVID?

This whole thing taught us that infections can cause chronic disease. That’s really the No. 1 lesson that I take from this pandemic – that infections can cause chronic disease.

Looking at only acute illness from COVID is really only looking at the tip of the iceberg. Beneath that tip of the iceberg lies this hidden toll of disease that we don’t really talk about that much.

This pandemic shone a very, very good light on the idea that there is really an intimate connection between infections and chronic disease. It was really hardwired into our medical training as doctors that most infections, when people get over the hump of the acute phase of the disease, it’s all behind them. I think long COVID has humbled us in many, many ways, but chief among those is the realization – the stark realization – that infections can cause chronic disease.

That’s really going back to your [first] question: What does it mean that some people are not recovering? They actually have chronic illness. I’m hoping that we will find a treatment, that we’ll start finding things that would help them get back to baseline. But at this point in time, what we’re dealing with is people with chronic illness or chronic disease that may continue to affect them for many years to come in the absence of a treatment or a cure.

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

People infected multiple times with COVID-19 are more likely to develop long COVID, and most never fully recover from the condition. Those are two of the most striking findings of a comprehensive new research study of 138,000 veterans.

Lead researcher Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, spoke with this news organization about his team’s findings, what we know – and don’t – about long COVID, and what it means for physicians treating patients with the condition.

Excerpts of the interview follow.

Your research concluded that for those infected early in the pandemic, some long COVID symptoms declined over 2 years, but some did not. You have also concluded that long COVID is a chronic disease. Why?

We’ve been in this journey a little bit more than three and a half years. Some patients do experience some recovery. But that’s not the norm. Most people do not really fully recover. The health trajectory for people with long COVID is really very heterogeneous. There is no one-size-fits-all. There’s really no one line that I could give you that could cover all your patients. But it is very, very, very clear that a bunch of them experienced long COVID for sure; that’s really happening.

It happened in the pre-Delta era and in the Delta era, and with Omicron subvariants, even now. There are people who think, “This is a nothing-burger anymore,” or “It’s not an issue anymore.” It’s still happening with the current variants. Vaccines do reduce risk for long COVID, but do not completely eliminate the risk for long COVID.

You work with patients with long COVID in the clinic and also analyze data from thousands more. If long COVID does not go away, what should doctors look for in everyday practice that will help them recognize and help patients with long COVID?

Long COVID is not uncommon. We see it in the clinic in large numbers. Whatever clinic you’re running – if you’re running a cardiology clinic, or a nephrology clinic, or diabetes, or primary care – probably some of your people have it. You may not know about it. They may not tell you about it. You may not recognize it.

Not all long COVID is the same, and that’s really what makes it complex and makes it really hard to deal with in the clinic. But that’s the reality that we’re all dealing with. And it’s multisystemic; it’s not like it affects the heart only, the brain only, or the autonomic nervous system only. It does not behave in the same way in different individuals – they may have different manifestations, various health trajectories, and different outcomes. It’s important for doctors to get up to speed on long COVID as a multisystem illness.

Management at this point is really managing the symptoms. We don’t have a treatment for it; we don’t have a cure for it.

Some patients experience what you’ve described as partial recovery. What does that look like?

Some individuals do experience some recovery over time, but for most individuals, the recovery is long and arduous. Long COVID can last with them for many years. Some people may come back to the clinic and say, “I’m doing better,” but if you really flesh it out and dig deeper, they didn’t do better; they adjusted to a new baseline. They used to walk the dog three to four blocks, and now they walk the dog only half a block. They used to do an activity with their partner every Saturday or Sunday, and now they do half of that.

If you’re a physician, a primary care provider, or any other provider who is dealing with a patient with long COVID, know that this is really happening. It can happen even in vaccinated individuals. The presentation is heterogeneous. Some people may present to you with and say. “Well, before I had COVID I was mentally sharp and now having I’m having difficulty with memory, etc.” It can sometimes present as fatigue or postexertional malaise.

In some instances, it can present as sleep problems. It can present as what we call postural orthostatic tachycardia syndrome (POTS). Those people get a significant increase in heart rate with postural changes.

What the most important thing we can we learn from the emergence of long COVID?

This whole thing taught us that infections can cause chronic disease. That’s really the No. 1 lesson that I take from this pandemic – that infections can cause chronic disease.

Looking at only acute illness from COVID is really only looking at the tip of the iceberg. Beneath that tip of the iceberg lies this hidden toll of disease that we don’t really talk about that much.

This pandemic shone a very, very good light on the idea that there is really an intimate connection between infections and chronic disease. It was really hardwired into our medical training as doctors that most infections, when people get over the hump of the acute phase of the disease, it’s all behind them. I think long COVID has humbled us in many, many ways, but chief among those is the realization – the stark realization – that infections can cause chronic disease.

That’s really going back to your [first] question: What does it mean that some people are not recovering? They actually have chronic illness. I’m hoping that we will find a treatment, that we’ll start finding things that would help them get back to baseline. But at this point in time, what we’re dealing with is people with chronic illness or chronic disease that may continue to affect them for many years to come in the absence of a treatment or a cure.

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

A pair of new studies published about long COVID have shed more light on the sometimes-disabling condition that affects millions of people in the United States. 

Scientists worldwide have been working to understand the wide-ranging condition, from risk factors to causes to potential treatments. 

In the first study, 31 adults underwent lumbar puncture and blood draws to look for changes in their immune systems and also to look for changes in the nerve cells that could affect transmission of signals to the brain.

Among the participants, 25 people had neurocognitive symptoms of long COVID, such as memory loss or attention problems. Six participants had fully recovered from COVID, and 17 people had never had COVID. 

Those who had COVID were diagnosed between March 2020 and May 2021. Their fluid samples were drawn at least three months after their first symptoms.

The results were published in the Journal of Infectious Diseases. Study results showed that long COVID does not appear to be linked to the SARS-CoV-2 virus invading the brain or causing active brain damage.

According to a summary of the study from the University of Gothenburg (Sweden), where the researchers work, “there were no significant differences between the groups when analyzing blood and cerebrospinal fluid for immune activation or brain injury markers. The findings thus suggest that post-COVID condition is not the result of ongoing infection, immune activation, or brain damage.”

In the second study, Norwegian researchers compared the likelihood of having 17 different long COVID symptoms based on whether a person had been infected with COVID. The analysis included 53,846 people who were diagnosed with COVID between February 2020 and February 2021, as well as more than 485,000 people who were not infected. Most people had not been vaccinated against COVID-19 during the time of the study.

The results were published in the journal BMC Infectious Diseases. Study results showed that people who had COVID were more than twice as likely to experience shortness of breath or fatigue. They were also more likely to experience memory loss or headache compared to people who never had COVID. Researchers only looked at symptoms that occurred at least three months after a COVID diagnosis.

They also found that hospitalization increased the risk for experiencing long COVID symptoms of shortness of breath, fatigue, and memory loss.

The authors noted that a limitation of their study was that, often, not all symptoms reported during a visit with a general practice medical provider are recorded in Norway, which could have affected the results.

A version of this article appeared on Medscape.com.

A pair of new studies published about long COVID have shed more light on the sometimes-disabling condition that affects millions of people in the United States. 

Scientists worldwide have been working to understand the wide-ranging condition, from risk factors to causes to potential treatments. 

In the first study, 31 adults underwent lumbar puncture and blood draws to look for changes in their immune systems and also to look for changes in the nerve cells that could affect transmission of signals to the brain.

Among the participants, 25 people had neurocognitive symptoms of long COVID, such as memory loss or attention problems. Six participants had fully recovered from COVID, and 17 people had never had COVID. 

Those who had COVID were diagnosed between March 2020 and May 2021. Their fluid samples were drawn at least three months after their first symptoms.

The results were published in the Journal of Infectious Diseases. Study results showed that long COVID does not appear to be linked to the SARS-CoV-2 virus invading the brain or causing active brain damage.

According to a summary of the study from the University of Gothenburg (Sweden), where the researchers work, “there were no significant differences between the groups when analyzing blood and cerebrospinal fluid for immune activation or brain injury markers. The findings thus suggest that post-COVID condition is not the result of ongoing infection, immune activation, or brain damage.”

In the second study, Norwegian researchers compared the likelihood of having 17 different long COVID symptoms based on whether a person had been infected with COVID. The analysis included 53,846 people who were diagnosed with COVID between February 2020 and February 2021, as well as more than 485,000 people who were not infected. Most people had not been vaccinated against COVID-19 during the time of the study.

The results were published in the journal BMC Infectious Diseases. Study results showed that people who had COVID were more than twice as likely to experience shortness of breath or fatigue. They were also more likely to experience memory loss or headache compared to people who never had COVID. Researchers only looked at symptoms that occurred at least three months after a COVID diagnosis.

They also found that hospitalization increased the risk for experiencing long COVID symptoms of shortness of breath, fatigue, and memory loss.

The authors noted that a limitation of their study was that, often, not all symptoms reported during a visit with a general practice medical provider are recorded in Norway, which could have affected the results.

A version of this article appeared on Medscape.com.

A pair of new studies published about long COVID have shed more light on the sometimes-disabling condition that affects millions of people in the United States. 

Scientists worldwide have been working to understand the wide-ranging condition, from risk factors to causes to potential treatments. 

In the first study, 31 adults underwent lumbar puncture and blood draws to look for changes in their immune systems and also to look for changes in the nerve cells that could affect transmission of signals to the brain.

Among the participants, 25 people had neurocognitive symptoms of long COVID, such as memory loss or attention problems. Six participants had fully recovered from COVID, and 17 people had never had COVID. 

Those who had COVID were diagnosed between March 2020 and May 2021. Their fluid samples were drawn at least three months after their first symptoms.

The results were published in the Journal of Infectious Diseases. Study results showed that long COVID does not appear to be linked to the SARS-CoV-2 virus invading the brain or causing active brain damage.

According to a summary of the study from the University of Gothenburg (Sweden), where the researchers work, “there were no significant differences between the groups when analyzing blood and cerebrospinal fluid for immune activation or brain injury markers. The findings thus suggest that post-COVID condition is not the result of ongoing infection, immune activation, or brain damage.”

In the second study, Norwegian researchers compared the likelihood of having 17 different long COVID symptoms based on whether a person had been infected with COVID. The analysis included 53,846 people who were diagnosed with COVID between February 2020 and February 2021, as well as more than 485,000 people who were not infected. Most people had not been vaccinated against COVID-19 during the time of the study.

The results were published in the journal BMC Infectious Diseases. Study results showed that people who had COVID were more than twice as likely to experience shortness of breath or fatigue. They were also more likely to experience memory loss or headache compared to people who never had COVID. Researchers only looked at symptoms that occurred at least three months after a COVID diagnosis.

They also found that hospitalization increased the risk for experiencing long COVID symptoms of shortness of breath, fatigue, and memory loss.

The authors noted that a limitation of their study was that, often, not all symptoms reported during a visit with a general practice medical provider are recorded in Norway, which could have affected the results.

A version of this article appeared on Medscape.com.

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

TOPLINE:

Severe mental illness (SMI) has been linked to a 50% increased risk for all-cause mortality risk after COVID-19, a large population-based study suggests.

METHODOLOGY:

• Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
• The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
• Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
• Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).

TAKEAWAY:

• Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
• Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
• After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.

IN PRACTICE:

“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.

SOURCE:

Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.

LIMITATIONS:

COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.

DISCLOSURES:

One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.

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

TOPLINE:

Severe mental illness (SMI) has been linked to a 50% increased risk for all-cause mortality risk after COVID-19, a large population-based study suggests.

METHODOLOGY:

• Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
• The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
• Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
• Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).

TAKEAWAY:

• Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
• Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
• After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.

IN PRACTICE:

“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.

SOURCE:

Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.

LIMITATIONS:

COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.

DISCLOSURES:

One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.

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

TOPLINE:

Severe mental illness (SMI) has been linked to a 50% increased risk for all-cause mortality risk after COVID-19, a large population-based study suggests.

METHODOLOGY:

• Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
• The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
• Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
• Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).

TAKEAWAY:

• Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
• Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
• After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.

IN PRACTICE:

“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.

SOURCE:

Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.

LIMITATIONS:

COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.

DISCLOSURES:

One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.

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

TOPLINE:

Nirmatrelvir-ritonavir doesn’t reduce the incidence of most post-COVID conditions, according to a new study. Thromboembolic events are the exception.
 

METHODOLOGY:

• A retrospective study of 9,593 veterans older than 65 years examined the impact of nirmatrelvir-ritonavir in comparison with no treatment on post–COVID-19 conditions (PCCs).
• Researchers coded 31 conditions, including those that fell into cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, and endocrine categories.
• The incidence of PCCs was analyzed 31-180 days after treatment.

TAKEAWAY:

• The combined incidence of venous thromboembolism and pulmonary embolism was reduced among patients given nirmatrelvir-ritonavir.
• No statistically significant reduction of other conditions was found.
• Results differ from the conclusions of a smaller study that found that the incidence of 10 of 13 PCCs was lower.

IN PRACTICE:

“Our results suggest that considerations about PCCs may not be an important factor in COVID-19 treatment decisions,” the authors write.

SOURCE:

The study was funded by the Department of Veterans Affairs and was published online in Annals of Internal Medicine. George Ioannou, MD, director of hepatology at the VA Puget Sound Health Care System in Seattle, led the study.

LIMITATIONS:

A large number of outcomes were observed, so it’s possible that the association between treatment with nirmatrelvir-ritonavir and reduced incidence of thromboembolic events occurred by chance.

Data on COVID-19 treatments and PCCs may be incomplete. The long-term effects of PCCs may not have been fully captured by the ICD-10, which was used for diagnosis codes.

Electronic health records did not accurately capture the symptom burden or the date symptoms began. Patients in the treatment arm may have had more symptoms than matched control persons who were not treated.
 

DISCLOSURES:

The authors reported relationships with the Korean Diabetes Association, the American Diabetes Association, the International Society for the Diabetic Foot, Quality Insights, Brown University, and the Society for Women in Urology, among others.

A version of this article appeared on Medscape.com.

TOPLINE:

Nirmatrelvir-ritonavir doesn’t reduce the incidence of most post-COVID conditions, according to a new study. Thromboembolic events are the exception.
 

METHODOLOGY:

• A retrospective study of 9,593 veterans older than 65 years examined the impact of nirmatrelvir-ritonavir in comparison with no treatment on post–COVID-19 conditions (PCCs).
• Researchers coded 31 conditions, including those that fell into cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, and endocrine categories.
• The incidence of PCCs was analyzed 31-180 days after treatment.

TAKEAWAY:

• The combined incidence of venous thromboembolism and pulmonary embolism was reduced among patients given nirmatrelvir-ritonavir.
• No statistically significant reduction of other conditions was found.
• Results differ from the conclusions of a smaller study that found that the incidence of 10 of 13 PCCs was lower.

IN PRACTICE:

“Our results suggest that considerations about PCCs may not be an important factor in COVID-19 treatment decisions,” the authors write.

SOURCE:

The study was funded by the Department of Veterans Affairs and was published online in Annals of Internal Medicine. George Ioannou, MD, director of hepatology at the VA Puget Sound Health Care System in Seattle, led the study.

LIMITATIONS:

A large number of outcomes were observed, so it’s possible that the association between treatment with nirmatrelvir-ritonavir and reduced incidence of thromboembolic events occurred by chance.

Data on COVID-19 treatments and PCCs may be incomplete. The long-term effects of PCCs may not have been fully captured by the ICD-10, which was used for diagnosis codes.

Electronic health records did not accurately capture the symptom burden or the date symptoms began. Patients in the treatment arm may have had more symptoms than matched control persons who were not treated.
 

DISCLOSURES:

The authors reported relationships with the Korean Diabetes Association, the American Diabetes Association, the International Society for the Diabetic Foot, Quality Insights, Brown University, and the Society for Women in Urology, among others.

A version of this article appeared on Medscape.com.

TOPLINE:

Nirmatrelvir-ritonavir doesn’t reduce the incidence of most post-COVID conditions, according to a new study. Thromboembolic events are the exception.
 

METHODOLOGY:

• A retrospective study of 9,593 veterans older than 65 years examined the impact of nirmatrelvir-ritonavir in comparison with no treatment on post–COVID-19 conditions (PCCs).
• Researchers coded 31 conditions, including those that fell into cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, and endocrine categories.
• The incidence of PCCs was analyzed 31-180 days after treatment.

TAKEAWAY:

• The combined incidence of venous thromboembolism and pulmonary embolism was reduced among patients given nirmatrelvir-ritonavir.
• No statistically significant reduction of other conditions was found.
• Results differ from the conclusions of a smaller study that found that the incidence of 10 of 13 PCCs was lower.

IN PRACTICE:

“Our results suggest that considerations about PCCs may not be an important factor in COVID-19 treatment decisions,” the authors write.

SOURCE:

The study was funded by the Department of Veterans Affairs and was published online in Annals of Internal Medicine. George Ioannou, MD, director of hepatology at the VA Puget Sound Health Care System in Seattle, led the study.

LIMITATIONS:

A large number of outcomes were observed, so it’s possible that the association between treatment with nirmatrelvir-ritonavir and reduced incidence of thromboembolic events occurred by chance.

Data on COVID-19 treatments and PCCs may be incomplete. The long-term effects of PCCs may not have been fully captured by the ICD-10, which was used for diagnosis codes.

Electronic health records did not accurately capture the symptom burden or the date symptoms began. Patients in the treatment arm may have had more symptoms than matched control persons who were not treated.
 

DISCLOSURES:

The authors reported relationships with the Korean Diabetes Association, the American Diabetes Association, the International Society for the Diabetic Foot, Quality Insights, Brown University, and the Society for Women in Urology, among others.

A version of this article appeared on Medscape.com.

TOPLINE:

Half of kids with COVID-19 become noninfectious 3 days after testing positive, whether they were vaccinated or not, according to a new study. The findings indicate that return-to-school policies for infected children may not need to differ on the basis of vaccine or booster status.

METHODOLOGY:

• The study looked at 76 children, both vaccinated and unvaccinated, aged 7-18 years who had tested positive for COVID-19. 
• Researchers performed nasal swabs every other day for 10 days, sending the swab to a lab to be tested for cytopathic effect (CPE), or cell death, an indicator of infectivity.
• They took pictures of the lab cultures to look for signs of CPE starting at 6 days after the test, which corresponds to the 2nd day after testing positive.
• If CPE characteristics were present in at least 30% of images, children were considered infectious.

TAKEAWAY:

• By day 3, half of study participants were noninfectious, independent of whether they had been vaccinated.
• By day 5, less than 25% of children were infectious, regardless of vaccination status.
• Among vaccinated children, the duration of infectivity was similar for children who received a booster and for those who had not.
• The authors state that these results are consistent with those of a study in adults with the Omicron variant, which found no association between vaccination status and infectivity duration.

IN PRACTICE:

“Our findings suggest that current policies requiring isolation for 5 days after a positive test might be appropriate, as the majority of children were not infectious by day 5. Additionally, return-to-school policies may not need to discriminate by vaccine or booster status,” the authors wrote. 

SOURCE:

The study was led by Neeraj Sood, PhD, of the University of Southern California in Los Angeles, and was published in JAMA Pediatrics.

LIMITATIONS:

The sample size was small, and the authors identified the potential for nonresponse bias. The research did not include data from children who didn’t receive a test. CPE is the standard for estimating infectivity, but it can still carry inaccuracies.

DISCLOSURES:

The authors report no disclosures. The study was funded by RF Catalytic Capital.

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

TOPLINE:

Half of kids with COVID-19 become noninfectious 3 days after testing positive, whether they were vaccinated or not, according to a new study. The findings indicate that return-to-school policies for infected children may not need to differ on the basis of vaccine or booster status.

METHODOLOGY:

• The study looked at 76 children, both vaccinated and unvaccinated, aged 7-18 years who had tested positive for COVID-19. 
• Researchers performed nasal swabs every other day for 10 days, sending the swab to a lab to be tested for cytopathic effect (CPE), or cell death, an indicator of infectivity.
• They took pictures of the lab cultures to look for signs of CPE starting at 6 days after the test, which corresponds to the 2nd day after testing positive.
• If CPE characteristics were present in at least 30% of images, children were considered infectious.

TAKEAWAY:

• By day 3, half of study participants were noninfectious, independent of whether they had been vaccinated.
• By day 5, less than 25% of children were infectious, regardless of vaccination status.
• Among vaccinated children, the duration of infectivity was similar for children who received a booster and for those who had not.
• The authors state that these results are consistent with those of a study in adults with the Omicron variant, which found no association between vaccination status and infectivity duration.

IN PRACTICE:

“Our findings suggest that current policies requiring isolation for 5 days after a positive test might be appropriate, as the majority of children were not infectious by day 5. Additionally, return-to-school policies may not need to discriminate by vaccine or booster status,” the authors wrote. 

SOURCE:

The study was led by Neeraj Sood, PhD, of the University of Southern California in Los Angeles, and was published in JAMA Pediatrics.

LIMITATIONS:

The sample size was small, and the authors identified the potential for nonresponse bias. The research did not include data from children who didn’t receive a test. CPE is the standard for estimating infectivity, but it can still carry inaccuracies.

DISCLOSURES:

The authors report no disclosures. The study was funded by RF Catalytic Capital.

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

TOPLINE:

Half of kids with COVID-19 become noninfectious 3 days after testing positive, whether they were vaccinated or not, according to a new study. The findings indicate that return-to-school policies for infected children may not need to differ on the basis of vaccine or booster status.

METHODOLOGY:

• The study looked at 76 children, both vaccinated and unvaccinated, aged 7-18 years who had tested positive for COVID-19. 
• Researchers performed nasal swabs every other day for 10 days, sending the swab to a lab to be tested for cytopathic effect (CPE), or cell death, an indicator of infectivity.
• They took pictures of the lab cultures to look for signs of CPE starting at 6 days after the test, which corresponds to the 2nd day after testing positive.
• If CPE characteristics were present in at least 30% of images, children were considered infectious.

TAKEAWAY:

• By day 3, half of study participants were noninfectious, independent of whether they had been vaccinated.
• By day 5, less than 25% of children were infectious, regardless of vaccination status.
• Among vaccinated children, the duration of infectivity was similar for children who received a booster and for those who had not.
• The authors state that these results are consistent with those of a study in adults with the Omicron variant, which found no association between vaccination status and infectivity duration.

IN PRACTICE:

“Our findings suggest that current policies requiring isolation for 5 days after a positive test might be appropriate, as the majority of children were not infectious by day 5. Additionally, return-to-school policies may not need to discriminate by vaccine or booster status,” the authors wrote. 

SOURCE:

The study was led by Neeraj Sood, PhD, of the University of Southern California in Los Angeles, and was published in JAMA Pediatrics.

LIMITATIONS:

The sample size was small, and the authors identified the potential for nonresponse bias. The research did not include data from children who didn’t receive a test. CPE is the standard for estimating infectivity, but it can still carry inaccuracies.

DISCLOSURES:

The authors report no disclosures. The study was funded by RF Catalytic Capital.

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

Nirmatrelvir-ritonavir (Paxlovid) is associated with a reduced risk for death or hospitalization in the most extremely vulnerable patients with COVID-19, new research suggests.

In a cohort study from British Columbia that included nearly 7,000 patients with COVID-19, nirmatrelvir-ritonavir was associated with a 2.5% reduction in risk for death or emergency hospitalization in clinically extremely vulnerable (CEV) patients who were severely immunocompromised. No significant benefit was observed in patients who were not immunocompromised.

“This finding could help substantially limit unnecessary use of nirmatrelvir and ritonavir in older, otherwise healthy individuals,” lead author Colin R. Dormuth, ScD, associate professor of anesthesiology, pharmacology, and therapeutics at the University of British Columbia, Vancouver, told this news organization. “Another finding that was surprising and might help place the role of nirmatrelvir and ritonavir in context is that even in severely immunocompromised individuals who did not take [the drug], the risk of death or hospitalization with COVID-19 was less than 4% in our study population.”

The study was published online in JAMA Network Open.
 

Who benefits?

The investigators analyzed medical records for 6,866 patients in British Columbia (median age, 70 years; 57% women) who presented between Feb. 1, 2022, and Feb. 3, 2023. Eligible patients belonged to one of four higher-risk groups who received priority for COVID-19 vaccination.

Two groups included CEV patients who were severely (CEV1) or moderately (CEV2) immunocompromised. The CEV3 group was not immunocompromised but had medical conditions associated with a high risk for complications from COVID-19. A fourth expanded eligibility (EXEL) group included higher-risk patients who were not in one of the other groups, such as unvaccinated patients older than age 70 years.

The investigators matched treated patients to untreated patients in the same vulnerability group according to age, sex, and month of infection. The primary outcome was death from any cause or emergency hospitalization with COVID-19 within 28 days.

Treatment with nirmatrelvir-ritonavir was associated with statistically significant relative reductions in the primary outcome, compared with no treatment, for patients in the CEV1 (risk difference, −2.5%) and CEV2 (RD, −1.7%) groups. In the CEV3 group, the RD of −1.3% was not statistically significant. In the EXEL group, treatment was associated with a higher risk for the primary outcome (RD, 1.0%), but the result was not statistically significant.

The results were “robust across sex and older vs. younger age,” the authors note. “No reduction in the primary outcome was observed in lower-risk individuals, including those aged 70 years or older without serious comorbidities.”

The combination of nirmatrelvir-ritonavir was approved for use in Canada based on interim efficacy and safety data from the Evaluation of Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, said Dr. Dormuth.

British Columbia’s eligibility criteria for nirmatrelvir-ritonavir coverage differ substantially from the criteria for participants in the EPIC-HR trial, he noted. Those patients were unvaccinated, had no natural immunity from a previous COVID-19 infection, and were infected with COVID-19 variants that were different from those now circulating. The current study was prompted by the need to look at a broader population of individuals in British Columbia with varying risks of complications from COVID-19 infection.

Before the study, a common view was that patients aged 70 and older would benefit from the drug, said Dr. Dormuth. “Our study, which accounted for medical conditions related to an individual’s vulnerability to complications, showed that older age on its own was not a reason to use nirmatrelvir and ritonavir once relevant medical conditions were taken into consideration.”

The researchers are working on a study to identify with greater specificity which comorbid conditions are most associated with nirmatrelvir-ritonavir effectiveness, he added. “It could be that a relatively small number of conditions can be used to identify most individuals who would benefit from the drug.”
 

‘Signal toward benefit’

Commenting on the findings for this news organization, Abhijit Duggal, MD, vice chair of critical care at the Cleveland Clinic, who was not involved in this study, said, “I’m always very wary when we look at observational data and we start saying the effectiveness is not really as high as was seen in other studies. We are seeing an effect with all these studies that seems to be in the right direction.

“Having said that,” he added, “is the effect going to be potentially more in patients at higher risk? Absolutely. I think these postmarket studies are really showing that after vaccination, if someone does get infected, this is a secondary option available to us that can prevent progression of the disease, which would likely be more severe in immunocompromised patients.”

Dr. Duggal was a coinvestigator on a recent study of more than 68,000 patients that showed that nirmatrelvir-ritonavir or molnupiravir was associated with reductions in mortality and hospitalization in nonhospitalized patients infected with the Omicron variant, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions.

“In all groups, there was a signal toward benefit,” said Dr. Duggal. “These studies tell us that these drugs do remain valid options. But their use needs to be discussed on a case-by-case basis with patients we feel are deteriorating or at a higher risk because of underlying disease processes.”

The study was supported by funding from the British Columbia Ministry of Health. Dr. Dormuth and Dr. Duggal report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Nirmatrelvir-ritonavir (Paxlovid) is associated with a reduced risk for death or hospitalization in the most extremely vulnerable patients with COVID-19, new research suggests.

In a cohort study from British Columbia that included nearly 7,000 patients with COVID-19, nirmatrelvir-ritonavir was associated with a 2.5% reduction in risk for death or emergency hospitalization in clinically extremely vulnerable (CEV) patients who were severely immunocompromised. No significant benefit was observed in patients who were not immunocompromised.

“This finding could help substantially limit unnecessary use of nirmatrelvir and ritonavir in older, otherwise healthy individuals,” lead author Colin R. Dormuth, ScD, associate professor of anesthesiology, pharmacology, and therapeutics at the University of British Columbia, Vancouver, told this news organization. “Another finding that was surprising and might help place the role of nirmatrelvir and ritonavir in context is that even in severely immunocompromised individuals who did not take [the drug], the risk of death or hospitalization with COVID-19 was less than 4% in our study population.”

The study was published online in JAMA Network Open.
 

Who benefits?

The investigators analyzed medical records for 6,866 patients in British Columbia (median age, 70 years; 57% women) who presented between Feb. 1, 2022, and Feb. 3, 2023. Eligible patients belonged to one of four higher-risk groups who received priority for COVID-19 vaccination.

Two groups included CEV patients who were severely (CEV1) or moderately (CEV2) immunocompromised. The CEV3 group was not immunocompromised but had medical conditions associated with a high risk for complications from COVID-19. A fourth expanded eligibility (EXEL) group included higher-risk patients who were not in one of the other groups, such as unvaccinated patients older than age 70 years.

The investigators matched treated patients to untreated patients in the same vulnerability group according to age, sex, and month of infection. The primary outcome was death from any cause or emergency hospitalization with COVID-19 within 28 days.

Treatment with nirmatrelvir-ritonavir was associated with statistically significant relative reductions in the primary outcome, compared with no treatment, for patients in the CEV1 (risk difference, −2.5%) and CEV2 (RD, −1.7%) groups. In the CEV3 group, the RD of −1.3% was not statistically significant. In the EXEL group, treatment was associated with a higher risk for the primary outcome (RD, 1.0%), but the result was not statistically significant.

The results were “robust across sex and older vs. younger age,” the authors note. “No reduction in the primary outcome was observed in lower-risk individuals, including those aged 70 years or older without serious comorbidities.”

The combination of nirmatrelvir-ritonavir was approved for use in Canada based on interim efficacy and safety data from the Evaluation of Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, said Dr. Dormuth.

British Columbia’s eligibility criteria for nirmatrelvir-ritonavir coverage differ substantially from the criteria for participants in the EPIC-HR trial, he noted. Those patients were unvaccinated, had no natural immunity from a previous COVID-19 infection, and were infected with COVID-19 variants that were different from those now circulating. The current study was prompted by the need to look at a broader population of individuals in British Columbia with varying risks of complications from COVID-19 infection.

Before the study, a common view was that patients aged 70 and older would benefit from the drug, said Dr. Dormuth. “Our study, which accounted for medical conditions related to an individual’s vulnerability to complications, showed that older age on its own was not a reason to use nirmatrelvir and ritonavir once relevant medical conditions were taken into consideration.”

The researchers are working on a study to identify with greater specificity which comorbid conditions are most associated with nirmatrelvir-ritonavir effectiveness, he added. “It could be that a relatively small number of conditions can be used to identify most individuals who would benefit from the drug.”
 

‘Signal toward benefit’

Commenting on the findings for this news organization, Abhijit Duggal, MD, vice chair of critical care at the Cleveland Clinic, who was not involved in this study, said, “I’m always very wary when we look at observational data and we start saying the effectiveness is not really as high as was seen in other studies. We are seeing an effect with all these studies that seems to be in the right direction.

“Having said that,” he added, “is the effect going to be potentially more in patients at higher risk? Absolutely. I think these postmarket studies are really showing that after vaccination, if someone does get infected, this is a secondary option available to us that can prevent progression of the disease, which would likely be more severe in immunocompromised patients.”

Dr. Duggal was a coinvestigator on a recent study of more than 68,000 patients that showed that nirmatrelvir-ritonavir or molnupiravir was associated with reductions in mortality and hospitalization in nonhospitalized patients infected with the Omicron variant, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions.

“In all groups, there was a signal toward benefit,” said Dr. Duggal. “These studies tell us that these drugs do remain valid options. But their use needs to be discussed on a case-by-case basis with patients we feel are deteriorating or at a higher risk because of underlying disease processes.”

The study was supported by funding from the British Columbia Ministry of Health. Dr. Dormuth and Dr. Duggal report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Nirmatrelvir-ritonavir (Paxlovid) is associated with a reduced risk for death or hospitalization in the most extremely vulnerable patients with COVID-19, new research suggests.

In a cohort study from British Columbia that included nearly 7,000 patients with COVID-19, nirmatrelvir-ritonavir was associated with a 2.5% reduction in risk for death or emergency hospitalization in clinically extremely vulnerable (CEV) patients who were severely immunocompromised. No significant benefit was observed in patients who were not immunocompromised.

“This finding could help substantially limit unnecessary use of nirmatrelvir and ritonavir in older, otherwise healthy individuals,” lead author Colin R. Dormuth, ScD, associate professor of anesthesiology, pharmacology, and therapeutics at the University of British Columbia, Vancouver, told this news organization. “Another finding that was surprising and might help place the role of nirmatrelvir and ritonavir in context is that even in severely immunocompromised individuals who did not take [the drug], the risk of death or hospitalization with COVID-19 was less than 4% in our study population.”

The study was published online in JAMA Network Open.
 

Who benefits?

The investigators analyzed medical records for 6,866 patients in British Columbia (median age, 70 years; 57% women) who presented between Feb. 1, 2022, and Feb. 3, 2023. Eligible patients belonged to one of four higher-risk groups who received priority for COVID-19 vaccination.

Two groups included CEV patients who were severely (CEV1) or moderately (CEV2) immunocompromised. The CEV3 group was not immunocompromised but had medical conditions associated with a high risk for complications from COVID-19. A fourth expanded eligibility (EXEL) group included higher-risk patients who were not in one of the other groups, such as unvaccinated patients older than age 70 years.

The investigators matched treated patients to untreated patients in the same vulnerability group according to age, sex, and month of infection. The primary outcome was death from any cause or emergency hospitalization with COVID-19 within 28 days.

Treatment with nirmatrelvir-ritonavir was associated with statistically significant relative reductions in the primary outcome, compared with no treatment, for patients in the CEV1 (risk difference, −2.5%) and CEV2 (RD, −1.7%) groups. In the CEV3 group, the RD of −1.3% was not statistically significant. In the EXEL group, treatment was associated with a higher risk for the primary outcome (RD, 1.0%), but the result was not statistically significant.

The results were “robust across sex and older vs. younger age,” the authors note. “No reduction in the primary outcome was observed in lower-risk individuals, including those aged 70 years or older without serious comorbidities.”

The combination of nirmatrelvir-ritonavir was approved for use in Canada based on interim efficacy and safety data from the Evaluation of Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, said Dr. Dormuth.

British Columbia’s eligibility criteria for nirmatrelvir-ritonavir coverage differ substantially from the criteria for participants in the EPIC-HR trial, he noted. Those patients were unvaccinated, had no natural immunity from a previous COVID-19 infection, and were infected with COVID-19 variants that were different from those now circulating. The current study was prompted by the need to look at a broader population of individuals in British Columbia with varying risks of complications from COVID-19 infection.

Before the study, a common view was that patients aged 70 and older would benefit from the drug, said Dr. Dormuth. “Our study, which accounted for medical conditions related to an individual’s vulnerability to complications, showed that older age on its own was not a reason to use nirmatrelvir and ritonavir once relevant medical conditions were taken into consideration.”

The researchers are working on a study to identify with greater specificity which comorbid conditions are most associated with nirmatrelvir-ritonavir effectiveness, he added. “It could be that a relatively small number of conditions can be used to identify most individuals who would benefit from the drug.”
 

‘Signal toward benefit’

Commenting on the findings for this news organization, Abhijit Duggal, MD, vice chair of critical care at the Cleveland Clinic, who was not involved in this study, said, “I’m always very wary when we look at observational data and we start saying the effectiveness is not really as high as was seen in other studies. We are seeing an effect with all these studies that seems to be in the right direction.

“Having said that,” he added, “is the effect going to be potentially more in patients at higher risk? Absolutely. I think these postmarket studies are really showing that after vaccination, if someone does get infected, this is a secondary option available to us that can prevent progression of the disease, which would likely be more severe in immunocompromised patients.”

Dr. Duggal was a coinvestigator on a recent study of more than 68,000 patients that showed that nirmatrelvir-ritonavir or molnupiravir was associated with reductions in mortality and hospitalization in nonhospitalized patients infected with the Omicron variant, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions.

“In all groups, there was a signal toward benefit,” said Dr. Duggal. “These studies tell us that these drugs do remain valid options. But their use needs to be discussed on a case-by-case basis with patients we feel are deteriorating or at a higher risk because of underlying disease processes.”

The study was supported by funding from the British Columbia Ministry of Health. Dr. Dormuth and Dr. Duggal report no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
• Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
•  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
• Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
•  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
• Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
•  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

In July 2023, nirsevimab (Beyfortus), a monoclonal antibody, was approved by the Food and Drug Administration for the prevention of respiratory syncytial virus (RSV) disease in infants and children younger than 2 years of age. On Aug. 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine use of it for all infants younger than 8 months of age born during or entering their first RSV season. Its use is also recommended for certain children 8-19 months of age who are at increased risk for severe RSV disease at the start of their second RSV season. Hearing the approval, I immediately had a flashback to residency, recalling the multiple infants admitted each fall and winter exhibiting classic symptoms including cough, rhinorrhea, nasal flaring, retractions, and wheezing with many having oxygen requirements and others needing intubation. Only supportive care was available.

RSV is the leading cause of infant hospitalizations. Annually, the CDC estimates there are 50,000-80,000 RSV hospitalizations and 100-300 RSV-related deaths in the United States in persons younger than 5 years of age. While premature infants have the highest rates of hospitalization (three times a term infant) about 79% of hospitalized children younger than 2 years have no underlying medical risks.¹ The majority of children will experience RSV as an upper respiratory infection within the first 2 years of life. However, severe disease requiring hospitalization is more likely to occur in premature infants and children younger than 6 months; children younger than 2 with congenital heart disease and/or chronic lung disease; children with severe cystic fibrosis; as well as the immunocompromised child and individuals with neuromuscular disorders that preclude clearing mucous secretions or have difficulty swallowing.

Palivizumab (Synagis), the first monoclonal antibody to prevent RSV in infants was licensed in 1998. Its use was limited to infants meeting specific criteria developed by the American Academy of Pediatrics. Only 5% of infants had access to it. It was a short-acting agent requiring monthly injections, which were very costly ($1,661-$2,584 per dose). Eligible infants could receive up to five injections per season. Several studies proved its use was not cost beneficial.

What are the advantages of nirsevimab? It’s a long-acting monoclonal antibody. Only one dose is required per season. Costs will significantly diminish. It is recommended for all infants younger than 8 months of age born during RSV season. Those children 8-19 months at risk for severe RSV disease can receive it prior to the start of their second RSV season. During RSV season (October 1 to March 31), the initial dose should be administered to newborns just prior to hospital discharge. Older infants and newborns who did not receive it prior to hospital discharge can receive it at their medical home. Newborns should receive it within the first week of life. It is covered by the Vaccine for Children Program. Simultaneous administration with routine childhood immunizations is recommended. Finally, RSV season may vary in tropical areas (Southern Florida, Puerto Rico. etc.) and Alaska. The timing of nirsevimab administration should be based on local RSV activity provided by state and local authorities.

In addition, the FDA approved an RSV vaccine (Abrysvo) for use in adults at least 60 years of age and in pregnant women at 32-36 weeks’ gestation. The latter is administered to prevent lower respiratory tract infection in infants from birth to 6 months. Recommendations have been published for administration in nonpregnant adults. Specific information is forthcoming in terms timing of administration of nirsevimab in infants whose mothers receive Abrysvo.

RSV season is quickly approaching. Detailed recommendations for administration and FAQ questions related to nirsevimab and palivizumab can be found at https://www.aap.org or https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.
 

Influenza

So, what about influenza? Vaccine composition has been tweaked to match the circulating viruses but the recommended age for annual routine administration remains unchanged. All persons at least 6 months of age should be vaccinated. Children between 6 months and 8 years need two doses at least 4 weeks apart when receiving vaccine for the first time. Immunizing everyone in the household is encouraged especially if there are household contacts at risk for developing severe disease, including infants too young to be vaccinated. Keep in mind children may be coinfected with multiple viruses. Adams and colleagues reviewed the prevalence of coinfection of influenza and Sars-CoV-2 in persons younger than 18 years reported to three CDC surveillance platforms during the 2021-2022 season.² Thirty-two of 575 hospitalized (6%) coinfections were analyzed and 7 of 44 (16%) deaths. Compared with patients without coinfections, the coinfected patients were more likely to require mechanical ventilation (13% vs. 4%) or CPAP (16% vs. 6%). Only 4 of 23 who were influenza vaccine eligible were vaccinated. Of seven coinfected children who died, none had received influenza vaccine and only one received an antiviral. Only 5 of 31 (16%) infected only with influenza were vaccinated.³

Influenza activity was lower than usual during the 2021-2022 season. However, this report revealed underuse of both influenza vaccine and antiviral therapy, both of which are routinely recommended.
 

COVID-19

What’s new with COVID-19? On Sept. 12, 2023, ACIP recommended that everyone at least 6 months of age receive the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines. Children at least 5 years of age need one dose and those younger need one or two doses depending on the number of doses previously received. Why the change? Circulating variants continue to change. There is a current uptick in cases including hospitalizations (7.7%) and deaths (4.5%) and it’s just the beginning of the season.⁴ Symptoms, risk groups and complications have not changed. The primary goal is to prevent infection, hospitalization, long term complications, and death.

We are now armed with the most up-to-date interventions to help prevent the acquisition of these three viruses. Our next step is recommending and delivering them to our patients.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She reported no relevant financial disclosures.

References

1.Suh M et al. J Infect Dis. 2022;226(Suppl 2):S154-36. doi: 10.1093/infdis/jiac120.

2. Adams K et al. MMWR Morb Mortal Wkly Rep. 2022;71:1589-96. doi: http://dx.doi.org/10.15585/mmwr.mm7150a4.

3. Pingali C et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72:912-9. doi: http://dx.doi.org/10.15585/mmwr.mm7234a3.

4. CDC Covid Data Tracker.

In July 2023, nirsevimab (Beyfortus), a monoclonal antibody, was approved by the Food and Drug Administration for the prevention of respiratory syncytial virus (RSV) disease in infants and children younger than 2 years of age. On Aug. 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine use of it for all infants younger than 8 months of age born during or entering their first RSV season. Its use is also recommended for certain children 8-19 months of age who are at increased risk for severe RSV disease at the start of their second RSV season. Hearing the approval, I immediately had a flashback to residency, recalling the multiple infants admitted each fall and winter exhibiting classic symptoms including cough, rhinorrhea, nasal flaring, retractions, and wheezing with many having oxygen requirements and others needing intubation. Only supportive care was available.

RSV is the leading cause of infant hospitalizations. Annually, the CDC estimates there are 50,000-80,000 RSV hospitalizations and 100-300 RSV-related deaths in the United States in persons younger than 5 years of age. While premature infants have the highest rates of hospitalization (three times a term infant) about 79% of hospitalized children younger than 2 years have no underlying medical risks.¹ The majority of children will experience RSV as an upper respiratory infection within the first 2 years of life. However, severe disease requiring hospitalization is more likely to occur in premature infants and children younger than 6 months; children younger than 2 with congenital heart disease and/or chronic lung disease; children with severe cystic fibrosis; as well as the immunocompromised child and individuals with neuromuscular disorders that preclude clearing mucous secretions or have difficulty swallowing.

Palivizumab (Synagis), the first monoclonal antibody to prevent RSV in infants was licensed in 1998. Its use was limited to infants meeting specific criteria developed by the American Academy of Pediatrics. Only 5% of infants had access to it. It was a short-acting agent requiring monthly injections, which were very costly ($1,661-$2,584 per dose). Eligible infants could receive up to five injections per season. Several studies proved its use was not cost beneficial.

What are the advantages of nirsevimab? It’s a long-acting monoclonal antibody. Only one dose is required per season. Costs will significantly diminish. It is recommended for all infants younger than 8 months of age born during RSV season. Those children 8-19 months at risk for severe RSV disease can receive it prior to the start of their second RSV season. During RSV season (October 1 to March 31), the initial dose should be administered to newborns just prior to hospital discharge. Older infants and newborns who did not receive it prior to hospital discharge can receive it at their medical home. Newborns should receive it within the first week of life. It is covered by the Vaccine for Children Program. Simultaneous administration with routine childhood immunizations is recommended. Finally, RSV season may vary in tropical areas (Southern Florida, Puerto Rico. etc.) and Alaska. The timing of nirsevimab administration should be based on local RSV activity provided by state and local authorities.

In addition, the FDA approved an RSV vaccine (Abrysvo) for use in adults at least 60 years of age and in pregnant women at 32-36 weeks’ gestation. The latter is administered to prevent lower respiratory tract infection in infants from birth to 6 months. Recommendations have been published for administration in nonpregnant adults. Specific information is forthcoming in terms timing of administration of nirsevimab in infants whose mothers receive Abrysvo.

RSV season is quickly approaching. Detailed recommendations for administration and FAQ questions related to nirsevimab and palivizumab can be found at https://www.aap.org or https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.
 

Influenza

So, what about influenza? Vaccine composition has been tweaked to match the circulating viruses but the recommended age for annual routine administration remains unchanged. All persons at least 6 months of age should be vaccinated. Children between 6 months and 8 years need two doses at least 4 weeks apart when receiving vaccine for the first time. Immunizing everyone in the household is encouraged especially if there are household contacts at risk for developing severe disease, including infants too young to be vaccinated. Keep in mind children may be coinfected with multiple viruses. Adams and colleagues reviewed the prevalence of coinfection of influenza and Sars-CoV-2 in persons younger than 18 years reported to three CDC surveillance platforms during the 2021-2022 season.² Thirty-two of 575 hospitalized (6%) coinfections were analyzed and 7 of 44 (16%) deaths. Compared with patients without coinfections, the coinfected patients were more likely to require mechanical ventilation (13% vs. 4%) or CPAP (16% vs. 6%). Only 4 of 23 who were influenza vaccine eligible were vaccinated. Of seven coinfected children who died, none had received influenza vaccine and only one received an antiviral. Only 5 of 31 (16%) infected only with influenza were vaccinated.³

Influenza activity was lower than usual during the 2021-2022 season. However, this report revealed underuse of both influenza vaccine and antiviral therapy, both of which are routinely recommended.
 

COVID-19

What’s new with COVID-19? On Sept. 12, 2023, ACIP recommended that everyone at least 6 months of age receive the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines. Children at least 5 years of age need one dose and those younger need one or two doses depending on the number of doses previously received. Why the change? Circulating variants continue to change. There is a current uptick in cases including hospitalizations (7.7%) and deaths (4.5%) and it’s just the beginning of the season.⁴ Symptoms, risk groups and complications have not changed. The primary goal is to prevent infection, hospitalization, long term complications, and death.

We are now armed with the most up-to-date interventions to help prevent the acquisition of these three viruses. Our next step is recommending and delivering them to our patients.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She reported no relevant financial disclosures.

References

1.Suh M et al. J Infect Dis. 2022;226(Suppl 2):S154-36. doi: 10.1093/infdis/jiac120.

2. Adams K et al. MMWR Morb Mortal Wkly Rep. 2022;71:1589-96. doi: http://dx.doi.org/10.15585/mmwr.mm7150a4.

3. Pingali C et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72:912-9. doi: http://dx.doi.org/10.15585/mmwr.mm7234a3.

4. CDC Covid Data Tracker.

In July 2023, nirsevimab (Beyfortus), a monoclonal antibody, was approved by the Food and Drug Administration for the prevention of respiratory syncytial virus (RSV) disease in infants and children younger than 2 years of age. On Aug. 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine use of it for all infants younger than 8 months of age born during or entering their first RSV season. Its use is also recommended for certain children 8-19 months of age who are at increased risk for severe RSV disease at the start of their second RSV season. Hearing the approval, I immediately had a flashback to residency, recalling the multiple infants admitted each fall and winter exhibiting classic symptoms including cough, rhinorrhea, nasal flaring, retractions, and wheezing with many having oxygen requirements and others needing intubation. Only supportive care was available.

RSV is the leading cause of infant hospitalizations. Annually, the CDC estimates there are 50,000-80,000 RSV hospitalizations and 100-300 RSV-related deaths in the United States in persons younger than 5 years of age. While premature infants have the highest rates of hospitalization (three times a term infant) about 79% of hospitalized children younger than 2 years have no underlying medical risks.¹ The majority of children will experience RSV as an upper respiratory infection within the first 2 years of life. However, severe disease requiring hospitalization is more likely to occur in premature infants and children younger than 6 months; children younger than 2 with congenital heart disease and/or chronic lung disease; children with severe cystic fibrosis; as well as the immunocompromised child and individuals with neuromuscular disorders that preclude clearing mucous secretions or have difficulty swallowing.

Palivizumab (Synagis), the first monoclonal antibody to prevent RSV in infants was licensed in 1998. Its use was limited to infants meeting specific criteria developed by the American Academy of Pediatrics. Only 5% of infants had access to it. It was a short-acting agent requiring monthly injections, which were very costly ($1,661-$2,584 per dose). Eligible infants could receive up to five injections per season. Several studies proved its use was not cost beneficial.

What are the advantages of nirsevimab? It’s a long-acting monoclonal antibody. Only one dose is required per season. Costs will significantly diminish. It is recommended for all infants younger than 8 months of age born during RSV season. Those children 8-19 months at risk for severe RSV disease can receive it prior to the start of their second RSV season. During RSV season (October 1 to March 31), the initial dose should be administered to newborns just prior to hospital discharge. Older infants and newborns who did not receive it prior to hospital discharge can receive it at their medical home. Newborns should receive it within the first week of life. It is covered by the Vaccine for Children Program. Simultaneous administration with routine childhood immunizations is recommended. Finally, RSV season may vary in tropical areas (Southern Florida, Puerto Rico. etc.) and Alaska. The timing of nirsevimab administration should be based on local RSV activity provided by state and local authorities.

In addition, the FDA approved an RSV vaccine (Abrysvo) for use in adults at least 60 years of age and in pregnant women at 32-36 weeks’ gestation. The latter is administered to prevent lower respiratory tract infection in infants from birth to 6 months. Recommendations have been published for administration in nonpregnant adults. Specific information is forthcoming in terms timing of administration of nirsevimab in infants whose mothers receive Abrysvo.

RSV season is quickly approaching. Detailed recommendations for administration and FAQ questions related to nirsevimab and palivizumab can be found at https://www.aap.org or https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.
 

Influenza

So, what about influenza? Vaccine composition has been tweaked to match the circulating viruses but the recommended age for annual routine administration remains unchanged. All persons at least 6 months of age should be vaccinated. Children between 6 months and 8 years need two doses at least 4 weeks apart when receiving vaccine for the first time. Immunizing everyone in the household is encouraged especially if there are household contacts at risk for developing severe disease, including infants too young to be vaccinated. Keep in mind children may be coinfected with multiple viruses. Adams and colleagues reviewed the prevalence of coinfection of influenza and Sars-CoV-2 in persons younger than 18 years reported to three CDC surveillance platforms during the 2021-2022 season.² Thirty-two of 575 hospitalized (6%) coinfections were analyzed and 7 of 44 (16%) deaths. Compared with patients without coinfections, the coinfected patients were more likely to require mechanical ventilation (13% vs. 4%) or CPAP (16% vs. 6%). Only 4 of 23 who were influenza vaccine eligible were vaccinated. Of seven coinfected children who died, none had received influenza vaccine and only one received an antiviral. Only 5 of 31 (16%) infected only with influenza were vaccinated.³

Influenza activity was lower than usual during the 2021-2022 season. However, this report revealed underuse of both influenza vaccine and antiviral therapy, both of which are routinely recommended.
 

COVID-19

What’s new with COVID-19? On Sept. 12, 2023, ACIP recommended that everyone at least 6 months of age receive the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines. Children at least 5 years of age need one dose and those younger need one or two doses depending on the number of doses previously received. Why the change? Circulating variants continue to change. There is a current uptick in cases including hospitalizations (7.7%) and deaths (4.5%) and it’s just the beginning of the season.⁴ Symptoms, risk groups and complications have not changed. The primary goal is to prevent infection, hospitalization, long term complications, and death.

We are now armed with the most up-to-date interventions to help prevent the acquisition of these three viruses. Our next step is recommending and delivering them to our patients.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She reported no relevant financial disclosures.

References

1.Suh M et al. J Infect Dis. 2022;226(Suppl 2):S154-36. doi: 10.1093/infdis/jiac120.

2. Adams K et al. MMWR Morb Mortal Wkly Rep. 2022;71:1589-96. doi: http://dx.doi.org/10.15585/mmwr.mm7150a4.

3. Pingali C et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72:912-9. doi: http://dx.doi.org/10.15585/mmwr.mm7234a3.

4. CDC Covid Data Tracker.

TOPLINE:

A new study finds SARS-CoV-2 directly infects the coronary vasculature and causes plaque inflammation, which could help explain why people with COVID-19 have an increased risk for ischemic cardiovascular complications up to 1 year after infection.

METHODOLOGY:

• Researchers obtained 27 coronary autopsy specimens from eight patients who died from COVID-19, mean age 70 years and 75% male. All had coronary artery disease and most had cardiovascular risk factors such as hypertension, were overweight or obese, and had hyperlipidemia and type 2 diabetes.
• All but one patient, who was pronounced dead before hospital admission, were hospitalized for an average of 17.6 days.
• To identify SARS-CoV-2 viral RNA (vRNA) in the autoptic coronary vasculature, researchers performed RNA fluorescence in situ hybridization (RNA-FISH) analysis for the vRNA encoding the spike (S) protein; they also probed the antisense strand of the S gene (S antisense), which is only produced during viral replication.

TAKEAWAY:

• The study found evidence of SARS-CoV-2 replication in all analyzed human autopsy coronaries regardless of their pathological classification, although viral replication was highest in early-stage lesions that progress to more advanced atherosclerotic plaques.
• Findings indicated that more than 79% of macrophages (white blood cells that help remove lipids) and more than 90% of foam cells (lipid-laden macrophages that are a hallmark of atherosclerosis at all stages of the disease) are S+, and more than 40% of both cell types are S antisense+, indicating SARS-CoV-2 can infect macrophages at a high rate.
• SARS-CoV-2 induced a strong inflammatory response as evidenced by release of cytokines (including interleukin-1 beta and interluekin-6 that are linked to myocardial infarction) in both macrophages and foam cells, which may contribute to the ischemic cardiovascular complications in patients with COVID-19.

IN PRACTICE:

“Our data conclusively demonstrate that SARS-CoV-2 is capable of infecting and replicating in macrophages within the coronary vasculature of patients with COVID-19,” write the authors, adding that SARS-CoV-2 preferentially replicates in foam cells, compared with other macrophages, suggesting these cells “might act as a reservoir of SARS-CoV-2 viral debris in the atherosclerotic plaque.”

SOURCE:

The study was led by Natalia Eberhardt, PhD, postdoctoral fellow, department of medicine, division of cardiology, New York University, and colleagues. It was published online in Nature Cardiovascular Research.

LIMITATIONS:

Findings are relevant only to the original strains of SARS-CoV-2 that circulated in New York between May 2020 and May 2021, and are not generalizable to patients younger and healthier than those from whom samples were obtained for the study.

DISCLOSURES:

The study received support from the National Institutes of Health. The authors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study finds SARS-CoV-2 directly infects the coronary vasculature and causes plaque inflammation, which could help explain why people with COVID-19 have an increased risk for ischemic cardiovascular complications up to 1 year after infection.

METHODOLOGY:

• Researchers obtained 27 coronary autopsy specimens from eight patients who died from COVID-19, mean age 70 years and 75% male. All had coronary artery disease and most had cardiovascular risk factors such as hypertension, were overweight or obese, and had hyperlipidemia and type 2 diabetes.
• All but one patient, who was pronounced dead before hospital admission, were hospitalized for an average of 17.6 days.
• To identify SARS-CoV-2 viral RNA (vRNA) in the autoptic coronary vasculature, researchers performed RNA fluorescence in situ hybridization (RNA-FISH) analysis for the vRNA encoding the spike (S) protein; they also probed the antisense strand of the S gene (S antisense), which is only produced during viral replication.

TAKEAWAY:

• The study found evidence of SARS-CoV-2 replication in all analyzed human autopsy coronaries regardless of their pathological classification, although viral replication was highest in early-stage lesions that progress to more advanced atherosclerotic plaques.
• Findings indicated that more than 79% of macrophages (white blood cells that help remove lipids) and more than 90% of foam cells (lipid-laden macrophages that are a hallmark of atherosclerosis at all stages of the disease) are S+, and more than 40% of both cell types are S antisense+, indicating SARS-CoV-2 can infect macrophages at a high rate.
• SARS-CoV-2 induced a strong inflammatory response as evidenced by release of cytokines (including interleukin-1 beta and interluekin-6 that are linked to myocardial infarction) in both macrophages and foam cells, which may contribute to the ischemic cardiovascular complications in patients with COVID-19.

IN PRACTICE:

“Our data conclusively demonstrate that SARS-CoV-2 is capable of infecting and replicating in macrophages within the coronary vasculature of patients with COVID-19,” write the authors, adding that SARS-CoV-2 preferentially replicates in foam cells, compared with other macrophages, suggesting these cells “might act as a reservoir of SARS-CoV-2 viral debris in the atherosclerotic plaque.”

SOURCE:

The study was led by Natalia Eberhardt, PhD, postdoctoral fellow, department of medicine, division of cardiology, New York University, and colleagues. It was published online in Nature Cardiovascular Research.

LIMITATIONS:

Findings are relevant only to the original strains of SARS-CoV-2 that circulated in New York between May 2020 and May 2021, and are not generalizable to patients younger and healthier than those from whom samples were obtained for the study.

DISCLOSURES:

The study received support from the National Institutes of Health. The authors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study finds SARS-CoV-2 directly infects the coronary vasculature and causes plaque inflammation, which could help explain why people with COVID-19 have an increased risk for ischemic cardiovascular complications up to 1 year after infection.

METHODOLOGY:

• Researchers obtained 27 coronary autopsy specimens from eight patients who died from COVID-19, mean age 70 years and 75% male. All had coronary artery disease and most had cardiovascular risk factors such as hypertension, were overweight or obese, and had hyperlipidemia and type 2 diabetes.
• All but one patient, who was pronounced dead before hospital admission, were hospitalized for an average of 17.6 days.
• To identify SARS-CoV-2 viral RNA (vRNA) in the autoptic coronary vasculature, researchers performed RNA fluorescence in situ hybridization (RNA-FISH) analysis for the vRNA encoding the spike (S) protein; they also probed the antisense strand of the S gene (S antisense), which is only produced during viral replication.

TAKEAWAY:

• The study found evidence of SARS-CoV-2 replication in all analyzed human autopsy coronaries regardless of their pathological classification, although viral replication was highest in early-stage lesions that progress to more advanced atherosclerotic plaques.
• Findings indicated that more than 79% of macrophages (white blood cells that help remove lipids) and more than 90% of foam cells (lipid-laden macrophages that are a hallmark of atherosclerosis at all stages of the disease) are S+, and more than 40% of both cell types are S antisense+, indicating SARS-CoV-2 can infect macrophages at a high rate.
• SARS-CoV-2 induced a strong inflammatory response as evidenced by release of cytokines (including interleukin-1 beta and interluekin-6 that are linked to myocardial infarction) in both macrophages and foam cells, which may contribute to the ischemic cardiovascular complications in patients with COVID-19.

IN PRACTICE:

“Our data conclusively demonstrate that SARS-CoV-2 is capable of infecting and replicating in macrophages within the coronary vasculature of patients with COVID-19,” write the authors, adding that SARS-CoV-2 preferentially replicates in foam cells, compared with other macrophages, suggesting these cells “might act as a reservoir of SARS-CoV-2 viral debris in the atherosclerotic plaque.”

SOURCE:

The study was led by Natalia Eberhardt, PhD, postdoctoral fellow, department of medicine, division of cardiology, New York University, and colleagues. It was published online in Nature Cardiovascular Research.

LIMITATIONS:

Findings are relevant only to the original strains of SARS-CoV-2 that circulated in New York between May 2020 and May 2021, and are not generalizable to patients younger and healthier than those from whom samples were obtained for the study.

DISCLOSURES:

The study received support from the National Institutes of Health. The authors report no relevant financial relationships.

A version of this article appeared on Medscape.com.