MDedge Pediatrics

Younger adolescents who underwent metabolic and bariatric surgery had outcomes similar to those of older adolescents undergoing the same procedure, according to recent research in Pediatrics.

Five years after metabolic and bariatric surgery (MBS), adolescents between ages 13 and 15 years had similar outcomes with regard to reduction in body mass index percentage, hypertension and dyslipidemia, and improved quality of life, compared with adolescents between ages 16 and 19 years, according to Sarah B. Ogle, DO, MS, of Children’s Hospital Colorado at the University of Colorado at Denver, Aurora, and colleagues.

“These results appear promising for the treatment of severe obesity in young patients,” Dr. Ogle and colleagues wrote, “however, further controlled studies are needed to fully evaluate the timing of surgery and extended long-term durability.”

The researchers analyzed the outcomes of adolescents enrolled in the Teen–Longitudinal Assessment of Bariatric Surgery who were aged 19 years or younger and underwent MBS between March 2007 and December 2011 at five U.S. centers. In the group of younger adolescents (66 participants), the mean age at surgery was 15.1 years, while the group of older adolescents (162 participants) had a mean age of 17.7 years at the time of surgery. Both groups consisted mostly of White (71.6%-72.7%) girls (72.7%-75.9%) who were morbidly obese (mean BMI, 52.4-53.1 kg/m²). With regard to baseline comorbidities, about three-quarters of participants in the younger (72.4%) and older (77.0%) adolescent groups had dyslipidemia. More than one-quarter of younger adolescents had hypertension (27.3%) compared with more than one-third of older adolescents (37.1%). The prevalence of type 2 diabetes was 10.6% in the younger adolescent group and 13.6% among older adolescents.

At 5-year follow-up, there was a similar BMI reduction maintained from baseline in the younger adolescent group (–22.2%; 95% confidence interval, –26.2% to –18.2%) and the older adolescent group (–24.6%; 95% CI, –27.7% to –22.5%; P = .59). There was a similar number of participants who had remission of dyslipidemia at 5 years in the younger adolescent group (61%; 95% CI, 46.3%-81.1%) and older adolescent group (58%; 95% CI, 48.0%-68.9%; P = .74). In participants with hypertension, 77% of younger adolescents (95% CI, 57.1%-100.0%) and 67% of older adolescents (95% CI, 54.5%-81.5%) achieved remission at 5 years after MBS, which showed no significant differences after adjustment (P = .84). For participants with type 2 diabetes at baseline, 83% of younger adolescents (6 participants) and 87% of older adolescents (15 participants) experienced remission by 5 years after surgery. Participants in both younger and older adolescent groups had similar quality of life scores at 5 years after surgery. When analyzing nutritional abnormalities, the researchers found younger adolescents in the group were less at risk for elevated transferrin levels (prevalence ratio, 0.52; P = .048) as well as less likely to have low vitamin D levels (prevalence ratio, 0.8; P = .034).
 

Pediatricians still concerned about safety

In an interview, Kelly A. Curran, MD, MA, assistant professor of pediatrics at University of Oklahoma Children’s Hospital in Oklahoma City, said that the findings by Dr. Ogle and colleagues add to a “growing body of literature about the importance of bariatric surgery for both younger and older adolescents.

“While many often see bariatric surgery as a ‘last resort,’ this study shows good outcomes in resolving obesity-related health conditions in both young and older teens over time – and something that should be considered more frequently than it is currently being used,” she said.

Guidelines from the American Society for Metabolic and Bariatric Surgery removed a restriction for younger age before a patient undergoes MBS, and a policy statement from the American Academy of Pediatrics encouraged increased use and access to MBS for younger adolescents. However, Dr. Curran noted that many pediatricians are still concerned about performing MBS on younger adolescents.

“Despite growing evidence of safety, I think many pediatricians worry about the potential for unintended consequences and potential impact on adolescent development or for lifelong micronutrition deficiencies – especially as there are no longitudinal studies over a lifetime,” she said.

“[W]ith the growing obesity epidemic and the long-term consequences of obesity on health and quality of life – the potential to help impact adolescents’ lives – for now and for the future – is impressive,” Dr. Curran said, acknowledging the ethical challenges involved with performing MBS on a patient who may be too young to understand the full risks and benefits of surgery.

“There are always inherent ethical challenges in providing surgery for patients too young to understand – we are asking parents to act in their child’s best interests, which may be murky to elucidate,” she explained. “While there is [a] growing body of literature around the safety and efficacy in bariatric surgery for children and adolescents, there are still many unanswered questions that remain – especially for parents. Parents can feel trapped in between these two choices – have children undergo surgery or stick with potentially less effective medical management.”

The limitations of the study include its observational nature, small sample size of some comorbidities, and a lack of diversity among participants, most of whom were White and female. In addition, “long-term studies examining the impact of bariatric surgery during adolescence would be important to give more perspective and guidance on the risks and benefits for teens,” Dr. Curran said.

The study was funded by the National Institutes of Health and grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as grants from Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital, Texas Children’s Hospital and Baylor College of Medicine, University of Pittsburgh, and the University of Alabama at Birmingham. The authors and Dr. Curran reported no conflicts of interest.
 

Younger adolescents who underwent metabolic and bariatric surgery had outcomes similar to those of older adolescents undergoing the same procedure, according to recent research in Pediatrics.

Five years after metabolic and bariatric surgery (MBS), adolescents between ages 13 and 15 years had similar outcomes with regard to reduction in body mass index percentage, hypertension and dyslipidemia, and improved quality of life, compared with adolescents between ages 16 and 19 years, according to Sarah B. Ogle, DO, MS, of Children’s Hospital Colorado at the University of Colorado at Denver, Aurora, and colleagues.

“These results appear promising for the treatment of severe obesity in young patients,” Dr. Ogle and colleagues wrote, “however, further controlled studies are needed to fully evaluate the timing of surgery and extended long-term durability.”

The researchers analyzed the outcomes of adolescents enrolled in the Teen–Longitudinal Assessment of Bariatric Surgery who were aged 19 years or younger and underwent MBS between March 2007 and December 2011 at five U.S. centers. In the group of younger adolescents (66 participants), the mean age at surgery was 15.1 years, while the group of older adolescents (162 participants) had a mean age of 17.7 years at the time of surgery. Both groups consisted mostly of White (71.6%-72.7%) girls (72.7%-75.9%) who were morbidly obese (mean BMI, 52.4-53.1 kg/m²). With regard to baseline comorbidities, about three-quarters of participants in the younger (72.4%) and older (77.0%) adolescent groups had dyslipidemia. More than one-quarter of younger adolescents had hypertension (27.3%) compared with more than one-third of older adolescents (37.1%). The prevalence of type 2 diabetes was 10.6% in the younger adolescent group and 13.6% among older adolescents.

At 5-year follow-up, there was a similar BMI reduction maintained from baseline in the younger adolescent group (–22.2%; 95% confidence interval, –26.2% to –18.2%) and the older adolescent group (–24.6%; 95% CI, –27.7% to –22.5%; P = .59). There was a similar number of participants who had remission of dyslipidemia at 5 years in the younger adolescent group (61%; 95% CI, 46.3%-81.1%) and older adolescent group (58%; 95% CI, 48.0%-68.9%; P = .74). In participants with hypertension, 77% of younger adolescents (95% CI, 57.1%-100.0%) and 67% of older adolescents (95% CI, 54.5%-81.5%) achieved remission at 5 years after MBS, which showed no significant differences after adjustment (P = .84). For participants with type 2 diabetes at baseline, 83% of younger adolescents (6 participants) and 87% of older adolescents (15 participants) experienced remission by 5 years after surgery. Participants in both younger and older adolescent groups had similar quality of life scores at 5 years after surgery. When analyzing nutritional abnormalities, the researchers found younger adolescents in the group were less at risk for elevated transferrin levels (prevalence ratio, 0.52; P = .048) as well as less likely to have low vitamin D levels (prevalence ratio, 0.8; P = .034).
 

Pediatricians still concerned about safety

In an interview, Kelly A. Curran, MD, MA, assistant professor of pediatrics at University of Oklahoma Children’s Hospital in Oklahoma City, said that the findings by Dr. Ogle and colleagues add to a “growing body of literature about the importance of bariatric surgery for both younger and older adolescents.

“While many often see bariatric surgery as a ‘last resort,’ this study shows good outcomes in resolving obesity-related health conditions in both young and older teens over time – and something that should be considered more frequently than it is currently being used,” she said.

Guidelines from the American Society for Metabolic and Bariatric Surgery removed a restriction for younger age before a patient undergoes MBS, and a policy statement from the American Academy of Pediatrics encouraged increased use and access to MBS for younger adolescents. However, Dr. Curran noted that many pediatricians are still concerned about performing MBS on younger adolescents.

“Despite growing evidence of safety, I think many pediatricians worry about the potential for unintended consequences and potential impact on adolescent development or for lifelong micronutrition deficiencies – especially as there are no longitudinal studies over a lifetime,” she said.

“[W]ith the growing obesity epidemic and the long-term consequences of obesity on health and quality of life – the potential to help impact adolescents’ lives – for now and for the future – is impressive,” Dr. Curran said, acknowledging the ethical challenges involved with performing MBS on a patient who may be too young to understand the full risks and benefits of surgery.

“There are always inherent ethical challenges in providing surgery for patients too young to understand – we are asking parents to act in their child’s best interests, which may be murky to elucidate,” she explained. “While there is [a] growing body of literature around the safety and efficacy in bariatric surgery for children and adolescents, there are still many unanswered questions that remain – especially for parents. Parents can feel trapped in between these two choices – have children undergo surgery or stick with potentially less effective medical management.”

The limitations of the study include its observational nature, small sample size of some comorbidities, and a lack of diversity among participants, most of whom were White and female. In addition, “long-term studies examining the impact of bariatric surgery during adolescence would be important to give more perspective and guidance on the risks and benefits for teens,” Dr. Curran said.

The study was funded by the National Institutes of Health and grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as grants from Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital, Texas Children’s Hospital and Baylor College of Medicine, University of Pittsburgh, and the University of Alabama at Birmingham. The authors and Dr. Curran reported no conflicts of interest.
 

Younger adolescents who underwent metabolic and bariatric surgery had outcomes similar to those of older adolescents undergoing the same procedure, according to recent research in Pediatrics.

Five years after metabolic and bariatric surgery (MBS), adolescents between ages 13 and 15 years had similar outcomes with regard to reduction in body mass index percentage, hypertension and dyslipidemia, and improved quality of life, compared with adolescents between ages 16 and 19 years, according to Sarah B. Ogle, DO, MS, of Children’s Hospital Colorado at the University of Colorado at Denver, Aurora, and colleagues.

“These results appear promising for the treatment of severe obesity in young patients,” Dr. Ogle and colleagues wrote, “however, further controlled studies are needed to fully evaluate the timing of surgery and extended long-term durability.”

The researchers analyzed the outcomes of adolescents enrolled in the Teen–Longitudinal Assessment of Bariatric Surgery who were aged 19 years or younger and underwent MBS between March 2007 and December 2011 at five U.S. centers. In the group of younger adolescents (66 participants), the mean age at surgery was 15.1 years, while the group of older adolescents (162 participants) had a mean age of 17.7 years at the time of surgery. Both groups consisted mostly of White (71.6%-72.7%) girls (72.7%-75.9%) who were morbidly obese (mean BMI, 52.4-53.1 kg/m²). With regard to baseline comorbidities, about three-quarters of participants in the younger (72.4%) and older (77.0%) adolescent groups had dyslipidemia. More than one-quarter of younger adolescents had hypertension (27.3%) compared with more than one-third of older adolescents (37.1%). The prevalence of type 2 diabetes was 10.6% in the younger adolescent group and 13.6% among older adolescents.

At 5-year follow-up, there was a similar BMI reduction maintained from baseline in the younger adolescent group (–22.2%; 95% confidence interval, –26.2% to –18.2%) and the older adolescent group (–24.6%; 95% CI, –27.7% to –22.5%; P = .59). There was a similar number of participants who had remission of dyslipidemia at 5 years in the younger adolescent group (61%; 95% CI, 46.3%-81.1%) and older adolescent group (58%; 95% CI, 48.0%-68.9%; P = .74). In participants with hypertension, 77% of younger adolescents (95% CI, 57.1%-100.0%) and 67% of older adolescents (95% CI, 54.5%-81.5%) achieved remission at 5 years after MBS, which showed no significant differences after adjustment (P = .84). For participants with type 2 diabetes at baseline, 83% of younger adolescents (6 participants) and 87% of older adolescents (15 participants) experienced remission by 5 years after surgery. Participants in both younger and older adolescent groups had similar quality of life scores at 5 years after surgery. When analyzing nutritional abnormalities, the researchers found younger adolescents in the group were less at risk for elevated transferrin levels (prevalence ratio, 0.52; P = .048) as well as less likely to have low vitamin D levels (prevalence ratio, 0.8; P = .034).
 

Pediatricians still concerned about safety

In an interview, Kelly A. Curran, MD, MA, assistant professor of pediatrics at University of Oklahoma Children’s Hospital in Oklahoma City, said that the findings by Dr. Ogle and colleagues add to a “growing body of literature about the importance of bariatric surgery for both younger and older adolescents.

“While many often see bariatric surgery as a ‘last resort,’ this study shows good outcomes in resolving obesity-related health conditions in both young and older teens over time – and something that should be considered more frequently than it is currently being used,” she said.

Guidelines from the American Society for Metabolic and Bariatric Surgery removed a restriction for younger age before a patient undergoes MBS, and a policy statement from the American Academy of Pediatrics encouraged increased use and access to MBS for younger adolescents. However, Dr. Curran noted that many pediatricians are still concerned about performing MBS on younger adolescents.

“Despite growing evidence of safety, I think many pediatricians worry about the potential for unintended consequences and potential impact on adolescent development or for lifelong micronutrition deficiencies – especially as there are no longitudinal studies over a lifetime,” she said.

“[W]ith the growing obesity epidemic and the long-term consequences of obesity on health and quality of life – the potential to help impact adolescents’ lives – for now and for the future – is impressive,” Dr. Curran said, acknowledging the ethical challenges involved with performing MBS on a patient who may be too young to understand the full risks and benefits of surgery.

“There are always inherent ethical challenges in providing surgery for patients too young to understand – we are asking parents to act in their child’s best interests, which may be murky to elucidate,” she explained. “While there is [a] growing body of literature around the safety and efficacy in bariatric surgery for children and adolescents, there are still many unanswered questions that remain – especially for parents. Parents can feel trapped in between these two choices – have children undergo surgery or stick with potentially less effective medical management.”

The limitations of the study include its observational nature, small sample size of some comorbidities, and a lack of diversity among participants, most of whom were White and female. In addition, “long-term studies examining the impact of bariatric surgery during adolescence would be important to give more perspective and guidance on the risks and benefits for teens,” Dr. Curran said.

The study was funded by the National Institutes of Health and grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as grants from Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital, Texas Children’s Hospital and Baylor College of Medicine, University of Pittsburgh, and the University of Alabama at Birmingham. The authors and Dr. Curran reported no conflicts of interest.
 

The Royal Swedish Academy of Sciences and the Crafoord Foundation in Lund has awarded Daniel Kastner, MD, PhD, its 2021 Crafoord Prize in Polyarthritis, “for establishing the concept of autoinflammatory diseases.” The prize, named after the donor Holger Crafoord because of his bout with severe rheumatoid arthritis toward the end of his life, is for 6 million Swedish kronor (approximately USD $700,000).

Dr. Kastner, scientific director at the U.S. National Human Genome Research Institute’s division of intramural research, received the award for identifying the mechanisms responsible for familial Mediterranean fever, tumor necrosis factor receptor–associated periodic syndrome, and other diagnoses within the group of autoinflammatory diseases.

“Dan Kastner is often called the father of autoinflammatory diseases, a title that he thoroughly deserves. His discoveries have taught us a great deal about the immune system and its functions, contributing to effective treatments that reduce the symptoms of diseases from which patients previously suffered enormously, sometimes leading to premature death,” Olle Kämpe, chair of the prize committee, said in a press announcement.

While the Crafoord Prize normally is awarded on a 3-year rotating basis for achievements in mathematics and astronomy, geosciences, and biosciences, the prize in polyarthritis is “only awarded when there has been scientific progress that motivates a prize,” according to the press release.

[email protected]

The Royal Swedish Academy of Sciences and the Crafoord Foundation in Lund has awarded Daniel Kastner, MD, PhD, its 2021 Crafoord Prize in Polyarthritis, “for establishing the concept of autoinflammatory diseases.” The prize, named after the donor Holger Crafoord because of his bout with severe rheumatoid arthritis toward the end of his life, is for 6 million Swedish kronor (approximately USD $700,000).

Dr. Kastner, scientific director at the U.S. National Human Genome Research Institute’s division of intramural research, received the award for identifying the mechanisms responsible for familial Mediterranean fever, tumor necrosis factor receptor–associated periodic syndrome, and other diagnoses within the group of autoinflammatory diseases.

“Dan Kastner is often called the father of autoinflammatory diseases, a title that he thoroughly deserves. His discoveries have taught us a great deal about the immune system and its functions, contributing to effective treatments that reduce the symptoms of diseases from which patients previously suffered enormously, sometimes leading to premature death,” Olle Kämpe, chair of the prize committee, said in a press announcement.

While the Crafoord Prize normally is awarded on a 3-year rotating basis for achievements in mathematics and astronomy, geosciences, and biosciences, the prize in polyarthritis is “only awarded when there has been scientific progress that motivates a prize,” according to the press release.

[email protected]

The Royal Swedish Academy of Sciences and the Crafoord Foundation in Lund has awarded Daniel Kastner, MD, PhD, its 2021 Crafoord Prize in Polyarthritis, “for establishing the concept of autoinflammatory diseases.” The prize, named after the donor Holger Crafoord because of his bout with severe rheumatoid arthritis toward the end of his life, is for 6 million Swedish kronor (approximately USD $700,000).

Dr. Kastner, scientific director at the U.S. National Human Genome Research Institute’s division of intramural research, received the award for identifying the mechanisms responsible for familial Mediterranean fever, tumor necrosis factor receptor–associated periodic syndrome, and other diagnoses within the group of autoinflammatory diseases.

“Dan Kastner is often called the father of autoinflammatory diseases, a title that he thoroughly deserves. His discoveries have taught us a great deal about the immune system and its functions, contributing to effective treatments that reduce the symptoms of diseases from which patients previously suffered enormously, sometimes leading to premature death,” Olle Kämpe, chair of the prize committee, said in a press announcement.

While the Crafoord Prize normally is awarded on a 3-year rotating basis for achievements in mathematics and astronomy, geosciences, and biosciences, the prize in polyarthritis is “only awarded when there has been scientific progress that motivates a prize,” according to the press release.

[email protected]

Oral antibiotic treatment for 7-10 days works for most feverish children with uncomplicated urinary tract infection (UTI), reported Tej K. Mattoo, MD, of Wayne State University, Detroit, and associates.

A good clinical assessment supported by laboratory results using a clean urine specimen is crucial to accurately diagnosing UTI in children, Dr. Mattoo and colleagues reported in a state-of-the-art review article in Pediatrics.

The authors set out to summarize the current literature on UTI in children with the goal of guiding clinical management. They provide a thorough summary of the research on a wide range of issues, including pathogenesis of acute pyelonephritis and renal scarring, risk factors for UTI and renal scarring, diagnosis and common errors in diagnosis, complications of UTI and post-UTI renal imaging, antibiotics, antimicrobial prophylaxis, surgical interventions, and prevention of recurrent UTIs.
 

What key steps make all the difference?

To help guide practicing physicians through this wealth of information, Dr. Mattoo noted in an interview that, although the review article offers “many takeaway messages,” there are several issues of crucial importance. Notably, urine collection in young children who are not yet toilet trained can present considerable challenges in achieving an accurate assessment. A contaminated urine specimen leads to unnecessary antibiotic treatment, and in some cases unwarranted hospitalization, intravenous lines, renal imaging, and follow-up investigations, Dr. Mattoo said.

Ureteral catheterization or suprapubic bladder aspiration are the preferred methods of specimen collection, especially in cases where specimens collected with a perineal bag are dipstick positive, the authors explained. Midstream collection (known as the Quick-Wee method) can also be used following stimulation of the suprapubic area with cold fluid-soaked gauze.

Also of considerable importance is distinguishing bladder infections from kidney infections whenever possible, Dr. Mattoo noted. The antibiotic treatment, complications, and follow-up plans can be different for each, he cautioned. The authors have provided a helpful table within the article to help make this differentiation.
 

Timing is crucial

Prescribing treatment with an antibiotic within 48 hours of fever onset is essential for the prevention of renal scarring, Dr. Mattoo advised. The key is to treat with the goal of avoiding long-term complications. Although there are some exceptions, most cases of UTI can be treated with oral antibiotics and do not require hospitalization.

Some children with first UTI need additional testing, such as renal imaging, to ensure that there are no underlying risk factors for UTI. These children, in particular, can be at an increased risk of recurrent UTI and renal scarring, Dr. Mattoo explained.

Antibiotic resistance is a major emerging problem in patients with UTI at all ages and we should use antibiotics only in patients who truly have a UTI that requires such treatment, he urged.

In an interview, Timothy Joos, MD, a Seattle internist and pediatrician in private practice, noted: “In the words of the British novelist Tom Holt, ‘There are few moments of clarity more profound than those that follow the emptying of an overcharged bladder. The world slows down, the focus sharpens, the brain comes back online. Huge nebulous difficulties prove on close calm examination to be merely cloud giants.’ Thank you to Drs. Mattoo, Nelson, and Shaikh for providing this clarity of current UTI diagnosis and management,” Dr. Joos said.

“It bears repeating that because of the rare prevalence of grade 4 to 5 vesicoureteral reflux in children with their first UTI, current guidelines recommend that a voiding cystourethrogram can be reserved for children with an abnormal ultrasound, atypical pathogen, complicated clinical course, or known renal scarring,” added Dr. Joos.

The authors had no relevant disclosures. Dr. Joos is a member of the Pediatric News editorial advisory board but had no other disclosures.

Oral antibiotic treatment for 7-10 days works for most feverish children with uncomplicated urinary tract infection (UTI), reported Tej K. Mattoo, MD, of Wayne State University, Detroit, and associates.

A good clinical assessment supported by laboratory results using a clean urine specimen is crucial to accurately diagnosing UTI in children, Dr. Mattoo and colleagues reported in a state-of-the-art review article in Pediatrics.

The authors set out to summarize the current literature on UTI in children with the goal of guiding clinical management. They provide a thorough summary of the research on a wide range of issues, including pathogenesis of acute pyelonephritis and renal scarring, risk factors for UTI and renal scarring, diagnosis and common errors in diagnosis, complications of UTI and post-UTI renal imaging, antibiotics, antimicrobial prophylaxis, surgical interventions, and prevention of recurrent UTIs.
 

What key steps make all the difference?

To help guide practicing physicians through this wealth of information, Dr. Mattoo noted in an interview that, although the review article offers “many takeaway messages,” there are several issues of crucial importance. Notably, urine collection in young children who are not yet toilet trained can present considerable challenges in achieving an accurate assessment. A contaminated urine specimen leads to unnecessary antibiotic treatment, and in some cases unwarranted hospitalization, intravenous lines, renal imaging, and follow-up investigations, Dr. Mattoo said.

Ureteral catheterization or suprapubic bladder aspiration are the preferred methods of specimen collection, especially in cases where specimens collected with a perineal bag are dipstick positive, the authors explained. Midstream collection (known as the Quick-Wee method) can also be used following stimulation of the suprapubic area with cold fluid-soaked gauze.

Also of considerable importance is distinguishing bladder infections from kidney infections whenever possible, Dr. Mattoo noted. The antibiotic treatment, complications, and follow-up plans can be different for each, he cautioned. The authors have provided a helpful table within the article to help make this differentiation.
 

Timing is crucial

Prescribing treatment with an antibiotic within 48 hours of fever onset is essential for the prevention of renal scarring, Dr. Mattoo advised. The key is to treat with the goal of avoiding long-term complications. Although there are some exceptions, most cases of UTI can be treated with oral antibiotics and do not require hospitalization.

Some children with first UTI need additional testing, such as renal imaging, to ensure that there are no underlying risk factors for UTI. These children, in particular, can be at an increased risk of recurrent UTI and renal scarring, Dr. Mattoo explained.

Antibiotic resistance is a major emerging problem in patients with UTI at all ages and we should use antibiotics only in patients who truly have a UTI that requires such treatment, he urged.

In an interview, Timothy Joos, MD, a Seattle internist and pediatrician in private practice, noted: “In the words of the British novelist Tom Holt, ‘There are few moments of clarity more profound than those that follow the emptying of an overcharged bladder. The world slows down, the focus sharpens, the brain comes back online. Huge nebulous difficulties prove on close calm examination to be merely cloud giants.’ Thank you to Drs. Mattoo, Nelson, and Shaikh for providing this clarity of current UTI diagnosis and management,” Dr. Joos said.

“It bears repeating that because of the rare prevalence of grade 4 to 5 vesicoureteral reflux in children with their first UTI, current guidelines recommend that a voiding cystourethrogram can be reserved for children with an abnormal ultrasound, atypical pathogen, complicated clinical course, or known renal scarring,” added Dr. Joos.

The authors had no relevant disclosures. Dr. Joos is a member of the Pediatric News editorial advisory board but had no other disclosures.

Oral antibiotic treatment for 7-10 days works for most feverish children with uncomplicated urinary tract infection (UTI), reported Tej K. Mattoo, MD, of Wayne State University, Detroit, and associates.

A good clinical assessment supported by laboratory results using a clean urine specimen is crucial to accurately diagnosing UTI in children, Dr. Mattoo and colleagues reported in a state-of-the-art review article in Pediatrics.

The authors set out to summarize the current literature on UTI in children with the goal of guiding clinical management. They provide a thorough summary of the research on a wide range of issues, including pathogenesis of acute pyelonephritis and renal scarring, risk factors for UTI and renal scarring, diagnosis and common errors in diagnosis, complications of UTI and post-UTI renal imaging, antibiotics, antimicrobial prophylaxis, surgical interventions, and prevention of recurrent UTIs.
 

What key steps make all the difference?

To help guide practicing physicians through this wealth of information, Dr. Mattoo noted in an interview that, although the review article offers “many takeaway messages,” there are several issues of crucial importance. Notably, urine collection in young children who are not yet toilet trained can present considerable challenges in achieving an accurate assessment. A contaminated urine specimen leads to unnecessary antibiotic treatment, and in some cases unwarranted hospitalization, intravenous lines, renal imaging, and follow-up investigations, Dr. Mattoo said.

Ureteral catheterization or suprapubic bladder aspiration are the preferred methods of specimen collection, especially in cases where specimens collected with a perineal bag are dipstick positive, the authors explained. Midstream collection (known as the Quick-Wee method) can also be used following stimulation of the suprapubic area with cold fluid-soaked gauze.

Also of considerable importance is distinguishing bladder infections from kidney infections whenever possible, Dr. Mattoo noted. The antibiotic treatment, complications, and follow-up plans can be different for each, he cautioned. The authors have provided a helpful table within the article to help make this differentiation.
 

Timing is crucial

Prescribing treatment with an antibiotic within 48 hours of fever onset is essential for the prevention of renal scarring, Dr. Mattoo advised. The key is to treat with the goal of avoiding long-term complications. Although there are some exceptions, most cases of UTI can be treated with oral antibiotics and do not require hospitalization.

Some children with first UTI need additional testing, such as renal imaging, to ensure that there are no underlying risk factors for UTI. These children, in particular, can be at an increased risk of recurrent UTI and renal scarring, Dr. Mattoo explained.

Antibiotic resistance is a major emerging problem in patients with UTI at all ages and we should use antibiotics only in patients who truly have a UTI that requires such treatment, he urged.

In an interview, Timothy Joos, MD, a Seattle internist and pediatrician in private practice, noted: “In the words of the British novelist Tom Holt, ‘There are few moments of clarity more profound than those that follow the emptying of an overcharged bladder. The world slows down, the focus sharpens, the brain comes back online. Huge nebulous difficulties prove on close calm examination to be merely cloud giants.’ Thank you to Drs. Mattoo, Nelson, and Shaikh for providing this clarity of current UTI diagnosis and management,” Dr. Joos said.

“It bears repeating that because of the rare prevalence of grade 4 to 5 vesicoureteral reflux in children with their first UTI, current guidelines recommend that a voiding cystourethrogram can be reserved for children with an abnormal ultrasound, atypical pathogen, complicated clinical course, or known renal scarring,” added Dr. Joos.

The authors had no relevant disclosures. Dr. Joos is a member of the Pediatric News editorial advisory board but had no other disclosures.

Clinicians using systemic retinoids for treating ichthyosis and other disorders of cornification (DOC) in children and adolescents should aim for the lowest dose possible to balance therapeutic goals with acceptable toxicity levels, advised the authors of a new consensus statement.

In the statement, published in Pediatric Dermatology, they also addressed the effects of topical and systemic retinoid use on bone, eye, cardiovascular, and mental health, and the risks some retinoids pose to reproductive health.

Many patients with these chronic conditions, driven by multiple genetic mutations, respond to topical and/or systemic retinoids. However, to date, no specific guidance has addressed the safety, efficacy, or overall precautions for their use in the pediatric population, one of the statement authors, Moise L. Levy, MD, professor of pediatrics and medicine at the University of Texas at Austin, said in an interview.

Dr. Levy was one of the physicians on the multidisciplinary panel, The Pediatric Dermatology Research Alliance Use of Retinoids in Ichthyosis Work Group, formed to devise best practice recommendations on the use of retinoids in the management of ichthyoses and other cornification disorders in children and adolescents. The panel conducted an extensive evidence-based literature review and met in person to arrive at their conclusions. Representation from the Foundation for Ichthyosis and Related Skin Types (FIRST) was also key to this work. “Additionally, the teratogenic effects of retinoids prompted examination of gynecologic considerations and the role of the iPLEDGE program in the United States on patient access to isotretinoin,” the authors wrote.


 

Retinoid effects, dosing

“Both topical and systemic retinoids can improve scaling in patients with select forms of ichthyosis,” and some subtypes of disease respond better to treatment than others, they noted. Oral or topical retinoids are known to improve cases of congenital ichthyosiform erythroderma (select genotypes), Sjögren-Larsson syndrome, ichthyosis follicularis–alopecia-photophobia syndromes and keratitis-ichthyosis-deafness syndrome, erythrokeratodermia variabilis, harlequin ichthyosis, ichthyosis with confetti, and other subtypes.

Comparatively, they added, there are no data on the use of retinoids, or data showing no improvement with retinoids for several ichthyosis subtypes, including congenital hemidysplasia with ichthyosiform erythroderma and limb defects, CHIME syndrome, Conradi-Hünermann-Happle syndrome, ichthyosis-hypotrichosis syndrome, ichthyosis-hypotrichosis-sclerosing cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome, peeling skin disease, Refsum syndrome, and trichothiodystrophy though the response to such cases may vary.

Retinoids may worsen conditions that lead to peeling or skin fragility, atopic diathesis, or excessive desquamation, “and should be used with caution,” the authors advised.

Pediatric and adult patients with moderate to severe disease and significant functional or psychological impairment “should be offered the opportunity to make a benefit/risk assessment of treatment” with a systemic retinoid, they added, noting that topical retinoids have a lower risk profile and may be a better choice for milder disease.

Clinicians should aim for the lowest dose possible “that will achieve and maintain the desired therapeutic effect with acceptable mucocutaneous and systemic toxicities,” the panel recommended. Lower doses work especially well in patients with epidermolytic ichthyoses and erythrokeratodermia variabilis.

“Given the cutaneous and extracutaneous toxicities of oral retinoids, lower doses were found to achieve the most acceptable risk-benefit result. Few individuals now receive more than 1 mg/kg per day of isotretinoin or 0.5 mg/kg per day of acitretin,” according to the panel.

Dosing decisions call for a group conversation between physicians, patients and caregivers, addressing skin care, comfort and appearance issues, risk of adverse effects, and tolerance of the therapy.
 

Retinoid effects on organs

The impact of retinoids on the body varies by organ system, type of therapy and dosage. Dose and duration of therapy, for example, help determine the toxic effects of retinoids on bone. “Long-term use of systemic retinoids in ichthyosis/DOC is associated with skeletal concerns,” noted the authors, adding that clinicians should still consider this therapeutic approach if there is a strong clinical case for using it in a patient.

Children on long-term systemic therapy should undergo a series of tests and evaluations for bone monitoring, including an annual growth assessment. The group also recommended a baseline skeletal radiographic survey when children are on long-term systemic retinoid therapy, repeated after 3-5 years or when symptoms are present. Clinicians should also inquire about diet and discuss with patients factors that impact susceptibility to retinoid bone toxicity, such as genetic risk, diet and physical activity.

They also recommended monitoring patients taking systemic retinoids for psychiatric symptoms.

Adolescents of childbearing potential using systemic retinoids, who are sexually active, should receive counseling about contraceptive options, and should use two forms of contraception, including one highly effective method, the statement advises.

In the United States, all patients and prescribers of isotretinoin must comply with iPLEDGE guidelines; the statement addresses the issue that iPLEDGE was not designed for long-term use of isotretinoin in patients with ichthyosis, and “imposes a significant burden” in this group.

Other practice gaps and unmet needs in this area of study were discussed, calling for a closer examination of optimal timing of therapy initiation, and the adverse effects of long-term retinoid treatment. “The work, as a whole, is a starting point for these important management issues,” said Dr. Levy.

Unrestricted educational grants from Sun Pharmaceuticals and FIRST funded this effort. Dr. Levy’s disclosed serving on the advisory board and as a consultant for Cassiopea, Regeneron, and UCB, and an investigator for Fibrocell, Galderma, Janssen, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or other relationships with various pharmaceutical companies.

Clinicians using systemic retinoids for treating ichthyosis and other disorders of cornification (DOC) in children and adolescents should aim for the lowest dose possible to balance therapeutic goals with acceptable toxicity levels, advised the authors of a new consensus statement.

In the statement, published in Pediatric Dermatology, they also addressed the effects of topical and systemic retinoid use on bone, eye, cardiovascular, and mental health, and the risks some retinoids pose to reproductive health.

Many patients with these chronic conditions, driven by multiple genetic mutations, respond to topical and/or systemic retinoids. However, to date, no specific guidance has addressed the safety, efficacy, or overall precautions for their use in the pediatric population, one of the statement authors, Moise L. Levy, MD, professor of pediatrics and medicine at the University of Texas at Austin, said in an interview.

Dr. Levy was one of the physicians on the multidisciplinary panel, The Pediatric Dermatology Research Alliance Use of Retinoids in Ichthyosis Work Group, formed to devise best practice recommendations on the use of retinoids in the management of ichthyoses and other cornification disorders in children and adolescents. The panel conducted an extensive evidence-based literature review and met in person to arrive at their conclusions. Representation from the Foundation for Ichthyosis and Related Skin Types (FIRST) was also key to this work. “Additionally, the teratogenic effects of retinoids prompted examination of gynecologic considerations and the role of the iPLEDGE program in the United States on patient access to isotretinoin,” the authors wrote.


 

Retinoid effects, dosing

“Both topical and systemic retinoids can improve scaling in patients with select forms of ichthyosis,” and some subtypes of disease respond better to treatment than others, they noted. Oral or topical retinoids are known to improve cases of congenital ichthyosiform erythroderma (select genotypes), Sjögren-Larsson syndrome, ichthyosis follicularis–alopecia-photophobia syndromes and keratitis-ichthyosis-deafness syndrome, erythrokeratodermia variabilis, harlequin ichthyosis, ichthyosis with confetti, and other subtypes.

Comparatively, they added, there are no data on the use of retinoids, or data showing no improvement with retinoids for several ichthyosis subtypes, including congenital hemidysplasia with ichthyosiform erythroderma and limb defects, CHIME syndrome, Conradi-Hünermann-Happle syndrome, ichthyosis-hypotrichosis syndrome, ichthyosis-hypotrichosis-sclerosing cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome, peeling skin disease, Refsum syndrome, and trichothiodystrophy though the response to such cases may vary.

Retinoids may worsen conditions that lead to peeling or skin fragility, atopic diathesis, or excessive desquamation, “and should be used with caution,” the authors advised.

Pediatric and adult patients with moderate to severe disease and significant functional or psychological impairment “should be offered the opportunity to make a benefit/risk assessment of treatment” with a systemic retinoid, they added, noting that topical retinoids have a lower risk profile and may be a better choice for milder disease.

Clinicians should aim for the lowest dose possible “that will achieve and maintain the desired therapeutic effect with acceptable mucocutaneous and systemic toxicities,” the panel recommended. Lower doses work especially well in patients with epidermolytic ichthyoses and erythrokeratodermia variabilis.

“Given the cutaneous and extracutaneous toxicities of oral retinoids, lower doses were found to achieve the most acceptable risk-benefit result. Few individuals now receive more than 1 mg/kg per day of isotretinoin or 0.5 mg/kg per day of acitretin,” according to the panel.

Dosing decisions call for a group conversation between physicians, patients and caregivers, addressing skin care, comfort and appearance issues, risk of adverse effects, and tolerance of the therapy.
 

Retinoid effects on organs

The impact of retinoids on the body varies by organ system, type of therapy and dosage. Dose and duration of therapy, for example, help determine the toxic effects of retinoids on bone. “Long-term use of systemic retinoids in ichthyosis/DOC is associated with skeletal concerns,” noted the authors, adding that clinicians should still consider this therapeutic approach if there is a strong clinical case for using it in a patient.

Children on long-term systemic therapy should undergo a series of tests and evaluations for bone monitoring, including an annual growth assessment. The group also recommended a baseline skeletal radiographic survey when children are on long-term systemic retinoid therapy, repeated after 3-5 years or when symptoms are present. Clinicians should also inquire about diet and discuss with patients factors that impact susceptibility to retinoid bone toxicity, such as genetic risk, diet and physical activity.

They also recommended monitoring patients taking systemic retinoids for psychiatric symptoms.

Adolescents of childbearing potential using systemic retinoids, who are sexually active, should receive counseling about contraceptive options, and should use two forms of contraception, including one highly effective method, the statement advises.

In the United States, all patients and prescribers of isotretinoin must comply with iPLEDGE guidelines; the statement addresses the issue that iPLEDGE was not designed for long-term use of isotretinoin in patients with ichthyosis, and “imposes a significant burden” in this group.

Other practice gaps and unmet needs in this area of study were discussed, calling for a closer examination of optimal timing of therapy initiation, and the adverse effects of long-term retinoid treatment. “The work, as a whole, is a starting point for these important management issues,” said Dr. Levy.

Unrestricted educational grants from Sun Pharmaceuticals and FIRST funded this effort. Dr. Levy’s disclosed serving on the advisory board and as a consultant for Cassiopea, Regeneron, and UCB, and an investigator for Fibrocell, Galderma, Janssen, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or other relationships with various pharmaceutical companies.

Clinicians using systemic retinoids for treating ichthyosis and other disorders of cornification (DOC) in children and adolescents should aim for the lowest dose possible to balance therapeutic goals with acceptable toxicity levels, advised the authors of a new consensus statement.

In the statement, published in Pediatric Dermatology, they also addressed the effects of topical and systemic retinoid use on bone, eye, cardiovascular, and mental health, and the risks some retinoids pose to reproductive health.

Many patients with these chronic conditions, driven by multiple genetic mutations, respond to topical and/or systemic retinoids. However, to date, no specific guidance has addressed the safety, efficacy, or overall precautions for their use in the pediatric population, one of the statement authors, Moise L. Levy, MD, professor of pediatrics and medicine at the University of Texas at Austin, said in an interview.

Dr. Levy was one of the physicians on the multidisciplinary panel, The Pediatric Dermatology Research Alliance Use of Retinoids in Ichthyosis Work Group, formed to devise best practice recommendations on the use of retinoids in the management of ichthyoses and other cornification disorders in children and adolescents. The panel conducted an extensive evidence-based literature review and met in person to arrive at their conclusions. Representation from the Foundation for Ichthyosis and Related Skin Types (FIRST) was also key to this work. “Additionally, the teratogenic effects of retinoids prompted examination of gynecologic considerations and the role of the iPLEDGE program in the United States on patient access to isotretinoin,” the authors wrote.


 

Retinoid effects, dosing

“Both topical and systemic retinoids can improve scaling in patients with select forms of ichthyosis,” and some subtypes of disease respond better to treatment than others, they noted. Oral or topical retinoids are known to improve cases of congenital ichthyosiform erythroderma (select genotypes), Sjögren-Larsson syndrome, ichthyosis follicularis–alopecia-photophobia syndromes and keratitis-ichthyosis-deafness syndrome, erythrokeratodermia variabilis, harlequin ichthyosis, ichthyosis with confetti, and other subtypes.

Comparatively, they added, there are no data on the use of retinoids, or data showing no improvement with retinoids for several ichthyosis subtypes, including congenital hemidysplasia with ichthyosiform erythroderma and limb defects, CHIME syndrome, Conradi-Hünermann-Happle syndrome, ichthyosis-hypotrichosis syndrome, ichthyosis-hypotrichosis-sclerosing cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome, peeling skin disease, Refsum syndrome, and trichothiodystrophy though the response to such cases may vary.

Retinoids may worsen conditions that lead to peeling or skin fragility, atopic diathesis, or excessive desquamation, “and should be used with caution,” the authors advised.

Pediatric and adult patients with moderate to severe disease and significant functional or psychological impairment “should be offered the opportunity to make a benefit/risk assessment of treatment” with a systemic retinoid, they added, noting that topical retinoids have a lower risk profile and may be a better choice for milder disease.

Clinicians should aim for the lowest dose possible “that will achieve and maintain the desired therapeutic effect with acceptable mucocutaneous and systemic toxicities,” the panel recommended. Lower doses work especially well in patients with epidermolytic ichthyoses and erythrokeratodermia variabilis.

“Given the cutaneous and extracutaneous toxicities of oral retinoids, lower doses were found to achieve the most acceptable risk-benefit result. Few individuals now receive more than 1 mg/kg per day of isotretinoin or 0.5 mg/kg per day of acitretin,” according to the panel.

Dosing decisions call for a group conversation between physicians, patients and caregivers, addressing skin care, comfort and appearance issues, risk of adverse effects, and tolerance of the therapy.
 

Retinoid effects on organs

The impact of retinoids on the body varies by organ system, type of therapy and dosage. Dose and duration of therapy, for example, help determine the toxic effects of retinoids on bone. “Long-term use of systemic retinoids in ichthyosis/DOC is associated with skeletal concerns,” noted the authors, adding that clinicians should still consider this therapeutic approach if there is a strong clinical case for using it in a patient.

Children on long-term systemic therapy should undergo a series of tests and evaluations for bone monitoring, including an annual growth assessment. The group also recommended a baseline skeletal radiographic survey when children are on long-term systemic retinoid therapy, repeated after 3-5 years or when symptoms are present. Clinicians should also inquire about diet and discuss with patients factors that impact susceptibility to retinoid bone toxicity, such as genetic risk, diet and physical activity.

They also recommended monitoring patients taking systemic retinoids for psychiatric symptoms.

Adolescents of childbearing potential using systemic retinoids, who are sexually active, should receive counseling about contraceptive options, and should use two forms of contraception, including one highly effective method, the statement advises.

In the United States, all patients and prescribers of isotretinoin must comply with iPLEDGE guidelines; the statement addresses the issue that iPLEDGE was not designed for long-term use of isotretinoin in patients with ichthyosis, and “imposes a significant burden” in this group.

Other practice gaps and unmet needs in this area of study were discussed, calling for a closer examination of optimal timing of therapy initiation, and the adverse effects of long-term retinoid treatment. “The work, as a whole, is a starting point for these important management issues,” said Dr. Levy.

Unrestricted educational grants from Sun Pharmaceuticals and FIRST funded this effort. Dr. Levy’s disclosed serving on the advisory board and as a consultant for Cassiopea, Regeneron, and UCB, and an investigator for Fibrocell, Galderma, Janssen, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or other relationships with various pharmaceutical companies.

A bag of Doritos, that’s all Princess wanted.

StHelena/Getty Images

Her mom calls her Princess, but her real name is Lindsey. She’s 17 and lives with her mom, Sandra, a nurse, outside Atlanta. On May 17, 2020, a Sunday, Lindsey decided she didn’t want breakfast; she wanted Doritos. So she left home and walked to Family Dollar, taking her pants off on the way, while her mom followed on foot, talking to the police on her phone as they went.

Lindsey has autism. It can be hard for her to communicate and navigate social situations. She thrives on routine and gets special help at school. Or got help, before the coronavirus pandemic closed schools and forced tens of millions of children to stay home. Sandra said that’s when their living hell started.

“It’s like her brain was wired,” she said. “She’d just put on her jacket, and she’s out the door. And I’m chasing her.”

On May 17, Sandra chased her all the way to Family Dollar. Hours later, Lindsey was in jail, charged with assaulting her mom. (KHN and NPR are not using the family’s last name.)

Lindsey is 1 of almost 3 million children in the United States who have a serious emotional or behavioral health condition. When the pandemic forced schools and doctors’ offices to close last spring, it also cut children off from the trained teachers and therapists who understand their needs.

As a result, many, like Lindsey, spiraled into EDs and even police custody. Federal data shows a nationwide surge of children in mental health crisis during the pandemic – a surge that’s further taxing an already overstretched safety net.
 

‘Take her’

Even after schools closed, Lindsey continued to wake up early, get dressed and wait for the bus. When she realized it had stopped coming, Sandra said, her daughter just started walking out of the house, wandering, a few times a week.

In those situations, Sandra did what many families in crisis report they’ve had to do since the pandemic began: Race through the short list of places she could call for help.

First, her state’s mental health crisis hotline. But they often put Sandra on hold.

“This is ridiculous,” she said of the wait. “It’s supposed to be a crisis team. But I’m on hold for 40, 50 minutes. And by the time you get on the phone, [the crisis] is done!”

Then there’s the local hospital’s ED, but Sandra said she had taken Lindsey there for previous crises and been told there isn’t much they can do.

That’s why, on May 17, when Lindsey walked to Family Dollar in just a red T-shirt and underwear to get that bag of Doritos, Sandra called the last option on her list: the police.

Sandra arrived at the store before the police and paid for the chips. According to Sandra and police records, when an officer approached, Lindsey grew agitated and hit her mom on the back, hard.

Sandra said she explained to the officer: “‘She’s autistic. You know, I’m okay. I’m a nurse. I just need to take her home and give her her medication.’ ”

Lindsey takes a mood stabilizer, but because she left home before breakfast, she hadn’t taken it that morning. The officer asked if Sandra wanted to take her to the nearest hospital.

The hospital wouldn’t be able to help Lindsey, Sandra said. It hadn’t before. “They already told me: ‘Ma’am, there’s nothing we can do.’ They just check her labs, it’s fine, and they ship her back home. There’s nothing [the hospital] can do,” she recalled telling the officer.

Sandra asked if the police could drive her daughter home so the teen could take her medication, but the officer said no, they couldn’t. The only other thing they could do, the officer said, was take Lindsey to jail for hitting her mom.

“I’ve tried everything,” Sandra said, exasperated. She paced the parking lot, feeling hopeless, sad and out of options. Finally, in tears, she told the officers: “Take her.”

Lindsey does not like to be touched and fought back when authorities tried to handcuff her. Several officers wrestled her to the ground. At that point, Sandra protested and said an officer threatened to arrest her, too, if she didn’t back away. Lindsey was taken to jail, where she spent much of the night until Sandra was able to post bail.

Clayton County Solicitor-General Charles Brooks denied that Sandra was threatened with arrest and said that, while Lindsey’s case is still pending, his office “is working to ensure that the resolution in this matter involves a plan for medication compliance and not punitive action.”

Sandra isn’t alone in her experience. Multiple families interviewed for this story reported similar experiences of calling in the police when a child was in crisis because caretakers didn’t feel they had any other option.
 

‘The whole system is really grinding to a halt’

Roughly 6% of U.S. children ages 6-17 years are living with serious emotional or behavioral difficulties, including children with autism, severe anxiety, depression and trauma-related mental health conditions.

Many of these children depend on schools for access to vital therapies. When schools and doctors’ offices stopped providing in-person services last spring, kids were untethered from the people and supports they rely on.

“The lack of in-person services is really detrimental,” said Susan Duffy, MD,a pediatrician and professor of emergency medicine at Brown University, Providence, R.I.

Marjorie, a mother in Florida, said her 15-year-old son has suffered during these disruptions. He has ADHD and oppositional defiant disorder, a condition marked by frequent and persistent hostility. Little things – like being asked to do schoolwork – can send him into a rage, leading to holes punched in walls, broken doors and violent threats. (The family’s last name or her son’s first name are not used to protect her son’s privacy and future prospects.)

The pandemic has shifted both school and her son’s therapy sessions online. But Marjorie said virtual therapy isn’t working because her son doesn’t focus well during sessions and tries to watch television instead. Lately, she has simply been canceling them.

“I was paying for appointments and there was no therapeutic value,” Marjorie said.

The issues cut across socioeconomic lines – affecting families with private insurance, like Marjorie, as well as those who receive coverage through Medicaid, a federal-state program that provides health insurance to low-income people and those with disabilities.

In the first few months of the pandemic, between March and May, children on Medicaid received 44% fewer outpatient mental health services – including therapy and in-home support – compared with the same time period in 2019, according to the Centers for Medicare & Medicaid Services. That’s even after accounting for increased telehealth appointments.

And while the nation’s EDs have seen a decline in overall visits, there was a relative increase in mental health visits for kids in 2020, compared with 2019.

The Centers for Disease Control and Prevention found that, from April to October 2020, hospitals across the United States saw a 24% increase in the proportion of mental health emergency visits for children aged 5-11 years, and a 31% increase for children aged 12-17.

“Proportionally, the number of mental health visits is far more significant than it has been in the past,” said Dr. Duffy. “Not only are we seeing more children, more children are being admitted” to inpatient care.

That’s because there are fewer outpatient services now available to children, she said, and because the conditions of the children showing up at EDs “are more serious.”

This crisis is not only making life harder for these kids and their families, but it’s also stressing the entire health care system.

Child and adolescent psychiatrists working in hospitals around the country said children are increasingly “boarding” in EDs for days, waiting for inpatient admission to a regular hospital or psychiatric hospital.

Before the pandemic, there was already a shortage of inpatient psychiatric beds for children, said Christopher Bellonci, MD, a child psychiatrist at Judge Baker Children’s Center in Boston. That shortage has only gotten worse as hospitals cut capacity to allow for more physical distancing within psychiatric units.

“The whole system is really grinding to a halt at a time when we have unprecedented need,” Dr. Bellonci said.
 

‘A signal that the rest of your system doesn’t work’

Psychiatrists on the front lines share the frustrations of parents struggling to find help for their children.

Part of the problem is there have never been enough psychiatrists and therapists trained to work with children, intervening in the early stages of their illness, said Jennifer Havens, MD, a child psychiatrist at New York University.

“Tons of people showing up in emergency rooms in bad shape is a signal that the rest of your system doesn’t work,” she said.

Too often, Dr. Havens said, services aren’t available until children are older – and in crisis. “Often for people who don’t have access to services, we wait until they’re too big to be managed.”

While the pandemic has made life harder for Marjorie and her son in Florida, she said it has always been difficult to find the support and care he needs. Last fall, he needed a psychiatric evaluation, but the nearest specialist who would accept her commercial insurance was 100 miles away, in Alabama.

“Even when you have the money or you have the insurance, it is still a travesty,” Marjorie said. “You cannot get help for these kids.”

Parents are frustrated, and so are psychiatrists on the front lines. C.J. Glawe, MD, who leads the psychiatric crisis department at Nationwide Children’s Hospital in Columbus, Ohio, said that once a child is stabilized after a crisis it can be hard to explain to parents that they may not be able to find follow-up care anywhere near their home.

“Especially when I can clearly tell you I know exactly what you need, I just can’t give it to you,” Dr. Glawe said. “It’s demoralizing.”

When states and communities fail to provide children the services they need to live at home, kids can deteriorate and even wind up in jail, like Lindsey. At that point, Dr. Glawe said, the cost and level of care required will be even higher, whether that’s hospitalization or long stays in residential treatment facilities.

That’s exactly the scenario Sandra, Lindsey’s mom, is hoping to avoid for her Princess.

“For me, as a nurse and as a provider, that will be the last thing for my daughter,” she said. “It’s like [state and local leaders] leave it to the school and the parent to deal with, and they don’t care. And that’s the problem. It’s sad because, if I’m not here...”

Her voice trailed off as tears welled.

“She didn’t ask to have autism.”

To help families like Sandra’s and Marjorie’s, advocates said, all levels of government need to invest in creating a mental health system that’s accessible to anyone who needs it.

But given that many states have seen their revenues drop because of the pandemic, there’s a concern services will instead be cut – at a time when the need has never been greater.

This story is part of a reporting partnership that includes NPR, Illinois Public Media and Kaiser Health News. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

A bag of Doritos, that’s all Princess wanted.

StHelena/Getty Images

Her mom calls her Princess, but her real name is Lindsey. She’s 17 and lives with her mom, Sandra, a nurse, outside Atlanta. On May 17, 2020, a Sunday, Lindsey decided she didn’t want breakfast; she wanted Doritos. So she left home and walked to Family Dollar, taking her pants off on the way, while her mom followed on foot, talking to the police on her phone as they went.

Lindsey has autism. It can be hard for her to communicate and navigate social situations. She thrives on routine and gets special help at school. Or got help, before the coronavirus pandemic closed schools and forced tens of millions of children to stay home. Sandra said that’s when their living hell started.

“It’s like her brain was wired,” she said. “She’d just put on her jacket, and she’s out the door. And I’m chasing her.”

On May 17, Sandra chased her all the way to Family Dollar. Hours later, Lindsey was in jail, charged with assaulting her mom. (KHN and NPR are not using the family’s last name.)

Lindsey is 1 of almost 3 million children in the United States who have a serious emotional or behavioral health condition. When the pandemic forced schools and doctors’ offices to close last spring, it also cut children off from the trained teachers and therapists who understand their needs.

As a result, many, like Lindsey, spiraled into EDs and even police custody. Federal data shows a nationwide surge of children in mental health crisis during the pandemic – a surge that’s further taxing an already overstretched safety net.
 

‘Take her’

Even after schools closed, Lindsey continued to wake up early, get dressed and wait for the bus. When she realized it had stopped coming, Sandra said, her daughter just started walking out of the house, wandering, a few times a week.

In those situations, Sandra did what many families in crisis report they’ve had to do since the pandemic began: Race through the short list of places she could call for help.

First, her state’s mental health crisis hotline. But they often put Sandra on hold.

“This is ridiculous,” she said of the wait. “It’s supposed to be a crisis team. But I’m on hold for 40, 50 minutes. And by the time you get on the phone, [the crisis] is done!”

Then there’s the local hospital’s ED, but Sandra said she had taken Lindsey there for previous crises and been told there isn’t much they can do.

That’s why, on May 17, when Lindsey walked to Family Dollar in just a red T-shirt and underwear to get that bag of Doritos, Sandra called the last option on her list: the police.

Sandra arrived at the store before the police and paid for the chips. According to Sandra and police records, when an officer approached, Lindsey grew agitated and hit her mom on the back, hard.

Sandra said she explained to the officer: “‘She’s autistic. You know, I’m okay. I’m a nurse. I just need to take her home and give her her medication.’ ”

Lindsey takes a mood stabilizer, but because she left home before breakfast, she hadn’t taken it that morning. The officer asked if Sandra wanted to take her to the nearest hospital.

The hospital wouldn’t be able to help Lindsey, Sandra said. It hadn’t before. “They already told me: ‘Ma’am, there’s nothing we can do.’ They just check her labs, it’s fine, and they ship her back home. There’s nothing [the hospital] can do,” she recalled telling the officer.

Sandra asked if the police could drive her daughter home so the teen could take her medication, but the officer said no, they couldn’t. The only other thing they could do, the officer said, was take Lindsey to jail for hitting her mom.

“I’ve tried everything,” Sandra said, exasperated. She paced the parking lot, feeling hopeless, sad and out of options. Finally, in tears, she told the officers: “Take her.”

Lindsey does not like to be touched and fought back when authorities tried to handcuff her. Several officers wrestled her to the ground. At that point, Sandra protested and said an officer threatened to arrest her, too, if she didn’t back away. Lindsey was taken to jail, where she spent much of the night until Sandra was able to post bail.

Clayton County Solicitor-General Charles Brooks denied that Sandra was threatened with arrest and said that, while Lindsey’s case is still pending, his office “is working to ensure that the resolution in this matter involves a plan for medication compliance and not punitive action.”

Sandra isn’t alone in her experience. Multiple families interviewed for this story reported similar experiences of calling in the police when a child was in crisis because caretakers didn’t feel they had any other option.
 

‘The whole system is really grinding to a halt’

Roughly 6% of U.S. children ages 6-17 years are living with serious emotional or behavioral difficulties, including children with autism, severe anxiety, depression and trauma-related mental health conditions.

Many of these children depend on schools for access to vital therapies. When schools and doctors’ offices stopped providing in-person services last spring, kids were untethered from the people and supports they rely on.

“The lack of in-person services is really detrimental,” said Susan Duffy, MD,a pediatrician and professor of emergency medicine at Brown University, Providence, R.I.

Marjorie, a mother in Florida, said her 15-year-old son has suffered during these disruptions. He has ADHD and oppositional defiant disorder, a condition marked by frequent and persistent hostility. Little things – like being asked to do schoolwork – can send him into a rage, leading to holes punched in walls, broken doors and violent threats. (The family’s last name or her son’s first name are not used to protect her son’s privacy and future prospects.)

The pandemic has shifted both school and her son’s therapy sessions online. But Marjorie said virtual therapy isn’t working because her son doesn’t focus well during sessions and tries to watch television instead. Lately, she has simply been canceling them.

“I was paying for appointments and there was no therapeutic value,” Marjorie said.

The issues cut across socioeconomic lines – affecting families with private insurance, like Marjorie, as well as those who receive coverage through Medicaid, a federal-state program that provides health insurance to low-income people and those with disabilities.

In the first few months of the pandemic, between March and May, children on Medicaid received 44% fewer outpatient mental health services – including therapy and in-home support – compared with the same time period in 2019, according to the Centers for Medicare & Medicaid Services. That’s even after accounting for increased telehealth appointments.

And while the nation’s EDs have seen a decline in overall visits, there was a relative increase in mental health visits for kids in 2020, compared with 2019.

The Centers for Disease Control and Prevention found that, from April to October 2020, hospitals across the United States saw a 24% increase in the proportion of mental health emergency visits for children aged 5-11 years, and a 31% increase for children aged 12-17.

“Proportionally, the number of mental health visits is far more significant than it has been in the past,” said Dr. Duffy. “Not only are we seeing more children, more children are being admitted” to inpatient care.

That’s because there are fewer outpatient services now available to children, she said, and because the conditions of the children showing up at EDs “are more serious.”

This crisis is not only making life harder for these kids and their families, but it’s also stressing the entire health care system.

Child and adolescent psychiatrists working in hospitals around the country said children are increasingly “boarding” in EDs for days, waiting for inpatient admission to a regular hospital or psychiatric hospital.

Before the pandemic, there was already a shortage of inpatient psychiatric beds for children, said Christopher Bellonci, MD, a child psychiatrist at Judge Baker Children’s Center in Boston. That shortage has only gotten worse as hospitals cut capacity to allow for more physical distancing within psychiatric units.

“The whole system is really grinding to a halt at a time when we have unprecedented need,” Dr. Bellonci said.
 

‘A signal that the rest of your system doesn’t work’

Psychiatrists on the front lines share the frustrations of parents struggling to find help for their children.

Part of the problem is there have never been enough psychiatrists and therapists trained to work with children, intervening in the early stages of their illness, said Jennifer Havens, MD, a child psychiatrist at New York University.

“Tons of people showing up in emergency rooms in bad shape is a signal that the rest of your system doesn’t work,” she said.

Too often, Dr. Havens said, services aren’t available until children are older – and in crisis. “Often for people who don’t have access to services, we wait until they’re too big to be managed.”

While the pandemic has made life harder for Marjorie and her son in Florida, she said it has always been difficult to find the support and care he needs. Last fall, he needed a psychiatric evaluation, but the nearest specialist who would accept her commercial insurance was 100 miles away, in Alabama.

“Even when you have the money or you have the insurance, it is still a travesty,” Marjorie said. “You cannot get help for these kids.”

Parents are frustrated, and so are psychiatrists on the front lines. C.J. Glawe, MD, who leads the psychiatric crisis department at Nationwide Children’s Hospital in Columbus, Ohio, said that once a child is stabilized after a crisis it can be hard to explain to parents that they may not be able to find follow-up care anywhere near their home.

“Especially when I can clearly tell you I know exactly what you need, I just can’t give it to you,” Dr. Glawe said. “It’s demoralizing.”

When states and communities fail to provide children the services they need to live at home, kids can deteriorate and even wind up in jail, like Lindsey. At that point, Dr. Glawe said, the cost and level of care required will be even higher, whether that’s hospitalization or long stays in residential treatment facilities.

That’s exactly the scenario Sandra, Lindsey’s mom, is hoping to avoid for her Princess.

“For me, as a nurse and as a provider, that will be the last thing for my daughter,” she said. “It’s like [state and local leaders] leave it to the school and the parent to deal with, and they don’t care. And that’s the problem. It’s sad because, if I’m not here...”

Her voice trailed off as tears welled.

“She didn’t ask to have autism.”

To help families like Sandra’s and Marjorie’s, advocates said, all levels of government need to invest in creating a mental health system that’s accessible to anyone who needs it.

But given that many states have seen their revenues drop because of the pandemic, there’s a concern services will instead be cut – at a time when the need has never been greater.

This story is part of a reporting partnership that includes NPR, Illinois Public Media and Kaiser Health News. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

A bag of Doritos, that’s all Princess wanted.

StHelena/Getty Images

Her mom calls her Princess, but her real name is Lindsey. She’s 17 and lives with her mom, Sandra, a nurse, outside Atlanta. On May 17, 2020, a Sunday, Lindsey decided she didn’t want breakfast; she wanted Doritos. So she left home and walked to Family Dollar, taking her pants off on the way, while her mom followed on foot, talking to the police on her phone as they went.

Lindsey has autism. It can be hard for her to communicate and navigate social situations. She thrives on routine and gets special help at school. Or got help, before the coronavirus pandemic closed schools and forced tens of millions of children to stay home. Sandra said that’s when their living hell started.

“It’s like her brain was wired,” she said. “She’d just put on her jacket, and she’s out the door. And I’m chasing her.”

On May 17, Sandra chased her all the way to Family Dollar. Hours later, Lindsey was in jail, charged with assaulting her mom. (KHN and NPR are not using the family’s last name.)

Lindsey is 1 of almost 3 million children in the United States who have a serious emotional or behavioral health condition. When the pandemic forced schools and doctors’ offices to close last spring, it also cut children off from the trained teachers and therapists who understand their needs.

As a result, many, like Lindsey, spiraled into EDs and even police custody. Federal data shows a nationwide surge of children in mental health crisis during the pandemic – a surge that’s further taxing an already overstretched safety net.
 

‘Take her’

Even after schools closed, Lindsey continued to wake up early, get dressed and wait for the bus. When she realized it had stopped coming, Sandra said, her daughter just started walking out of the house, wandering, a few times a week.

In those situations, Sandra did what many families in crisis report they’ve had to do since the pandemic began: Race through the short list of places she could call for help.

First, her state’s mental health crisis hotline. But they often put Sandra on hold.

“This is ridiculous,” she said of the wait. “It’s supposed to be a crisis team. But I’m on hold for 40, 50 minutes. And by the time you get on the phone, [the crisis] is done!”

Then there’s the local hospital’s ED, but Sandra said she had taken Lindsey there for previous crises and been told there isn’t much they can do.

That’s why, on May 17, when Lindsey walked to Family Dollar in just a red T-shirt and underwear to get that bag of Doritos, Sandra called the last option on her list: the police.

Sandra arrived at the store before the police and paid for the chips. According to Sandra and police records, when an officer approached, Lindsey grew agitated and hit her mom on the back, hard.

Sandra said she explained to the officer: “‘She’s autistic. You know, I’m okay. I’m a nurse. I just need to take her home and give her her medication.’ ”

Lindsey takes a mood stabilizer, but because she left home before breakfast, she hadn’t taken it that morning. The officer asked if Sandra wanted to take her to the nearest hospital.

The hospital wouldn’t be able to help Lindsey, Sandra said. It hadn’t before. “They already told me: ‘Ma’am, there’s nothing we can do.’ They just check her labs, it’s fine, and they ship her back home. There’s nothing [the hospital] can do,” she recalled telling the officer.

Sandra asked if the police could drive her daughter home so the teen could take her medication, but the officer said no, they couldn’t. The only other thing they could do, the officer said, was take Lindsey to jail for hitting her mom.

“I’ve tried everything,” Sandra said, exasperated. She paced the parking lot, feeling hopeless, sad and out of options. Finally, in tears, she told the officers: “Take her.”

Lindsey does not like to be touched and fought back when authorities tried to handcuff her. Several officers wrestled her to the ground. At that point, Sandra protested and said an officer threatened to arrest her, too, if she didn’t back away. Lindsey was taken to jail, where she spent much of the night until Sandra was able to post bail.

Clayton County Solicitor-General Charles Brooks denied that Sandra was threatened with arrest and said that, while Lindsey’s case is still pending, his office “is working to ensure that the resolution in this matter involves a plan for medication compliance and not punitive action.”

Sandra isn’t alone in her experience. Multiple families interviewed for this story reported similar experiences of calling in the police when a child was in crisis because caretakers didn’t feel they had any other option.
 

‘The whole system is really grinding to a halt’

Roughly 6% of U.S. children ages 6-17 years are living with serious emotional or behavioral difficulties, including children with autism, severe anxiety, depression and trauma-related mental health conditions.

Many of these children depend on schools for access to vital therapies. When schools and doctors’ offices stopped providing in-person services last spring, kids were untethered from the people and supports they rely on.

“The lack of in-person services is really detrimental,” said Susan Duffy, MD,a pediatrician and professor of emergency medicine at Brown University, Providence, R.I.

Marjorie, a mother in Florida, said her 15-year-old son has suffered during these disruptions. He has ADHD and oppositional defiant disorder, a condition marked by frequent and persistent hostility. Little things – like being asked to do schoolwork – can send him into a rage, leading to holes punched in walls, broken doors and violent threats. (The family’s last name or her son’s first name are not used to protect her son’s privacy and future prospects.)

The pandemic has shifted both school and her son’s therapy sessions online. But Marjorie said virtual therapy isn’t working because her son doesn’t focus well during sessions and tries to watch television instead. Lately, she has simply been canceling them.

“I was paying for appointments and there was no therapeutic value,” Marjorie said.

The issues cut across socioeconomic lines – affecting families with private insurance, like Marjorie, as well as those who receive coverage through Medicaid, a federal-state program that provides health insurance to low-income people and those with disabilities.

In the first few months of the pandemic, between March and May, children on Medicaid received 44% fewer outpatient mental health services – including therapy and in-home support – compared with the same time period in 2019, according to the Centers for Medicare & Medicaid Services. That’s even after accounting for increased telehealth appointments.

And while the nation’s EDs have seen a decline in overall visits, there was a relative increase in mental health visits for kids in 2020, compared with 2019.

The Centers for Disease Control and Prevention found that, from April to October 2020, hospitals across the United States saw a 24% increase in the proportion of mental health emergency visits for children aged 5-11 years, and a 31% increase for children aged 12-17.

“Proportionally, the number of mental health visits is far more significant than it has been in the past,” said Dr. Duffy. “Not only are we seeing more children, more children are being admitted” to inpatient care.

That’s because there are fewer outpatient services now available to children, she said, and because the conditions of the children showing up at EDs “are more serious.”

This crisis is not only making life harder for these kids and their families, but it’s also stressing the entire health care system.

Child and adolescent psychiatrists working in hospitals around the country said children are increasingly “boarding” in EDs for days, waiting for inpatient admission to a regular hospital or psychiatric hospital.

Before the pandemic, there was already a shortage of inpatient psychiatric beds for children, said Christopher Bellonci, MD, a child psychiatrist at Judge Baker Children’s Center in Boston. That shortage has only gotten worse as hospitals cut capacity to allow for more physical distancing within psychiatric units.

“The whole system is really grinding to a halt at a time when we have unprecedented need,” Dr. Bellonci said.
 

‘A signal that the rest of your system doesn’t work’

Psychiatrists on the front lines share the frustrations of parents struggling to find help for their children.

Part of the problem is there have never been enough psychiatrists and therapists trained to work with children, intervening in the early stages of their illness, said Jennifer Havens, MD, a child psychiatrist at New York University.

“Tons of people showing up in emergency rooms in bad shape is a signal that the rest of your system doesn’t work,” she said.

Too often, Dr. Havens said, services aren’t available until children are older – and in crisis. “Often for people who don’t have access to services, we wait until they’re too big to be managed.”

While the pandemic has made life harder for Marjorie and her son in Florida, she said it has always been difficult to find the support and care he needs. Last fall, he needed a psychiatric evaluation, but the nearest specialist who would accept her commercial insurance was 100 miles away, in Alabama.

“Even when you have the money or you have the insurance, it is still a travesty,” Marjorie said. “You cannot get help for these kids.”

Parents are frustrated, and so are psychiatrists on the front lines. C.J. Glawe, MD, who leads the psychiatric crisis department at Nationwide Children’s Hospital in Columbus, Ohio, said that once a child is stabilized after a crisis it can be hard to explain to parents that they may not be able to find follow-up care anywhere near their home.

“Especially when I can clearly tell you I know exactly what you need, I just can’t give it to you,” Dr. Glawe said. “It’s demoralizing.”

When states and communities fail to provide children the services they need to live at home, kids can deteriorate and even wind up in jail, like Lindsey. At that point, Dr. Glawe said, the cost and level of care required will be even higher, whether that’s hospitalization or long stays in residential treatment facilities.

That’s exactly the scenario Sandra, Lindsey’s mom, is hoping to avoid for her Princess.

“For me, as a nurse and as a provider, that will be the last thing for my daughter,” she said. “It’s like [state and local leaders] leave it to the school and the parent to deal with, and they don’t care. And that’s the problem. It’s sad because, if I’m not here...”

Her voice trailed off as tears welled.

“She didn’t ask to have autism.”

To help families like Sandra’s and Marjorie’s, advocates said, all levels of government need to invest in creating a mental health system that’s accessible to anyone who needs it.

But given that many states have seen their revenues drop because of the pandemic, there’s a concern services will instead be cut – at a time when the need has never been greater.

This story is part of a reporting partnership that includes NPR, Illinois Public Media and Kaiser Health News. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.

“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.

The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.

Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”

Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.

Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.

“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.

The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.

“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”

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

The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.

“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.

The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.

Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”

Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.

Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.

“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.

The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.

“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”

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

The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.

“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.

The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.

Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”

Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.

Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.

“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.

The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.

“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”

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

School antibullying programs may have small effect sizes but a valuable population impact, according to research published in JAMA Pediatrics.

A meta-analysis of 69 randomized trials with more than 111,600 participants found that school antibullying programs had a statistically significant effect on reducing bullying and improving mental health.

The investigators estimated population effect numbers for the interventions, such as the number of students needed to participate in an antibullying program to prevent one case of bullying.

Assuming a bullying prevalence of 15%, “an average antibullying intervention needs to include 207 people to prevent 1 case of bullying perpetration or 140 people to prevent 1 case of bullying exposure,” reported David Fraguas, MD, PhD, of the Institute of Psychiatry and Mental Health at Hospital Clínico San Carlos in Madrid, and colleagues. To improve mental health, the average antibullying program needs to include 107 people, the results indicate.

Few trials assessed the same antibullying program, so the researchers examined antibullying programs as a whole. Still, “not all antibullying programs are efficacious,” and “effectiveness may vary in different settings,” they noted.
 

Public health implications

Schools frequently implement programs to address bullying, which research suggests is a prevalent, modifiable risk factor for mental health disorders and therefore a “major public health concern,” the authors said. Studies have suggested that antibullying programs may be effective, though the evidence has been unclear.

“I see teens with mental health issues frequently in my practice, and often during their assessment, these patients and parents disclose a history of bullying at school or online,” said Kelly A. Curran, MD, associate professor of pediatrics at the University of Oklahoma, Oklahoma City. “The impact of bullying on these teens is obvious – from the mental health issues to school absenteeism and dropouts to long-term health consequences. Often, parents ask for guidance on how to ‘make it stop’ or for help working with the teen’s school. It’s hard in these cases as a clinician to know what to recommend – while it’s clear that the bullying is contributing to the teen’s health issues, giving evidenced-based guidance on bullying has been difficult.”

Relative to control groups

To assess the population impact of antibullying interventions, Dr. Fraguas and collaborators conducted random-effects meta-analyses. They identified 69 trials that included 56,511 participants in intervention groups and 55,148 in control groups. Five of the trials tested interventions targeting cyberbullying.

Participants ranged in age from 4 to 17 years, and the weighted average age was 11 years. The durations of the interventions ranged from 1 week to more than 2 years, with an average duration of 29.4 weeks.

“Antibullying interventions showed statistically significant effectiveness compared with control groups on all assessed bullying-related outcomes after the intervention,” the researchers reported. “The effect sizes were mostly statistically significant and small ... with high statistical heterogeneity and risk of publication bias. Antibullying interventions also showed statistically significant effectiveness in improving mental health problems (e.g., anxiety and depression) at study endpoint, with small effect size.”

Consistent with prior research, results varied by region. For example, interventions in Europe, where 31 of the trials were conducted, significantly decreased bullying exposure and attitudes that encourage bullying, whereas interventions in North America, where 19 of the trials were conducted, did not. In addition, European trials found greater effect sizes for the outcome measure of increasing attitudes that discourage bullying, compared with North American trials. The regional differences could reflect different programs or study designs, or differences in “social, educational, or cultural context,” the authors said.
 

‘Substantial’ impact

Together, the findings suggest that “universal antibullying interventions have a substantial population impact,” Dr. Fraguas and coauthors wrote. “To put these results into context, the [population impact number] is 35,450 for taking aspirin to avoid 1 death during the 6 months after a first nonhemorrhagic stroke, and the [population impact number] is 324 for human papillomavirus vaccination in girls to prevent cervical cancer.”

Furthermore, the interventions appear to be safe, they said. None of the trials in the meta-analysis reported an increase in bullying perpetration or bullying exposure at the end of the study or during follow-up, and mental health improved in all trials that assessed that outcome.
 

Pediatricians may be seen as resource

“From our survey work among parents all across Chicago, we know that almost one-half of all parents with children in school are concerned that their children get bullied,” said Matthew M. Davis, MD chair of the department of pediatrics at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics, medicine, medical social sciences, and preventive medicine at Northwestern University in Chicago. “Among those parents, about one-half sought help from a teacher and about one-third asked a school administrator or school social worker for help. That means that schools are, by far, the go-to source for help when parents are worried about bullying.”

The survey of 1,642 parents in Chicago also found that 20% of parents with concerns sought help from mental health care providers, and 16% sought help from their pediatricians.

“Pediatricians can provide psychosocial support for their patients who are being bullied,” Dr. Davis said. “They can also talk with patients and their parents/guardians about how to team up with school personnel to address the bullying in the school environment.”

The meta-analysis was supported by grants from Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), cofinanced by the European Regional Development Fund from the European Commission. It also was supported by Madrid Regional Government, European Union programs, Fundación Familia Alonso, Fundación Alicia Koplowitz, and Fundación Mutua Madrileña.

Dr. Fraguas disclosed consulting for or receiving fees from Angelini, Eisai, IE4Lab, Janssen, Lundbeck, and Otsuka and grant support from Fundación Alicia Koplowitz and Instituto de Salud Carlos III. Coauthors disclosed financial ties to pharmaceutical companies, as well as government and foundation grants. Dr. Curran is a member of the Pediatric News editorial advisory board. Dr. Davis had no relevant disclosures.

[email protected]

School antibullying programs may have small effect sizes but a valuable population impact, according to research published in JAMA Pediatrics.

A meta-analysis of 69 randomized trials with more than 111,600 participants found that school antibullying programs had a statistically significant effect on reducing bullying and improving mental health.

The investigators estimated population effect numbers for the interventions, such as the number of students needed to participate in an antibullying program to prevent one case of bullying.

Assuming a bullying prevalence of 15%, “an average antibullying intervention needs to include 207 people to prevent 1 case of bullying perpetration or 140 people to prevent 1 case of bullying exposure,” reported David Fraguas, MD, PhD, of the Institute of Psychiatry and Mental Health at Hospital Clínico San Carlos in Madrid, and colleagues. To improve mental health, the average antibullying program needs to include 107 people, the results indicate.

Few trials assessed the same antibullying program, so the researchers examined antibullying programs as a whole. Still, “not all antibullying programs are efficacious,” and “effectiveness may vary in different settings,” they noted.
 

Public health implications

Schools frequently implement programs to address bullying, which research suggests is a prevalent, modifiable risk factor for mental health disorders and therefore a “major public health concern,” the authors said. Studies have suggested that antibullying programs may be effective, though the evidence has been unclear.

“I see teens with mental health issues frequently in my practice, and often during their assessment, these patients and parents disclose a history of bullying at school or online,” said Kelly A. Curran, MD, associate professor of pediatrics at the University of Oklahoma, Oklahoma City. “The impact of bullying on these teens is obvious – from the mental health issues to school absenteeism and dropouts to long-term health consequences. Often, parents ask for guidance on how to ‘make it stop’ or for help working with the teen’s school. It’s hard in these cases as a clinician to know what to recommend – while it’s clear that the bullying is contributing to the teen’s health issues, giving evidenced-based guidance on bullying has been difficult.”

Relative to control groups

To assess the population impact of antibullying interventions, Dr. Fraguas and collaborators conducted random-effects meta-analyses. They identified 69 trials that included 56,511 participants in intervention groups and 55,148 in control groups. Five of the trials tested interventions targeting cyberbullying.

Participants ranged in age from 4 to 17 years, and the weighted average age was 11 years. The durations of the interventions ranged from 1 week to more than 2 years, with an average duration of 29.4 weeks.

“Antibullying interventions showed statistically significant effectiveness compared with control groups on all assessed bullying-related outcomes after the intervention,” the researchers reported. “The effect sizes were mostly statistically significant and small ... with high statistical heterogeneity and risk of publication bias. Antibullying interventions also showed statistically significant effectiveness in improving mental health problems (e.g., anxiety and depression) at study endpoint, with small effect size.”

Consistent with prior research, results varied by region. For example, interventions in Europe, where 31 of the trials were conducted, significantly decreased bullying exposure and attitudes that encourage bullying, whereas interventions in North America, where 19 of the trials were conducted, did not. In addition, European trials found greater effect sizes for the outcome measure of increasing attitudes that discourage bullying, compared with North American trials. The regional differences could reflect different programs or study designs, or differences in “social, educational, or cultural context,” the authors said.
 

‘Substantial’ impact

Together, the findings suggest that “universal antibullying interventions have a substantial population impact,” Dr. Fraguas and coauthors wrote. “To put these results into context, the [population impact number] is 35,450 for taking aspirin to avoid 1 death during the 6 months after a first nonhemorrhagic stroke, and the [population impact number] is 324 for human papillomavirus vaccination in girls to prevent cervical cancer.”

Furthermore, the interventions appear to be safe, they said. None of the trials in the meta-analysis reported an increase in bullying perpetration or bullying exposure at the end of the study or during follow-up, and mental health improved in all trials that assessed that outcome.
 

Pediatricians may be seen as resource

“From our survey work among parents all across Chicago, we know that almost one-half of all parents with children in school are concerned that their children get bullied,” said Matthew M. Davis, MD chair of the department of pediatrics at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics, medicine, medical social sciences, and preventive medicine at Northwestern University in Chicago. “Among those parents, about one-half sought help from a teacher and about one-third asked a school administrator or school social worker for help. That means that schools are, by far, the go-to source for help when parents are worried about bullying.”

The survey of 1,642 parents in Chicago also found that 20% of parents with concerns sought help from mental health care providers, and 16% sought help from their pediatricians.

“Pediatricians can provide psychosocial support for their patients who are being bullied,” Dr. Davis said. “They can also talk with patients and their parents/guardians about how to team up with school personnel to address the bullying in the school environment.”

The meta-analysis was supported by grants from Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), cofinanced by the European Regional Development Fund from the European Commission. It also was supported by Madrid Regional Government, European Union programs, Fundación Familia Alonso, Fundación Alicia Koplowitz, and Fundación Mutua Madrileña.

Dr. Fraguas disclosed consulting for or receiving fees from Angelini, Eisai, IE4Lab, Janssen, Lundbeck, and Otsuka and grant support from Fundación Alicia Koplowitz and Instituto de Salud Carlos III. Coauthors disclosed financial ties to pharmaceutical companies, as well as government and foundation grants. Dr. Curran is a member of the Pediatric News editorial advisory board. Dr. Davis had no relevant disclosures.

[email protected]

School antibullying programs may have small effect sizes but a valuable population impact, according to research published in JAMA Pediatrics.

A meta-analysis of 69 randomized trials with more than 111,600 participants found that school antibullying programs had a statistically significant effect on reducing bullying and improving mental health.

The investigators estimated population effect numbers for the interventions, such as the number of students needed to participate in an antibullying program to prevent one case of bullying.

Assuming a bullying prevalence of 15%, “an average antibullying intervention needs to include 207 people to prevent 1 case of bullying perpetration or 140 people to prevent 1 case of bullying exposure,” reported David Fraguas, MD, PhD, of the Institute of Psychiatry and Mental Health at Hospital Clínico San Carlos in Madrid, and colleagues. To improve mental health, the average antibullying program needs to include 107 people, the results indicate.

Few trials assessed the same antibullying program, so the researchers examined antibullying programs as a whole. Still, “not all antibullying programs are efficacious,” and “effectiveness may vary in different settings,” they noted.
 

Public health implications

Schools frequently implement programs to address bullying, which research suggests is a prevalent, modifiable risk factor for mental health disorders and therefore a “major public health concern,” the authors said. Studies have suggested that antibullying programs may be effective, though the evidence has been unclear.

“I see teens with mental health issues frequently in my practice, and often during their assessment, these patients and parents disclose a history of bullying at school or online,” said Kelly A. Curran, MD, associate professor of pediatrics at the University of Oklahoma, Oklahoma City. “The impact of bullying on these teens is obvious – from the mental health issues to school absenteeism and dropouts to long-term health consequences. Often, parents ask for guidance on how to ‘make it stop’ or for help working with the teen’s school. It’s hard in these cases as a clinician to know what to recommend – while it’s clear that the bullying is contributing to the teen’s health issues, giving evidenced-based guidance on bullying has been difficult.”

Relative to control groups

To assess the population impact of antibullying interventions, Dr. Fraguas and collaborators conducted random-effects meta-analyses. They identified 69 trials that included 56,511 participants in intervention groups and 55,148 in control groups. Five of the trials tested interventions targeting cyberbullying.

Participants ranged in age from 4 to 17 years, and the weighted average age was 11 years. The durations of the interventions ranged from 1 week to more than 2 years, with an average duration of 29.4 weeks.

“Antibullying interventions showed statistically significant effectiveness compared with control groups on all assessed bullying-related outcomes after the intervention,” the researchers reported. “The effect sizes were mostly statistically significant and small ... with high statistical heterogeneity and risk of publication bias. Antibullying interventions also showed statistically significant effectiveness in improving mental health problems (e.g., anxiety and depression) at study endpoint, with small effect size.”

Consistent with prior research, results varied by region. For example, interventions in Europe, where 31 of the trials were conducted, significantly decreased bullying exposure and attitudes that encourage bullying, whereas interventions in North America, where 19 of the trials were conducted, did not. In addition, European trials found greater effect sizes for the outcome measure of increasing attitudes that discourage bullying, compared with North American trials. The regional differences could reflect different programs or study designs, or differences in “social, educational, or cultural context,” the authors said.
 

‘Substantial’ impact

Together, the findings suggest that “universal antibullying interventions have a substantial population impact,” Dr. Fraguas and coauthors wrote. “To put these results into context, the [population impact number] is 35,450 for taking aspirin to avoid 1 death during the 6 months after a first nonhemorrhagic stroke, and the [population impact number] is 324 for human papillomavirus vaccination in girls to prevent cervical cancer.”

Furthermore, the interventions appear to be safe, they said. None of the trials in the meta-analysis reported an increase in bullying perpetration or bullying exposure at the end of the study or during follow-up, and mental health improved in all trials that assessed that outcome.
 

Pediatricians may be seen as resource

“From our survey work among parents all across Chicago, we know that almost one-half of all parents with children in school are concerned that their children get bullied,” said Matthew M. Davis, MD chair of the department of pediatrics at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics, medicine, medical social sciences, and preventive medicine at Northwestern University in Chicago. “Among those parents, about one-half sought help from a teacher and about one-third asked a school administrator or school social worker for help. That means that schools are, by far, the go-to source for help when parents are worried about bullying.”

The survey of 1,642 parents in Chicago also found that 20% of parents with concerns sought help from mental health care providers, and 16% sought help from their pediatricians.

“Pediatricians can provide psychosocial support for their patients who are being bullied,” Dr. Davis said. “They can also talk with patients and their parents/guardians about how to team up with school personnel to address the bullying in the school environment.”

The meta-analysis was supported by grants from Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), cofinanced by the European Regional Development Fund from the European Commission. It also was supported by Madrid Regional Government, European Union programs, Fundación Familia Alonso, Fundación Alicia Koplowitz, and Fundación Mutua Madrileña.

Dr. Fraguas disclosed consulting for or receiving fees from Angelini, Eisai, IE4Lab, Janssen, Lundbeck, and Otsuka and grant support from Fundación Alicia Koplowitz and Instituto de Salud Carlos III. Coauthors disclosed financial ties to pharmaceutical companies, as well as government and foundation grants. Dr. Curran is a member of the Pediatric News editorial advisory board. Dr. Davis had no relevant disclosures.

[email protected]

More people with fever and body aches are turning to NSAIDs to ease symptoms, but the drugs have come under new scrutiny as investigators work to determine whether they are a safe way to relieve the pain of COVID-19 vaccination or symptoms of the disease.

Early on in the pandemic, French health officials warned that NSAIDs, such as ibuprofen, could worsen coronavirus disease, and they recommended switching to acetaminophen instead.

The National Health Service in the United Kingdom followed with a similar recommendation for acetaminophen.

But the European Medicines Agency took a different approach, reporting “no scientific evidence” that NSAIDs could worsen COVID-19. The U.S. Food and Drug Administration also opted not to take a stance.

The debate prompted discussion on social media, with various reactions from around the world. It also inspired Craig Wilen, MD, PhD, from Yale University, New Haven, Conn., and associates to examine the effect of NSAIDs on COVID-19 infection and immune response. Their findings were published online Jan.20 in the Journal of Virology.

“It really bothered me that non–evidence-based decisions were driving the conversation,” Dr. Wilen said. “Millions of people are taking NSAIDs every day and clinical decisions about their care shouldn’t be made on a hypothesis.”

One theory is that NSAIDs alter susceptibility to infection by modifying ACE2. The drugs might also change the cell entry receptor for SARS-CoV-2, alter virus replication, or even modify the immune response.

British researchers, also questioning the safety of NSAIDs in patients with COVID-19, delved into National Health Service records to study two large groups of patients, some of whom were taking the pain relievers.

“We were watching the controversy and the lack of evidence and wanted to contribute,” lead investigator Angel Wong, PhD, from the London School of Hygiene and Tropical Medicine, said in an interview.

And with nearly 11 million NSAID prescriptions dispensed in primary care in England alone in the past 12 months, the inconsistency was concerning.

The team compared COVID-19–related deaths in two groups: one group of more than 700,000 people taking NSAIDs, including patients with rheumatoid arthritis and osteoarthritis; and another of almost 3.5 million people not on the medication.

NSAIDs work by inhibiting cyclooxygenase-1 and COX-2 enzymes in the body, which are crucial for the generation of prostaglandins. These lipid molecules play a role in inflammation and are blocked by NSAIDs.

The investigators found no evidence of a harmful effect of NSAIDs on COVID-19-related deaths; their results were published online Jan. 21 in the Annals of the Rheumatic Diseases.

The results, they pointed out, are in line with a Danish study that also showed no evidence of a higher risk for severe COVID-19 outcomes with NSAID use.

“It’s reassuring,” Dr. Wong said, “that patients can safely continue treatment.”
 

More new evidence

Dr. Wilen’s team found that SARS-CoV-2 infection stimulated COX-2 expression in human and mice cells. However, suppression of COX-2 by two commonly used NSAIDs, ibuprofen and meloxicam, had no effect on ACE2 expression, viral entry, or viral replication.

In their mouse model of SARS-CoV-2 infection, the investigators saw that NSAIDs impaired the production of proinflammatory cytokines and neutralizing antibodies. The findings suggest that NSAIDs influence COVID-19 outcomes by dampening the inflammatory response and production of protective antibodies, rather than modifying susceptibility to infection or viral replication.

Understanding the effect of NSAIDs on cytokine production is critical, Dr. Wilen pointed out, because they might be protective early in COVID-19 but pathologic at later stages.

Timing is crucial in the case of other immunomodulatory drugs. For example, dexamethasone lowers mortality in COVID-19 patients on respiratory support but is potentially harmful for those with milder disease.

There still is a lot to learn, Dr. Wilen acknowledged. “We may be seeing something similar going on with NSAIDs, where the timing of treatment is important.”

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

More people with fever and body aches are turning to NSAIDs to ease symptoms, but the drugs have come under new scrutiny as investigators work to determine whether they are a safe way to relieve the pain of COVID-19 vaccination or symptoms of the disease.

Early on in the pandemic, French health officials warned that NSAIDs, such as ibuprofen, could worsen coronavirus disease, and they recommended switching to acetaminophen instead.

The National Health Service in the United Kingdom followed with a similar recommendation for acetaminophen.

But the European Medicines Agency took a different approach, reporting “no scientific evidence” that NSAIDs could worsen COVID-19. The U.S. Food and Drug Administration also opted not to take a stance.

The debate prompted discussion on social media, with various reactions from around the world. It also inspired Craig Wilen, MD, PhD, from Yale University, New Haven, Conn., and associates to examine the effect of NSAIDs on COVID-19 infection and immune response. Their findings were published online Jan.20 in the Journal of Virology.

“It really bothered me that non–evidence-based decisions were driving the conversation,” Dr. Wilen said. “Millions of people are taking NSAIDs every day and clinical decisions about their care shouldn’t be made on a hypothesis.”

One theory is that NSAIDs alter susceptibility to infection by modifying ACE2. The drugs might also change the cell entry receptor for SARS-CoV-2, alter virus replication, or even modify the immune response.

British researchers, also questioning the safety of NSAIDs in patients with COVID-19, delved into National Health Service records to study two large groups of patients, some of whom were taking the pain relievers.

“We were watching the controversy and the lack of evidence and wanted to contribute,” lead investigator Angel Wong, PhD, from the London School of Hygiene and Tropical Medicine, said in an interview.

And with nearly 11 million NSAID prescriptions dispensed in primary care in England alone in the past 12 months, the inconsistency was concerning.

The team compared COVID-19–related deaths in two groups: one group of more than 700,000 people taking NSAIDs, including patients with rheumatoid arthritis and osteoarthritis; and another of almost 3.5 million people not on the medication.

NSAIDs work by inhibiting cyclooxygenase-1 and COX-2 enzymes in the body, which are crucial for the generation of prostaglandins. These lipid molecules play a role in inflammation and are blocked by NSAIDs.

The investigators found no evidence of a harmful effect of NSAIDs on COVID-19-related deaths; their results were published online Jan. 21 in the Annals of the Rheumatic Diseases.

The results, they pointed out, are in line with a Danish study that also showed no evidence of a higher risk for severe COVID-19 outcomes with NSAID use.

“It’s reassuring,” Dr. Wong said, “that patients can safely continue treatment.”
 

More new evidence

Dr. Wilen’s team found that SARS-CoV-2 infection stimulated COX-2 expression in human and mice cells. However, suppression of COX-2 by two commonly used NSAIDs, ibuprofen and meloxicam, had no effect on ACE2 expression, viral entry, or viral replication.

In their mouse model of SARS-CoV-2 infection, the investigators saw that NSAIDs impaired the production of proinflammatory cytokines and neutralizing antibodies. The findings suggest that NSAIDs influence COVID-19 outcomes by dampening the inflammatory response and production of protective antibodies, rather than modifying susceptibility to infection or viral replication.

Understanding the effect of NSAIDs on cytokine production is critical, Dr. Wilen pointed out, because they might be protective early in COVID-19 but pathologic at later stages.

Timing is crucial in the case of other immunomodulatory drugs. For example, dexamethasone lowers mortality in COVID-19 patients on respiratory support but is potentially harmful for those with milder disease.

There still is a lot to learn, Dr. Wilen acknowledged. “We may be seeing something similar going on with NSAIDs, where the timing of treatment is important.”

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

More people with fever and body aches are turning to NSAIDs to ease symptoms, but the drugs have come under new scrutiny as investigators work to determine whether they are a safe way to relieve the pain of COVID-19 vaccination or symptoms of the disease.

Early on in the pandemic, French health officials warned that NSAIDs, such as ibuprofen, could worsen coronavirus disease, and they recommended switching to acetaminophen instead.

The National Health Service in the United Kingdom followed with a similar recommendation for acetaminophen.

But the European Medicines Agency took a different approach, reporting “no scientific evidence” that NSAIDs could worsen COVID-19. The U.S. Food and Drug Administration also opted not to take a stance.

The debate prompted discussion on social media, with various reactions from around the world. It also inspired Craig Wilen, MD, PhD, from Yale University, New Haven, Conn., and associates to examine the effect of NSAIDs on COVID-19 infection and immune response. Their findings were published online Jan.20 in the Journal of Virology.

“It really bothered me that non–evidence-based decisions were driving the conversation,” Dr. Wilen said. “Millions of people are taking NSAIDs every day and clinical decisions about their care shouldn’t be made on a hypothesis.”

One theory is that NSAIDs alter susceptibility to infection by modifying ACE2. The drugs might also change the cell entry receptor for SARS-CoV-2, alter virus replication, or even modify the immune response.

British researchers, also questioning the safety of NSAIDs in patients with COVID-19, delved into National Health Service records to study two large groups of patients, some of whom were taking the pain relievers.

“We were watching the controversy and the lack of evidence and wanted to contribute,” lead investigator Angel Wong, PhD, from the London School of Hygiene and Tropical Medicine, said in an interview.

And with nearly 11 million NSAID prescriptions dispensed in primary care in England alone in the past 12 months, the inconsistency was concerning.

The team compared COVID-19–related deaths in two groups: one group of more than 700,000 people taking NSAIDs, including patients with rheumatoid arthritis and osteoarthritis; and another of almost 3.5 million people not on the medication.

NSAIDs work by inhibiting cyclooxygenase-1 and COX-2 enzymes in the body, which are crucial for the generation of prostaglandins. These lipid molecules play a role in inflammation and are blocked by NSAIDs.

The investigators found no evidence of a harmful effect of NSAIDs on COVID-19-related deaths; their results were published online Jan. 21 in the Annals of the Rheumatic Diseases.

The results, they pointed out, are in line with a Danish study that also showed no evidence of a higher risk for severe COVID-19 outcomes with NSAID use.

“It’s reassuring,” Dr. Wong said, “that patients can safely continue treatment.”
 

More new evidence

Dr. Wilen’s team found that SARS-CoV-2 infection stimulated COX-2 expression in human and mice cells. However, suppression of COX-2 by two commonly used NSAIDs, ibuprofen and meloxicam, had no effect on ACE2 expression, viral entry, or viral replication.

In their mouse model of SARS-CoV-2 infection, the investigators saw that NSAIDs impaired the production of proinflammatory cytokines and neutralizing antibodies. The findings suggest that NSAIDs influence COVID-19 outcomes by dampening the inflammatory response and production of protective antibodies, rather than modifying susceptibility to infection or viral replication.

Understanding the effect of NSAIDs on cytokine production is critical, Dr. Wilen pointed out, because they might be protective early in COVID-19 but pathologic at later stages.

Timing is crucial in the case of other immunomodulatory drugs. For example, dexamethasone lowers mortality in COVID-19 patients on respiratory support but is potentially harmful for those with milder disease.

There still is a lot to learn, Dr. Wilen acknowledged. “We may be seeing something similar going on with NSAIDs, where the timing of treatment is important.”

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

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented Jan. 28 at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection,” Naima Joseph, MD, MPH, of Emory University, Atlanta, said in an interview.

“Our data demonstrate maternal capacity to mount an appropriate and robust immune response,” and maternal protective immunity lasted at least 28 days after infection, Dr. Joseph said. “Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates.”

The researchers analyzed the amount of IgG and IgM antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein.

The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days.

All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies.

“It’s reassuring that, so far, the physiological response is exactly what we expected it to be,” Judette Louis, MD, MPH, an associate professor of ob.gyn. and the ob.gyn. department chair at the University of South Florida, Tampa, said in an interview. “It’s what we would expect, but it’s always helpful to have more data to support that. Otherwise, you’re extrapolating from what you know from other conditions,” said Dr. Louis, who moderated the oral abstracts session.

Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Infants’ cord blood titers were significantly lower than their corresponding maternal samples, independently of symptoms or latency from infection to delivery (P < .001), Dr. Joseph reported.

“Transplacental efficiency in other pathogens has been shown to be correlated with neonatal immunity when the ratio of cord to maternal blood is greater than 1,” Dr. Joseph said in her presentation. Their data showed “suboptimal efficiency” at a ratio of 0.81.

The study’s small sample size and lack of a control group were weaknesses, but a major strength was having a population at disproportionately higher risk for infection and severe morbidity than the general population.
 

Implications for maternal COVID-19 vaccination

Although the data are not yet available, Dr. Joseph said they have expanded their protocol to include vaccinated pregnant women.

“The key to developing an effective vaccine [for pregnant people] is in really characterizing adaptive immunity in pregnancy,” Dr. Joseph told SMFM attendees. “I think that these findings inform further vaccine development in demonstrating that maternal immunity is robust.”

The World Health Organization recently recommended withholding COVID-19 vaccines from pregnant people, but the SMFM and American College of Obstetricians and Gynecologists subsequently issued a joint statement reaffirming that the COVID-19 vaccines authorized by the FDA “should not be withheld from pregnant individuals who choose to receive the vaccine.”

“One of the questions people ask is whether in pregnancy you’re going to mount a good response to the vaccine the way you would outside of pregnancy,” Dr. Louis said. “If we can demonstrate that you do, that may provide the information that some mothers need to make their decisions.” Data such as those from Dr. Joseph’s study can also inform recommendations on timing of maternal vaccination.

“For instance, Dr. Joseph demonstrated that, 28 days out from the infection, you had more antibodies, so there may be a scenario where we say this vaccine may be more beneficial in the middle of the pregnancy for the purpose of forming those antibodies,” Dr. Louis said.
 

Consensus emerging from maternal antibodies data

The findings from Dr. Joseph’s study mirror those reported in a study published online Jan. 29 in JAMA Pediatrics. That study, led by Dustin D. Flannery, DO, MSCE, of Children’s Hospital of Philadelphia, also examined maternal and neonatal levels of IgG and IgM antibodies against the receptor binding domain of the SARS-CoV-2 spike protein. They also found a positive correlation between cord blood and maternal IgG concentrations (P < .001), but notably, the ratio of cord to maternal blood titers was greater than 1, unlike in Dr. Joseph’s study.

For their study, Dr. Flannery and colleagues obtained maternal and cord blood sera at the time of delivery from 1471 pairs of mothers and infants, independently of COVID status during pregnancy. The average maternal age was 32 years, and just over a quarter of the population (26%) were Black, non-Hispanic women. About half (51%) were White, 12% were Hispanic, and 7% were Asian.

About 6% of the women had either IgG or IgM antibodies at delivery, and 87% of infants born to those mothers had measurable IgG in their cord blood. No infants had IgM antibodies. As with the study presented at SMFM, the mothers’ infections included asymptomatic, mild, moderate, and severe cases, and the degree of severity of cases had no apparent effect on infant antibody concentrations. Most of the women who tested positive for COVID-19 (60%) were asymptomatic.

Among the 11 mothers who had antibodies but whose infants’ cord blood did not, 5 had only IgM antibodies, and 6 had significantly lower IgG concentrations than those seen in the other mothers.

In a commentary about the JAMA Pediatrics study, Flor Munoz, MD, of the Baylor College of Medicine, Houston, suggested that the findings are grounds for optimism about a maternal vaccination strategy to protect infants from COVID-19.

“However, the timing of maternal vaccination to protect the infant, as opposed to the mother alone, would necessitate an adequate interval from vaccination to delivery (of at least 4 weeks), while vaccination early in gestation and even late in the third trimester could still be protective for the mother,” Dr. Munoz wrote.

Given the interval between two-dose vaccination regimens and the fact that transplacental transfer begins at about the 17th week of gestation, “maternal vaccination starting in the early second trimester of gestation might be optimal to achieve the highest levels of antibodies in the newborn,” Dr. Munoz wrote. But questions remain, such as how effective the neonatal antibodies would be in protecting against COVID-19 and how long they last after birth.

No external funding was used in Dr. Joseph’s study. Dr. Joseph and Dr. Louis have disclosed no relevant financial relationships. The JAMA Pediatrics study was funded by the Children’s Hospital of Philadelphia. One coauthor received consultancy fees from Sanofi Pasteur, Lumen, Novavax, and Merck unrelated to the study. Dr. Munoz served on the data and safety monitoring boards of Moderna, Pfizer, Virometix, and Meissa Vaccines and has received grants from Novavax Research and Gilead Research.

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

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented Jan. 28 at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection,” Naima Joseph, MD, MPH, of Emory University, Atlanta, said in an interview.

“Our data demonstrate maternal capacity to mount an appropriate and robust immune response,” and maternal protective immunity lasted at least 28 days after infection, Dr. Joseph said. “Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates.”

The researchers analyzed the amount of IgG and IgM antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein.

The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days.

All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies.

“It’s reassuring that, so far, the physiological response is exactly what we expected it to be,” Judette Louis, MD, MPH, an associate professor of ob.gyn. and the ob.gyn. department chair at the University of South Florida, Tampa, said in an interview. “It’s what we would expect, but it’s always helpful to have more data to support that. Otherwise, you’re extrapolating from what you know from other conditions,” said Dr. Louis, who moderated the oral abstracts session.

Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Infants’ cord blood titers were significantly lower than their corresponding maternal samples, independently of symptoms or latency from infection to delivery (P < .001), Dr. Joseph reported.

“Transplacental efficiency in other pathogens has been shown to be correlated with neonatal immunity when the ratio of cord to maternal blood is greater than 1,” Dr. Joseph said in her presentation. Their data showed “suboptimal efficiency” at a ratio of 0.81.

The study’s small sample size and lack of a control group were weaknesses, but a major strength was having a population at disproportionately higher risk for infection and severe morbidity than the general population.
 

Implications for maternal COVID-19 vaccination

Although the data are not yet available, Dr. Joseph said they have expanded their protocol to include vaccinated pregnant women.

“The key to developing an effective vaccine [for pregnant people] is in really characterizing adaptive immunity in pregnancy,” Dr. Joseph told SMFM attendees. “I think that these findings inform further vaccine development in demonstrating that maternal immunity is robust.”

The World Health Organization recently recommended withholding COVID-19 vaccines from pregnant people, but the SMFM and American College of Obstetricians and Gynecologists subsequently issued a joint statement reaffirming that the COVID-19 vaccines authorized by the FDA “should not be withheld from pregnant individuals who choose to receive the vaccine.”

“One of the questions people ask is whether in pregnancy you’re going to mount a good response to the vaccine the way you would outside of pregnancy,” Dr. Louis said. “If we can demonstrate that you do, that may provide the information that some mothers need to make their decisions.” Data such as those from Dr. Joseph’s study can also inform recommendations on timing of maternal vaccination.

“For instance, Dr. Joseph demonstrated that, 28 days out from the infection, you had more antibodies, so there may be a scenario where we say this vaccine may be more beneficial in the middle of the pregnancy for the purpose of forming those antibodies,” Dr. Louis said.
 

Consensus emerging from maternal antibodies data

The findings from Dr. Joseph’s study mirror those reported in a study published online Jan. 29 in JAMA Pediatrics. That study, led by Dustin D. Flannery, DO, MSCE, of Children’s Hospital of Philadelphia, also examined maternal and neonatal levels of IgG and IgM antibodies against the receptor binding domain of the SARS-CoV-2 spike protein. They also found a positive correlation between cord blood and maternal IgG concentrations (P < .001), but notably, the ratio of cord to maternal blood titers was greater than 1, unlike in Dr. Joseph’s study.

For their study, Dr. Flannery and colleagues obtained maternal and cord blood sera at the time of delivery from 1471 pairs of mothers and infants, independently of COVID status during pregnancy. The average maternal age was 32 years, and just over a quarter of the population (26%) were Black, non-Hispanic women. About half (51%) were White, 12% were Hispanic, and 7% were Asian.

About 6% of the women had either IgG or IgM antibodies at delivery, and 87% of infants born to those mothers had measurable IgG in their cord blood. No infants had IgM antibodies. As with the study presented at SMFM, the mothers’ infections included asymptomatic, mild, moderate, and severe cases, and the degree of severity of cases had no apparent effect on infant antibody concentrations. Most of the women who tested positive for COVID-19 (60%) were asymptomatic.

Among the 11 mothers who had antibodies but whose infants’ cord blood did not, 5 had only IgM antibodies, and 6 had significantly lower IgG concentrations than those seen in the other mothers.

In a commentary about the JAMA Pediatrics study, Flor Munoz, MD, of the Baylor College of Medicine, Houston, suggested that the findings are grounds for optimism about a maternal vaccination strategy to protect infants from COVID-19.

“However, the timing of maternal vaccination to protect the infant, as opposed to the mother alone, would necessitate an adequate interval from vaccination to delivery (of at least 4 weeks), while vaccination early in gestation and even late in the third trimester could still be protective for the mother,” Dr. Munoz wrote.

Given the interval between two-dose vaccination regimens and the fact that transplacental transfer begins at about the 17th week of gestation, “maternal vaccination starting in the early second trimester of gestation might be optimal to achieve the highest levels of antibodies in the newborn,” Dr. Munoz wrote. But questions remain, such as how effective the neonatal antibodies would be in protecting against COVID-19 and how long they last after birth.

No external funding was used in Dr. Joseph’s study. Dr. Joseph and Dr. Louis have disclosed no relevant financial relationships. The JAMA Pediatrics study was funded by the Children’s Hospital of Philadelphia. One coauthor received consultancy fees from Sanofi Pasteur, Lumen, Novavax, and Merck unrelated to the study. Dr. Munoz served on the data and safety monitoring boards of Moderna, Pfizer, Virometix, and Meissa Vaccines and has received grants from Novavax Research and Gilead Research.

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

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented Jan. 28 at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection,” Naima Joseph, MD, MPH, of Emory University, Atlanta, said in an interview.

“Our data demonstrate maternal capacity to mount an appropriate and robust immune response,” and maternal protective immunity lasted at least 28 days after infection, Dr. Joseph said. “Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates.”

The researchers analyzed the amount of IgG and IgM antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein.

The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days.

All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies.

“It’s reassuring that, so far, the physiological response is exactly what we expected it to be,” Judette Louis, MD, MPH, an associate professor of ob.gyn. and the ob.gyn. department chair at the University of South Florida, Tampa, said in an interview. “It’s what we would expect, but it’s always helpful to have more data to support that. Otherwise, you’re extrapolating from what you know from other conditions,” said Dr. Louis, who moderated the oral abstracts session.

Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Infants’ cord blood titers were significantly lower than their corresponding maternal samples, independently of symptoms or latency from infection to delivery (P < .001), Dr. Joseph reported.

“Transplacental efficiency in other pathogens has been shown to be correlated with neonatal immunity when the ratio of cord to maternal blood is greater than 1,” Dr. Joseph said in her presentation. Their data showed “suboptimal efficiency” at a ratio of 0.81.

The study’s small sample size and lack of a control group were weaknesses, but a major strength was having a population at disproportionately higher risk for infection and severe morbidity than the general population.
 

Implications for maternal COVID-19 vaccination

Although the data are not yet available, Dr. Joseph said they have expanded their protocol to include vaccinated pregnant women.

“The key to developing an effective vaccine [for pregnant people] is in really characterizing adaptive immunity in pregnancy,” Dr. Joseph told SMFM attendees. “I think that these findings inform further vaccine development in demonstrating that maternal immunity is robust.”

The World Health Organization recently recommended withholding COVID-19 vaccines from pregnant people, but the SMFM and American College of Obstetricians and Gynecologists subsequently issued a joint statement reaffirming that the COVID-19 vaccines authorized by the FDA “should not be withheld from pregnant individuals who choose to receive the vaccine.”

“One of the questions people ask is whether in pregnancy you’re going to mount a good response to the vaccine the way you would outside of pregnancy,” Dr. Louis said. “If we can demonstrate that you do, that may provide the information that some mothers need to make their decisions.” Data such as those from Dr. Joseph’s study can also inform recommendations on timing of maternal vaccination.

“For instance, Dr. Joseph demonstrated that, 28 days out from the infection, you had more antibodies, so there may be a scenario where we say this vaccine may be more beneficial in the middle of the pregnancy for the purpose of forming those antibodies,” Dr. Louis said.
 

Consensus emerging from maternal antibodies data

The findings from Dr. Joseph’s study mirror those reported in a study published online Jan. 29 in JAMA Pediatrics. That study, led by Dustin D. Flannery, DO, MSCE, of Children’s Hospital of Philadelphia, also examined maternal and neonatal levels of IgG and IgM antibodies against the receptor binding domain of the SARS-CoV-2 spike protein. They also found a positive correlation between cord blood and maternal IgG concentrations (P < .001), but notably, the ratio of cord to maternal blood titers was greater than 1, unlike in Dr. Joseph’s study.

For their study, Dr. Flannery and colleagues obtained maternal and cord blood sera at the time of delivery from 1471 pairs of mothers and infants, independently of COVID status during pregnancy. The average maternal age was 32 years, and just over a quarter of the population (26%) were Black, non-Hispanic women. About half (51%) were White, 12% were Hispanic, and 7% were Asian.

About 6% of the women had either IgG or IgM antibodies at delivery, and 87% of infants born to those mothers had measurable IgG in their cord blood. No infants had IgM antibodies. As with the study presented at SMFM, the mothers’ infections included asymptomatic, mild, moderate, and severe cases, and the degree of severity of cases had no apparent effect on infant antibody concentrations. Most of the women who tested positive for COVID-19 (60%) were asymptomatic.

Among the 11 mothers who had antibodies but whose infants’ cord blood did not, 5 had only IgM antibodies, and 6 had significantly lower IgG concentrations than those seen in the other mothers.

In a commentary about the JAMA Pediatrics study, Flor Munoz, MD, of the Baylor College of Medicine, Houston, suggested that the findings are grounds for optimism about a maternal vaccination strategy to protect infants from COVID-19.

“However, the timing of maternal vaccination to protect the infant, as opposed to the mother alone, would necessitate an adequate interval from vaccination to delivery (of at least 4 weeks), while vaccination early in gestation and even late in the third trimester could still be protective for the mother,” Dr. Munoz wrote.

Given the interval between two-dose vaccination regimens and the fact that transplacental transfer begins at about the 17th week of gestation, “maternal vaccination starting in the early second trimester of gestation might be optimal to achieve the highest levels of antibodies in the newborn,” Dr. Munoz wrote. But questions remain, such as how effective the neonatal antibodies would be in protecting against COVID-19 and how long they last after birth.

No external funding was used in Dr. Joseph’s study. Dr. Joseph and Dr. Louis have disclosed no relevant financial relationships. The JAMA Pediatrics study was funded by the Children’s Hospital of Philadelphia. One coauthor received consultancy fees from Sanofi Pasteur, Lumen, Novavax, and Merck unrelated to the study. Dr. Munoz served on the data and safety monitoring boards of Moderna, Pfizer, Virometix, and Meissa Vaccines and has received grants from Novavax Research and Gilead Research.

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