COVID-19 Updates

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

As restrictions lift and mask mandates become scarce, Americans are filling their social calendars and booking vacations. While some are rejoicing, health care professionals say others are emerging from the pandemic with more health-related fears.

COVID-19 has caused more anxiety and depression for many over the course of the pandemic. A survey from the CDC and the Census Bureau found the percentage of adults with symptoms of an anxiety or depressive disorder increased from 36.4% to 41.5% from August 2020 to February 2021.

But this phenomenon will not just disappear as COVID-19 cases decrease, said Reese Druckenmiller, a clinical social worker for the Mayo Clinic Health System.

“There are still people out there not wanting to leave home,” she said. “Some folks inherently struggle with anxiety more than others, and we know anxiety can come from different experiences and traumas. This pandemic has been traumatic for people.”

Though there is little research on the psychological effects of pandemic outbreaks, scientists are beginning to explore this. A recent review published in the International Journal of Cognitive Therapy concluded that, based on available research and the effects of previous pandemics, COVID-19 will likely have a significant effect on people’s mental health, particularly those who already have obsessive-compulsive disorder and health anxiety, along with people on the front line of health care.

According to the authors, since the virus doesn’t have symptoms among certain populations, there’s more anxiety about becoming infected and unknowingly spreading it to vulnerable people.

Not to mention the influx of anxiety-provoking news over the past year, Ms. Druckenmiller noted.

“One thing I noticed during the pandemic: The news changed. There were still regular news stories, but at the forefront of every single newscast was the numbers, how many people have died, how many people are hospitalized,” she said.

Some of Ms. Druckenmiller’s own patients who are more health-focused saw this as an added burden – another source of anxiety.

For those still uncomfortable with an abrupt reentry into public spaces, Ms. Druckenmiller recommended taking small steps. Start leaving the house every day, she suggested, even if it’s just for a walk. It is also important to be honest with loved ones about your own comfort level.

“Our brain is very flexible and fluid, but it also doesn’t just switch on a dime,” she said. “If I’ve been told over the past year this is a horrible thing that could kill me, my brain can’t adjust that fast. We need evidence through experience.”

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

As restrictions lift and mask mandates become scarce, Americans are filling their social calendars and booking vacations. While some are rejoicing, health care professionals say others are emerging from the pandemic with more health-related fears.

COVID-19 has caused more anxiety and depression for many over the course of the pandemic. A survey from the CDC and the Census Bureau found the percentage of adults with symptoms of an anxiety or depressive disorder increased from 36.4% to 41.5% from August 2020 to February 2021.

But this phenomenon will not just disappear as COVID-19 cases decrease, said Reese Druckenmiller, a clinical social worker for the Mayo Clinic Health System.

“There are still people out there not wanting to leave home,” she said. “Some folks inherently struggle with anxiety more than others, and we know anxiety can come from different experiences and traumas. This pandemic has been traumatic for people.”

Though there is little research on the psychological effects of pandemic outbreaks, scientists are beginning to explore this. A recent review published in the International Journal of Cognitive Therapy concluded that, based on available research and the effects of previous pandemics, COVID-19 will likely have a significant effect on people’s mental health, particularly those who already have obsessive-compulsive disorder and health anxiety, along with people on the front line of health care.

According to the authors, since the virus doesn’t have symptoms among certain populations, there’s more anxiety about becoming infected and unknowingly spreading it to vulnerable people.

Not to mention the influx of anxiety-provoking news over the past year, Ms. Druckenmiller noted.

“One thing I noticed during the pandemic: The news changed. There were still regular news stories, but at the forefront of every single newscast was the numbers, how many people have died, how many people are hospitalized,” she said.

Some of Ms. Druckenmiller’s own patients who are more health-focused saw this as an added burden – another source of anxiety.

For those still uncomfortable with an abrupt reentry into public spaces, Ms. Druckenmiller recommended taking small steps. Start leaving the house every day, she suggested, even if it’s just for a walk. It is also important to be honest with loved ones about your own comfort level.

“Our brain is very flexible and fluid, but it also doesn’t just switch on a dime,” she said. “If I’ve been told over the past year this is a horrible thing that could kill me, my brain can’t adjust that fast. We need evidence through experience.”

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

As restrictions lift and mask mandates become scarce, Americans are filling their social calendars and booking vacations. While some are rejoicing, health care professionals say others are emerging from the pandemic with more health-related fears.

COVID-19 has caused more anxiety and depression for many over the course of the pandemic. A survey from the CDC and the Census Bureau found the percentage of adults with symptoms of an anxiety or depressive disorder increased from 36.4% to 41.5% from August 2020 to February 2021.

But this phenomenon will not just disappear as COVID-19 cases decrease, said Reese Druckenmiller, a clinical social worker for the Mayo Clinic Health System.

“There are still people out there not wanting to leave home,” she said. “Some folks inherently struggle with anxiety more than others, and we know anxiety can come from different experiences and traumas. This pandemic has been traumatic for people.”

Though there is little research on the psychological effects of pandemic outbreaks, scientists are beginning to explore this. A recent review published in the International Journal of Cognitive Therapy concluded that, based on available research and the effects of previous pandemics, COVID-19 will likely have a significant effect on people’s mental health, particularly those who already have obsessive-compulsive disorder and health anxiety, along with people on the front line of health care.

According to the authors, since the virus doesn’t have symptoms among certain populations, there’s more anxiety about becoming infected and unknowingly spreading it to vulnerable people.

Not to mention the influx of anxiety-provoking news over the past year, Ms. Druckenmiller noted.

“One thing I noticed during the pandemic: The news changed. There were still regular news stories, but at the forefront of every single newscast was the numbers, how many people have died, how many people are hospitalized,” she said.

Some of Ms. Druckenmiller’s own patients who are more health-focused saw this as an added burden – another source of anxiety.

For those still uncomfortable with an abrupt reentry into public spaces, Ms. Druckenmiller recommended taking small steps. Start leaving the house every day, she suggested, even if it’s just for a walk. It is also important to be honest with loved ones about your own comfort level.

“Our brain is very flexible and fluid, but it also doesn’t just switch on a dime,” she said. “If I’ve been told over the past year this is a horrible thing that could kill me, my brain can’t adjust that fast. We need evidence through experience.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Houston Methodist Hospital in June 2021 enforced an April mandate that all its employees, about 26,000 of them, must be vaccinated against COVID-19. In the following weeks, many other large health care systems adopted a similar employer mandate.

Compliance with Houston Methodist’s mandate has been very high at nearly 99%. There were some deferrals, mostly because of pregnancy. There were some “medical and personal” exemptions for less than 1% of employees. The reasons for those personal exemptions have not been made public. A lawsuit by 117 employees objecting to the vaccine mandate was dismissed by a federal district judge on June 12.

Objections to the vaccine mandate have rarely involved religious-based conscientious objections, which need to be accommodated differently, legally and ethically. The objections have been disagreements on the science. As a politician said decades ago: “People are entitled to their own opinions, but not their own facts.” A medical institution is an excellent organization for determining the risks and benefits of vaccination. The judge dismissing the case was very critical of the characterizations used by the plaintiffs.

The vaccine mandate has strong ethical support from both the universalizability principle of Kant and a consequentialist analysis. The U.S. Equal Employment Opportunity Commission on May 28, 2021, released technical assistance that has generally been interpreted to support an employer’s right to set vaccine requirements. HIPAA does not forbid an employer from asking about vaccination, but the EEOC guidance reminds employers that if they do ask, employers have legal obligations to protect the health information and keep it separate from other personnel files.

In the past few years, many hospitals and clinics have adopted mandates for influenza vaccines. In many children’s hospitals staff have been required to have chicken pox vaccines (or, as in my case, titers showing immunity from the real thing – I’m old) since the early 2000s. Measles titers (again, mine were acquired naturally – I still remember the illness and recommend against that) and TB status are occasionally required for locum tenens positions. I keep copies of these labs alongside copies of my diplomas. To me, the COVID-19 mandate is not capricious.

Some people have pointed out that the COVID-19 vaccines are not fully Food and Drug Administration approved. They are used under an emergency use authorization. Any traction that distinction might have had ethically and scientifically in November 2020 has disappeared with the experience of 9 months and 300 million doses in the United States. Dr. Fauci on July 11, 2021, said: “These vaccines are as good as officially approved with all the I’s dotted and the T’s crossed.”

On July 12, 2021, French President Macron, facing a resurgence of the pandemic because of the delta variant, announced a national vaccine mandate for all health care workers. He also announced plans to require proof of vaccination (or prior disease) in order to enter amusement parks, restaurants, and other public facilities. The ethics of his plans have been debated by ethicists and politicians for months under the rubric of a “vaccine passport.” England has required proof of vaccination or a recent negative COVID-19 test before entering soccer stadiums. In the United States, some localities, particularly those where the local politicians are against the vaccine, have passed laws proscribing the creation of these passport-like restrictions. Elsewhere, many businesses have already started to exclude customers who are not vaccinated. Airlines, hotels, and cruise ships are at the forefront of this. Society has started to create consequences for not getting the vaccine. President Macron indicated that the goal was now to put restrictions on the unvaccinated rather than on everyone.

Pediatricians are experts on the importance of consequences for misbehavior and refusals. It is a frequent topic of conversation with parents of toddlers and teenagers. Consequences are ethical, just, and effective ways of promoting safe and fair behavior. At this point, the public has been educated about the disease and the vaccines. In the United States, there has been ample access to the vaccine. It is time to enforce consequences.

Daily vaccination rates in the United States have slowed to 25% of the peak rates. The reasons for hesitancy have been analyzed in many publications. Further public education hasn’t been productive, so empathic listening has been urged to overcome hesitancy. (A similar program has long been advocated to deal with hesitancy for teenage HPV vaccines.) President Biden on July 6, 2021, proposed a program of going door to door to overcome resistance.

The world is in a race between vaccines and the delta variant. The Delta variant is moving the finish line, with some French epidemiologists advising President Macron that this more contagious variant may require a 90% vaccination level to achieve herd immunity. Israel has started giving a third booster shot in select situations and Pfizer is considering the idea. I agree with providing education, using empathic listening, and improving access. Those are all reasonable, even necessary, strategies. But at this point, I anchor my suggestions with the same advice pediatricians have long given to parents. Set rules and create consequences for misbehavior.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures. Email him at [email protected].

Houston Methodist Hospital in June 2021 enforced an April mandate that all its employees, about 26,000 of them, must be vaccinated against COVID-19. In the following weeks, many other large health care systems adopted a similar employer mandate.

Compliance with Houston Methodist’s mandate has been very high at nearly 99%. There were some deferrals, mostly because of pregnancy. There were some “medical and personal” exemptions for less than 1% of employees. The reasons for those personal exemptions have not been made public. A lawsuit by 117 employees objecting to the vaccine mandate was dismissed by a federal district judge on June 12.

Objections to the vaccine mandate have rarely involved religious-based conscientious objections, which need to be accommodated differently, legally and ethically. The objections have been disagreements on the science. As a politician said decades ago: “People are entitled to their own opinions, but not their own facts.” A medical institution is an excellent organization for determining the risks and benefits of vaccination. The judge dismissing the case was very critical of the characterizations used by the plaintiffs.

The vaccine mandate has strong ethical support from both the universalizability principle of Kant and a consequentialist analysis. The U.S. Equal Employment Opportunity Commission on May 28, 2021, released technical assistance that has generally been interpreted to support an employer’s right to set vaccine requirements. HIPAA does not forbid an employer from asking about vaccination, but the EEOC guidance reminds employers that if they do ask, employers have legal obligations to protect the health information and keep it separate from other personnel files.

In the past few years, many hospitals and clinics have adopted mandates for influenza vaccines. In many children’s hospitals staff have been required to have chicken pox vaccines (or, as in my case, titers showing immunity from the real thing – I’m old) since the early 2000s. Measles titers (again, mine were acquired naturally – I still remember the illness and recommend against that) and TB status are occasionally required for locum tenens positions. I keep copies of these labs alongside copies of my diplomas. To me, the COVID-19 mandate is not capricious.

Some people have pointed out that the COVID-19 vaccines are not fully Food and Drug Administration approved. They are used under an emergency use authorization. Any traction that distinction might have had ethically and scientifically in November 2020 has disappeared with the experience of 9 months and 300 million doses in the United States. Dr. Fauci on July 11, 2021, said: “These vaccines are as good as officially approved with all the I’s dotted and the T’s crossed.”

On July 12, 2021, French President Macron, facing a resurgence of the pandemic because of the delta variant, announced a national vaccine mandate for all health care workers. He also announced plans to require proof of vaccination (or prior disease) in order to enter amusement parks, restaurants, and other public facilities. The ethics of his plans have been debated by ethicists and politicians for months under the rubric of a “vaccine passport.” England has required proof of vaccination or a recent negative COVID-19 test before entering soccer stadiums. In the United States, some localities, particularly those where the local politicians are against the vaccine, have passed laws proscribing the creation of these passport-like restrictions. Elsewhere, many businesses have already started to exclude customers who are not vaccinated. Airlines, hotels, and cruise ships are at the forefront of this. Society has started to create consequences for not getting the vaccine. President Macron indicated that the goal was now to put restrictions on the unvaccinated rather than on everyone.

Pediatricians are experts on the importance of consequences for misbehavior and refusals. It is a frequent topic of conversation with parents of toddlers and teenagers. Consequences are ethical, just, and effective ways of promoting safe and fair behavior. At this point, the public has been educated about the disease and the vaccines. In the United States, there has been ample access to the vaccine. It is time to enforce consequences.

Daily vaccination rates in the United States have slowed to 25% of the peak rates. The reasons for hesitancy have been analyzed in many publications. Further public education hasn’t been productive, so empathic listening has been urged to overcome hesitancy. (A similar program has long been advocated to deal with hesitancy for teenage HPV vaccines.) President Biden on July 6, 2021, proposed a program of going door to door to overcome resistance.

The world is in a race between vaccines and the delta variant. The Delta variant is moving the finish line, with some French epidemiologists advising President Macron that this more contagious variant may require a 90% vaccination level to achieve herd immunity. Israel has started giving a third booster shot in select situations and Pfizer is considering the idea. I agree with providing education, using empathic listening, and improving access. Those are all reasonable, even necessary, strategies. But at this point, I anchor my suggestions with the same advice pediatricians have long given to parents. Set rules and create consequences for misbehavior.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures. Email him at [email protected].

Houston Methodist Hospital in June 2021 enforced an April mandate that all its employees, about 26,000 of them, must be vaccinated against COVID-19. In the following weeks, many other large health care systems adopted a similar employer mandate.

Compliance with Houston Methodist’s mandate has been very high at nearly 99%. There were some deferrals, mostly because of pregnancy. There were some “medical and personal” exemptions for less than 1% of employees. The reasons for those personal exemptions have not been made public. A lawsuit by 117 employees objecting to the vaccine mandate was dismissed by a federal district judge on June 12.

Objections to the vaccine mandate have rarely involved religious-based conscientious objections, which need to be accommodated differently, legally and ethically. The objections have been disagreements on the science. As a politician said decades ago: “People are entitled to their own opinions, but not their own facts.” A medical institution is an excellent organization for determining the risks and benefits of vaccination. The judge dismissing the case was very critical of the characterizations used by the plaintiffs.

The vaccine mandate has strong ethical support from both the universalizability principle of Kant and a consequentialist analysis. The U.S. Equal Employment Opportunity Commission on May 28, 2021, released technical assistance that has generally been interpreted to support an employer’s right to set vaccine requirements. HIPAA does not forbid an employer from asking about vaccination, but the EEOC guidance reminds employers that if they do ask, employers have legal obligations to protect the health information and keep it separate from other personnel files.

In the past few years, many hospitals and clinics have adopted mandates for influenza vaccines. In many children’s hospitals staff have been required to have chicken pox vaccines (or, as in my case, titers showing immunity from the real thing – I’m old) since the early 2000s. Measles titers (again, mine were acquired naturally – I still remember the illness and recommend against that) and TB status are occasionally required for locum tenens positions. I keep copies of these labs alongside copies of my diplomas. To me, the COVID-19 mandate is not capricious.

Some people have pointed out that the COVID-19 vaccines are not fully Food and Drug Administration approved. They are used under an emergency use authorization. Any traction that distinction might have had ethically and scientifically in November 2020 has disappeared with the experience of 9 months and 300 million doses in the United States. Dr. Fauci on July 11, 2021, said: “These vaccines are as good as officially approved with all the I’s dotted and the T’s crossed.”

On July 12, 2021, French President Macron, facing a resurgence of the pandemic because of the delta variant, announced a national vaccine mandate for all health care workers. He also announced plans to require proof of vaccination (or prior disease) in order to enter amusement parks, restaurants, and other public facilities. The ethics of his plans have been debated by ethicists and politicians for months under the rubric of a “vaccine passport.” England has required proof of vaccination or a recent negative COVID-19 test before entering soccer stadiums. In the United States, some localities, particularly those where the local politicians are against the vaccine, have passed laws proscribing the creation of these passport-like restrictions. Elsewhere, many businesses have already started to exclude customers who are not vaccinated. Airlines, hotels, and cruise ships are at the forefront of this. Society has started to create consequences for not getting the vaccine. President Macron indicated that the goal was now to put restrictions on the unvaccinated rather than on everyone.

Pediatricians are experts on the importance of consequences for misbehavior and refusals. It is a frequent topic of conversation with parents of toddlers and teenagers. Consequences are ethical, just, and effective ways of promoting safe and fair behavior. At this point, the public has been educated about the disease and the vaccines. In the United States, there has been ample access to the vaccine. It is time to enforce consequences.

Daily vaccination rates in the United States have slowed to 25% of the peak rates. The reasons for hesitancy have been analyzed in many publications. Further public education hasn’t been productive, so empathic listening has been urged to overcome hesitancy. (A similar program has long been advocated to deal with hesitancy for teenage HPV vaccines.) President Biden on July 6, 2021, proposed a program of going door to door to overcome resistance.

The world is in a race between vaccines and the delta variant. The Delta variant is moving the finish line, with some French epidemiologists advising President Macron that this more contagious variant may require a 90% vaccination level to achieve herd immunity. Israel has started giving a third booster shot in select situations and Pfizer is considering the idea. I agree with providing education, using empathic listening, and improving access. Those are all reasonable, even necessary, strategies. But at this point, I anchor my suggestions with the same advice pediatricians have long given to parents. Set rules and create consequences for misbehavior.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures. Email him at [email protected].

As your patients return to your offices for annual exams and sports physicals before the school year starts, everyone will still be processing the challenges, losses, and grief that have marked end of the COVID experience. There will be questions about the safety of vaccines for younger children, whether foreign travel is now a reasonable option, and about how best to help children – school age and teenagers, vulnerable and secure – get their footing socially and academically in the new school year. But dig a little, and you may hear about the silver linings of this past year: children who enjoyed having more time with their parents, parents who were with their families rather than in a car commuting for hours a day or traveling many days a month, grocery deliveries that eased the parent’s workload, adolescents who were able to pull back from overscheduled days, and opportunities for calm conversations that occurred quite naturally during nightly family dinners. Office visits present a dual opportunity to review – what were the psychological costs of COVID and what were positive personal and family adaptations to COVID they may want to continue as the pandemic ends?

Family dinner: Whether because sports practice was suspended, schooling was virtual, or working was at home, many families returned to eating dinner together during the pandemic year. Nightly dinners are a simple but powerful routine allowing all members of a family to reconnect and recharge together, and they are often the first things to disappear in the face of school, sports, and work demands. Research over the past several decades has demonstrated that regular family dinners are associated with better academic performance and higher self-esteem in children. They are also associated with lower rates of depression, substance abuse, eating disorders, and pregnancy in adolescents. Finally, they are associated with better cardiovascular health and lower rates of obesity in both youth and parents. The response is dose dependent, with more regular dinners leading to better outcomes. The food can be simple, what matters most is that the tone is warm, sharing, and curious, not rigid and controlling. Families can be an essential source of support as they help put events and feelings into context, giving them meaning or a framework based on the parents’ past, values, or perspective and on the family’s cultural history. Everyone benefits as family members cope with small and large setbacks, share values, and celebrate one another’s small and large successes. The return of the family dinner table, as often as is reasonable, is one “consequence” of COVID that families should try to preserve.

Consistent virtual family visits: Many families managed the cancellation of holiday visits or supported elderly relatives by connecting with family virtually. For some families, a weekly Zoom call came to function like a weekly family dinner with cousins and grandparents. Not only do these regular video calls protect elderly relatives from loneliness and isolation, but they also made it very easy for extended families to stay connected. Children cannot have too many caring adults around them, and regular calls mean that aunts, uncles, and grandparents can be an enthusiastic audience for their achievements and can offer perspective and guidance when needed. Staying connected without having to manage hours of travel makes it easy to build and maintain these family connections, creating bonds that will be deeper and stronger. Like family dinner, regular virtual gatherings with extended family are unequivocally beneficial for younger and older children and a valuable legacy of COVID.

Lowering the pressure: Many children struggled to stay engaged with virtual school and deeply missed time with friends or in activities like woodshop, soccer, or theater. But many other children had a chance to slow down from a relentless schedule of school, homework, sports, clubs, music lessons, tutoring, and on and on. For these children, many of whom are intensely ambitious and were not willing to voluntarily give up any activities, the forced slowdown of COVID has offered a new perspective on how they might manage their time. The COVID slowdown shone a light on the value of spending enough time in an activity to really learn it, and then choosing which activities to continue to explore and master, while opening time to explore new activities. There was also more time for “senseless fun,” activities that do not lead to achievement or recognition, but are simply fun, e.g., playing video games, splashing in a pool, or surfing the web. This process is critical to healthy development in early and later adolescence, and for many driven teenagers, it has been replaced by a tightly packed schedule of activities they felt they “should” be doing. If these young people hear from you that not only does the COVID pace feel better, but it can also contribute to better health and more meaningful learning and engagement, they may adopt a more thoughtful and intentional approach to managing their most precious asset – their time. Your discussion about prioritizing healthy exercise, virtual visits with friends, hobbies, or even senseless fun might reset the pressure gauge from high to moderate.

Homework help: Many children (and teenagers) found that their parents became an important source of academic support during the year of virtual school. While few parents welcomed the chance to master calculus, it is powerful for parents to know what their children are facing at school and for children to know that their parents are available to help them when they face a challenge. When parents can bear uncertainty, frustration, and even failure alongside their children, they help their children to cultivate tenacity and resilience, whether or not they can help them with a chemistry problem. Some parents will have special skills like knowing a language, being a good writer, or an academic expertise related to their work. But what matters more is working out how to help, not pressure or argue – how to share knowledge in a pleasurable manner. While it is important for children to have access to teachers and tutors with the knowledge and skills to help them learn specific subjects, the positive presence and involvement of their parents can make a valuable contribution to their psychological and educational development.

New ritual: Over the past 16 months, families found many creative ways to pass time together, from evening walks to reading aloud, listening to music, and even mastering new card games. The family evenings of a century earlier, when family members listened together to radio programs, practiced music, or played board games, seemed to have returned. While everyone could still escape to their own space to be on a screen activity alone, solitary computer time was leavened by collective time. Families may have rediscovered joy in shared recreation, exploration, or diversion. This kind of family time is a reward in itself, but it also deepens a child’s connections to everyone in their family. Such time provides lessons in how to turn boredom into something meaningful and even fun. COVID forced families inward and gave them more time. There were many costs including illness, deaths of friends and relatives, loss of time with peers, missed activities and milestones, and an impaired education. However, many of the coerced adaptations had a silver lining or unanticipated benefit. Keeping some of those benefits post COVID could enhance the lives of every member of the family.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

As your patients return to your offices for annual exams and sports physicals before the school year starts, everyone will still be processing the challenges, losses, and grief that have marked end of the COVID experience. There will be questions about the safety of vaccines for younger children, whether foreign travel is now a reasonable option, and about how best to help children – school age and teenagers, vulnerable and secure – get their footing socially and academically in the new school year. But dig a little, and you may hear about the silver linings of this past year: children who enjoyed having more time with their parents, parents who were with their families rather than in a car commuting for hours a day or traveling many days a month, grocery deliveries that eased the parent’s workload, adolescents who were able to pull back from overscheduled days, and opportunities for calm conversations that occurred quite naturally during nightly family dinners. Office visits present a dual opportunity to review – what were the psychological costs of COVID and what were positive personal and family adaptations to COVID they may want to continue as the pandemic ends?

Family dinner: Whether because sports practice was suspended, schooling was virtual, or working was at home, many families returned to eating dinner together during the pandemic year. Nightly dinners are a simple but powerful routine allowing all members of a family to reconnect and recharge together, and they are often the first things to disappear in the face of school, sports, and work demands. Research over the past several decades has demonstrated that regular family dinners are associated with better academic performance and higher self-esteem in children. They are also associated with lower rates of depression, substance abuse, eating disorders, and pregnancy in adolescents. Finally, they are associated with better cardiovascular health and lower rates of obesity in both youth and parents. The response is dose dependent, with more regular dinners leading to better outcomes. The food can be simple, what matters most is that the tone is warm, sharing, and curious, not rigid and controlling. Families can be an essential source of support as they help put events and feelings into context, giving them meaning or a framework based on the parents’ past, values, or perspective and on the family’s cultural history. Everyone benefits as family members cope with small and large setbacks, share values, and celebrate one another’s small and large successes. The return of the family dinner table, as often as is reasonable, is one “consequence” of COVID that families should try to preserve.

Consistent virtual family visits: Many families managed the cancellation of holiday visits or supported elderly relatives by connecting with family virtually. For some families, a weekly Zoom call came to function like a weekly family dinner with cousins and grandparents. Not only do these regular video calls protect elderly relatives from loneliness and isolation, but they also made it very easy for extended families to stay connected. Children cannot have too many caring adults around them, and regular calls mean that aunts, uncles, and grandparents can be an enthusiastic audience for their achievements and can offer perspective and guidance when needed. Staying connected without having to manage hours of travel makes it easy to build and maintain these family connections, creating bonds that will be deeper and stronger. Like family dinner, regular virtual gatherings with extended family are unequivocally beneficial for younger and older children and a valuable legacy of COVID.

Lowering the pressure: Many children struggled to stay engaged with virtual school and deeply missed time with friends or in activities like woodshop, soccer, or theater. But many other children had a chance to slow down from a relentless schedule of school, homework, sports, clubs, music lessons, tutoring, and on and on. For these children, many of whom are intensely ambitious and were not willing to voluntarily give up any activities, the forced slowdown of COVID has offered a new perspective on how they might manage their time. The COVID slowdown shone a light on the value of spending enough time in an activity to really learn it, and then choosing which activities to continue to explore and master, while opening time to explore new activities. There was also more time for “senseless fun,” activities that do not lead to achievement or recognition, but are simply fun, e.g., playing video games, splashing in a pool, or surfing the web. This process is critical to healthy development in early and later adolescence, and for many driven teenagers, it has been replaced by a tightly packed schedule of activities they felt they “should” be doing. If these young people hear from you that not only does the COVID pace feel better, but it can also contribute to better health and more meaningful learning and engagement, they may adopt a more thoughtful and intentional approach to managing their most precious asset – their time. Your discussion about prioritizing healthy exercise, virtual visits with friends, hobbies, or even senseless fun might reset the pressure gauge from high to moderate.

Homework help: Many children (and teenagers) found that their parents became an important source of academic support during the year of virtual school. While few parents welcomed the chance to master calculus, it is powerful for parents to know what their children are facing at school and for children to know that their parents are available to help them when they face a challenge. When parents can bear uncertainty, frustration, and even failure alongside their children, they help their children to cultivate tenacity and resilience, whether or not they can help them with a chemistry problem. Some parents will have special skills like knowing a language, being a good writer, or an academic expertise related to their work. But what matters more is working out how to help, not pressure or argue – how to share knowledge in a pleasurable manner. While it is important for children to have access to teachers and tutors with the knowledge and skills to help them learn specific subjects, the positive presence and involvement of their parents can make a valuable contribution to their psychological and educational development.

New ritual: Over the past 16 months, families found many creative ways to pass time together, from evening walks to reading aloud, listening to music, and even mastering new card games. The family evenings of a century earlier, when family members listened together to radio programs, practiced music, or played board games, seemed to have returned. While everyone could still escape to their own space to be on a screen activity alone, solitary computer time was leavened by collective time. Families may have rediscovered joy in shared recreation, exploration, or diversion. This kind of family time is a reward in itself, but it also deepens a child’s connections to everyone in their family. Such time provides lessons in how to turn boredom into something meaningful and even fun. COVID forced families inward and gave them more time. There were many costs including illness, deaths of friends and relatives, loss of time with peers, missed activities and milestones, and an impaired education. However, many of the coerced adaptations had a silver lining or unanticipated benefit. Keeping some of those benefits post COVID could enhance the lives of every member of the family.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

As your patients return to your offices for annual exams and sports physicals before the school year starts, everyone will still be processing the challenges, losses, and grief that have marked end of the COVID experience. There will be questions about the safety of vaccines for younger children, whether foreign travel is now a reasonable option, and about how best to help children – school age and teenagers, vulnerable and secure – get their footing socially and academically in the new school year. But dig a little, and you may hear about the silver linings of this past year: children who enjoyed having more time with their parents, parents who were with their families rather than in a car commuting for hours a day or traveling many days a month, grocery deliveries that eased the parent’s workload, adolescents who were able to pull back from overscheduled days, and opportunities for calm conversations that occurred quite naturally during nightly family dinners. Office visits present a dual opportunity to review – what were the psychological costs of COVID and what were positive personal and family adaptations to COVID they may want to continue as the pandemic ends?

Family dinner: Whether because sports practice was suspended, schooling was virtual, or working was at home, many families returned to eating dinner together during the pandemic year. Nightly dinners are a simple but powerful routine allowing all members of a family to reconnect and recharge together, and they are often the first things to disappear in the face of school, sports, and work demands. Research over the past several decades has demonstrated that regular family dinners are associated with better academic performance and higher self-esteem in children. They are also associated with lower rates of depression, substance abuse, eating disorders, and pregnancy in adolescents. Finally, they are associated with better cardiovascular health and lower rates of obesity in both youth and parents. The response is dose dependent, with more regular dinners leading to better outcomes. The food can be simple, what matters most is that the tone is warm, sharing, and curious, not rigid and controlling. Families can be an essential source of support as they help put events and feelings into context, giving them meaning or a framework based on the parents’ past, values, or perspective and on the family’s cultural history. Everyone benefits as family members cope with small and large setbacks, share values, and celebrate one another’s small and large successes. The return of the family dinner table, as often as is reasonable, is one “consequence” of COVID that families should try to preserve.

Consistent virtual family visits: Many families managed the cancellation of holiday visits or supported elderly relatives by connecting with family virtually. For some families, a weekly Zoom call came to function like a weekly family dinner with cousins and grandparents. Not only do these regular video calls protect elderly relatives from loneliness and isolation, but they also made it very easy for extended families to stay connected. Children cannot have too many caring adults around them, and regular calls mean that aunts, uncles, and grandparents can be an enthusiastic audience for their achievements and can offer perspective and guidance when needed. Staying connected without having to manage hours of travel makes it easy to build and maintain these family connections, creating bonds that will be deeper and stronger. Like family dinner, regular virtual gatherings with extended family are unequivocally beneficial for younger and older children and a valuable legacy of COVID.

Lowering the pressure: Many children struggled to stay engaged with virtual school and deeply missed time with friends or in activities like woodshop, soccer, or theater. But many other children had a chance to slow down from a relentless schedule of school, homework, sports, clubs, music lessons, tutoring, and on and on. For these children, many of whom are intensely ambitious and were not willing to voluntarily give up any activities, the forced slowdown of COVID has offered a new perspective on how they might manage their time. The COVID slowdown shone a light on the value of spending enough time in an activity to really learn it, and then choosing which activities to continue to explore and master, while opening time to explore new activities. There was also more time for “senseless fun,” activities that do not lead to achievement or recognition, but are simply fun, e.g., playing video games, splashing in a pool, or surfing the web. This process is critical to healthy development in early and later adolescence, and for many driven teenagers, it has been replaced by a tightly packed schedule of activities they felt they “should” be doing. If these young people hear from you that not only does the COVID pace feel better, but it can also contribute to better health and more meaningful learning and engagement, they may adopt a more thoughtful and intentional approach to managing their most precious asset – their time. Your discussion about prioritizing healthy exercise, virtual visits with friends, hobbies, or even senseless fun might reset the pressure gauge from high to moderate.

Homework help: Many children (and teenagers) found that their parents became an important source of academic support during the year of virtual school. While few parents welcomed the chance to master calculus, it is powerful for parents to know what their children are facing at school and for children to know that their parents are available to help them when they face a challenge. When parents can bear uncertainty, frustration, and even failure alongside their children, they help their children to cultivate tenacity and resilience, whether or not they can help them with a chemistry problem. Some parents will have special skills like knowing a language, being a good writer, or an academic expertise related to their work. But what matters more is working out how to help, not pressure or argue – how to share knowledge in a pleasurable manner. While it is important for children to have access to teachers and tutors with the knowledge and skills to help them learn specific subjects, the positive presence and involvement of their parents can make a valuable contribution to their psychological and educational development.

New ritual: Over the past 16 months, families found many creative ways to pass time together, from evening walks to reading aloud, listening to music, and even mastering new card games. The family evenings of a century earlier, when family members listened together to radio programs, practiced music, or played board games, seemed to have returned. While everyone could still escape to their own space to be on a screen activity alone, solitary computer time was leavened by collective time. Families may have rediscovered joy in shared recreation, exploration, or diversion. This kind of family time is a reward in itself, but it also deepens a child’s connections to everyone in their family. Such time provides lessons in how to turn boredom into something meaningful and even fun. COVID forced families inward and gave them more time. There were many costs including illness, deaths of friends and relatives, loss of time with peers, missed activities and milestones, and an impaired education. However, many of the coerced adaptations had a silver lining or unanticipated benefit. Keeping some of those benefits post COVID could enhance the lives of every member of the family.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

In April, 92 people gathered in Texas for a wedding. To lower the chances of COVID-19 infection, the festivities were held outside under a large, open-air tent. All 92 guests were required to be fully vaccinated.

Despite those precautions, six people tested positive for the coronavirus and one of them died, Forbes magazine reported, citing a preprint published in medRxiv.

Researchers from Baylor College of Medicine said viral sequencing suggests “the strain containing the Delta variant was transmitted to wedding guests from two patients traveling from India. With no history of vaccine failure in these patients, our observations suggest these are true cases of vaccine breakthrough, mediated by the Delta variant.”

Three females and three males aged 53-69 tested positive for COVID-19. Three were overweight, but none had significant comorbidities or a history of failed vaccination.

The first people to get sick were a man and woman who traveled from India, Forbes reported. The man had no health problems, but the woman had diabetes. Both had gotten two doses of the Covaxin BBV152 vaccine before leaving India.

They tested positive for COVID-19 4 days after the wedding, and the man became so ill he was hospitalized. Six days after the wedding, he died, according to Forbes.

Two people who’d gotten the Pfizer/BioNTech vaccine and two people who received the Moderna vaccine interacted with the first two people, and they also tested positive. One of them, a man in his 60s, had to be hospitalized.

The researchers said their findings suggest the Delta variant “may possess immune evasion” in patients that received the Pfizer, Moderna, or Covaxin vaccines.

Forbes summed it up this way: “While the available COVID-19 vaccines can offer good protection against COVID-19, the protection is not perfect. As long as the pandemic is continuing, it is better to maintain multiple layers of COVID-19 precautions when you can.”
 

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

In April, 92 people gathered in Texas for a wedding. To lower the chances of COVID-19 infection, the festivities were held outside under a large, open-air tent. All 92 guests were required to be fully vaccinated.

Despite those precautions, six people tested positive for the coronavirus and one of them died, Forbes magazine reported, citing a preprint published in medRxiv.

Researchers from Baylor College of Medicine said viral sequencing suggests “the strain containing the Delta variant was transmitted to wedding guests from two patients traveling from India. With no history of vaccine failure in these patients, our observations suggest these are true cases of vaccine breakthrough, mediated by the Delta variant.”

Three females and three males aged 53-69 tested positive for COVID-19. Three were overweight, but none had significant comorbidities or a history of failed vaccination.

The first people to get sick were a man and woman who traveled from India, Forbes reported. The man had no health problems, but the woman had diabetes. Both had gotten two doses of the Covaxin BBV152 vaccine before leaving India.

They tested positive for COVID-19 4 days after the wedding, and the man became so ill he was hospitalized. Six days after the wedding, he died, according to Forbes.

Two people who’d gotten the Pfizer/BioNTech vaccine and two people who received the Moderna vaccine interacted with the first two people, and they also tested positive. One of them, a man in his 60s, had to be hospitalized.

The researchers said their findings suggest the Delta variant “may possess immune evasion” in patients that received the Pfizer, Moderna, or Covaxin vaccines.

Forbes summed it up this way: “While the available COVID-19 vaccines can offer good protection against COVID-19, the protection is not perfect. As long as the pandemic is continuing, it is better to maintain multiple layers of COVID-19 precautions when you can.”
 

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

In April, 92 people gathered in Texas for a wedding. To lower the chances of COVID-19 infection, the festivities were held outside under a large, open-air tent. All 92 guests were required to be fully vaccinated.

Despite those precautions, six people tested positive for the coronavirus and one of them died, Forbes magazine reported, citing a preprint published in medRxiv.

Researchers from Baylor College of Medicine said viral sequencing suggests “the strain containing the Delta variant was transmitted to wedding guests from two patients traveling from India. With no history of vaccine failure in these patients, our observations suggest these are true cases of vaccine breakthrough, mediated by the Delta variant.”

Three females and three males aged 53-69 tested positive for COVID-19. Three were overweight, but none had significant comorbidities or a history of failed vaccination.

The first people to get sick were a man and woman who traveled from India, Forbes reported. The man had no health problems, but the woman had diabetes. Both had gotten two doses of the Covaxin BBV152 vaccine before leaving India.

They tested positive for COVID-19 4 days after the wedding, and the man became so ill he was hospitalized. Six days after the wedding, he died, according to Forbes.

Two people who’d gotten the Pfizer/BioNTech vaccine and two people who received the Moderna vaccine interacted with the first two people, and they also tested positive. One of them, a man in his 60s, had to be hospitalized.

The researchers said their findings suggest the Delta variant “may possess immune evasion” in patients that received the Pfizer, Moderna, or Covaxin vaccines.

Forbes summed it up this way: “While the available COVID-19 vaccines can offer good protection against COVID-19, the protection is not perfect. As long as the pandemic is continuing, it is better to maintain multiple layers of COVID-19 precautions when you can.”
 

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

Patients with cancer have shown varying responses to COVID-19 vaccination, with good responses in patients with solid tumors (even while on systemic therapy) and poor responses in patients with blood cancers, particularly those on immunosuppressive therapies.

The data are evolving to show factors associated with a poor response but are not strong enough yet to recommend booster shots, say researchers.

The work is defining who will likely need a COVID vaccine booster when they become available. “It’s definitely not all cancer patients,” said Dimpy Shah, MD, PhD, a cancer epidemiologist at the Mays Cancer Center, University of Texas, San Antonio.
 

Public anxiously awaiting boosters

Boosters aren’t recommended in the United States at the moment, in large part because the Emergency Use Authorization under which the vaccines are being administered allows for only two shots of the Pfizer and Moderna vaccines and one shot of the Johnson & Johnson vaccine.

Even so, regulators and policymakers are “keenly aware that physicians and patients alike are anxious to get going and start doing boosters,” Dr. Shah said. There’s concern that antibody response might wane over time, perhaps even more quickly in patients with cancer.

Pfizer is already in talks with the U.S. Food and Drug Administration to authorize a third dose of its vaccine in the United States. Guidelines could very well change in coming months, said Ghady Haidar, MD, a specialist in infectious diseases and cancer at the University of Pittsburgh.

However, it’s still early in the game, and it’s not clear yet if boosters are necessary in cancer, Dr. Haidar said in an interview.

For one thing, it’s unknown if poor antibody response really means that patients aren’t protected, he explained. The vaccines elicit T-cell responses that could protect patients regardless of antibody levels. It’s also unclear if antibody titer levels are clinically relevant, and there hasn’t been much indication yet that less-than-robust vaccine responses translate to worse COVID outcomes in patients with cancer.

Those and other questions are areas of active investigation by Dr. Shah, Dr. Haidar, and others. Dozens of clinical trials are investigating vaccine response in patients with cancer, including the use of boosters.

Meanwhile, some cancer patients aren’t waiting around for more study results. “I get many, many emails a day” about booster shots, Dr. Haidar said. “We recommend against” them for now but some people bend the rules and get an extra shot anyway. “I get it. People are apprehensive.”
 

Three COVID deaths despite full vaccination

The vaccine clinical trials had fewer patients with cancer, so researchers are moving fast to backfill the data. Although there is some variation in what’s being reported, an overall picture is slowly emerging.

Dr. Shah and her team reported on responses to the mRNA COVID vaccines from Pfizer and Moderna and found a 94% seroconversion rate in 131 patients with cancer 3-4 weeks after their second dose of vaccine. They also found good responses among patients on cytotoxic chemotherapy within 6 months of their first vaccine dose, although their antibody titer levels were significantly lower than seen in other patients with cancer.

Investigators from Montefiore Medical Center in New York City also recently reported a 94% seroconversion rate among 200 patients with cancer, including 98% seroconversion in patients with solid tumors. Rates were lower in patients with blood cancers but were still 85% overall, with 70% conversion among patients on anti-CD20 therapies and 73% among stem cell transplant patients. 

Dr. Haidar’s group reported a seroconversion rate of 82.4% among patients with solid tumors but only 54.7% among those with blood cancer. Risk factors for poor response included treatment with antimetabolites and anti-CD20 therapies, and, in the solid tumor group, radiation therapy, likely because of its overall toxicity and impact on lymphocyte function.   

Israeli investigators reported in May a 90% seroconversion rate after two doses of the Pfizer vaccine among 102 patients with solid tumors on active treatment, which compared favorably to the 100% conversion rate in healthy controls, but they noted that antibody titers were considerably lower in patients with cancer.

The only variable associated with lower titer levels was combined use of chemotherapy and immunotherapy, they noted. There were also three women on dose-dense chemotherapy for breast cancer who did not produce any antibodies.

In a study limited to patients with blood cancers, a Lithuanian team recently reported that among 885 patients, those on Bruton tyrosine kinase inhibitors, ruxolitinib (Jakafi), venetoclax (Venclexta), or anti-CD20 therapies mounted almost no antibody response to the Pfizer vaccine.

The Lithuanian group also reported nine breakthrough COVID infections among their fully vaccinated blood cancer patients, including three deaths.  

A team from the Icahn School of Medicine at Mount Sinai, New York reported that more than 15% of 260 patients with multiple myeloma also had no response to the Pfizer or Moderna vaccine; they were on BCMA-targeted therapy or anti-CD38 monoclonal antibody therapy at the time of vaccination, but a few had undergone CAR-T cell therapy more than 3 months beforehand.
 

Heated debate about antibody testing

Despite these reports of some patients with cancer having poorer responses, there’s some uncertainty over the benefit of giving a third (booster) shot.

There’s the question about the clinical relevance of antibody titer levels, and very little work has been done to date on cellular T-cell immunity from the vaccines.  

“Right now, we are using titer levels like they actually mean something when they might not,” said Ravi Parikh, MD, a genitourinary and thoracic oncologist at the University of Pennsylvania, Philadelphia, who co-wrote an editorial that accompanies the Israeli report.

That’s one of the reasons why the FDA and others do not currently recommend antibody tests for COVID vaccine decisions outside of a clinical trial, but not everyone agrees with that position.

There’s been “a lot of heated debate in the medical community” over the issue, Dr. Haidar said.

The Icahn team, for instance, said that their results “underscore the need for routine serological monitoring of [multiple myeloma] patients following COVID-19 vaccination” to see if they might still need to mask-up and socially distance. 

There is precedence, too, for vaccine boosters in cancer. As Dr. Parikh noted in his editorial, guidelines recommend revaccination after stem cell transplant for meningococcus, tetanus, and varicella, and other infections.

In France, COVID booster shots are already standard care for patients on dialysis and those on anti-CD20 agents, as well as for solid organ transplant recipients, for whom the literature supporting the benefit of COVID boosters is much more evolved than in cancer.

Israel has also authorized vaccine boosters for immunocompromised patients, including those with cancer, according to news reports.

It is also almost certain that the FDA will grant a formal approval for the COVID vaccines, at which point doctors will be free to administer boosters as they see fit.

“People are going to have to think really hard about what to do with them” if guidance hasn’t changed by then, Dr. Haidar said.

As the story unfolds, Dr. Haidar and others said in an interview that the take-home message for oncologists remains largely what it has been – namely to get patients vaccinated but also to consider masks and social distancing afterward for those at risk of a poor response. 

Dr. Shah, Dr. Haidar, and Dr. Parikh have disclosed no relevant financial relationships. Dr. Parikh is a regular contributor to Medscape Oncology.

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

Patients with cancer have shown varying responses to COVID-19 vaccination, with good responses in patients with solid tumors (even while on systemic therapy) and poor responses in patients with blood cancers, particularly those on immunosuppressive therapies.

The data are evolving to show factors associated with a poor response but are not strong enough yet to recommend booster shots, say researchers.

The work is defining who will likely need a COVID vaccine booster when they become available. “It’s definitely not all cancer patients,” said Dimpy Shah, MD, PhD, a cancer epidemiologist at the Mays Cancer Center, University of Texas, San Antonio.
 

Public anxiously awaiting boosters

Boosters aren’t recommended in the United States at the moment, in large part because the Emergency Use Authorization under which the vaccines are being administered allows for only two shots of the Pfizer and Moderna vaccines and one shot of the Johnson & Johnson vaccine.

Even so, regulators and policymakers are “keenly aware that physicians and patients alike are anxious to get going and start doing boosters,” Dr. Shah said. There’s concern that antibody response might wane over time, perhaps even more quickly in patients with cancer.

Pfizer is already in talks with the U.S. Food and Drug Administration to authorize a third dose of its vaccine in the United States. Guidelines could very well change in coming months, said Ghady Haidar, MD, a specialist in infectious diseases and cancer at the University of Pittsburgh.

However, it’s still early in the game, and it’s not clear yet if boosters are necessary in cancer, Dr. Haidar said in an interview.

For one thing, it’s unknown if poor antibody response really means that patients aren’t protected, he explained. The vaccines elicit T-cell responses that could protect patients regardless of antibody levels. It’s also unclear if antibody titer levels are clinically relevant, and there hasn’t been much indication yet that less-than-robust vaccine responses translate to worse COVID outcomes in patients with cancer.

Those and other questions are areas of active investigation by Dr. Shah, Dr. Haidar, and others. Dozens of clinical trials are investigating vaccine response in patients with cancer, including the use of boosters.

Meanwhile, some cancer patients aren’t waiting around for more study results. “I get many, many emails a day” about booster shots, Dr. Haidar said. “We recommend against” them for now but some people bend the rules and get an extra shot anyway. “I get it. People are apprehensive.”
 

Three COVID deaths despite full vaccination

The vaccine clinical trials had fewer patients with cancer, so researchers are moving fast to backfill the data. Although there is some variation in what’s being reported, an overall picture is slowly emerging.

Dr. Shah and her team reported on responses to the mRNA COVID vaccines from Pfizer and Moderna and found a 94% seroconversion rate in 131 patients with cancer 3-4 weeks after their second dose of vaccine. They also found good responses among patients on cytotoxic chemotherapy within 6 months of their first vaccine dose, although their antibody titer levels were significantly lower than seen in other patients with cancer.

Investigators from Montefiore Medical Center in New York City also recently reported a 94% seroconversion rate among 200 patients with cancer, including 98% seroconversion in patients with solid tumors. Rates were lower in patients with blood cancers but were still 85% overall, with 70% conversion among patients on anti-CD20 therapies and 73% among stem cell transplant patients. 

Dr. Haidar’s group reported a seroconversion rate of 82.4% among patients with solid tumors but only 54.7% among those with blood cancer. Risk factors for poor response included treatment with antimetabolites and anti-CD20 therapies, and, in the solid tumor group, radiation therapy, likely because of its overall toxicity and impact on lymphocyte function.   

Israeli investigators reported in May a 90% seroconversion rate after two doses of the Pfizer vaccine among 102 patients with solid tumors on active treatment, which compared favorably to the 100% conversion rate in healthy controls, but they noted that antibody titers were considerably lower in patients with cancer.

The only variable associated with lower titer levels was combined use of chemotherapy and immunotherapy, they noted. There were also three women on dose-dense chemotherapy for breast cancer who did not produce any antibodies.

In a study limited to patients with blood cancers, a Lithuanian team recently reported that among 885 patients, those on Bruton tyrosine kinase inhibitors, ruxolitinib (Jakafi), venetoclax (Venclexta), or anti-CD20 therapies mounted almost no antibody response to the Pfizer vaccine.

The Lithuanian group also reported nine breakthrough COVID infections among their fully vaccinated blood cancer patients, including three deaths.  

A team from the Icahn School of Medicine at Mount Sinai, New York reported that more than 15% of 260 patients with multiple myeloma also had no response to the Pfizer or Moderna vaccine; they were on BCMA-targeted therapy or anti-CD38 monoclonal antibody therapy at the time of vaccination, but a few had undergone CAR-T cell therapy more than 3 months beforehand.
 

Heated debate about antibody testing

Despite these reports of some patients with cancer having poorer responses, there’s some uncertainty over the benefit of giving a third (booster) shot.

There’s the question about the clinical relevance of antibody titer levels, and very little work has been done to date on cellular T-cell immunity from the vaccines.  

“Right now, we are using titer levels like they actually mean something when they might not,” said Ravi Parikh, MD, a genitourinary and thoracic oncologist at the University of Pennsylvania, Philadelphia, who co-wrote an editorial that accompanies the Israeli report.

That’s one of the reasons why the FDA and others do not currently recommend antibody tests for COVID vaccine decisions outside of a clinical trial, but not everyone agrees with that position.

There’s been “a lot of heated debate in the medical community” over the issue, Dr. Haidar said.

The Icahn team, for instance, said that their results “underscore the need for routine serological monitoring of [multiple myeloma] patients following COVID-19 vaccination” to see if they might still need to mask-up and socially distance. 

There is precedence, too, for vaccine boosters in cancer. As Dr. Parikh noted in his editorial, guidelines recommend revaccination after stem cell transplant for meningococcus, tetanus, and varicella, and other infections.

In France, COVID booster shots are already standard care for patients on dialysis and those on anti-CD20 agents, as well as for solid organ transplant recipients, for whom the literature supporting the benefit of COVID boosters is much more evolved than in cancer.

Israel has also authorized vaccine boosters for immunocompromised patients, including those with cancer, according to news reports.

It is also almost certain that the FDA will grant a formal approval for the COVID vaccines, at which point doctors will be free to administer boosters as they see fit.

“People are going to have to think really hard about what to do with them” if guidance hasn’t changed by then, Dr. Haidar said.

As the story unfolds, Dr. Haidar and others said in an interview that the take-home message for oncologists remains largely what it has been – namely to get patients vaccinated but also to consider masks and social distancing afterward for those at risk of a poor response. 

Dr. Shah, Dr. Haidar, and Dr. Parikh have disclosed no relevant financial relationships. Dr. Parikh is a regular contributor to Medscape Oncology.

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

Patients with cancer have shown varying responses to COVID-19 vaccination, with good responses in patients with solid tumors (even while on systemic therapy) and poor responses in patients with blood cancers, particularly those on immunosuppressive therapies.

The data are evolving to show factors associated with a poor response but are not strong enough yet to recommend booster shots, say researchers.

The work is defining who will likely need a COVID vaccine booster when they become available. “It’s definitely not all cancer patients,” said Dimpy Shah, MD, PhD, a cancer epidemiologist at the Mays Cancer Center, University of Texas, San Antonio.
 

Public anxiously awaiting boosters

Boosters aren’t recommended in the United States at the moment, in large part because the Emergency Use Authorization under which the vaccines are being administered allows for only two shots of the Pfizer and Moderna vaccines and one shot of the Johnson & Johnson vaccine.

Even so, regulators and policymakers are “keenly aware that physicians and patients alike are anxious to get going and start doing boosters,” Dr. Shah said. There’s concern that antibody response might wane over time, perhaps even more quickly in patients with cancer.

Pfizer is already in talks with the U.S. Food and Drug Administration to authorize a third dose of its vaccine in the United States. Guidelines could very well change in coming months, said Ghady Haidar, MD, a specialist in infectious diseases and cancer at the University of Pittsburgh.

However, it’s still early in the game, and it’s not clear yet if boosters are necessary in cancer, Dr. Haidar said in an interview.

For one thing, it’s unknown if poor antibody response really means that patients aren’t protected, he explained. The vaccines elicit T-cell responses that could protect patients regardless of antibody levels. It’s also unclear if antibody titer levels are clinically relevant, and there hasn’t been much indication yet that less-than-robust vaccine responses translate to worse COVID outcomes in patients with cancer.

Those and other questions are areas of active investigation by Dr. Shah, Dr. Haidar, and others. Dozens of clinical trials are investigating vaccine response in patients with cancer, including the use of boosters.

Meanwhile, some cancer patients aren’t waiting around for more study results. “I get many, many emails a day” about booster shots, Dr. Haidar said. “We recommend against” them for now but some people bend the rules and get an extra shot anyway. “I get it. People are apprehensive.”
 

Three COVID deaths despite full vaccination

The vaccine clinical trials had fewer patients with cancer, so researchers are moving fast to backfill the data. Although there is some variation in what’s being reported, an overall picture is slowly emerging.

Dr. Shah and her team reported on responses to the mRNA COVID vaccines from Pfizer and Moderna and found a 94% seroconversion rate in 131 patients with cancer 3-4 weeks after their second dose of vaccine. They also found good responses among patients on cytotoxic chemotherapy within 6 months of their first vaccine dose, although their antibody titer levels were significantly lower than seen in other patients with cancer.

Investigators from Montefiore Medical Center in New York City also recently reported a 94% seroconversion rate among 200 patients with cancer, including 98% seroconversion in patients with solid tumors. Rates were lower in patients with blood cancers but were still 85% overall, with 70% conversion among patients on anti-CD20 therapies and 73% among stem cell transplant patients. 

Dr. Haidar’s group reported a seroconversion rate of 82.4% among patients with solid tumors but only 54.7% among those with blood cancer. Risk factors for poor response included treatment with antimetabolites and anti-CD20 therapies, and, in the solid tumor group, radiation therapy, likely because of its overall toxicity and impact on lymphocyte function.   

Israeli investigators reported in May a 90% seroconversion rate after two doses of the Pfizer vaccine among 102 patients with solid tumors on active treatment, which compared favorably to the 100% conversion rate in healthy controls, but they noted that antibody titers were considerably lower in patients with cancer.

The only variable associated with lower titer levels was combined use of chemotherapy and immunotherapy, they noted. There were also three women on dose-dense chemotherapy for breast cancer who did not produce any antibodies.

In a study limited to patients with blood cancers, a Lithuanian team recently reported that among 885 patients, those on Bruton tyrosine kinase inhibitors, ruxolitinib (Jakafi), venetoclax (Venclexta), or anti-CD20 therapies mounted almost no antibody response to the Pfizer vaccine.

The Lithuanian group also reported nine breakthrough COVID infections among their fully vaccinated blood cancer patients, including three deaths.  

A team from the Icahn School of Medicine at Mount Sinai, New York reported that more than 15% of 260 patients with multiple myeloma also had no response to the Pfizer or Moderna vaccine; they were on BCMA-targeted therapy or anti-CD38 monoclonal antibody therapy at the time of vaccination, but a few had undergone CAR-T cell therapy more than 3 months beforehand.
 

Heated debate about antibody testing

Despite these reports of some patients with cancer having poorer responses, there’s some uncertainty over the benefit of giving a third (booster) shot.

There’s the question about the clinical relevance of antibody titer levels, and very little work has been done to date on cellular T-cell immunity from the vaccines.  

“Right now, we are using titer levels like they actually mean something when they might not,” said Ravi Parikh, MD, a genitourinary and thoracic oncologist at the University of Pennsylvania, Philadelphia, who co-wrote an editorial that accompanies the Israeli report.

That’s one of the reasons why the FDA and others do not currently recommend antibody tests for COVID vaccine decisions outside of a clinical trial, but not everyone agrees with that position.

There’s been “a lot of heated debate in the medical community” over the issue, Dr. Haidar said.

The Icahn team, for instance, said that their results “underscore the need for routine serological monitoring of [multiple myeloma] patients following COVID-19 vaccination” to see if they might still need to mask-up and socially distance. 

There is precedence, too, for vaccine boosters in cancer. As Dr. Parikh noted in his editorial, guidelines recommend revaccination after stem cell transplant for meningococcus, tetanus, and varicella, and other infections.

In France, COVID booster shots are already standard care for patients on dialysis and those on anti-CD20 agents, as well as for solid organ transplant recipients, for whom the literature supporting the benefit of COVID boosters is much more evolved than in cancer.

Israel has also authorized vaccine boosters for immunocompromised patients, including those with cancer, according to news reports.

It is also almost certain that the FDA will grant a formal approval for the COVID vaccines, at which point doctors will be free to administer boosters as they see fit.

“People are going to have to think really hard about what to do with them” if guidance hasn’t changed by then, Dr. Haidar said.

As the story unfolds, Dr. Haidar and others said in an interview that the take-home message for oncologists remains largely what it has been – namely to get patients vaccinated but also to consider masks and social distancing afterward for those at risk of a poor response. 

Dr. Shah, Dr. Haidar, and Dr. Parikh have disclosed no relevant financial relationships. Dr. Parikh is a regular contributor to Medscape Oncology.

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