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In Case You Missed It: COVID
Understanding, Diagnosing, and Treating Long COVID
As the pandemic wanes, the public is clamoring for a return to normal. But individuals with long COVID face a challenging journey to get back to their baseline. Here’s what clinicians need to know to help patients with long COVID.
The COVID-19 pandemic is waning. The official federal public health emergency ended on May 11, 2023. Moreover, the public is ready to move on 3 years after the beginning of a pandemic that resulted in over a million deaths in the United States.
But not everyone can go back to normal. The Centers for Disease Control and Prevention (CDC) estimates that 1 in 13 US adults (7.5%) have long COVID symptoms. Many of these people feel as if they are the forgotten patients. While everyone else is moving on, a significant number of people have not returned to their baseline.
A group from Yale School of Medicine, myself included, reviewed a number of studies to gain a better understanding of 1) how long COVID manifests and 2) potential treatment options. Highlights of our evaluation are presented here.
Long COVID: The Basics
What exactly is long COVID-19, and how is it thought to develop?
The World Health Organization (WHO) defines long COVID as symptoms that persist 3 months postinfection, last for ≥ 2 months, and are not attributable to another cause.
Hypotheses about the mechanisms of long COVID include the presence of a persistent viral reservoir, an imbalance in the viral and microbial ecosystems, reactivation of latent DNA viruses, and endothelial dysfunction.
Who is most at risk?
Females
Older individuals
Individuals with preexisting conditions, including hypertension, diabetes, obesity, and lung disease
Individuals who experienced > 5 symptoms within the first week of COVID-19 illness
Individuals with breakthrough infections after vaccination against COVID-19 appear to be at increased risk of at least 1 postacute condition
Additionally, as the risk of contracting COVID-19 is demonstrably higher in certain racial and ethnic populations, it stands to reason that more of these individuals will experience long COVID.
Long COVID symptoms: how long is long?
Long COVID symptoms may persist for 2 years after initial infection. One analysis from China showed that nearly 7 in 10 patients experienced at least 1 ongoing symptom 6 months following infection, with more than half reporting symptoms at 24 months. Dyspnea, anxiety, and depression are especially persistent.
In another analysis, 90% of individuals reported symptoms 35 weeks postinfection. Symptoms did not only occur in people who were hospitalized; they also occurred in people who had a “mild case.”
Clinical Manifestations of Long COVID
More than 50 symptoms have been identified as potentially associated with long COVID. The most common manifestations involve pulmonary, cardiac, and neuropsychiatric sequelae. There is no single test to determine if symptoms are due to long COVID.
Pulmonary
How it manifests
Chronic cough
Shortness of breath
Interstitial lung disease
Treatment options
Treatment options are variable and depend on predominant symptoms. Chronic cough should be managed based on primary etiology. Treatment for interstitial lung disease depends on whether the process continues to evolve or stabilizes. The role of antifibrotics in these patients is being investigated. Lung transplantation has largely been reserved for unresolved acute injury.
Cardiac
How it manifests
Postacute sequelae cardiovascular disease, where cardiovascular disorders are uncovered during diagnostic testing
Postacute sequelae cardiovascular syndrome, such as exercise intolerance, tachycardia and chest pain, and dyspnea
Other important considerations:
Cardiac symptoms can occur independent of preexisting conditions, severity, course of acute illness, and time from original diagnosis
Cardiac involvement can occur in any age group
One analysis revealed increased risk of stroke, arrythmias, pericarditis, myocarditis, and ischemic heart disease 1 year after COVID-19 infection
Postural orthostatic tachycardia syndrome (POTS) and neurogenic orthostatic hypotension have also been observed
Treatment options
Treatment options are dictated by clinical manifestations and course. Patients who have autonomic dysfunction can be advised to increase salt and water intake since hypovolemia can worsen symptoms. Consider fludrocortisone and midodrine along with recumbent and semirecumbent exercises as tolerated, as exercise can sometimes worsen symptoms.
Neuropsychiatric
How it manifests
Patients can present with fatigue, memory disorders, headache, vertigo, myalgia, neuropathy, and smell and taste disorders, and there have been reports of cognitive decline postinfection.
Other important considerations:
A retrospective cohort study revealed that 34% of individuals had a new neurological or psychiatric diagnosis in the first 6 months after infection, including intracranial hemorrhage, ischemic stroke, parkinsonism, and dementia. Many COVID survivors experienced critical illness requiring mechanical ventilation, sedation, and paralytics, increasing the odds of developing postintensive care syndrome
Treatment options
Use of standard of care treatments, as well as neurocognitive rehabilitation and psychosocial support, is recommended for specific neuropsychiatric conditions. Patients with headache may benefit from treatment with amitriptyline or similar medications. Olfactory training and intranasal treatments can benefit those with loss of smell.
Future Directions
Two medications that may hold promise for treating individuals long COVID symptoms are currently undergoing early investigation.
Pyridostigmine may help improve peak exercise capacity
Pyridostigmine improved peak exercise oxygen uptake in patients with chronic fatigue syndrome in a randomized, double-blind, placebo-controlled trial involving 45 individuals. Participants were assigned to receive either pyridostigmine 60 mg orally or placebo, and the pyridostigmine group showed an improved peak exercise uptake via increased cardiac output and right ventricular filling pressures.
An investigational compound may improve fatigue-based symptoms
A 4-week protocol using the compound AXA1125 improved fatigue-based symptoms in patients with long COVID in a double-blind, randomized, controlled phase 2a pilot study involving 41 individuals. Investigators looked at average change in postexertional skeletal muscle phosphocreatine (PCr) recovery rate from baseline to day 28 after moderate exercise as well as fatigue levels. Although PCr recovery rate did not differ significantly between groups, use of the compound was linked with significant reduction in fatigue-based symptoms.
Summary
It is important to exercise caution when interpreting data involving individuals with long COVID. Most studies to date are retrospective and observational, definitions and assessments are not yet standardized, and long-term follow-up is lacking, among other factors.
Clinicians should remain vigilant, keeping the following in mind as they see patients who may be experiencing long COVID:
Those most at risk include females, older individuals, those with obesity, people with preexisting conditions, individuals who experienced multiple symptoms early in their COVID-19 illness, and those who had breakthrough infections after COVID-19 vaccination
Symptoms may persist up to 2 years after acute infection
The most common manifestations of long COVID involve pulmonary, cardiac, and neuropsychiatric complications
Two medications, pyridostigmine and the compound AXA1125, are under investigation and may hold promise in treating some symptoms
As the pandemic wanes, the public is clamoring for a return to normal. But individuals with long COVID face a challenging journey to get back to their baseline. Here’s what clinicians need to know to help patients with long COVID.
The COVID-19 pandemic is waning. The official federal public health emergency ended on May 11, 2023. Moreover, the public is ready to move on 3 years after the beginning of a pandemic that resulted in over a million deaths in the United States.
But not everyone can go back to normal. The Centers for Disease Control and Prevention (CDC) estimates that 1 in 13 US adults (7.5%) have long COVID symptoms. Many of these people feel as if they are the forgotten patients. While everyone else is moving on, a significant number of people have not returned to their baseline.
A group from Yale School of Medicine, myself included, reviewed a number of studies to gain a better understanding of 1) how long COVID manifests and 2) potential treatment options. Highlights of our evaluation are presented here.
Long COVID: The Basics
What exactly is long COVID-19, and how is it thought to develop?
The World Health Organization (WHO) defines long COVID as symptoms that persist 3 months postinfection, last for ≥ 2 months, and are not attributable to another cause.
Hypotheses about the mechanisms of long COVID include the presence of a persistent viral reservoir, an imbalance in the viral and microbial ecosystems, reactivation of latent DNA viruses, and endothelial dysfunction.
Who is most at risk?
Females
Older individuals
Individuals with preexisting conditions, including hypertension, diabetes, obesity, and lung disease
Individuals who experienced > 5 symptoms within the first week of COVID-19 illness
Individuals with breakthrough infections after vaccination against COVID-19 appear to be at increased risk of at least 1 postacute condition
Additionally, as the risk of contracting COVID-19 is demonstrably higher in certain racial and ethnic populations, it stands to reason that more of these individuals will experience long COVID.
Long COVID symptoms: how long is long?
Long COVID symptoms may persist for 2 years after initial infection. One analysis from China showed that nearly 7 in 10 patients experienced at least 1 ongoing symptom 6 months following infection, with more than half reporting symptoms at 24 months. Dyspnea, anxiety, and depression are especially persistent.
In another analysis, 90% of individuals reported symptoms 35 weeks postinfection. Symptoms did not only occur in people who were hospitalized; they also occurred in people who had a “mild case.”
Clinical Manifestations of Long COVID
More than 50 symptoms have been identified as potentially associated with long COVID. The most common manifestations involve pulmonary, cardiac, and neuropsychiatric sequelae. There is no single test to determine if symptoms are due to long COVID.
Pulmonary
How it manifests
Chronic cough
Shortness of breath
Interstitial lung disease
Treatment options
Treatment options are variable and depend on predominant symptoms. Chronic cough should be managed based on primary etiology. Treatment for interstitial lung disease depends on whether the process continues to evolve or stabilizes. The role of antifibrotics in these patients is being investigated. Lung transplantation has largely been reserved for unresolved acute injury.
Cardiac
How it manifests
Postacute sequelae cardiovascular disease, where cardiovascular disorders are uncovered during diagnostic testing
Postacute sequelae cardiovascular syndrome, such as exercise intolerance, tachycardia and chest pain, and dyspnea
Other important considerations:
Cardiac symptoms can occur independent of preexisting conditions, severity, course of acute illness, and time from original diagnosis
Cardiac involvement can occur in any age group
One analysis revealed increased risk of stroke, arrythmias, pericarditis, myocarditis, and ischemic heart disease 1 year after COVID-19 infection
Postural orthostatic tachycardia syndrome (POTS) and neurogenic orthostatic hypotension have also been observed
Treatment options
Treatment options are dictated by clinical manifestations and course. Patients who have autonomic dysfunction can be advised to increase salt and water intake since hypovolemia can worsen symptoms. Consider fludrocortisone and midodrine along with recumbent and semirecumbent exercises as tolerated, as exercise can sometimes worsen symptoms.
Neuropsychiatric
How it manifests
Patients can present with fatigue, memory disorders, headache, vertigo, myalgia, neuropathy, and smell and taste disorders, and there have been reports of cognitive decline postinfection.
Other important considerations:
A retrospective cohort study revealed that 34% of individuals had a new neurological or psychiatric diagnosis in the first 6 months after infection, including intracranial hemorrhage, ischemic stroke, parkinsonism, and dementia. Many COVID survivors experienced critical illness requiring mechanical ventilation, sedation, and paralytics, increasing the odds of developing postintensive care syndrome
Treatment options
Use of standard of care treatments, as well as neurocognitive rehabilitation and psychosocial support, is recommended for specific neuropsychiatric conditions. Patients with headache may benefit from treatment with amitriptyline or similar medications. Olfactory training and intranasal treatments can benefit those with loss of smell.
Future Directions
Two medications that may hold promise for treating individuals long COVID symptoms are currently undergoing early investigation.
Pyridostigmine may help improve peak exercise capacity
Pyridostigmine improved peak exercise oxygen uptake in patients with chronic fatigue syndrome in a randomized, double-blind, placebo-controlled trial involving 45 individuals. Participants were assigned to receive either pyridostigmine 60 mg orally or placebo, and the pyridostigmine group showed an improved peak exercise uptake via increased cardiac output and right ventricular filling pressures.
An investigational compound may improve fatigue-based symptoms
A 4-week protocol using the compound AXA1125 improved fatigue-based symptoms in patients with long COVID in a double-blind, randomized, controlled phase 2a pilot study involving 41 individuals. Investigators looked at average change in postexertional skeletal muscle phosphocreatine (PCr) recovery rate from baseline to day 28 after moderate exercise as well as fatigue levels. Although PCr recovery rate did not differ significantly between groups, use of the compound was linked with significant reduction in fatigue-based symptoms.
Summary
It is important to exercise caution when interpreting data involving individuals with long COVID. Most studies to date are retrospective and observational, definitions and assessments are not yet standardized, and long-term follow-up is lacking, among other factors.
Clinicians should remain vigilant, keeping the following in mind as they see patients who may be experiencing long COVID:
Those most at risk include females, older individuals, those with obesity, people with preexisting conditions, individuals who experienced multiple symptoms early in their COVID-19 illness, and those who had breakthrough infections after COVID-19 vaccination
Symptoms may persist up to 2 years after acute infection
The most common manifestations of long COVID involve pulmonary, cardiac, and neuropsychiatric complications
Two medications, pyridostigmine and the compound AXA1125, are under investigation and may hold promise in treating some symptoms
As the pandemic wanes, the public is clamoring for a return to normal. But individuals with long COVID face a challenging journey to get back to their baseline. Here’s what clinicians need to know to help patients with long COVID.
The COVID-19 pandemic is waning. The official federal public health emergency ended on May 11, 2023. Moreover, the public is ready to move on 3 years after the beginning of a pandemic that resulted in over a million deaths in the United States.
But not everyone can go back to normal. The Centers for Disease Control and Prevention (CDC) estimates that 1 in 13 US adults (7.5%) have long COVID symptoms. Many of these people feel as if they are the forgotten patients. While everyone else is moving on, a significant number of people have not returned to their baseline.
A group from Yale School of Medicine, myself included, reviewed a number of studies to gain a better understanding of 1) how long COVID manifests and 2) potential treatment options. Highlights of our evaluation are presented here.
Long COVID: The Basics
What exactly is long COVID-19, and how is it thought to develop?
The World Health Organization (WHO) defines long COVID as symptoms that persist 3 months postinfection, last for ≥ 2 months, and are not attributable to another cause.
Hypotheses about the mechanisms of long COVID include the presence of a persistent viral reservoir, an imbalance in the viral and microbial ecosystems, reactivation of latent DNA viruses, and endothelial dysfunction.
Who is most at risk?
Females
Older individuals
Individuals with preexisting conditions, including hypertension, diabetes, obesity, and lung disease
Individuals who experienced > 5 symptoms within the first week of COVID-19 illness
Individuals with breakthrough infections after vaccination against COVID-19 appear to be at increased risk of at least 1 postacute condition
Additionally, as the risk of contracting COVID-19 is demonstrably higher in certain racial and ethnic populations, it stands to reason that more of these individuals will experience long COVID.
Long COVID symptoms: how long is long?
Long COVID symptoms may persist for 2 years after initial infection. One analysis from China showed that nearly 7 in 10 patients experienced at least 1 ongoing symptom 6 months following infection, with more than half reporting symptoms at 24 months. Dyspnea, anxiety, and depression are especially persistent.
In another analysis, 90% of individuals reported symptoms 35 weeks postinfection. Symptoms did not only occur in people who were hospitalized; they also occurred in people who had a “mild case.”
Clinical Manifestations of Long COVID
More than 50 symptoms have been identified as potentially associated with long COVID. The most common manifestations involve pulmonary, cardiac, and neuropsychiatric sequelae. There is no single test to determine if symptoms are due to long COVID.
Pulmonary
How it manifests
Chronic cough
Shortness of breath
Interstitial lung disease
Treatment options
Treatment options are variable and depend on predominant symptoms. Chronic cough should be managed based on primary etiology. Treatment for interstitial lung disease depends on whether the process continues to evolve or stabilizes. The role of antifibrotics in these patients is being investigated. Lung transplantation has largely been reserved for unresolved acute injury.
Cardiac
How it manifests
Postacute sequelae cardiovascular disease, where cardiovascular disorders are uncovered during diagnostic testing
Postacute sequelae cardiovascular syndrome, such as exercise intolerance, tachycardia and chest pain, and dyspnea
Other important considerations:
Cardiac symptoms can occur independent of preexisting conditions, severity, course of acute illness, and time from original diagnosis
Cardiac involvement can occur in any age group
One analysis revealed increased risk of stroke, arrythmias, pericarditis, myocarditis, and ischemic heart disease 1 year after COVID-19 infection
Postural orthostatic tachycardia syndrome (POTS) and neurogenic orthostatic hypotension have also been observed
Treatment options
Treatment options are dictated by clinical manifestations and course. Patients who have autonomic dysfunction can be advised to increase salt and water intake since hypovolemia can worsen symptoms. Consider fludrocortisone and midodrine along with recumbent and semirecumbent exercises as tolerated, as exercise can sometimes worsen symptoms.
Neuropsychiatric
How it manifests
Patients can present with fatigue, memory disorders, headache, vertigo, myalgia, neuropathy, and smell and taste disorders, and there have been reports of cognitive decline postinfection.
Other important considerations:
A retrospective cohort study revealed that 34% of individuals had a new neurological or psychiatric diagnosis in the first 6 months after infection, including intracranial hemorrhage, ischemic stroke, parkinsonism, and dementia. Many COVID survivors experienced critical illness requiring mechanical ventilation, sedation, and paralytics, increasing the odds of developing postintensive care syndrome
Treatment options
Use of standard of care treatments, as well as neurocognitive rehabilitation and psychosocial support, is recommended for specific neuropsychiatric conditions. Patients with headache may benefit from treatment with amitriptyline or similar medications. Olfactory training and intranasal treatments can benefit those with loss of smell.
Future Directions
Two medications that may hold promise for treating individuals long COVID symptoms are currently undergoing early investigation.
Pyridostigmine may help improve peak exercise capacity
Pyridostigmine improved peak exercise oxygen uptake in patients with chronic fatigue syndrome in a randomized, double-blind, placebo-controlled trial involving 45 individuals. Participants were assigned to receive either pyridostigmine 60 mg orally or placebo, and the pyridostigmine group showed an improved peak exercise uptake via increased cardiac output and right ventricular filling pressures.
An investigational compound may improve fatigue-based symptoms
A 4-week protocol using the compound AXA1125 improved fatigue-based symptoms in patients with long COVID in a double-blind, randomized, controlled phase 2a pilot study involving 41 individuals. Investigators looked at average change in postexertional skeletal muscle phosphocreatine (PCr) recovery rate from baseline to day 28 after moderate exercise as well as fatigue levels. Although PCr recovery rate did not differ significantly between groups, use of the compound was linked with significant reduction in fatigue-based symptoms.
Summary
It is important to exercise caution when interpreting data involving individuals with long COVID. Most studies to date are retrospective and observational, definitions and assessments are not yet standardized, and long-term follow-up is lacking, among other factors.
Clinicians should remain vigilant, keeping the following in mind as they see patients who may be experiencing long COVID:
Those most at risk include females, older individuals, those with obesity, people with preexisting conditions, individuals who experienced multiple symptoms early in their COVID-19 illness, and those who had breakthrough infections after COVID-19 vaccination
Symptoms may persist up to 2 years after acute infection
The most common manifestations of long COVID involve pulmonary, cardiac, and neuropsychiatric complications
Two medications, pyridostigmine and the compound AXA1125, are under investigation and may hold promise in treating some symptoms
Agency issues advisory on mental health symptoms of long COVID
The nine mental health symptoms highlighted in the advisory are fatigue; cognitive impairment, including brain fog; anxiety; depression; obsessive-compulsive disorder; sleep disorders; PTSD; psychotic disorder; and start of a substance use disorder.
The advisory noted that social factors can contribute to the mental health problems for racial and ethnic minorities; people with limited access to health care; people who already have behavioral health conditions and physical disabilities; and people who are lesbian, gay, bisexual, transgender, queer, or intersex.
“Long COVID has a range of burdensome physical symptoms and can take a toll on a person’s mental health. It can be very challenging for a person, whether they are impacted themselves, or they are a caregiver for someone who is affected,” Health and Human Services Secretary Xavier Becerra said in a statement. “This advisory helps to raise awareness, especially among primary care practitioners and clinicians who are often the ones treating patients with long COVID.”
The department says about 10% of people infected with COVID have at least one long COVID symptom. Physical symptoms include dizziness, stomach upset, heart palpitations, issues with sexual desire or capacity, loss of smell or taste, thirst, chronic coughing, chest pain, and abnormal movements.
“We know that people living with long COVID need help today, and providers need help understanding what long COVID is and how to treat it,” Admiral Rachel Levine, MD, assistant secretary for health, said in the statement. “This advisory helps bridge that gap for the behavioral health impacts of long COVID.”
A version of this article first appeared on WebMD.com.
The nine mental health symptoms highlighted in the advisory are fatigue; cognitive impairment, including brain fog; anxiety; depression; obsessive-compulsive disorder; sleep disorders; PTSD; psychotic disorder; and start of a substance use disorder.
The advisory noted that social factors can contribute to the mental health problems for racial and ethnic minorities; people with limited access to health care; people who already have behavioral health conditions and physical disabilities; and people who are lesbian, gay, bisexual, transgender, queer, or intersex.
“Long COVID has a range of burdensome physical symptoms and can take a toll on a person’s mental health. It can be very challenging for a person, whether they are impacted themselves, or they are a caregiver for someone who is affected,” Health and Human Services Secretary Xavier Becerra said in a statement. “This advisory helps to raise awareness, especially among primary care practitioners and clinicians who are often the ones treating patients with long COVID.”
The department says about 10% of people infected with COVID have at least one long COVID symptom. Physical symptoms include dizziness, stomach upset, heart palpitations, issues with sexual desire or capacity, loss of smell or taste, thirst, chronic coughing, chest pain, and abnormal movements.
“We know that people living with long COVID need help today, and providers need help understanding what long COVID is and how to treat it,” Admiral Rachel Levine, MD, assistant secretary for health, said in the statement. “This advisory helps bridge that gap for the behavioral health impacts of long COVID.”
A version of this article first appeared on WebMD.com.
The nine mental health symptoms highlighted in the advisory are fatigue; cognitive impairment, including brain fog; anxiety; depression; obsessive-compulsive disorder; sleep disorders; PTSD; psychotic disorder; and start of a substance use disorder.
The advisory noted that social factors can contribute to the mental health problems for racial and ethnic minorities; people with limited access to health care; people who already have behavioral health conditions and physical disabilities; and people who are lesbian, gay, bisexual, transgender, queer, or intersex.
“Long COVID has a range of burdensome physical symptoms and can take a toll on a person’s mental health. It can be very challenging for a person, whether they are impacted themselves, or they are a caregiver for someone who is affected,” Health and Human Services Secretary Xavier Becerra said in a statement. “This advisory helps to raise awareness, especially among primary care practitioners and clinicians who are often the ones treating patients with long COVID.”
The department says about 10% of people infected with COVID have at least one long COVID symptom. Physical symptoms include dizziness, stomach upset, heart palpitations, issues with sexual desire or capacity, loss of smell or taste, thirst, chronic coughing, chest pain, and abnormal movements.
“We know that people living with long COVID need help today, and providers need help understanding what long COVID is and how to treat it,” Admiral Rachel Levine, MD, assistant secretary for health, said in the statement. “This advisory helps bridge that gap for the behavioral health impacts of long COVID.”
A version of this article first appeared on WebMD.com.
International rights group calls out United States for allowing hospitals to push millions into debt
Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.
In a new report, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients’ human rights.
“Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working,” concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.
The report continues: “The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abusive medical billing and debt collection practices and undermines human rights, including the right to health.”
Nationwide, about 100 million people – or 41% of adults – have some form of health care debt, a KFF survey conducted for the KFF Health News–NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.
About a third of U.S. adults with health care debt owed money for hospitalization, KFF’s polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.
The scale of this crisis – which is unparalleled among wealthy nations – compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. “Historically, Human Rights Watch has been an organization that has focused on international human rights issues,” he said. “But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights.”
Hospital industry officials defend their work, citing hospitals’ broader work to help the communities they serve. “As a field, hospitals provide more benefit to their communities than any other sector in health care,” Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.
Federal law requires private, tax-exempt hospitals – which make up more than half the nation’s medical centers – to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.
At the same time, thousands of medical centers – including many tax-exempt ones – engage in aggressive debt collection tactics to pursue patients, including garnishing patients’ wages, placing liens on their homes, or selling their debt to third-party debt collectors.
Overall, KFF Health News found that most of the nation’s approximately 5,100 hospitals serving the general public have policies to use legal action or other aggressive tactics against patients. And one in five will deny nonemergency care to people with outstanding debt.
“Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax status as they pursue families for medical debt,” said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients’ homes.
Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.
The Human Rights Watch report – titled “In Sheep’s Clothing: United States’ Poorly Regulated Nonprofit Hospitals Undermine Health Care Access” – lists more than a dozen recommendations. These include:
- Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
- The IRS should set uniform national standards on patients’ eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
- The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
- The federal Centers for Medicare & Medicaid Services, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.
“Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices,” Mr. McConnell said. “The reason this keeps happening is the absence of clear guidelines and the federal government’s inadequate enforcement of existing regulations.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.
Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.
In a new report, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients’ human rights.
“Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working,” concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.
The report continues: “The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abusive medical billing and debt collection practices and undermines human rights, including the right to health.”
Nationwide, about 100 million people – or 41% of adults – have some form of health care debt, a KFF survey conducted for the KFF Health News–NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.
About a third of U.S. adults with health care debt owed money for hospitalization, KFF’s polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.
The scale of this crisis – which is unparalleled among wealthy nations – compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. “Historically, Human Rights Watch has been an organization that has focused on international human rights issues,” he said. “But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights.”
Hospital industry officials defend their work, citing hospitals’ broader work to help the communities they serve. “As a field, hospitals provide more benefit to their communities than any other sector in health care,” Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.
Federal law requires private, tax-exempt hospitals – which make up more than half the nation’s medical centers – to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.
At the same time, thousands of medical centers – including many tax-exempt ones – engage in aggressive debt collection tactics to pursue patients, including garnishing patients’ wages, placing liens on their homes, or selling their debt to third-party debt collectors.
Overall, KFF Health News found that most of the nation’s approximately 5,100 hospitals serving the general public have policies to use legal action or other aggressive tactics against patients. And one in five will deny nonemergency care to people with outstanding debt.
“Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax status as they pursue families for medical debt,” said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients’ homes.
Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.
The Human Rights Watch report – titled “In Sheep’s Clothing: United States’ Poorly Regulated Nonprofit Hospitals Undermine Health Care Access” – lists more than a dozen recommendations. These include:
- Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
- The IRS should set uniform national standards on patients’ eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
- The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
- The federal Centers for Medicare & Medicaid Services, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.
“Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices,” Mr. McConnell said. “The reason this keeps happening is the absence of clear guidelines and the federal government’s inadequate enforcement of existing regulations.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.
Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.
In a new report, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients’ human rights.
“Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working,” concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.
The report continues: “The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abusive medical billing and debt collection practices and undermines human rights, including the right to health.”
Nationwide, about 100 million people – or 41% of adults – have some form of health care debt, a KFF survey conducted for the KFF Health News–NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.
About a third of U.S. adults with health care debt owed money for hospitalization, KFF’s polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.
The scale of this crisis – which is unparalleled among wealthy nations – compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. “Historically, Human Rights Watch has been an organization that has focused on international human rights issues,” he said. “But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights.”
Hospital industry officials defend their work, citing hospitals’ broader work to help the communities they serve. “As a field, hospitals provide more benefit to their communities than any other sector in health care,” Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.
Federal law requires private, tax-exempt hospitals – which make up more than half the nation’s medical centers – to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.
At the same time, thousands of medical centers – including many tax-exempt ones – engage in aggressive debt collection tactics to pursue patients, including garnishing patients’ wages, placing liens on their homes, or selling their debt to third-party debt collectors.
Overall, KFF Health News found that most of the nation’s approximately 5,100 hospitals serving the general public have policies to use legal action or other aggressive tactics against patients. And one in five will deny nonemergency care to people with outstanding debt.
“Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax status as they pursue families for medical debt,” said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients’ homes.
Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.
The Human Rights Watch report – titled “In Sheep’s Clothing: United States’ Poorly Regulated Nonprofit Hospitals Undermine Health Care Access” – lists more than a dozen recommendations. These include:
- Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
- The IRS should set uniform national standards on patients’ eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
- The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
- The federal Centers for Medicare & Medicaid Services, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.
“Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices,” Mr. McConnell said. “The reason this keeps happening is the absence of clear guidelines and the federal government’s inadequate enforcement of existing regulations.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.
Patients with post-COVID cognitive symptoms may have gliosis
In a case-control study of 40 patients who were treated at a tertiary care psychiatric hospital in Canada, the level of translocator protein total distribution volume (TSPO VT), a marker of gliosis, was 9.23 mL/cm3 among patients with COVID-DC and 7.72 mL/cm3 among control persons. Differences were particularly notable in the ventral striatum and dorsal putamen.
“Most theories assume there is inflammation in the brain [with] long COVID,” but that assumption had not been studied, author Jeffrey H. Meyer, MD, PhD, Canada Research Chair in Neurochemistry of Major Depressive Disorder at the University of Toronto, said in an interview. “Such information is pivotal to developing treatments.”
The study was published online in JAMA Psychiatry.
Quantifiable marker
The investigators sought to determine whether levels of TSPO VT, which are quantifiable with PET, are elevated in the dorsal putamen, ventral striatum, prefrontal cortex, anterior cingulate cortex, and hippocampus of patients with COVID-DC, compared with patients without this syndrome. These brain regions were chosen, according to the authors, “because injury in these regions, which can cause gliosis, also induces symptoms of COVID-DC.”
The study was conducted from April 2021 through June 30, 2022. The investigators compared levels of TSPO VT in the selected brain regions of 20 participants with COVID-DC (mean age, 32.7 years; 60% women) with that of 20 control persons (mean age, 33.3 years; 55% women). TSPO VT was measured with fluorine F18–labeled N-(2-(2-fluoroethoxy)benzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET.
The difference in TSPO VT was most noticeable in the ventral striatum (mean difference, 1.97 mL/cm3) and dorsal putamen (mean difference, 1.70 mL/cm3). The study authors suggest that gliosis in these areas may explain some of the persistent symptoms reported in structured clinical interviews and assessed on neuropsychological and psychological testing.
For patients with COVID-DC, motor speed on the finger-tapping test was negatively associated with dorsal putamen TSPO VT (r, −0.53). The 10 participants with COVID-DC whose speed was lowest had higher mean dorsal putamen TSPO VT levels than those of control persons by 2.3 mL/cm3.
The investigators could not assess a possible association between the ventral striatum TSPO VT and anhedonia because all participants had these symptoms. No significant correlations were found between depression and TSPO VT in the prefrontal cortex or anterior cingulate cortex.
The authors acknowledged that the study was cross-sectional, and so the duration of persistently elevated TSPO VT is not yet known. In addition, elevation in TSPO VT is not completely specific to glial cells, and although correlations with finger-tapping test performance reflect associations between brain changes and symptoms, they do not prove cause and effect.
“Presently, clinicians can use treatments for symptoms in other illnesses that are [also] common with long COVID. We need better than this,” said Dr. Meyer. “Clients with long COVID should be able to state their symptoms, and the practitioner should have an evidence-based matching treatment to recommend.”
Research is ongoing. “We are acquiring more information regarding different types of inflammation in the brain, whether there is ongoing injury, and whether treatments that influence inflammation are helpful,” said Dr. Meyer.
Jigsaw puzzle
“While this is an important piece in the jigsaw puzzle of neuroinflammation in chronic neurological disease, it is important to keep in mind that we still lack understanding of the complex picture for several reasons,” Alexander Gerhard, MD, honorary senior lecturer in neuroscience at the University of Manchester, England, wrote in an accompanying editorial.
Among these reasons is that the PET technique used in the study is noisy and not restricted to glial cells, he wrote. TSPO expression is only one part of the brain’s neuroinflammatory response, but PET techniques “do not currently allow us to distinguish between different states of microglial activation.” In addition, “a much more detailed understanding of microglial activation at different time points” is needed before neuroinflammatory changes can be targeted therapeutically, Dr. Gerhard wrote.
In a comment, Vilma Gabbay, MD, professor of psychiatry and neuroscience and director of biomarkers and dimensional psychiatry in the Psychiatry Research Institute at Montefiore Einstein, Albert Einstein College of Medicine, New York, said that “this is an important initial step to better understand the neuropsychiatric consequences of COVID even in only a mild and moderate viral illness.” TSPO imaging through PET scanning has been used as an index for neuroinflammation and gliosis. Researchers have used it to study neurodegenerative diseases, but as the authors noted, the ligand is not specific for gliosis.
“Follow-up large cohort studies including other measures of neuroimaging modalities assessing circuitry and neurochemistry are needed,” she said. “Similarly, studying the blood-brain barrier will also allow us to better understand how the immune reaction in the blood transitions to the brain.”
This field of research is evolving, and clinical trials are ongoing, Dr. Gabbay added. Meanwhile, clinicians should monitor for, assess, and treat neuropsychiatric symptoms and “follow the literature for new research and management recommendations.”
The study was primarily funded by a Canadian Institutes of Health Research Project grant to the authors, with some funding from the Canadian Institute for Military and Veteran Health Research. Dr. Meyer received support from their Canada Research Chair awards and received grants and support from several pharmaceutical companies outside of the submitted work. Dr. Gerhard and Dr. Gabbay disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a case-control study of 40 patients who were treated at a tertiary care psychiatric hospital in Canada, the level of translocator protein total distribution volume (TSPO VT), a marker of gliosis, was 9.23 mL/cm3 among patients with COVID-DC and 7.72 mL/cm3 among control persons. Differences were particularly notable in the ventral striatum and dorsal putamen.
“Most theories assume there is inflammation in the brain [with] long COVID,” but that assumption had not been studied, author Jeffrey H. Meyer, MD, PhD, Canada Research Chair in Neurochemistry of Major Depressive Disorder at the University of Toronto, said in an interview. “Such information is pivotal to developing treatments.”
The study was published online in JAMA Psychiatry.
Quantifiable marker
The investigators sought to determine whether levels of TSPO VT, which are quantifiable with PET, are elevated in the dorsal putamen, ventral striatum, prefrontal cortex, anterior cingulate cortex, and hippocampus of patients with COVID-DC, compared with patients without this syndrome. These brain regions were chosen, according to the authors, “because injury in these regions, which can cause gliosis, also induces symptoms of COVID-DC.”
The study was conducted from April 2021 through June 30, 2022. The investigators compared levels of TSPO VT in the selected brain regions of 20 participants with COVID-DC (mean age, 32.7 years; 60% women) with that of 20 control persons (mean age, 33.3 years; 55% women). TSPO VT was measured with fluorine F18–labeled N-(2-(2-fluoroethoxy)benzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET.
The difference in TSPO VT was most noticeable in the ventral striatum (mean difference, 1.97 mL/cm3) and dorsal putamen (mean difference, 1.70 mL/cm3). The study authors suggest that gliosis in these areas may explain some of the persistent symptoms reported in structured clinical interviews and assessed on neuropsychological and psychological testing.
For patients with COVID-DC, motor speed on the finger-tapping test was negatively associated with dorsal putamen TSPO VT (r, −0.53). The 10 participants with COVID-DC whose speed was lowest had higher mean dorsal putamen TSPO VT levels than those of control persons by 2.3 mL/cm3.
The investigators could not assess a possible association between the ventral striatum TSPO VT and anhedonia because all participants had these symptoms. No significant correlations were found between depression and TSPO VT in the prefrontal cortex or anterior cingulate cortex.
The authors acknowledged that the study was cross-sectional, and so the duration of persistently elevated TSPO VT is not yet known. In addition, elevation in TSPO VT is not completely specific to glial cells, and although correlations with finger-tapping test performance reflect associations between brain changes and symptoms, they do not prove cause and effect.
“Presently, clinicians can use treatments for symptoms in other illnesses that are [also] common with long COVID. We need better than this,” said Dr. Meyer. “Clients with long COVID should be able to state their symptoms, and the practitioner should have an evidence-based matching treatment to recommend.”
Research is ongoing. “We are acquiring more information regarding different types of inflammation in the brain, whether there is ongoing injury, and whether treatments that influence inflammation are helpful,” said Dr. Meyer.
Jigsaw puzzle
“While this is an important piece in the jigsaw puzzle of neuroinflammation in chronic neurological disease, it is important to keep in mind that we still lack understanding of the complex picture for several reasons,” Alexander Gerhard, MD, honorary senior lecturer in neuroscience at the University of Manchester, England, wrote in an accompanying editorial.
Among these reasons is that the PET technique used in the study is noisy and not restricted to glial cells, he wrote. TSPO expression is only one part of the brain’s neuroinflammatory response, but PET techniques “do not currently allow us to distinguish between different states of microglial activation.” In addition, “a much more detailed understanding of microglial activation at different time points” is needed before neuroinflammatory changes can be targeted therapeutically, Dr. Gerhard wrote.
In a comment, Vilma Gabbay, MD, professor of psychiatry and neuroscience and director of biomarkers and dimensional psychiatry in the Psychiatry Research Institute at Montefiore Einstein, Albert Einstein College of Medicine, New York, said that “this is an important initial step to better understand the neuropsychiatric consequences of COVID even in only a mild and moderate viral illness.” TSPO imaging through PET scanning has been used as an index for neuroinflammation and gliosis. Researchers have used it to study neurodegenerative diseases, but as the authors noted, the ligand is not specific for gliosis.
“Follow-up large cohort studies including other measures of neuroimaging modalities assessing circuitry and neurochemistry are needed,” she said. “Similarly, studying the blood-brain barrier will also allow us to better understand how the immune reaction in the blood transitions to the brain.”
This field of research is evolving, and clinical trials are ongoing, Dr. Gabbay added. Meanwhile, clinicians should monitor for, assess, and treat neuropsychiatric symptoms and “follow the literature for new research and management recommendations.”
The study was primarily funded by a Canadian Institutes of Health Research Project grant to the authors, with some funding from the Canadian Institute for Military and Veteran Health Research. Dr. Meyer received support from their Canada Research Chair awards and received grants and support from several pharmaceutical companies outside of the submitted work. Dr. Gerhard and Dr. Gabbay disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a case-control study of 40 patients who were treated at a tertiary care psychiatric hospital in Canada, the level of translocator protein total distribution volume (TSPO VT), a marker of gliosis, was 9.23 mL/cm3 among patients with COVID-DC and 7.72 mL/cm3 among control persons. Differences were particularly notable in the ventral striatum and dorsal putamen.
“Most theories assume there is inflammation in the brain [with] long COVID,” but that assumption had not been studied, author Jeffrey H. Meyer, MD, PhD, Canada Research Chair in Neurochemistry of Major Depressive Disorder at the University of Toronto, said in an interview. “Such information is pivotal to developing treatments.”
The study was published online in JAMA Psychiatry.
Quantifiable marker
The investigators sought to determine whether levels of TSPO VT, which are quantifiable with PET, are elevated in the dorsal putamen, ventral striatum, prefrontal cortex, anterior cingulate cortex, and hippocampus of patients with COVID-DC, compared with patients without this syndrome. These brain regions were chosen, according to the authors, “because injury in these regions, which can cause gliosis, also induces symptoms of COVID-DC.”
The study was conducted from April 2021 through June 30, 2022. The investigators compared levels of TSPO VT in the selected brain regions of 20 participants with COVID-DC (mean age, 32.7 years; 60% women) with that of 20 control persons (mean age, 33.3 years; 55% women). TSPO VT was measured with fluorine F18–labeled N-(2-(2-fluoroethoxy)benzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET.
The difference in TSPO VT was most noticeable in the ventral striatum (mean difference, 1.97 mL/cm3) and dorsal putamen (mean difference, 1.70 mL/cm3). The study authors suggest that gliosis in these areas may explain some of the persistent symptoms reported in structured clinical interviews and assessed on neuropsychological and psychological testing.
For patients with COVID-DC, motor speed on the finger-tapping test was negatively associated with dorsal putamen TSPO VT (r, −0.53). The 10 participants with COVID-DC whose speed was lowest had higher mean dorsal putamen TSPO VT levels than those of control persons by 2.3 mL/cm3.
The investigators could not assess a possible association between the ventral striatum TSPO VT and anhedonia because all participants had these symptoms. No significant correlations were found between depression and TSPO VT in the prefrontal cortex or anterior cingulate cortex.
The authors acknowledged that the study was cross-sectional, and so the duration of persistently elevated TSPO VT is not yet known. In addition, elevation in TSPO VT is not completely specific to glial cells, and although correlations with finger-tapping test performance reflect associations between brain changes and symptoms, they do not prove cause and effect.
“Presently, clinicians can use treatments for symptoms in other illnesses that are [also] common with long COVID. We need better than this,” said Dr. Meyer. “Clients with long COVID should be able to state their symptoms, and the practitioner should have an evidence-based matching treatment to recommend.”
Research is ongoing. “We are acquiring more information regarding different types of inflammation in the brain, whether there is ongoing injury, and whether treatments that influence inflammation are helpful,” said Dr. Meyer.
Jigsaw puzzle
“While this is an important piece in the jigsaw puzzle of neuroinflammation in chronic neurological disease, it is important to keep in mind that we still lack understanding of the complex picture for several reasons,” Alexander Gerhard, MD, honorary senior lecturer in neuroscience at the University of Manchester, England, wrote in an accompanying editorial.
Among these reasons is that the PET technique used in the study is noisy and not restricted to glial cells, he wrote. TSPO expression is only one part of the brain’s neuroinflammatory response, but PET techniques “do not currently allow us to distinguish between different states of microglial activation.” In addition, “a much more detailed understanding of microglial activation at different time points” is needed before neuroinflammatory changes can be targeted therapeutically, Dr. Gerhard wrote.
In a comment, Vilma Gabbay, MD, professor of psychiatry and neuroscience and director of biomarkers and dimensional psychiatry in the Psychiatry Research Institute at Montefiore Einstein, Albert Einstein College of Medicine, New York, said that “this is an important initial step to better understand the neuropsychiatric consequences of COVID even in only a mild and moderate viral illness.” TSPO imaging through PET scanning has been used as an index for neuroinflammation and gliosis. Researchers have used it to study neurodegenerative diseases, but as the authors noted, the ligand is not specific for gliosis.
“Follow-up large cohort studies including other measures of neuroimaging modalities assessing circuitry and neurochemistry are needed,” she said. “Similarly, studying the blood-brain barrier will also allow us to better understand how the immune reaction in the blood transitions to the brain.”
This field of research is evolving, and clinical trials are ongoing, Dr. Gabbay added. Meanwhile, clinicians should monitor for, assess, and treat neuropsychiatric symptoms and “follow the literature for new research and management recommendations.”
The study was primarily funded by a Canadian Institutes of Health Research Project grant to the authors, with some funding from the Canadian Institute for Military and Veteran Health Research. Dr. Meyer received support from their Canada Research Chair awards and received grants and support from several pharmaceutical companies outside of the submitted work. Dr. Gerhard and Dr. Gabbay disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Latest data: COVID vaccine safety, protection, and breakthrough infections in inflammatory, autoimmune diseases
MILAN – The impact of the COVID-19 pandemic on patients with rheumatic and nonrheumatic autoimmune diseases is ongoing and not yet fully comprehended. New data presented at the annual European Congress of Rheumatology, primarily derived from the global COVID-19 in Autoimmune Diseases (COVAD) survey but not limited to it, provide reassurance regarding the protection and safety of COVID-19 vaccines for older and younger adults, as well as for pregnant and breastfeeding women. These data also explore the influence of underlying diseases and medications on breakthrough SARS-CoV-2 infections and infection outcomes.
Safety of vaccines in patients with autoimmune or immune-mediated diseases
Following vaccination, even with low levels of antibodies, the risk of severe COVID-19 remains relatively low for patients who receive immunosuppressive therapy for various immune-mediated inflammatory diseases (IMIDs). This encouraging finding comes from the Nor-vaC study, presented by Hilde Ørbo, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo.
During the presentation, Dr. Ørbo stated: “We did not find any specific diagnosis or medication associated with a significantly higher risk of hospitalization.” Receiving booster doses of the vaccine, having high levels of anti-spike antibodies after vaccination, and achieving hybrid immunity are correlated with further reductions in the risk of breakthrough SARS-CoV-2 infections.
Between Feb. 15, 2021, and Feb. 15, 2023, COVID-19 affected a similar proportion among the 729 patients and 350 healthy control persons (67% and 68%, respectively). Among the patients, 22 reported severe COVID-19, whereas none of the healthy control persons did. However, there were no fatalities among the patients. The study cohort consisted of patients with various IMIDs; 70% had an inflammatory joint disease. The use of immunosuppressive medications also varied, with 63% of patients using tumor necrosis factor inhibitors, either as monotherapy or in combination with other treatments, and other patients taking medications such as methotrexate, interleukin inhibitors, Janus kinase inhibitors, vedolizumab (Entyvio), and others.
While being older than 70 years and the presence of comorbidities were identified as risk factors for severe COVID-19, there was a significant reduction in risk with each additional vaccine dose. These results support the protective role of repeated COVID-19 vaccination for patients with IMIDs who are receiving immunosuppressive therapies; they yield a favorable prognosis even with the Omicron variant.
The study further compared the risk of severe COVID-19 between a group with hybrid immunity (having received three vaccine doses and experiencing breakthrough infection with the Omicron variant) and a group that received a fourth vaccine dose within the same time frame. The difference was striking: Hybrid immunity was associated with a 5.8-fold decrease in risk, compared with four-dose vaccination (P < .0001).
The level of antibodies, measured 2-4 weeks after the last vaccination, was predictive of the risk of breakthrough COVID-19. An antibody level above 6000 binding antibody units/mL after vaccination was significantly associated with a reduction in risk. “We can conclude that patients who receive multiple vaccine doses have a lower risk of COVID-19,” Dr. Ørbo said. “In patients who recently experienced breakthrough infections, the administration of a booster vaccine dose might be delayed.”
“The virus has undergone changes throughout the pandemic, while the vaccines have remained relatively stable. Are we anticipating more infections over time?” asked Hendrik Schulze-Koops, MD, PhD, of Ludwig Maximilians University of Munich (Germany), the session moderator. In response, Dr. Ørbo stated that 85% of the recorded infections in the study occurred after the emergence of the Omicron variant, and time was considered a covariable in the analysis.
These data shed light on a topic discussed by Pedro Machado, MD, PhD, professor and consultant in rheumatology and neuromuscular diseases at University College London, during his scientific session talk entitled, “Unsolved Issues of COVID Vaccination and Re-vaccination.” Dr. Machado referred to the VROOM study published in 2022, which examined the interruption of methotrexate for 2 weeks following booster administration. Both groups demonstrated a significant antibody response, but the group that stopped taking methotrexate showed double the antibody titers.
However, he emphasized, “what remains unknown is the clinical relevance of these differences in terms of severe infection, hospitalization, or even death. The potential benefit of increased immunogenicity by interrupting conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] such as methotrexate before or after vaccination needs to be balanced against the potential risk of disease flare. Ultimately, decision-making should be individualized based on factors such as comorbidities, disease activity, and other considerations.” The results presented by Dr. Ørbo suggest that, while there may be a clinical difference in terms of severe infection, the overall prognosis for vaccinated patients is reasonably good.
Regarding other DMARDs, such as biologics, the approach may differ. Dr. Machado suggested: “In patients using rituximab or other B cell–depleting therapies, SARS-CoV-2 vaccination should be scheduled in a way that optimizes vaccine immunogenicity. A minimum of 10 B cells/mcL of blood is likely a relevant threshold above which a sufficient cellular and immune response is established.”
COVID vaccines are safe for pregnant and breastfeeding women
According to data from the COVAD study, which comprised two global cross-sectional surveys conducted in 2021 and 2022, the COVID-19 vaccine appeared safe for pregnant and breastfeeding women with autoimmune diseases (AID).
Presenter Laura Andreoli, MD, PhD, of the University of Brescia (Italy), said that, although pregnant patients with AID reported more adverse events related to vaccination, these rates were not significantly higher than those among pregnant, healthy control persons who were without AID. No difference in adverse events was observed between breastfeeding women and healthy control persons, and the incidence of disease flares did not significantly differ among all groups.
“In summary, this study provides initial insights into the safety of COVID-19 vaccination during the gestational and postpartum periods in women with autoimmune diseases. These reassuring observations will hopefully improve clinician-patient communication and address hesitancy towards COVID-19 vaccination, as the benefits for the mother and fetus through passive immunization appear to outweigh potential risks,” Dr. Andreoli said in an interview.
“The large number of participants and the global geographical spread of the COVAD survey were very beneficial in gaining access to this important subset of patients,” added Dr. Andreoli. However, she acknowledged that patients with low socioeconomic status and/or high disability were likely underrepresented. While no data on pregnancy outcomes have been collected thus far, Dr. Andreoli expressed the desire to include them in the study’s follow-up.
The COVAD survey data also indicate that, in general, vaccine hesitancy among patients with AID is decreasing; from 2021 to 2022, it declined from 16.5% to 5.1%, as Dr. Machado indicated in his presentation.
Multiple factors contribute to breakthrough infections
The risk of breakthrough SARS-CoV-2 infections after vaccination varies among patients with rheumatoid arthritis and rheumatic or nonrheumatic autoimmune diseases, primarily depending on the underlying condition rather than the immunosuppressive medication. Environmental factors also appear to play a role. This complex landscape emerges from a further analysis of the COVAD survey dataset.
Alessia Alunno, MD, PhD, of the University of L’Aquila (Italy), presented a detailed and occasionally counterintuitive picture of similarities and differences among young adult patients (aged 18-35 years), mostly women, with various rheumatic and nonrheumatic diseases in relation to COVID-19. Most notably, the type of disease seemed to have more significance than the immunosuppression resulting from the treatment regimen. This held true for vaccine safety as well as for the risk of breakthrough COVID-19 and symptom profiles.
Patients with rheumatic disease (RMD) and nonrheumatic autoimmune disease (nr-AD) had significantly different therapeutic profiles on average. Before vaccination, 45% of patients with RMD used glucocorticoids (GC), and 91% used immunosuppressants (IS). In contrast, only 9.5% of nr-AD patients used GC, and 21% were taking IS.
Interestingly, the overall prevalence of reported SARS-CoV-2 infections was not influenced by medication and was practically identical (25% to 28%) across all groups. However, there were intriguing differences in the occurrence of infections before and after vaccination between disease groups. Prevaccine infections were less frequent among patients with RMD compared with healthy control persons (adjusted odds ratio, 0.6), while the rates were similar among patients with nr-AD and healthy control persons. On the other hand, breakthrough infections were more frequent in patients with RMD (aOR, 2.7), whereas the rate was similar between healthy control persons and patients with nr-AD.
Despite a much lower rate of GC/IS use, patients with nr-AD experienced repeated infections more frequently. In contrast, patients with RMD were less prone to multiple infections, even compared with healthy control persons (aOR, 0.5).
Regarding the disease profile, fewer than 5% of all infected patients required advanced therapies for SARS-CoV-2 infection. Notably, all SARS-CoV-2 infections in patients with nr-AD were symptomatic, whereas among patients with RMD and healthy control persons, the incidence of asymptomatic infections was 3%. The rate of hospital admissions was 4% for patients with RMD, compared with 2% for patients with nr-AD and 1% for control persons. The RMD group exhibited some differences between prevaccine infections and breakthrough infections, including a significantly lower frequency of loss of smell and taste during breakthrough infections. Overall, patients with RMD and COVID-19 experienced cough, runny nose, throat pain, nausea, and vomiting more frequently. In contrast, patients with nr-AD had a much higher risk of skin rashes during breakthrough infections (aOR, 8.7).
Vaccine adverse events (AEs) were also influenced by the underlying disease. Patients with RMD and those with nr-AD were more likely to experience mild AEs after the first or second dose, compared with healthy control persons (adjusted OR, 2.4 and 2.0, respectively). The most common early, mild AEs across all groups were injection-site pain, headache, and fatigue, but they occurred more frequently in the nr-AD group than in the RMD or healthy control group. Additionally, fever and chills occurred more frequently among the nr-AD group. Late, mild AEs and severe AEs were rare and affected all groups equally.
“The overall incidence of AEs was very low. Our results certainly do not undermine the safety of vaccines,” Dr. Alunno said.
Disease flares were more common after vaccination (10% with RMD and 7% with nr-AD) than after infection (5% with RMD and 1.5% with nr-AD). Furthermore, in many cases, after vaccination, flares required a change of medications, particularly for patients with RMD.
Additional results from the COVAD survey from January to July 2022, presented by Naveen Ravichandran, MD, DM, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, revealed a higher prevalence (OR, 1.2; P = .001) of breakthrough infections among patients with RA. A total of 22.6% of patients with RA experienced breakthrough infections, compared with 20.6% for patients with other autoimmune rheumatic diseases and 18.4% of healthy control persons. Hospitalizations and the need for advanced treatment were also more common among patients with RA (30.9%) than among healthy control persons (13.9%). Patients with RA who had breakthrough infections tended to be older (closer to 50 years of age on average) and female, and they were more likely to have comorbidities and mental disorders. The human development index of the patient’s country of residence also played a role. Further research is necessary to understand how breakthrough infection outcomes are affected by a patient’s socioeconomic situation.
According to Dr. Ravichandran, medication was not a significant factor, except for the use of steroids and rituximab, which were associated with a higher risk of severe COVID-19 and hospitalization. Patients using rituximab, in particular, faced significantly increased odds for hospitalization (OR, 3.4) and severe breakthrough COVID-19 (OR, 3.0).
Session moderator Kim Lauper, MD, of the University of Geneva, cautioned: “The roles of disease and medication are challenging to separate. Some diseases require a more aggressive immunosuppressive regimen. It’s possible that different diseases affect the immune system differently, but it is not easy to demonstrate.”
The complications observed in the data warrant further study, as mentioned by Dr. Schulze-Koops: “We have a problem tied to the time line of the pandemic, where we had different viruses, different population behaviors, different treatments, and different standards of care over time. We also have differences between ethnic communities and regions of the world. But most importantly, we have different viruses: From the original strain to Delta to Omicron, we know they have very different clinical outcomes. I believe we need more scientific research to unravel these factors.”
Dr. Ørbo, Dr. Ravichandran, Dr. Andreoli, and Dr. Alunno reported no relevant financial relationships. Dr. Machado has received grants and/or honoraria from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB.
A version of this article originally appeared on Medscape.com.
MILAN – The impact of the COVID-19 pandemic on patients with rheumatic and nonrheumatic autoimmune diseases is ongoing and not yet fully comprehended. New data presented at the annual European Congress of Rheumatology, primarily derived from the global COVID-19 in Autoimmune Diseases (COVAD) survey but not limited to it, provide reassurance regarding the protection and safety of COVID-19 vaccines for older and younger adults, as well as for pregnant and breastfeeding women. These data also explore the influence of underlying diseases and medications on breakthrough SARS-CoV-2 infections and infection outcomes.
Safety of vaccines in patients with autoimmune or immune-mediated diseases
Following vaccination, even with low levels of antibodies, the risk of severe COVID-19 remains relatively low for patients who receive immunosuppressive therapy for various immune-mediated inflammatory diseases (IMIDs). This encouraging finding comes from the Nor-vaC study, presented by Hilde Ørbo, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo.
During the presentation, Dr. Ørbo stated: “We did not find any specific diagnosis or medication associated with a significantly higher risk of hospitalization.” Receiving booster doses of the vaccine, having high levels of anti-spike antibodies after vaccination, and achieving hybrid immunity are correlated with further reductions in the risk of breakthrough SARS-CoV-2 infections.
Between Feb. 15, 2021, and Feb. 15, 2023, COVID-19 affected a similar proportion among the 729 patients and 350 healthy control persons (67% and 68%, respectively). Among the patients, 22 reported severe COVID-19, whereas none of the healthy control persons did. However, there were no fatalities among the patients. The study cohort consisted of patients with various IMIDs; 70% had an inflammatory joint disease. The use of immunosuppressive medications also varied, with 63% of patients using tumor necrosis factor inhibitors, either as monotherapy or in combination with other treatments, and other patients taking medications such as methotrexate, interleukin inhibitors, Janus kinase inhibitors, vedolizumab (Entyvio), and others.
While being older than 70 years and the presence of comorbidities were identified as risk factors for severe COVID-19, there was a significant reduction in risk with each additional vaccine dose. These results support the protective role of repeated COVID-19 vaccination for patients with IMIDs who are receiving immunosuppressive therapies; they yield a favorable prognosis even with the Omicron variant.
The study further compared the risk of severe COVID-19 between a group with hybrid immunity (having received three vaccine doses and experiencing breakthrough infection with the Omicron variant) and a group that received a fourth vaccine dose within the same time frame. The difference was striking: Hybrid immunity was associated with a 5.8-fold decrease in risk, compared with four-dose vaccination (P < .0001).
The level of antibodies, measured 2-4 weeks after the last vaccination, was predictive of the risk of breakthrough COVID-19. An antibody level above 6000 binding antibody units/mL after vaccination was significantly associated with a reduction in risk. “We can conclude that patients who receive multiple vaccine doses have a lower risk of COVID-19,” Dr. Ørbo said. “In patients who recently experienced breakthrough infections, the administration of a booster vaccine dose might be delayed.”
“The virus has undergone changes throughout the pandemic, while the vaccines have remained relatively stable. Are we anticipating more infections over time?” asked Hendrik Schulze-Koops, MD, PhD, of Ludwig Maximilians University of Munich (Germany), the session moderator. In response, Dr. Ørbo stated that 85% of the recorded infections in the study occurred after the emergence of the Omicron variant, and time was considered a covariable in the analysis.
These data shed light on a topic discussed by Pedro Machado, MD, PhD, professor and consultant in rheumatology and neuromuscular diseases at University College London, during his scientific session talk entitled, “Unsolved Issues of COVID Vaccination and Re-vaccination.” Dr. Machado referred to the VROOM study published in 2022, which examined the interruption of methotrexate for 2 weeks following booster administration. Both groups demonstrated a significant antibody response, but the group that stopped taking methotrexate showed double the antibody titers.
However, he emphasized, “what remains unknown is the clinical relevance of these differences in terms of severe infection, hospitalization, or even death. The potential benefit of increased immunogenicity by interrupting conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] such as methotrexate before or after vaccination needs to be balanced against the potential risk of disease flare. Ultimately, decision-making should be individualized based on factors such as comorbidities, disease activity, and other considerations.” The results presented by Dr. Ørbo suggest that, while there may be a clinical difference in terms of severe infection, the overall prognosis for vaccinated patients is reasonably good.
Regarding other DMARDs, such as biologics, the approach may differ. Dr. Machado suggested: “In patients using rituximab or other B cell–depleting therapies, SARS-CoV-2 vaccination should be scheduled in a way that optimizes vaccine immunogenicity. A minimum of 10 B cells/mcL of blood is likely a relevant threshold above which a sufficient cellular and immune response is established.”
COVID vaccines are safe for pregnant and breastfeeding women
According to data from the COVAD study, which comprised two global cross-sectional surveys conducted in 2021 and 2022, the COVID-19 vaccine appeared safe for pregnant and breastfeeding women with autoimmune diseases (AID).
Presenter Laura Andreoli, MD, PhD, of the University of Brescia (Italy), said that, although pregnant patients with AID reported more adverse events related to vaccination, these rates were not significantly higher than those among pregnant, healthy control persons who were without AID. No difference in adverse events was observed between breastfeeding women and healthy control persons, and the incidence of disease flares did not significantly differ among all groups.
“In summary, this study provides initial insights into the safety of COVID-19 vaccination during the gestational and postpartum periods in women with autoimmune diseases. These reassuring observations will hopefully improve clinician-patient communication and address hesitancy towards COVID-19 vaccination, as the benefits for the mother and fetus through passive immunization appear to outweigh potential risks,” Dr. Andreoli said in an interview.
“The large number of participants and the global geographical spread of the COVAD survey were very beneficial in gaining access to this important subset of patients,” added Dr. Andreoli. However, she acknowledged that patients with low socioeconomic status and/or high disability were likely underrepresented. While no data on pregnancy outcomes have been collected thus far, Dr. Andreoli expressed the desire to include them in the study’s follow-up.
The COVAD survey data also indicate that, in general, vaccine hesitancy among patients with AID is decreasing; from 2021 to 2022, it declined from 16.5% to 5.1%, as Dr. Machado indicated in his presentation.
Multiple factors contribute to breakthrough infections
The risk of breakthrough SARS-CoV-2 infections after vaccination varies among patients with rheumatoid arthritis and rheumatic or nonrheumatic autoimmune diseases, primarily depending on the underlying condition rather than the immunosuppressive medication. Environmental factors also appear to play a role. This complex landscape emerges from a further analysis of the COVAD survey dataset.
Alessia Alunno, MD, PhD, of the University of L’Aquila (Italy), presented a detailed and occasionally counterintuitive picture of similarities and differences among young adult patients (aged 18-35 years), mostly women, with various rheumatic and nonrheumatic diseases in relation to COVID-19. Most notably, the type of disease seemed to have more significance than the immunosuppression resulting from the treatment regimen. This held true for vaccine safety as well as for the risk of breakthrough COVID-19 and symptom profiles.
Patients with rheumatic disease (RMD) and nonrheumatic autoimmune disease (nr-AD) had significantly different therapeutic profiles on average. Before vaccination, 45% of patients with RMD used glucocorticoids (GC), and 91% used immunosuppressants (IS). In contrast, only 9.5% of nr-AD patients used GC, and 21% were taking IS.
Interestingly, the overall prevalence of reported SARS-CoV-2 infections was not influenced by medication and was practically identical (25% to 28%) across all groups. However, there were intriguing differences in the occurrence of infections before and after vaccination between disease groups. Prevaccine infections were less frequent among patients with RMD compared with healthy control persons (adjusted odds ratio, 0.6), while the rates were similar among patients with nr-AD and healthy control persons. On the other hand, breakthrough infections were more frequent in patients with RMD (aOR, 2.7), whereas the rate was similar between healthy control persons and patients with nr-AD.
Despite a much lower rate of GC/IS use, patients with nr-AD experienced repeated infections more frequently. In contrast, patients with RMD were less prone to multiple infections, even compared with healthy control persons (aOR, 0.5).
Regarding the disease profile, fewer than 5% of all infected patients required advanced therapies for SARS-CoV-2 infection. Notably, all SARS-CoV-2 infections in patients with nr-AD were symptomatic, whereas among patients with RMD and healthy control persons, the incidence of asymptomatic infections was 3%. The rate of hospital admissions was 4% for patients with RMD, compared with 2% for patients with nr-AD and 1% for control persons. The RMD group exhibited some differences between prevaccine infections and breakthrough infections, including a significantly lower frequency of loss of smell and taste during breakthrough infections. Overall, patients with RMD and COVID-19 experienced cough, runny nose, throat pain, nausea, and vomiting more frequently. In contrast, patients with nr-AD had a much higher risk of skin rashes during breakthrough infections (aOR, 8.7).
Vaccine adverse events (AEs) were also influenced by the underlying disease. Patients with RMD and those with nr-AD were more likely to experience mild AEs after the first or second dose, compared with healthy control persons (adjusted OR, 2.4 and 2.0, respectively). The most common early, mild AEs across all groups were injection-site pain, headache, and fatigue, but they occurred more frequently in the nr-AD group than in the RMD or healthy control group. Additionally, fever and chills occurred more frequently among the nr-AD group. Late, mild AEs and severe AEs were rare and affected all groups equally.
“The overall incidence of AEs was very low. Our results certainly do not undermine the safety of vaccines,” Dr. Alunno said.
Disease flares were more common after vaccination (10% with RMD and 7% with nr-AD) than after infection (5% with RMD and 1.5% with nr-AD). Furthermore, in many cases, after vaccination, flares required a change of medications, particularly for patients with RMD.
Additional results from the COVAD survey from January to July 2022, presented by Naveen Ravichandran, MD, DM, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, revealed a higher prevalence (OR, 1.2; P = .001) of breakthrough infections among patients with RA. A total of 22.6% of patients with RA experienced breakthrough infections, compared with 20.6% for patients with other autoimmune rheumatic diseases and 18.4% of healthy control persons. Hospitalizations and the need for advanced treatment were also more common among patients with RA (30.9%) than among healthy control persons (13.9%). Patients with RA who had breakthrough infections tended to be older (closer to 50 years of age on average) and female, and they were more likely to have comorbidities and mental disorders. The human development index of the patient’s country of residence also played a role. Further research is necessary to understand how breakthrough infection outcomes are affected by a patient’s socioeconomic situation.
According to Dr. Ravichandran, medication was not a significant factor, except for the use of steroids and rituximab, which were associated with a higher risk of severe COVID-19 and hospitalization. Patients using rituximab, in particular, faced significantly increased odds for hospitalization (OR, 3.4) and severe breakthrough COVID-19 (OR, 3.0).
Session moderator Kim Lauper, MD, of the University of Geneva, cautioned: “The roles of disease and medication are challenging to separate. Some diseases require a more aggressive immunosuppressive regimen. It’s possible that different diseases affect the immune system differently, but it is not easy to demonstrate.”
The complications observed in the data warrant further study, as mentioned by Dr. Schulze-Koops: “We have a problem tied to the time line of the pandemic, where we had different viruses, different population behaviors, different treatments, and different standards of care over time. We also have differences between ethnic communities and regions of the world. But most importantly, we have different viruses: From the original strain to Delta to Omicron, we know they have very different clinical outcomes. I believe we need more scientific research to unravel these factors.”
Dr. Ørbo, Dr. Ravichandran, Dr. Andreoli, and Dr. Alunno reported no relevant financial relationships. Dr. Machado has received grants and/or honoraria from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB.
A version of this article originally appeared on Medscape.com.
MILAN – The impact of the COVID-19 pandemic on patients with rheumatic and nonrheumatic autoimmune diseases is ongoing and not yet fully comprehended. New data presented at the annual European Congress of Rheumatology, primarily derived from the global COVID-19 in Autoimmune Diseases (COVAD) survey but not limited to it, provide reassurance regarding the protection and safety of COVID-19 vaccines for older and younger adults, as well as for pregnant and breastfeeding women. These data also explore the influence of underlying diseases and medications on breakthrough SARS-CoV-2 infections and infection outcomes.
Safety of vaccines in patients with autoimmune or immune-mediated diseases
Following vaccination, even with low levels of antibodies, the risk of severe COVID-19 remains relatively low for patients who receive immunosuppressive therapy for various immune-mediated inflammatory diseases (IMIDs). This encouraging finding comes from the Nor-vaC study, presented by Hilde Ørbo, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo.
During the presentation, Dr. Ørbo stated: “We did not find any specific diagnosis or medication associated with a significantly higher risk of hospitalization.” Receiving booster doses of the vaccine, having high levels of anti-spike antibodies after vaccination, and achieving hybrid immunity are correlated with further reductions in the risk of breakthrough SARS-CoV-2 infections.
Between Feb. 15, 2021, and Feb. 15, 2023, COVID-19 affected a similar proportion among the 729 patients and 350 healthy control persons (67% and 68%, respectively). Among the patients, 22 reported severe COVID-19, whereas none of the healthy control persons did. However, there were no fatalities among the patients. The study cohort consisted of patients with various IMIDs; 70% had an inflammatory joint disease. The use of immunosuppressive medications also varied, with 63% of patients using tumor necrosis factor inhibitors, either as monotherapy or in combination with other treatments, and other patients taking medications such as methotrexate, interleukin inhibitors, Janus kinase inhibitors, vedolizumab (Entyvio), and others.
While being older than 70 years and the presence of comorbidities were identified as risk factors for severe COVID-19, there was a significant reduction in risk with each additional vaccine dose. These results support the protective role of repeated COVID-19 vaccination for patients with IMIDs who are receiving immunosuppressive therapies; they yield a favorable prognosis even with the Omicron variant.
The study further compared the risk of severe COVID-19 between a group with hybrid immunity (having received three vaccine doses and experiencing breakthrough infection with the Omicron variant) and a group that received a fourth vaccine dose within the same time frame. The difference was striking: Hybrid immunity was associated with a 5.8-fold decrease in risk, compared with four-dose vaccination (P < .0001).
The level of antibodies, measured 2-4 weeks after the last vaccination, was predictive of the risk of breakthrough COVID-19. An antibody level above 6000 binding antibody units/mL after vaccination was significantly associated with a reduction in risk. “We can conclude that patients who receive multiple vaccine doses have a lower risk of COVID-19,” Dr. Ørbo said. “In patients who recently experienced breakthrough infections, the administration of a booster vaccine dose might be delayed.”
“The virus has undergone changes throughout the pandemic, while the vaccines have remained relatively stable. Are we anticipating more infections over time?” asked Hendrik Schulze-Koops, MD, PhD, of Ludwig Maximilians University of Munich (Germany), the session moderator. In response, Dr. Ørbo stated that 85% of the recorded infections in the study occurred after the emergence of the Omicron variant, and time was considered a covariable in the analysis.
These data shed light on a topic discussed by Pedro Machado, MD, PhD, professor and consultant in rheumatology and neuromuscular diseases at University College London, during his scientific session talk entitled, “Unsolved Issues of COVID Vaccination and Re-vaccination.” Dr. Machado referred to the VROOM study published in 2022, which examined the interruption of methotrexate for 2 weeks following booster administration. Both groups demonstrated a significant antibody response, but the group that stopped taking methotrexate showed double the antibody titers.
However, he emphasized, “what remains unknown is the clinical relevance of these differences in terms of severe infection, hospitalization, or even death. The potential benefit of increased immunogenicity by interrupting conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] such as methotrexate before or after vaccination needs to be balanced against the potential risk of disease flare. Ultimately, decision-making should be individualized based on factors such as comorbidities, disease activity, and other considerations.” The results presented by Dr. Ørbo suggest that, while there may be a clinical difference in terms of severe infection, the overall prognosis for vaccinated patients is reasonably good.
Regarding other DMARDs, such as biologics, the approach may differ. Dr. Machado suggested: “In patients using rituximab or other B cell–depleting therapies, SARS-CoV-2 vaccination should be scheduled in a way that optimizes vaccine immunogenicity. A minimum of 10 B cells/mcL of blood is likely a relevant threshold above which a sufficient cellular and immune response is established.”
COVID vaccines are safe for pregnant and breastfeeding women
According to data from the COVAD study, which comprised two global cross-sectional surveys conducted in 2021 and 2022, the COVID-19 vaccine appeared safe for pregnant and breastfeeding women with autoimmune diseases (AID).
Presenter Laura Andreoli, MD, PhD, of the University of Brescia (Italy), said that, although pregnant patients with AID reported more adverse events related to vaccination, these rates were not significantly higher than those among pregnant, healthy control persons who were without AID. No difference in adverse events was observed between breastfeeding women and healthy control persons, and the incidence of disease flares did not significantly differ among all groups.
“In summary, this study provides initial insights into the safety of COVID-19 vaccination during the gestational and postpartum periods in women with autoimmune diseases. These reassuring observations will hopefully improve clinician-patient communication and address hesitancy towards COVID-19 vaccination, as the benefits for the mother and fetus through passive immunization appear to outweigh potential risks,” Dr. Andreoli said in an interview.
“The large number of participants and the global geographical spread of the COVAD survey were very beneficial in gaining access to this important subset of patients,” added Dr. Andreoli. However, she acknowledged that patients with low socioeconomic status and/or high disability were likely underrepresented. While no data on pregnancy outcomes have been collected thus far, Dr. Andreoli expressed the desire to include them in the study’s follow-up.
The COVAD survey data also indicate that, in general, vaccine hesitancy among patients with AID is decreasing; from 2021 to 2022, it declined from 16.5% to 5.1%, as Dr. Machado indicated in his presentation.
Multiple factors contribute to breakthrough infections
The risk of breakthrough SARS-CoV-2 infections after vaccination varies among patients with rheumatoid arthritis and rheumatic or nonrheumatic autoimmune diseases, primarily depending on the underlying condition rather than the immunosuppressive medication. Environmental factors also appear to play a role. This complex landscape emerges from a further analysis of the COVAD survey dataset.
Alessia Alunno, MD, PhD, of the University of L’Aquila (Italy), presented a detailed and occasionally counterintuitive picture of similarities and differences among young adult patients (aged 18-35 years), mostly women, with various rheumatic and nonrheumatic diseases in relation to COVID-19. Most notably, the type of disease seemed to have more significance than the immunosuppression resulting from the treatment regimen. This held true for vaccine safety as well as for the risk of breakthrough COVID-19 and symptom profiles.
Patients with rheumatic disease (RMD) and nonrheumatic autoimmune disease (nr-AD) had significantly different therapeutic profiles on average. Before vaccination, 45% of patients with RMD used glucocorticoids (GC), and 91% used immunosuppressants (IS). In contrast, only 9.5% of nr-AD patients used GC, and 21% were taking IS.
Interestingly, the overall prevalence of reported SARS-CoV-2 infections was not influenced by medication and was practically identical (25% to 28%) across all groups. However, there were intriguing differences in the occurrence of infections before and after vaccination between disease groups. Prevaccine infections were less frequent among patients with RMD compared with healthy control persons (adjusted odds ratio, 0.6), while the rates were similar among patients with nr-AD and healthy control persons. On the other hand, breakthrough infections were more frequent in patients with RMD (aOR, 2.7), whereas the rate was similar between healthy control persons and patients with nr-AD.
Despite a much lower rate of GC/IS use, patients with nr-AD experienced repeated infections more frequently. In contrast, patients with RMD were less prone to multiple infections, even compared with healthy control persons (aOR, 0.5).
Regarding the disease profile, fewer than 5% of all infected patients required advanced therapies for SARS-CoV-2 infection. Notably, all SARS-CoV-2 infections in patients with nr-AD were symptomatic, whereas among patients with RMD and healthy control persons, the incidence of asymptomatic infections was 3%. The rate of hospital admissions was 4% for patients with RMD, compared with 2% for patients with nr-AD and 1% for control persons. The RMD group exhibited some differences between prevaccine infections and breakthrough infections, including a significantly lower frequency of loss of smell and taste during breakthrough infections. Overall, patients with RMD and COVID-19 experienced cough, runny nose, throat pain, nausea, and vomiting more frequently. In contrast, patients with nr-AD had a much higher risk of skin rashes during breakthrough infections (aOR, 8.7).
Vaccine adverse events (AEs) were also influenced by the underlying disease. Patients with RMD and those with nr-AD were more likely to experience mild AEs after the first or second dose, compared with healthy control persons (adjusted OR, 2.4 and 2.0, respectively). The most common early, mild AEs across all groups were injection-site pain, headache, and fatigue, but they occurred more frequently in the nr-AD group than in the RMD or healthy control group. Additionally, fever and chills occurred more frequently among the nr-AD group. Late, mild AEs and severe AEs were rare and affected all groups equally.
“The overall incidence of AEs was very low. Our results certainly do not undermine the safety of vaccines,” Dr. Alunno said.
Disease flares were more common after vaccination (10% with RMD and 7% with nr-AD) than after infection (5% with RMD and 1.5% with nr-AD). Furthermore, in many cases, after vaccination, flares required a change of medications, particularly for patients with RMD.
Additional results from the COVAD survey from January to July 2022, presented by Naveen Ravichandran, MD, DM, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, revealed a higher prevalence (OR, 1.2; P = .001) of breakthrough infections among patients with RA. A total of 22.6% of patients with RA experienced breakthrough infections, compared with 20.6% for patients with other autoimmune rheumatic diseases and 18.4% of healthy control persons. Hospitalizations and the need for advanced treatment were also more common among patients with RA (30.9%) than among healthy control persons (13.9%). Patients with RA who had breakthrough infections tended to be older (closer to 50 years of age on average) and female, and they were more likely to have comorbidities and mental disorders. The human development index of the patient’s country of residence also played a role. Further research is necessary to understand how breakthrough infection outcomes are affected by a patient’s socioeconomic situation.
According to Dr. Ravichandran, medication was not a significant factor, except for the use of steroids and rituximab, which were associated with a higher risk of severe COVID-19 and hospitalization. Patients using rituximab, in particular, faced significantly increased odds for hospitalization (OR, 3.4) and severe breakthrough COVID-19 (OR, 3.0).
Session moderator Kim Lauper, MD, of the University of Geneva, cautioned: “The roles of disease and medication are challenging to separate. Some diseases require a more aggressive immunosuppressive regimen. It’s possible that different diseases affect the immune system differently, but it is not easy to demonstrate.”
The complications observed in the data warrant further study, as mentioned by Dr. Schulze-Koops: “We have a problem tied to the time line of the pandemic, where we had different viruses, different population behaviors, different treatments, and different standards of care over time. We also have differences between ethnic communities and regions of the world. But most importantly, we have different viruses: From the original strain to Delta to Omicron, we know they have very different clinical outcomes. I believe we need more scientific research to unravel these factors.”
Dr. Ørbo, Dr. Ravichandran, Dr. Andreoli, and Dr. Alunno reported no relevant financial relationships. Dr. Machado has received grants and/or honoraria from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB.
A version of this article originally appeared on Medscape.com.
AT EULAR 2023
Millions who had COVID-19 still don’t have sense of smell, taste
Almost 36 million people were diagnosed in 2021, and 60% of them reported accompanying losses in smell or taste, according to the study by Mass Eye and Ear, which is affiliated with Harvard Medical School, Boston. The study was published in The Laryngoscope.
Most people fully regained the senses, but about 24% didn’t get smell back completely, and more than 3% had no recovery, the researchers reported. The numbers were similar among those who lost the sense of taste, they added.
“Many people never fully recovered,” Neil Bhattacharyya, MD, professor of otolaryngology and one of the study’s authors, told Fortune, estimating that up to 6 million people still have lingering symptoms. “If you lost your sense of smell, did you get it back? There’s about a one in four chance you didn’t. That’s terrible.”
Researchers looked at the records of 30,000 adults who had COVID-19 in 2021. They reported that patients who suffered more severe cases were less likely to regain some or all their senses.
Some patients said they lost appetite because they couldn’t smell food. There’s concern, too, about losing the ability to smell gas and smoke, spoiled food, and dirty diapers.
People with symptoms should see their doctors, Dr. Bhattacharyya said. The symptoms might be caused by something other than lingering COVID-19 effects and might be treatable.
A version of this article first appeared on WebMD.com.
Almost 36 million people were diagnosed in 2021, and 60% of them reported accompanying losses in smell or taste, according to the study by Mass Eye and Ear, which is affiliated with Harvard Medical School, Boston. The study was published in The Laryngoscope.
Most people fully regained the senses, but about 24% didn’t get smell back completely, and more than 3% had no recovery, the researchers reported. The numbers were similar among those who lost the sense of taste, they added.
“Many people never fully recovered,” Neil Bhattacharyya, MD, professor of otolaryngology and one of the study’s authors, told Fortune, estimating that up to 6 million people still have lingering symptoms. “If you lost your sense of smell, did you get it back? There’s about a one in four chance you didn’t. That’s terrible.”
Researchers looked at the records of 30,000 adults who had COVID-19 in 2021. They reported that patients who suffered more severe cases were less likely to regain some or all their senses.
Some patients said they lost appetite because they couldn’t smell food. There’s concern, too, about losing the ability to smell gas and smoke, spoiled food, and dirty diapers.
People with symptoms should see their doctors, Dr. Bhattacharyya said. The symptoms might be caused by something other than lingering COVID-19 effects and might be treatable.
A version of this article first appeared on WebMD.com.
Almost 36 million people were diagnosed in 2021, and 60% of them reported accompanying losses in smell or taste, according to the study by Mass Eye and Ear, which is affiliated with Harvard Medical School, Boston. The study was published in The Laryngoscope.
Most people fully regained the senses, but about 24% didn’t get smell back completely, and more than 3% had no recovery, the researchers reported. The numbers were similar among those who lost the sense of taste, they added.
“Many people never fully recovered,” Neil Bhattacharyya, MD, professor of otolaryngology and one of the study’s authors, told Fortune, estimating that up to 6 million people still have lingering symptoms. “If you lost your sense of smell, did you get it back? There’s about a one in four chance you didn’t. That’s terrible.”
Researchers looked at the records of 30,000 adults who had COVID-19 in 2021. They reported that patients who suffered more severe cases were less likely to regain some or all their senses.
Some patients said they lost appetite because they couldn’t smell food. There’s concern, too, about losing the ability to smell gas and smoke, spoiled food, and dirty diapers.
People with symptoms should see their doctors, Dr. Bhattacharyya said. The symptoms might be caused by something other than lingering COVID-19 effects and might be treatable.
A version of this article first appeared on WebMD.com.
FROM THE LARYNGOSCOPE
Sewer data says Ohio person has had COVID for 2 years
The strain of the virus appears to be unique, the researchers said.
The mutated version of the virus was discovered by a team of researchers, led by University of Missouri–Columbia virologist Marc Johnson, PhD, that has been studying standalone mutations identified in wastewater. On Twitter, Dr. Johnson said their work could help warn people of a potential risk.
“If you knew of an exposure of a group of people to a deadly disease, there would be an obligation to inform them,” he wrote.
He believes the infected person lives in Columbus, works at a courthouse in a nearby county, and has gut health problems. The county where the person works has a population of just 15,000 people but had record COVID wastewater levels in May, The Columbus Dispatch reported. The unique COVID strain that Dr. Johnson is researching was the only COVID strain found in Fayette County’s wastewater.
“This person was shedding thousands of times more material than a normal person ever would,” Dr. Johnson told the Dispatch. “I think this person isn’t well. ... I’m guessing they have GI issues.”
Monitoring wastewater for COVID-19 is only used to inform public health officials of community levels and spread of the virus. People with COVID are not tracked down using such information.
The Centers for Disease Control and Prevention told the Dispatch that the findings do not mean there’s a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC wrote in a statement to the newspaper. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
Ohio health officials told the newspaper that they don’t consider the situation a public health threat because the cryptic strain hasn’t spread beyond two sewer sheds for those 2 years.
Dr. Johnson and colleagues have been researching other unique COVID strains found in wastewater. They wrote a paper about a case in Wisconsin currently in preprint.
In the paper, the researchers suggest some people are persistently infected, calling them “prolonged shedders.” The researchers wrote that prolonged shedders could be human or “nonhuman,” and that “increased global monitoring of such lineages in wastewater could help anticipate future circulating mutations and/or variants of concern.”
Earlier in 2023, the CDC announced it was ending its community-level reporting of COVID test data and would rely more heavily on hospitalization reports and wastewater monitoring. COVID hospitalizations dipped to 7,212 nationally for the week of June 1-8, which is a 6% decline from the week prior, according to the CDC. That number of hospitalizations equals about two hospitalizations per 100,000 people.
A version of this article first appeared on WebMD.com.
The strain of the virus appears to be unique, the researchers said.
The mutated version of the virus was discovered by a team of researchers, led by University of Missouri–Columbia virologist Marc Johnson, PhD, that has been studying standalone mutations identified in wastewater. On Twitter, Dr. Johnson said their work could help warn people of a potential risk.
“If you knew of an exposure of a group of people to a deadly disease, there would be an obligation to inform them,” he wrote.
He believes the infected person lives in Columbus, works at a courthouse in a nearby county, and has gut health problems. The county where the person works has a population of just 15,000 people but had record COVID wastewater levels in May, The Columbus Dispatch reported. The unique COVID strain that Dr. Johnson is researching was the only COVID strain found in Fayette County’s wastewater.
“This person was shedding thousands of times more material than a normal person ever would,” Dr. Johnson told the Dispatch. “I think this person isn’t well. ... I’m guessing they have GI issues.”
Monitoring wastewater for COVID-19 is only used to inform public health officials of community levels and spread of the virus. People with COVID are not tracked down using such information.
The Centers for Disease Control and Prevention told the Dispatch that the findings do not mean there’s a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC wrote in a statement to the newspaper. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
Ohio health officials told the newspaper that they don’t consider the situation a public health threat because the cryptic strain hasn’t spread beyond two sewer sheds for those 2 years.
Dr. Johnson and colleagues have been researching other unique COVID strains found in wastewater. They wrote a paper about a case in Wisconsin currently in preprint.
In the paper, the researchers suggest some people are persistently infected, calling them “prolonged shedders.” The researchers wrote that prolonged shedders could be human or “nonhuman,” and that “increased global monitoring of such lineages in wastewater could help anticipate future circulating mutations and/or variants of concern.”
Earlier in 2023, the CDC announced it was ending its community-level reporting of COVID test data and would rely more heavily on hospitalization reports and wastewater monitoring. COVID hospitalizations dipped to 7,212 nationally for the week of June 1-8, which is a 6% decline from the week prior, according to the CDC. That number of hospitalizations equals about two hospitalizations per 100,000 people.
A version of this article first appeared on WebMD.com.
The strain of the virus appears to be unique, the researchers said.
The mutated version of the virus was discovered by a team of researchers, led by University of Missouri–Columbia virologist Marc Johnson, PhD, that has been studying standalone mutations identified in wastewater. On Twitter, Dr. Johnson said their work could help warn people of a potential risk.
“If you knew of an exposure of a group of people to a deadly disease, there would be an obligation to inform them,” he wrote.
He believes the infected person lives in Columbus, works at a courthouse in a nearby county, and has gut health problems. The county where the person works has a population of just 15,000 people but had record COVID wastewater levels in May, The Columbus Dispatch reported. The unique COVID strain that Dr. Johnson is researching was the only COVID strain found in Fayette County’s wastewater.
“This person was shedding thousands of times more material than a normal person ever would,” Dr. Johnson told the Dispatch. “I think this person isn’t well. ... I’m guessing they have GI issues.”
Monitoring wastewater for COVID-19 is only used to inform public health officials of community levels and spread of the virus. People with COVID are not tracked down using such information.
The Centers for Disease Control and Prevention told the Dispatch that the findings do not mean there’s a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC wrote in a statement to the newspaper. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
Ohio health officials told the newspaper that they don’t consider the situation a public health threat because the cryptic strain hasn’t spread beyond two sewer sheds for those 2 years.
Dr. Johnson and colleagues have been researching other unique COVID strains found in wastewater. They wrote a paper about a case in Wisconsin currently in preprint.
In the paper, the researchers suggest some people are persistently infected, calling them “prolonged shedders.” The researchers wrote that prolonged shedders could be human or “nonhuman,” and that “increased global monitoring of such lineages in wastewater could help anticipate future circulating mutations and/or variants of concern.”
Earlier in 2023, the CDC announced it was ending its community-level reporting of COVID test data and would rely more heavily on hospitalization reports and wastewater monitoring. COVID hospitalizations dipped to 7,212 nationally for the week of June 1-8, which is a 6% decline from the week prior, according to the CDC. That number of hospitalizations equals about two hospitalizations per 100,000 people.
A version of this article first appeared on WebMD.com.
Long COVID risk not higher with rheumatic diseases
MILAN – presented at the annual European Congress of Rheumatology.
Although more patients with inflammatory rheumatic diseases (iRD) report symptoms resembling long COVID, the data suggest that many of these symptoms can be attributed to the underlying rheumatic disease. “Overall, we find the data quite reassuring,” said Laura Boekel, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Center.
The results were also published in The Lancet Rheumatology.
The risk of developing long COVID after infection with the Omicron variant appeared to be higher in patients with iRD, with 21% meeting the criteria set by the World Health Organization, compared with 13% of healthy individuals (odds ratio, 1.58; P = .037). Fatigue and loss of fitness were the most common long COVID symptoms reported by both iRD patients and controls. However, the difference in risk decreased after accounting for factors that are significantly associated with an increased risk for long COVID, such as body mass index and the severity of the acute COVID-19 infection (adjusted OR, 1.46; P = .081). The duration of symptoms did not show a statistically significant difference.
Kim Lauper, MD, University of Geneva, who chaired the session in which Ms. Boekel reported the study, said in an interview that the data should be interpreted with caution. “The data demonstrate that rheumatic disease itself is not a risk factor for long COVID. However, patients with rheumatic diseases are at a higher risk of severe disease, which in turn increases the likelihood of long COVID. Therefore, as a population, these patients are more susceptible to long COVID overall.”
Moreover, irrespective of their previous COVID-19 infection status, iRD patients often exhibit symptoms similar to those of long COVID even without a prior COVID-19 infection. (There was no history of COVID-19 in 21% of iRD patients vs. 11% of controls.) This suggests that some of the reported long COVID symptoms may actually be clinical manifestations of the underlying rheumatic disease, thereby complicating the diagnosis of long COVID in this population. The study employed the WHO definition of long COVID, which includes persistent symptoms lasting at least 8 weeks, beginning within 3 months of a confirmed SARS-CoV-2 infection, and that cannot be attributed to an alternative diagnosis. However, the data presented in Milan indicate that the WHO definition “is not well suited for patients with iRD due to significant overlap in symptoms and features,” Ms. Boekel concluded.
The cases of Omicron COVID-19 were identified during Jan. 1–April 25, 2022, among iRD patients recruited from the Amsterdam Rheumatology and Immunology Center. The population with confirmed SARS-CoV-2 Omicron infection during this period was monitored for long COVID. The total number of patients included in the study consisted of 77 iRD patients and 23 healthy controls. When asked about the potential risk of selection bias in the survey, Ms. Boekel stated that only approximately 8% of participants declined to respond, and the nonresponders were comparable with the respondents. She concluded that “the risk of selection bias is minimal.”
In an editorial published in The Lancet Rheumatology, Leonard H. Calabrese, DO, Cleveland Clinic, provided his insights on the findings. He emphasized that, “at present, long COVID remains an important reality that significantly impacts the lives of millions of individuals, yet it remains incompletely defined. ... These limitations in defining cases should not in any way undermine the experiences of those suffering from long COVID. Instead, they should serve as a reminder that, at this stage of the pandemic, we unfortunately still lack validated classification criteria for long COVID. It is crucial to include non–SARS-CoV-2–infected controls in all studies to further enhance our understanding.”
Ms. Boekel and coauthors, as well as Dr. Lauper and Dr. Calabrese, reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
MILAN – presented at the annual European Congress of Rheumatology.
Although more patients with inflammatory rheumatic diseases (iRD) report symptoms resembling long COVID, the data suggest that many of these symptoms can be attributed to the underlying rheumatic disease. “Overall, we find the data quite reassuring,” said Laura Boekel, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Center.
The results were also published in The Lancet Rheumatology.
The risk of developing long COVID after infection with the Omicron variant appeared to be higher in patients with iRD, with 21% meeting the criteria set by the World Health Organization, compared with 13% of healthy individuals (odds ratio, 1.58; P = .037). Fatigue and loss of fitness were the most common long COVID symptoms reported by both iRD patients and controls. However, the difference in risk decreased after accounting for factors that are significantly associated with an increased risk for long COVID, such as body mass index and the severity of the acute COVID-19 infection (adjusted OR, 1.46; P = .081). The duration of symptoms did not show a statistically significant difference.
Kim Lauper, MD, University of Geneva, who chaired the session in which Ms. Boekel reported the study, said in an interview that the data should be interpreted with caution. “The data demonstrate that rheumatic disease itself is not a risk factor for long COVID. However, patients with rheumatic diseases are at a higher risk of severe disease, which in turn increases the likelihood of long COVID. Therefore, as a population, these patients are more susceptible to long COVID overall.”
Moreover, irrespective of their previous COVID-19 infection status, iRD patients often exhibit symptoms similar to those of long COVID even without a prior COVID-19 infection. (There was no history of COVID-19 in 21% of iRD patients vs. 11% of controls.) This suggests that some of the reported long COVID symptoms may actually be clinical manifestations of the underlying rheumatic disease, thereby complicating the diagnosis of long COVID in this population. The study employed the WHO definition of long COVID, which includes persistent symptoms lasting at least 8 weeks, beginning within 3 months of a confirmed SARS-CoV-2 infection, and that cannot be attributed to an alternative diagnosis. However, the data presented in Milan indicate that the WHO definition “is not well suited for patients with iRD due to significant overlap in symptoms and features,” Ms. Boekel concluded.
The cases of Omicron COVID-19 were identified during Jan. 1–April 25, 2022, among iRD patients recruited from the Amsterdam Rheumatology and Immunology Center. The population with confirmed SARS-CoV-2 Omicron infection during this period was monitored for long COVID. The total number of patients included in the study consisted of 77 iRD patients and 23 healthy controls. When asked about the potential risk of selection bias in the survey, Ms. Boekel stated that only approximately 8% of participants declined to respond, and the nonresponders were comparable with the respondents. She concluded that “the risk of selection bias is minimal.”
In an editorial published in The Lancet Rheumatology, Leonard H. Calabrese, DO, Cleveland Clinic, provided his insights on the findings. He emphasized that, “at present, long COVID remains an important reality that significantly impacts the lives of millions of individuals, yet it remains incompletely defined. ... These limitations in defining cases should not in any way undermine the experiences of those suffering from long COVID. Instead, they should serve as a reminder that, at this stage of the pandemic, we unfortunately still lack validated classification criteria for long COVID. It is crucial to include non–SARS-CoV-2–infected controls in all studies to further enhance our understanding.”
Ms. Boekel and coauthors, as well as Dr. Lauper and Dr. Calabrese, reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
MILAN – presented at the annual European Congress of Rheumatology.
Although more patients with inflammatory rheumatic diseases (iRD) report symptoms resembling long COVID, the data suggest that many of these symptoms can be attributed to the underlying rheumatic disease. “Overall, we find the data quite reassuring,” said Laura Boekel, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Center.
The results were also published in The Lancet Rheumatology.
The risk of developing long COVID after infection with the Omicron variant appeared to be higher in patients with iRD, with 21% meeting the criteria set by the World Health Organization, compared with 13% of healthy individuals (odds ratio, 1.58; P = .037). Fatigue and loss of fitness were the most common long COVID symptoms reported by both iRD patients and controls. However, the difference in risk decreased after accounting for factors that are significantly associated with an increased risk for long COVID, such as body mass index and the severity of the acute COVID-19 infection (adjusted OR, 1.46; P = .081). The duration of symptoms did not show a statistically significant difference.
Kim Lauper, MD, University of Geneva, who chaired the session in which Ms. Boekel reported the study, said in an interview that the data should be interpreted with caution. “The data demonstrate that rheumatic disease itself is not a risk factor for long COVID. However, patients with rheumatic diseases are at a higher risk of severe disease, which in turn increases the likelihood of long COVID. Therefore, as a population, these patients are more susceptible to long COVID overall.”
Moreover, irrespective of their previous COVID-19 infection status, iRD patients often exhibit symptoms similar to those of long COVID even without a prior COVID-19 infection. (There was no history of COVID-19 in 21% of iRD patients vs. 11% of controls.) This suggests that some of the reported long COVID symptoms may actually be clinical manifestations of the underlying rheumatic disease, thereby complicating the diagnosis of long COVID in this population. The study employed the WHO definition of long COVID, which includes persistent symptoms lasting at least 8 weeks, beginning within 3 months of a confirmed SARS-CoV-2 infection, and that cannot be attributed to an alternative diagnosis. However, the data presented in Milan indicate that the WHO definition “is not well suited for patients with iRD due to significant overlap in symptoms and features,” Ms. Boekel concluded.
The cases of Omicron COVID-19 were identified during Jan. 1–April 25, 2022, among iRD patients recruited from the Amsterdam Rheumatology and Immunology Center. The population with confirmed SARS-CoV-2 Omicron infection during this period was monitored for long COVID. The total number of patients included in the study consisted of 77 iRD patients and 23 healthy controls. When asked about the potential risk of selection bias in the survey, Ms. Boekel stated that only approximately 8% of participants declined to respond, and the nonresponders were comparable with the respondents. She concluded that “the risk of selection bias is minimal.”
In an editorial published in The Lancet Rheumatology, Leonard H. Calabrese, DO, Cleveland Clinic, provided his insights on the findings. He emphasized that, “at present, long COVID remains an important reality that significantly impacts the lives of millions of individuals, yet it remains incompletely defined. ... These limitations in defining cases should not in any way undermine the experiences of those suffering from long COVID. Instead, they should serve as a reminder that, at this stage of the pandemic, we unfortunately still lack validated classification criteria for long COVID. It is crucial to include non–SARS-CoV-2–infected controls in all studies to further enhance our understanding.”
Ms. Boekel and coauthors, as well as Dr. Lauper and Dr. Calabrese, reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT EULAR 2023
Menopause and long COVID: What women should know
British researchers have noted that women at midlife who have long COVID seem to get specific, and severe, symptoms, including brain fog, fatigue, new-onset dizziness, and difficulty sleeping through the night.
Doctors also think it’s possible that long COVID worsens the symptoms of perimenopause and menopause. Lower levels of estrogen and testosterone appear to be the reason.
“A long COVID theory is that there is a temporary disruption to physiological ovarian steroid hormone production, which could [worsen] symptoms of perimenopause and menopause,” said JoAnn V. Pinkerton, MD, professor of obstetrics at the University of Virginia, Charlottesville, and executive director of the North American Menopause Society.
Long COVID symptoms and menopause symptoms can also be very hard to tell apart.
Another U.K. study cautions that because of this kind of symptom overlap, women at midlife may be misdiagnosed. Research from the North American Menopause Society shows that many women may have trouble recovering from long COVID unless their hormone deficiency is treated.
What are the symptoms of long COVID?
There are over 200 symptoms that have been associated with long COVID, according to the American Medical Association. Some common symptoms are currently defined as the following: feeling extremely tired, feeling depleted after exertion, cognitive issues such as brain fog, heart beating over 100 times a minute, and a loss of sense of smell and taste.
Long COVID symptoms begin a few weeks to a few months after a COVID infection. They can last an indefinite amount of time, but “the hope is that long COVID will not be lifelong,” said Clare Flannery, MD, an endocrinologist and associate professor in the departments of obstetrics, gynecology and reproductive sciences and internal medicine at Yale University, New Haven, Conn.
What are the symptoms of menopause?
Some symptoms of menopause include vaginal infections, irregular bleeding, urinary problems, and sexual problems.
Women in their middle years have other symptoms that can be the same as perimenopause/menopause symptoms.
“Common symptoms of perimenopause and menopause which may also be symptoms ascribed to long COVID include hot flashes, night sweats, disrupted sleep, low mood, depression or anxiety, decreased concentration, memory problems, joint and muscle pains, and headaches,” Dr. Pinkerton said.
Can long COVID actually bring on menopause?
In short: Possibly.
A new study from the Massachusetts Institute of Technology/Patient-Led Research Collaborative/University of California, San Francisco, found that long COVID can cause disruptions to a woman’s menstrual cycle, ovaries, fertility, and menopause itself.
This could be caused by chronic inflammation caused by long COVID on hormones as well. This kind of inflammatory response could explain irregularities in a woman’s menstrual cycle, according to the Newson Health Research and Education study. For instance, “when the body has inflammation, ovulation can happen,” Dr. Flannery said.
The mechanism for how long COVID could spur menopause can also involve a woman’s ovaries.
“Since the theory is that COVID affects the ovary with declines in ovarian reserve and ovarian function, it makes sense that long COVID could bring on symptoms of perimenopause or menopause more acutely or more severely and lengthen the symptoms of the perimenopause and menopausal transition,” Dr. Pinkerton said.
How can hormone replacement therapy benefit women dealing with long COVID during menopause?
Estradiol, the strongest estrogen hormone in a woman’s body, has already been shown to have a positive effect against COVID.
“Estradiol therapy treats symptoms more aggressively in the setting of long COVID,” said Dr. Flannery.
Estradiol is also a form of hormone therapy for menopause symptoms.
“Estradiol has been shown to help hot flashes, night sweats, and sleep and improve mood during perimenopause,” said Dr. Pinkerton. “So it’s likely that perimenopausal or menopausal women with long COVID would see improvements both due to the action of estradiol on the ovary seen during COVID and the improvements in symptoms.”
Estrogen-based hormone therapy has been linked to an increased risk for endometrial, breast, and ovarian cancer, according to the American Cancer Society. This means you should carefully consider how comfortable you are with those additional risks before starting this kind of therapy.
“Which of your symptoms are the most difficult to manage? You may see if you can navigate one to three of them. What are you willing to do for your symptoms? If a woman is willing to favor her sleep for the next 6 months to a year, she may be willing to change how she perceives her risk for cancer,” Dr. Flannery said. “What risk is a woman willing to take? I think if someone has a very low concern about a risk of cancer, and she’s suffering a disrupted life, then taking estradiol in a 1- to 2-year trial period could be critical to help.”
What else can help ease long COVID during menopause?
Getting the COVID vaccine, as well as getting a booster, could help. Not only will this help prevent people from being reinfected with COVID, which can worsen symptoms, but a new Swedish study says there is no evidence that it will cause postmenopausal problems like irregular bleeding.
“Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal,” said study coauthor Rickard Ljung, MD, PhD, MPH, professor and acting head of the pharmacoepidemiology and analysis department in the division of use and information of the Swedish Medical Products Agency in Uppsala.
A version of this article first appeared on WebMD.com.
British researchers have noted that women at midlife who have long COVID seem to get specific, and severe, symptoms, including brain fog, fatigue, new-onset dizziness, and difficulty sleeping through the night.
Doctors also think it’s possible that long COVID worsens the symptoms of perimenopause and menopause. Lower levels of estrogen and testosterone appear to be the reason.
“A long COVID theory is that there is a temporary disruption to physiological ovarian steroid hormone production, which could [worsen] symptoms of perimenopause and menopause,” said JoAnn V. Pinkerton, MD, professor of obstetrics at the University of Virginia, Charlottesville, and executive director of the North American Menopause Society.
Long COVID symptoms and menopause symptoms can also be very hard to tell apart.
Another U.K. study cautions that because of this kind of symptom overlap, women at midlife may be misdiagnosed. Research from the North American Menopause Society shows that many women may have trouble recovering from long COVID unless their hormone deficiency is treated.
What are the symptoms of long COVID?
There are over 200 symptoms that have been associated with long COVID, according to the American Medical Association. Some common symptoms are currently defined as the following: feeling extremely tired, feeling depleted after exertion, cognitive issues such as brain fog, heart beating over 100 times a minute, and a loss of sense of smell and taste.
Long COVID symptoms begin a few weeks to a few months after a COVID infection. They can last an indefinite amount of time, but “the hope is that long COVID will not be lifelong,” said Clare Flannery, MD, an endocrinologist and associate professor in the departments of obstetrics, gynecology and reproductive sciences and internal medicine at Yale University, New Haven, Conn.
What are the symptoms of menopause?
Some symptoms of menopause include vaginal infections, irregular bleeding, urinary problems, and sexual problems.
Women in their middle years have other symptoms that can be the same as perimenopause/menopause symptoms.
“Common symptoms of perimenopause and menopause which may also be symptoms ascribed to long COVID include hot flashes, night sweats, disrupted sleep, low mood, depression or anxiety, decreased concentration, memory problems, joint and muscle pains, and headaches,” Dr. Pinkerton said.
Can long COVID actually bring on menopause?
In short: Possibly.
A new study from the Massachusetts Institute of Technology/Patient-Led Research Collaborative/University of California, San Francisco, found that long COVID can cause disruptions to a woman’s menstrual cycle, ovaries, fertility, and menopause itself.
This could be caused by chronic inflammation caused by long COVID on hormones as well. This kind of inflammatory response could explain irregularities in a woman’s menstrual cycle, according to the Newson Health Research and Education study. For instance, “when the body has inflammation, ovulation can happen,” Dr. Flannery said.
The mechanism for how long COVID could spur menopause can also involve a woman’s ovaries.
“Since the theory is that COVID affects the ovary with declines in ovarian reserve and ovarian function, it makes sense that long COVID could bring on symptoms of perimenopause or menopause more acutely or more severely and lengthen the symptoms of the perimenopause and menopausal transition,” Dr. Pinkerton said.
How can hormone replacement therapy benefit women dealing with long COVID during menopause?
Estradiol, the strongest estrogen hormone in a woman’s body, has already been shown to have a positive effect against COVID.
“Estradiol therapy treats symptoms more aggressively in the setting of long COVID,” said Dr. Flannery.
Estradiol is also a form of hormone therapy for menopause symptoms.
“Estradiol has been shown to help hot flashes, night sweats, and sleep and improve mood during perimenopause,” said Dr. Pinkerton. “So it’s likely that perimenopausal or menopausal women with long COVID would see improvements both due to the action of estradiol on the ovary seen during COVID and the improvements in symptoms.”
Estrogen-based hormone therapy has been linked to an increased risk for endometrial, breast, and ovarian cancer, according to the American Cancer Society. This means you should carefully consider how comfortable you are with those additional risks before starting this kind of therapy.
“Which of your symptoms are the most difficult to manage? You may see if you can navigate one to three of them. What are you willing to do for your symptoms? If a woman is willing to favor her sleep for the next 6 months to a year, she may be willing to change how she perceives her risk for cancer,” Dr. Flannery said. “What risk is a woman willing to take? I think if someone has a very low concern about a risk of cancer, and she’s suffering a disrupted life, then taking estradiol in a 1- to 2-year trial period could be critical to help.”
What else can help ease long COVID during menopause?
Getting the COVID vaccine, as well as getting a booster, could help. Not only will this help prevent people from being reinfected with COVID, which can worsen symptoms, but a new Swedish study says there is no evidence that it will cause postmenopausal problems like irregular bleeding.
“Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal,” said study coauthor Rickard Ljung, MD, PhD, MPH, professor and acting head of the pharmacoepidemiology and analysis department in the division of use and information of the Swedish Medical Products Agency in Uppsala.
A version of this article first appeared on WebMD.com.
British researchers have noted that women at midlife who have long COVID seem to get specific, and severe, symptoms, including brain fog, fatigue, new-onset dizziness, and difficulty sleeping through the night.
Doctors also think it’s possible that long COVID worsens the symptoms of perimenopause and menopause. Lower levels of estrogen and testosterone appear to be the reason.
“A long COVID theory is that there is a temporary disruption to physiological ovarian steroid hormone production, which could [worsen] symptoms of perimenopause and menopause,” said JoAnn V. Pinkerton, MD, professor of obstetrics at the University of Virginia, Charlottesville, and executive director of the North American Menopause Society.
Long COVID symptoms and menopause symptoms can also be very hard to tell apart.
Another U.K. study cautions that because of this kind of symptom overlap, women at midlife may be misdiagnosed. Research from the North American Menopause Society shows that many women may have trouble recovering from long COVID unless their hormone deficiency is treated.
What are the symptoms of long COVID?
There are over 200 symptoms that have been associated with long COVID, according to the American Medical Association. Some common symptoms are currently defined as the following: feeling extremely tired, feeling depleted after exertion, cognitive issues such as brain fog, heart beating over 100 times a minute, and a loss of sense of smell and taste.
Long COVID symptoms begin a few weeks to a few months after a COVID infection. They can last an indefinite amount of time, but “the hope is that long COVID will not be lifelong,” said Clare Flannery, MD, an endocrinologist and associate professor in the departments of obstetrics, gynecology and reproductive sciences and internal medicine at Yale University, New Haven, Conn.
What are the symptoms of menopause?
Some symptoms of menopause include vaginal infections, irregular bleeding, urinary problems, and sexual problems.
Women in their middle years have other symptoms that can be the same as perimenopause/menopause symptoms.
“Common symptoms of perimenopause and menopause which may also be symptoms ascribed to long COVID include hot flashes, night sweats, disrupted sleep, low mood, depression or anxiety, decreased concentration, memory problems, joint and muscle pains, and headaches,” Dr. Pinkerton said.
Can long COVID actually bring on menopause?
In short: Possibly.
A new study from the Massachusetts Institute of Technology/Patient-Led Research Collaborative/University of California, San Francisco, found that long COVID can cause disruptions to a woman’s menstrual cycle, ovaries, fertility, and menopause itself.
This could be caused by chronic inflammation caused by long COVID on hormones as well. This kind of inflammatory response could explain irregularities in a woman’s menstrual cycle, according to the Newson Health Research and Education study. For instance, “when the body has inflammation, ovulation can happen,” Dr. Flannery said.
The mechanism for how long COVID could spur menopause can also involve a woman’s ovaries.
“Since the theory is that COVID affects the ovary with declines in ovarian reserve and ovarian function, it makes sense that long COVID could bring on symptoms of perimenopause or menopause more acutely or more severely and lengthen the symptoms of the perimenopause and menopausal transition,” Dr. Pinkerton said.
How can hormone replacement therapy benefit women dealing with long COVID during menopause?
Estradiol, the strongest estrogen hormone in a woman’s body, has already been shown to have a positive effect against COVID.
“Estradiol therapy treats symptoms more aggressively in the setting of long COVID,” said Dr. Flannery.
Estradiol is also a form of hormone therapy for menopause symptoms.
“Estradiol has been shown to help hot flashes, night sweats, and sleep and improve mood during perimenopause,” said Dr. Pinkerton. “So it’s likely that perimenopausal or menopausal women with long COVID would see improvements both due to the action of estradiol on the ovary seen during COVID and the improvements in symptoms.”
Estrogen-based hormone therapy has been linked to an increased risk for endometrial, breast, and ovarian cancer, according to the American Cancer Society. This means you should carefully consider how comfortable you are with those additional risks before starting this kind of therapy.
“Which of your symptoms are the most difficult to manage? You may see if you can navigate one to three of them. What are you willing to do for your symptoms? If a woman is willing to favor her sleep for the next 6 months to a year, she may be willing to change how she perceives her risk for cancer,” Dr. Flannery said. “What risk is a woman willing to take? I think if someone has a very low concern about a risk of cancer, and she’s suffering a disrupted life, then taking estradiol in a 1- to 2-year trial period could be critical to help.”
What else can help ease long COVID during menopause?
Getting the COVID vaccine, as well as getting a booster, could help. Not only will this help prevent people from being reinfected with COVID, which can worsen symptoms, but a new Swedish study says there is no evidence that it will cause postmenopausal problems like irregular bleeding.
“Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal,” said study coauthor Rickard Ljung, MD, PhD, MPH, professor and acting head of the pharmacoepidemiology and analysis department in the division of use and information of the Swedish Medical Products Agency in Uppsala.
A version of this article first appeared on WebMD.com.
COVID vaccines safe for young children, study finds
TOPLINE:
COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.
METHODOLOGY:
- Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
- Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech , and 112,006 doses given to children aged 5 and younger who received the Moderna version.
- Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.
TAKEAWAY:
- One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.
IN PRACTICE:
“These results can provide reassurance to clinicians, parents, and policymakers alike.”
STUDY DETAILS:
The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and was funded by the Centers for Disease Control and Prevention.
LIMITATIONS:
The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.
DISCLOSURES:
A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.
A version of this article first appeared on Medscape.com.
TOPLINE:
COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.
METHODOLOGY:
- Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
- Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech , and 112,006 doses given to children aged 5 and younger who received the Moderna version.
- Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.
TAKEAWAY:
- One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.
IN PRACTICE:
“These results can provide reassurance to clinicians, parents, and policymakers alike.”
STUDY DETAILS:
The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and was funded by the Centers for Disease Control and Prevention.
LIMITATIONS:
The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.
DISCLOSURES:
A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.
A version of this article first appeared on Medscape.com.
TOPLINE:
COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.
METHODOLOGY:
- Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
- Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech , and 112,006 doses given to children aged 5 and younger who received the Moderna version.
- Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.
TAKEAWAY:
- One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.
IN PRACTICE:
“These results can provide reassurance to clinicians, parents, and policymakers alike.”
STUDY DETAILS:
The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and was funded by the Centers for Disease Control and Prevention.
LIMITATIONS:
The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.
DISCLOSURES:
A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.
A version of this article first appeared on Medscape.com.
FROM PEDIATRICS