Autism rates trending upwards, CDC reports

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Childhood autism rates have ticked up once again, according to the latest data from Centers for Disease Control and Prevention.

According to the CDC, 1 in 36 (2.8%) 8-year-old children have been identified with autism spectrum disorder (ASD) – up from the previous 2018 estimate of 1 in 44 (2.3%).

The updated data come from 11 communities in the Autism and Developmental Disabilities Monitoring (ADDM) network and were published online in Morbidity and Mortality Weekly Report.

A separate report in the MMWR on 4-year-old children in the same 11 communities highlights the impact of COVID-19, showing disruptions in progress in early autism detection.

In the early months of the pandemic, 4-year-old children were less likely to have an evaluation or be identified with ASD than 8-year-old children when they were the same age. This coincides with interruptions in childcare and health care services during the COVID-19 pandemic.

“Disruptions due to the pandemic in the timely evaluation of children and delays in connecting children to the services and support they need could have long-lasting effects,” Karen Remley, MD, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a statement.

“The data in this report can help communities better understand how the pandemic impacted early identification of autism in young children and anticipate future needs as these children get older,” Dr. Remley noted.
 

Shifting demographics

The latest data also show that ASD prevalence among Asian, Black, and Hispanic children was at least 30% higher in 2020 than in 2018, and ASD prevalence among White children was 14.6% higher than in 2018.

For the first time, according to the CDC, the percentage of 8-year-old Asian/Pacific Islander (3.3%), Hispanic (3.2%) and Black (2.9%) children identified with autism was higher than the percentage of 8-year-old White children (2.4%).

This is the opposite of racial and ethnic differences seen in previous ADDM reports for 8-year-olds. These shifts may reflect improved screening, awareness, and access to services among historically underserved groups, the CDC said.

Disparities for co-occurring intellectual disability have also persisted, with a higher percentage of Black children with autism identified with intellectual disability compared with White, Hispanic, or Asian/Pacific Islander children with autism. These differences could relate in part to access to services that diagnose and support children with autism, the CDC noted.

Overall, autism prevalence within the 11 ADDM communities was nearly four times higher for boys than girls. However, it’s the first time that the prevalence of autism among 8-year-old girls has topped 1%.
 

Community differences

Autism prevalence in the 11 ADDM communities ranged from 1 in 43 (2.3%) children in Maryland to 1 in 22 (4.5%) in California – variations that could be due to how communities identify children with autism.

This variability affords an opportunity to compare local policies and models for delivering diagnostic and interventional services that could enhance autism identification and provide more comprehensive support to people with autism, the CDC said.
 

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

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Childhood autism rates have ticked up once again, according to the latest data from Centers for Disease Control and Prevention.

According to the CDC, 1 in 36 (2.8%) 8-year-old children have been identified with autism spectrum disorder (ASD) – up from the previous 2018 estimate of 1 in 44 (2.3%).

The updated data come from 11 communities in the Autism and Developmental Disabilities Monitoring (ADDM) network and were published online in Morbidity and Mortality Weekly Report.

A separate report in the MMWR on 4-year-old children in the same 11 communities highlights the impact of COVID-19, showing disruptions in progress in early autism detection.

In the early months of the pandemic, 4-year-old children were less likely to have an evaluation or be identified with ASD than 8-year-old children when they were the same age. This coincides with interruptions in childcare and health care services during the COVID-19 pandemic.

“Disruptions due to the pandemic in the timely evaluation of children and delays in connecting children to the services and support they need could have long-lasting effects,” Karen Remley, MD, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a statement.

“The data in this report can help communities better understand how the pandemic impacted early identification of autism in young children and anticipate future needs as these children get older,” Dr. Remley noted.
 

Shifting demographics

The latest data also show that ASD prevalence among Asian, Black, and Hispanic children was at least 30% higher in 2020 than in 2018, and ASD prevalence among White children was 14.6% higher than in 2018.

For the first time, according to the CDC, the percentage of 8-year-old Asian/Pacific Islander (3.3%), Hispanic (3.2%) and Black (2.9%) children identified with autism was higher than the percentage of 8-year-old White children (2.4%).

This is the opposite of racial and ethnic differences seen in previous ADDM reports for 8-year-olds. These shifts may reflect improved screening, awareness, and access to services among historically underserved groups, the CDC said.

Disparities for co-occurring intellectual disability have also persisted, with a higher percentage of Black children with autism identified with intellectual disability compared with White, Hispanic, or Asian/Pacific Islander children with autism. These differences could relate in part to access to services that diagnose and support children with autism, the CDC noted.

Overall, autism prevalence within the 11 ADDM communities was nearly four times higher for boys than girls. However, it’s the first time that the prevalence of autism among 8-year-old girls has topped 1%.
 

Community differences

Autism prevalence in the 11 ADDM communities ranged from 1 in 43 (2.3%) children in Maryland to 1 in 22 (4.5%) in California – variations that could be due to how communities identify children with autism.

This variability affords an opportunity to compare local policies and models for delivering diagnostic and interventional services that could enhance autism identification and provide more comprehensive support to people with autism, the CDC said.
 

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

Childhood autism rates have ticked up once again, according to the latest data from Centers for Disease Control and Prevention.

According to the CDC, 1 in 36 (2.8%) 8-year-old children have been identified with autism spectrum disorder (ASD) – up from the previous 2018 estimate of 1 in 44 (2.3%).

The updated data come from 11 communities in the Autism and Developmental Disabilities Monitoring (ADDM) network and were published online in Morbidity and Mortality Weekly Report.

A separate report in the MMWR on 4-year-old children in the same 11 communities highlights the impact of COVID-19, showing disruptions in progress in early autism detection.

In the early months of the pandemic, 4-year-old children were less likely to have an evaluation or be identified with ASD than 8-year-old children when they were the same age. This coincides with interruptions in childcare and health care services during the COVID-19 pandemic.

“Disruptions due to the pandemic in the timely evaluation of children and delays in connecting children to the services and support they need could have long-lasting effects,” Karen Remley, MD, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a statement.

“The data in this report can help communities better understand how the pandemic impacted early identification of autism in young children and anticipate future needs as these children get older,” Dr. Remley noted.
 

Shifting demographics

The latest data also show that ASD prevalence among Asian, Black, and Hispanic children was at least 30% higher in 2020 than in 2018, and ASD prevalence among White children was 14.6% higher than in 2018.

For the first time, according to the CDC, the percentage of 8-year-old Asian/Pacific Islander (3.3%), Hispanic (3.2%) and Black (2.9%) children identified with autism was higher than the percentage of 8-year-old White children (2.4%).

This is the opposite of racial and ethnic differences seen in previous ADDM reports for 8-year-olds. These shifts may reflect improved screening, awareness, and access to services among historically underserved groups, the CDC said.

Disparities for co-occurring intellectual disability have also persisted, with a higher percentage of Black children with autism identified with intellectual disability compared with White, Hispanic, or Asian/Pacific Islander children with autism. These differences could relate in part to access to services that diagnose and support children with autism, the CDC noted.

Overall, autism prevalence within the 11 ADDM communities was nearly four times higher for boys than girls. However, it’s the first time that the prevalence of autism among 8-year-old girls has topped 1%.
 

Community differences

Autism prevalence in the 11 ADDM communities ranged from 1 in 43 (2.3%) children in Maryland to 1 in 22 (4.5%) in California – variations that could be due to how communities identify children with autism.

This variability affords an opportunity to compare local policies and models for delivering diagnostic and interventional services that could enhance autism identification and provide more comprehensive support to people with autism, the CDC said.
 

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

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Air pollution may be causing eczema

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New research shows that chemicals from car exhaust, wildfires, and cigarette smoke impair the skin’s ability to make healthy oil, making it more likely to get eczema.

The finding points scientists toward how to better treat the skin ailment. There are now more than three times as many eczema cases as there were in the 1970s, and it now affects as many as 20% of children and 10% of adults.

“I think these authors are spot-on in recognizing that the incidence of allergic conditions is increasing concurrently with how different pollutants are increasing in our environment,” said Denver-based pediatric allergist and immunologist Jessica Hui, MD, according to NBC News. “We’re finally understanding more about why people are getting eczema.”

Some people get eczema because of genetics, but the new research built on the previous understanding of how chemicals called diisocyanates can trigger the eczema symptoms of severe itching, skin redness, and oozing or painful rashes. An experiment on mice showed that exposure to a specific part of diisocyanates, called isocyanates, disrupted oil production that the skin needs to stay healthy.

Researchers at the National Institutes of Health “found that when bacteria that live on healthy skin are exposed to isocyanate, they must adapt to survive,” the agency summarized in a news release. “When they adapt, these bacteria shift their metabolism away from making the lipids, or oils, that skin needs to stay healthy. This finding suggests that eczema may be treatable by replacing the modified skin bacteria with healthy bacteria.”



The study was published in the journal Science Advances.

The chemicals also trigger a message to the brain that causes skin inflammation and itching, lead researcher Ian Myles, MD, told NBC News. Dr. Myles is also chief of the Epithelial Research Unit in the National Institute of Allergy and Infectious Diseases Laboratory of Clinical Immunology and Microbiology.

“So much of this is out of our control. I mean, you can’t shut the highways down,” he said of the environmental sources.

Previous research that explored attempting to restore healthy skin bacteria called Roseomonas mucosa to treat eczema symptoms had mixed results. The NIH says it has made the bacteria available “for commercial, nontherapeutic development ... as a potentially beneficial probiotic.”

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

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New research shows that chemicals from car exhaust, wildfires, and cigarette smoke impair the skin’s ability to make healthy oil, making it more likely to get eczema.

The finding points scientists toward how to better treat the skin ailment. There are now more than three times as many eczema cases as there were in the 1970s, and it now affects as many as 20% of children and 10% of adults.

“I think these authors are spot-on in recognizing that the incidence of allergic conditions is increasing concurrently with how different pollutants are increasing in our environment,” said Denver-based pediatric allergist and immunologist Jessica Hui, MD, according to NBC News. “We’re finally understanding more about why people are getting eczema.”

Some people get eczema because of genetics, but the new research built on the previous understanding of how chemicals called diisocyanates can trigger the eczema symptoms of severe itching, skin redness, and oozing or painful rashes. An experiment on mice showed that exposure to a specific part of diisocyanates, called isocyanates, disrupted oil production that the skin needs to stay healthy.

Researchers at the National Institutes of Health “found that when bacteria that live on healthy skin are exposed to isocyanate, they must adapt to survive,” the agency summarized in a news release. “When they adapt, these bacteria shift their metabolism away from making the lipids, or oils, that skin needs to stay healthy. This finding suggests that eczema may be treatable by replacing the modified skin bacteria with healthy bacteria.”



The study was published in the journal Science Advances.

The chemicals also trigger a message to the brain that causes skin inflammation and itching, lead researcher Ian Myles, MD, told NBC News. Dr. Myles is also chief of the Epithelial Research Unit in the National Institute of Allergy and Infectious Diseases Laboratory of Clinical Immunology and Microbiology.

“So much of this is out of our control. I mean, you can’t shut the highways down,” he said of the environmental sources.

Previous research that explored attempting to restore healthy skin bacteria called Roseomonas mucosa to treat eczema symptoms had mixed results. The NIH says it has made the bacteria available “for commercial, nontherapeutic development ... as a potentially beneficial probiotic.”

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

New research shows that chemicals from car exhaust, wildfires, and cigarette smoke impair the skin’s ability to make healthy oil, making it more likely to get eczema.

The finding points scientists toward how to better treat the skin ailment. There are now more than three times as many eczema cases as there were in the 1970s, and it now affects as many as 20% of children and 10% of adults.

“I think these authors are spot-on in recognizing that the incidence of allergic conditions is increasing concurrently with how different pollutants are increasing in our environment,” said Denver-based pediatric allergist and immunologist Jessica Hui, MD, according to NBC News. “We’re finally understanding more about why people are getting eczema.”

Some people get eczema because of genetics, but the new research built on the previous understanding of how chemicals called diisocyanates can trigger the eczema symptoms of severe itching, skin redness, and oozing or painful rashes. An experiment on mice showed that exposure to a specific part of diisocyanates, called isocyanates, disrupted oil production that the skin needs to stay healthy.

Researchers at the National Institutes of Health “found that when bacteria that live on healthy skin are exposed to isocyanate, they must adapt to survive,” the agency summarized in a news release. “When they adapt, these bacteria shift their metabolism away from making the lipids, or oils, that skin needs to stay healthy. This finding suggests that eczema may be treatable by replacing the modified skin bacteria with healthy bacteria.”



The study was published in the journal Science Advances.

The chemicals also trigger a message to the brain that causes skin inflammation and itching, lead researcher Ian Myles, MD, told NBC News. Dr. Myles is also chief of the Epithelial Research Unit in the National Institute of Allergy and Infectious Diseases Laboratory of Clinical Immunology and Microbiology.

“So much of this is out of our control. I mean, you can’t shut the highways down,” he said of the environmental sources.

Previous research that explored attempting to restore healthy skin bacteria called Roseomonas mucosa to treat eczema symptoms had mixed results. The NIH says it has made the bacteria available “for commercial, nontherapeutic development ... as a potentially beneficial probiotic.”

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

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FDA approves new formulation of Hyrimoz adalimumab biosimilar

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The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

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

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The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

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

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

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

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COVID in pregnancy may affect boys’ neurodevelopment: Study

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Boys born to mothers infected with SARS‐CoV‐2 during pregnancy may be more likely to receive a diagnosis of a neurodevelopmental disorder by age 12 months, according to new research.

Andrea G. Edlow, MD, MSc, with Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues examined data from 18,355 births between March 1, 2020, and May 31, 2021, at eight hospitals across two health systems in Massachusetts.

Of these births, 883 (4.8%) were to individuals who tested positive for SARS‐CoV‐2 during pregnancy. Among the children exposed to SARS‐CoV‐2 in the womb, 26 (3%) received a neurodevelopmental diagnosis, including disorders of motor function, speech and language, and psychological development, by age 1 year. In the group unexposed to the virus, 1.8% received such a diagnosis.

After adjusting for factors such as race, insurance, maternal age, and preterm birth, Dr. Edlow’s group found that a positive test for SARS-CoV-2 during pregnancy was  associated with an increased risk for neurodevelopmental diagnoses at 12 months among boys (adjusted odds ratio, 1.94; 95% confidence interval, 1.12-3.17; P = .01), but not among girls.

In a subset of children with data available at 18 months, the correlation among boys at that age was less pronounced and not statistically significant (aOR, 1.42; 95% CI, 0.92-2.11; P = .10).  

The findings were published online in JAMA Network Open

Prior epidemiological research has suggested that maternal infection during pregnancy is associated with heightened risk for a range of neurodevelopmental disorders, including autism and schizophrenia, in offspring, the authors wrote.

“The neurodevelopmental risk associated with maternal SARS-CoV-2 infection was disproportionately high in male infants, consistent with the known increased vulnerability of males in the face of prenatal adverse exposures,” Dr. Edlow said in a news release about the findings.

Larger studies and longer follow‐up are needed to confirm and reliably estimate the risk, the researchers said.

“It is not clear that the changes we can detect at 12 and 18 months will be indicative of persistent risks for disorders such as autism spectrum disorder, intellectual disability, or schizophrenia,” they write.

New data published online by the Centers for Disease Control and Prevention show that in 11 communities in 2020, 1 in 36 (2.8%) 8-year-old children had been identified with autism spectrum disorder, an increase from 2.3% in 2018. The data also show that the early months of the pandemic may have disrupted autism detection efforts among 4-year-olds.

The investigators were supported by grants from the National Institutes of Health and the Simons Foundation Autism Research Initiative. Coauthors disclosed consulting for or receiving personal fees from biotechnology and pharmaceutical companies.

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

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Boys born to mothers infected with SARS‐CoV‐2 during pregnancy may be more likely to receive a diagnosis of a neurodevelopmental disorder by age 12 months, according to new research.

Andrea G. Edlow, MD, MSc, with Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues examined data from 18,355 births between March 1, 2020, and May 31, 2021, at eight hospitals across two health systems in Massachusetts.

Of these births, 883 (4.8%) were to individuals who tested positive for SARS‐CoV‐2 during pregnancy. Among the children exposed to SARS‐CoV‐2 in the womb, 26 (3%) received a neurodevelopmental diagnosis, including disorders of motor function, speech and language, and psychological development, by age 1 year. In the group unexposed to the virus, 1.8% received such a diagnosis.

After adjusting for factors such as race, insurance, maternal age, and preterm birth, Dr. Edlow’s group found that a positive test for SARS-CoV-2 during pregnancy was  associated with an increased risk for neurodevelopmental diagnoses at 12 months among boys (adjusted odds ratio, 1.94; 95% confidence interval, 1.12-3.17; P = .01), but not among girls.

In a subset of children with data available at 18 months, the correlation among boys at that age was less pronounced and not statistically significant (aOR, 1.42; 95% CI, 0.92-2.11; P = .10).  

The findings were published online in JAMA Network Open

Prior epidemiological research has suggested that maternal infection during pregnancy is associated with heightened risk for a range of neurodevelopmental disorders, including autism and schizophrenia, in offspring, the authors wrote.

“The neurodevelopmental risk associated with maternal SARS-CoV-2 infection was disproportionately high in male infants, consistent with the known increased vulnerability of males in the face of prenatal adverse exposures,” Dr. Edlow said in a news release about the findings.

Larger studies and longer follow‐up are needed to confirm and reliably estimate the risk, the researchers said.

“It is not clear that the changes we can detect at 12 and 18 months will be indicative of persistent risks for disorders such as autism spectrum disorder, intellectual disability, or schizophrenia,” they write.

New data published online by the Centers for Disease Control and Prevention show that in 11 communities in 2020, 1 in 36 (2.8%) 8-year-old children had been identified with autism spectrum disorder, an increase from 2.3% in 2018. The data also show that the early months of the pandemic may have disrupted autism detection efforts among 4-year-olds.

The investigators were supported by grants from the National Institutes of Health and the Simons Foundation Autism Research Initiative. Coauthors disclosed consulting for or receiving personal fees from biotechnology and pharmaceutical companies.

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

Boys born to mothers infected with SARS‐CoV‐2 during pregnancy may be more likely to receive a diagnosis of a neurodevelopmental disorder by age 12 months, according to new research.

Andrea G. Edlow, MD, MSc, with Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues examined data from 18,355 births between March 1, 2020, and May 31, 2021, at eight hospitals across two health systems in Massachusetts.

Of these births, 883 (4.8%) were to individuals who tested positive for SARS‐CoV‐2 during pregnancy. Among the children exposed to SARS‐CoV‐2 in the womb, 26 (3%) received a neurodevelopmental diagnosis, including disorders of motor function, speech and language, and psychological development, by age 1 year. In the group unexposed to the virus, 1.8% received such a diagnosis.

After adjusting for factors such as race, insurance, maternal age, and preterm birth, Dr. Edlow’s group found that a positive test for SARS-CoV-2 during pregnancy was  associated with an increased risk for neurodevelopmental diagnoses at 12 months among boys (adjusted odds ratio, 1.94; 95% confidence interval, 1.12-3.17; P = .01), but not among girls.

In a subset of children with data available at 18 months, the correlation among boys at that age was less pronounced and not statistically significant (aOR, 1.42; 95% CI, 0.92-2.11; P = .10).  

The findings were published online in JAMA Network Open

Prior epidemiological research has suggested that maternal infection during pregnancy is associated with heightened risk for a range of neurodevelopmental disorders, including autism and schizophrenia, in offspring, the authors wrote.

“The neurodevelopmental risk associated with maternal SARS-CoV-2 infection was disproportionately high in male infants, consistent with the known increased vulnerability of males in the face of prenatal adverse exposures,” Dr. Edlow said in a news release about the findings.

Larger studies and longer follow‐up are needed to confirm and reliably estimate the risk, the researchers said.

“It is not clear that the changes we can detect at 12 and 18 months will be indicative of persistent risks for disorders such as autism spectrum disorder, intellectual disability, or schizophrenia,” they write.

New data published online by the Centers for Disease Control and Prevention show that in 11 communities in 2020, 1 in 36 (2.8%) 8-year-old children had been identified with autism spectrum disorder, an increase from 2.3% in 2018. The data also show that the early months of the pandemic may have disrupted autism detection efforts among 4-year-olds.

The investigators were supported by grants from the National Institutes of Health and the Simons Foundation Autism Research Initiative. Coauthors disclosed consulting for or receiving personal fees from biotechnology and pharmaceutical companies.

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

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Like mother, like daughter? Moms pass obesity risk to girls

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Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m2.

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

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Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m2.

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m2.

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

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Liquid albuterol shortage effects reduced by alternative drugs, similar shortages may be increasingly common

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A nationwide shortage of liquid albuterol is having minimal impact on patient care, as treatment alternatives are available, and supply appears to be recovering fast, suggest accounts from experts at health care centers around the country.

The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.

The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.

Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.

Dr. David R. Stukus


Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.

Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.

“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”

Even infants and toddlers can use inhalers

Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.

“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”

The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.

“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”

National Jewish Health
Dr. Nathan Rabinovitch

Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.

While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.

Personal preferences may also considered, he added.

“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”

Michican Medicine
Dr. Kelly O'Shea

One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.

“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”

She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.

“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
 

 

 

Generic drug shortages becoming more common

While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.

University of Pittsburgh School of Medicine
Dr. Katie J. Suda

“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.

The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.

The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.

A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.

“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”

The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.

Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.

When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.

Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.

Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.

“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.

Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.

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A nationwide shortage of liquid albuterol is having minimal impact on patient care, as treatment alternatives are available, and supply appears to be recovering fast, suggest accounts from experts at health care centers around the country.

The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.

The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.

Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.

Dr. David R. Stukus


Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.

Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.

“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”

Even infants and toddlers can use inhalers

Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.

“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”

The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.

“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”

National Jewish Health
Dr. Nathan Rabinovitch

Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.

While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.

Personal preferences may also considered, he added.

“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”

Michican Medicine
Dr. Kelly O'Shea

One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.

“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”

She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.

“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
 

 

 

Generic drug shortages becoming more common

While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.

University of Pittsburgh School of Medicine
Dr. Katie J. Suda

“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.

The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.

The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.

A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.

“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”

The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.

Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.

When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.

Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.

Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.

“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.

Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.

A nationwide shortage of liquid albuterol is having minimal impact on patient care, as treatment alternatives are available, and supply appears to be recovering fast, suggest accounts from experts at health care centers around the country.

The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.

The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.

Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.

Dr. David R. Stukus


Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.

Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.

“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”

Even infants and toddlers can use inhalers

Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.

“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”

The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.

“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”

National Jewish Health
Dr. Nathan Rabinovitch

Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.

While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.

Personal preferences may also considered, he added.

“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”

Michican Medicine
Dr. Kelly O'Shea

One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.

“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”

She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.

“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
 

 

 

Generic drug shortages becoming more common

While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.

University of Pittsburgh School of Medicine
Dr. Katie J. Suda

“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.

The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.

The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.

A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.

“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”

The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.

Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.

When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.

Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.

Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.

“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.

Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.

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Screen time and teenagers: Principles for parents

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The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.

Dr. Susan D. Swick

This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.

We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.

Dr. Michael S. Jellinek

Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.

Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
 

First: Know your child

Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.

 

 

Second: Use adolescent development as your guide

For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.

Independence

Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?

Social relationships

One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.

Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
 

Investigating and experimenting with interests (identity)

Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.

Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
 

Managing anxiety or distress

Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.

Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
 

 

 

Self-care

Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.

Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
 

Third: Be mindful of what you model

Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.

It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
 

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

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The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.

Dr. Susan D. Swick

This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.

We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.

Dr. Michael S. Jellinek

Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.

Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
 

First: Know your child

Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.

 

 

Second: Use adolescent development as your guide

For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.

Independence

Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?

Social relationships

One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.

Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
 

Investigating and experimenting with interests (identity)

Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.

Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
 

Managing anxiety or distress

Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.

Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
 

 

 

Self-care

Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.

Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
 

Third: Be mindful of what you model

Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.

It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
 

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

The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.

Dr. Susan D. Swick

This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.

We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.

Dr. Michael S. Jellinek

Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.

Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
 

First: Know your child

Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.

 

 

Second: Use adolescent development as your guide

For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.

Independence

Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?

Social relationships

One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.

Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
 

Investigating and experimenting with interests (identity)

Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.

Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
 

Managing anxiety or distress

Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.

Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
 

 

 

Self-care

Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.

Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
 

Third: Be mindful of what you model

Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.

It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
 

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

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Children with ASD less likely to get vision screening

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Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.

The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.

While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.

The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
 

Racial, age disparities as well

Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.

The lowest rates of screening occurred in the youngest children, at the 3-year visit.

The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
 

Photoscreening vs. acuity screening

The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.

“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”

The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.

Less patient participation is required for photoscreening and it can be done in less than 2 minutes.

If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
 

Photoscreening takes 90 seconds

“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.

Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.

“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”

He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.

“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.

That, he said, may be a focus area for improving the screening numbers.

Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”

When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.

“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
 

Reimbursement concerns for photoscreening

This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.

They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.

The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”

The study authors and Dr. Adesman reported no relevant financial relationships.

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Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.

The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.

While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.

The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
 

Racial, age disparities as well

Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.

The lowest rates of screening occurred in the youngest children, at the 3-year visit.

The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
 

Photoscreening vs. acuity screening

The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.

“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”

The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.

Less patient participation is required for photoscreening and it can be done in less than 2 minutes.

If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
 

Photoscreening takes 90 seconds

“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.

Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.

“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”

He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.

“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.

That, he said, may be a focus area for improving the screening numbers.

Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”

When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.

“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
 

Reimbursement concerns for photoscreening

This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.

They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.

The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”

The study authors and Dr. Adesman reported no relevant financial relationships.

Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.

The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.

While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.

The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
 

Racial, age disparities as well

Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.

The lowest rates of screening occurred in the youngest children, at the 3-year visit.

The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
 

Photoscreening vs. acuity screening

The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.

“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”

The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.

Less patient participation is required for photoscreening and it can be done in less than 2 minutes.

If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
 

Photoscreening takes 90 seconds

“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.

Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.

“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”

He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.

“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.

That, he said, may be a focus area for improving the screening numbers.

Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”

When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.

“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
 

Reimbursement concerns for photoscreening

This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.

They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.

The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”

The study authors and Dr. Adesman reported no relevant financial relationships.

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COVID-19 vaccinations lag in youngest children

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Case: A 3-year-old girl presented to the emergency department after a brief seizure at home. She looked well on physical exam except for a fever of 103° F and thick rhinorrhea.

The intern on duty methodically worked through the standard list of questions. “Immunizations up to date?” she asked.

“Absolutely,” the child’s mom responded. “She’s had everything that’s recommended.”

“Including COVID-19 vaccine?” the intern prompted.

Dr. Kristina A. Bryant

“No.” The mom responded with a shake of her head. “We don’t do that vaccine.”

That mom is not alone. 

COVID-19 vaccines for children as young as 6 months were given emergency-use authorization by the Food and Drug Administration in June 2022 and in February 2023, the Advisory Committee on Immunization Practices included COVID-19 vaccine on the routine childhood immunization schedule.

COVID-19 vaccines are safe in young children, and they prevent the most severe outcomes associated with infection, including hospitalization. Newly released data confirm that the COVID-19 vaccines produced by Moderna and Pfizer also provide protection against symptomatic infection for at least 4 months after completion of the monovalent primary series. 

In a Morbidity and Mortality Weekly Report released on Feb. 17, 2023, the Centers for Disease Control and Prevention reported the results of a test-negative design case-control study that enrolled symptomatic children tested for SARS-CoV-2 infection through Feb. 5, 2023, as part of the Increasing Community Access to Testing (ICATT) program.1 ICATT provides SARS-CoV-2 testing to persons aged at least 3 years at pharmacy and community-based testing sites nationwide.

Two doses of monovalent Moderna vaccine (complete primary series) was 60% effective against symptomatic infection (95% confidence interval, 49%-68%) 2 weeks to 2 months after receipt of the second dose. Vaccine effectiveness dropped to 36% (95% CI, 15%-52%) 3-4 months after the second dose. Three doses of monovalent Pfizer-BioNTech vaccine (complete primary series) was 31% effective (95% CI, 7%-49%) at preventing symptomatic infection 2 weeks to 4 months after receipt of the third dose. A bivalent vaccine dose for eligible children is expected to provide more protection against currently circulating SARS-CoV-2 variants. 

Kymber Ezell, BA

Despite evidence of vaccine efficacy, very few parents are opting to protect their young children with the COVID-19 vaccine. The CDC reports that, as of March 1, 2023, only 8% of children under 2 years and 10.5% of children aged 2-4 years have initiated a COVID vaccine series. The American Academy of Pediatrics has emphasized that 15.0 million children between the ages of 6 months and 4 years have not yet received their first COVID-19 vaccine dose.

While the reasons underlying low COVID-19 vaccination rates in young children are complex, themes emerge. Socioeconomic disparities contributing to low vaccination rates in young children were highlighted in another recent MMWR article.2 Through Dec. 1, 2022, vaccination coverage was lower in rural counties (3.4%) than in urban counties (10.5%). Rates were lower in Black and Hispanic children than in White and Asian children. 

According to the CDC, high rates of poverty in Black and Hispanic communities may affect vaccination coverage by affecting caregivers’ access to vaccination sites or ability to leave work to take their child to be vaccinated. Pediatric care providers have repeatedly been identified by parents as a source of trusted vaccine information and a strong provider recommendation is associated with vaccination, but not all families are receiving vaccine advice. In a 2022 Kaiser Family Foundation survey, parents of young children with annual household incomes above $90,000 were more likely to talk to their pediatrician about a COVID-19 vaccine than families with lower incomes.3Vaccine hesitancy, fueled by general confusion and skepticism, is another factor contributing to low vaccination rates. Admittedly, the recommendations are complex and on March 14, 2023, the FDA again revised the emergency-use authorization for young children. Some caregivers continue to express concerns about vaccine side effects as well as the belief that the vaccine won’t prevent their child from getting sick. 

Kendall Purcell, MD, a pediatrician with Norton Children’s Medical Group in Louisville, Ky., recommends COVID-19 vaccination for her patients because it reduces the risk of severe disease. That factored into her own decision to vaccinate her 4-year-old son and 1-year-old daughter, but she hasn’t been able to convince the parents of all her patients. “Some feel that COVID-19 is not as severe for children, so the risks don’t outweigh the benefits when it comes to vaccinating their children.” Back to our case: In the ED the intern reviewed the laboratory testing she had ordered. She then sat down with the mother of the 3-year-old girl to discuss the diagnosis: febrile seizure associated with COVID-19 infection. Febrile seizures are a well-recognized but uncommon complication of COVID-19 in children. In a retrospective cohort study using electronic health record data, febrile seizures occurred in 0.5% of 8,854 children aged 0-5 years with COVID-19 infection.4 About 9% of these children required critical care services. In another cohort of hospitalized children, neurologic complications occurred in 7% of children hospitalized with COVID-19.5 Febrile and nonfebrile seizures were most commonly observed.

“I really thought COVID-19 was no big deal in young kids,” the mom said. “Parents need the facts.”

The facts are these: Through Dec. 2, 2022, more than 3 million cases of COVID-19 have been reported in children aged younger than 5 years. While COVID is generally less severe in young children than older adults, it is difficult to predict which children will become seriously ill. When children are hospitalized, one in four requires intensive care. COVID-19 is now a vaccine-preventable disease, but too many children remain unprotected.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. Ms. Ezell is a recent graduate from Indiana University Southeast with a Bachelor of Arts in English. They have no conflicts of interest.

References

1. Fleming-Dutra KE et al. Morb Mortal Wkly Rep. 2023;72:177-182.

2. Murthy BP et al. Morb Mortal Wkly Rep. 2023;72:183-9.

3. Lopes L et al. KFF COVID-19 vaccine monitor: July 2022. San Francisco: Kaiser Family Foundation, 2022.

4. Cadet K et al. J Child Neurol. 2022 Apr;37(5):410-5.

5. Antoon JW et al. Pediatrics. 2022 Nov 1;150(5):e2022058167.

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Case: A 3-year-old girl presented to the emergency department after a brief seizure at home. She looked well on physical exam except for a fever of 103° F and thick rhinorrhea.

The intern on duty methodically worked through the standard list of questions. “Immunizations up to date?” she asked.

“Absolutely,” the child’s mom responded. “She’s had everything that’s recommended.”

“Including COVID-19 vaccine?” the intern prompted.

Dr. Kristina A. Bryant

“No.” The mom responded with a shake of her head. “We don’t do that vaccine.”

That mom is not alone. 

COVID-19 vaccines for children as young as 6 months were given emergency-use authorization by the Food and Drug Administration in June 2022 and in February 2023, the Advisory Committee on Immunization Practices included COVID-19 vaccine on the routine childhood immunization schedule.

COVID-19 vaccines are safe in young children, and they prevent the most severe outcomes associated with infection, including hospitalization. Newly released data confirm that the COVID-19 vaccines produced by Moderna and Pfizer also provide protection against symptomatic infection for at least 4 months after completion of the monovalent primary series. 

In a Morbidity and Mortality Weekly Report released on Feb. 17, 2023, the Centers for Disease Control and Prevention reported the results of a test-negative design case-control study that enrolled symptomatic children tested for SARS-CoV-2 infection through Feb. 5, 2023, as part of the Increasing Community Access to Testing (ICATT) program.1 ICATT provides SARS-CoV-2 testing to persons aged at least 3 years at pharmacy and community-based testing sites nationwide.

Two doses of monovalent Moderna vaccine (complete primary series) was 60% effective against symptomatic infection (95% confidence interval, 49%-68%) 2 weeks to 2 months after receipt of the second dose. Vaccine effectiveness dropped to 36% (95% CI, 15%-52%) 3-4 months after the second dose. Three doses of monovalent Pfizer-BioNTech vaccine (complete primary series) was 31% effective (95% CI, 7%-49%) at preventing symptomatic infection 2 weeks to 4 months after receipt of the third dose. A bivalent vaccine dose for eligible children is expected to provide more protection against currently circulating SARS-CoV-2 variants. 

Kymber Ezell, BA

Despite evidence of vaccine efficacy, very few parents are opting to protect their young children with the COVID-19 vaccine. The CDC reports that, as of March 1, 2023, only 8% of children under 2 years and 10.5% of children aged 2-4 years have initiated a COVID vaccine series. The American Academy of Pediatrics has emphasized that 15.0 million children between the ages of 6 months and 4 years have not yet received their first COVID-19 vaccine dose.

While the reasons underlying low COVID-19 vaccination rates in young children are complex, themes emerge. Socioeconomic disparities contributing to low vaccination rates in young children were highlighted in another recent MMWR article.2 Through Dec. 1, 2022, vaccination coverage was lower in rural counties (3.4%) than in urban counties (10.5%). Rates were lower in Black and Hispanic children than in White and Asian children. 

According to the CDC, high rates of poverty in Black and Hispanic communities may affect vaccination coverage by affecting caregivers’ access to vaccination sites or ability to leave work to take their child to be vaccinated. Pediatric care providers have repeatedly been identified by parents as a source of trusted vaccine information and a strong provider recommendation is associated with vaccination, but not all families are receiving vaccine advice. In a 2022 Kaiser Family Foundation survey, parents of young children with annual household incomes above $90,000 were more likely to talk to their pediatrician about a COVID-19 vaccine than families with lower incomes.3Vaccine hesitancy, fueled by general confusion and skepticism, is another factor contributing to low vaccination rates. Admittedly, the recommendations are complex and on March 14, 2023, the FDA again revised the emergency-use authorization for young children. Some caregivers continue to express concerns about vaccine side effects as well as the belief that the vaccine won’t prevent their child from getting sick. 

Kendall Purcell, MD, a pediatrician with Norton Children’s Medical Group in Louisville, Ky., recommends COVID-19 vaccination for her patients because it reduces the risk of severe disease. That factored into her own decision to vaccinate her 4-year-old son and 1-year-old daughter, but she hasn’t been able to convince the parents of all her patients. “Some feel that COVID-19 is not as severe for children, so the risks don’t outweigh the benefits when it comes to vaccinating their children.” Back to our case: In the ED the intern reviewed the laboratory testing she had ordered. She then sat down with the mother of the 3-year-old girl to discuss the diagnosis: febrile seizure associated with COVID-19 infection. Febrile seizures are a well-recognized but uncommon complication of COVID-19 in children. In a retrospective cohort study using electronic health record data, febrile seizures occurred in 0.5% of 8,854 children aged 0-5 years with COVID-19 infection.4 About 9% of these children required critical care services. In another cohort of hospitalized children, neurologic complications occurred in 7% of children hospitalized with COVID-19.5 Febrile and nonfebrile seizures were most commonly observed.

“I really thought COVID-19 was no big deal in young kids,” the mom said. “Parents need the facts.”

The facts are these: Through Dec. 2, 2022, more than 3 million cases of COVID-19 have been reported in children aged younger than 5 years. While COVID is generally less severe in young children than older adults, it is difficult to predict which children will become seriously ill. When children are hospitalized, one in four requires intensive care. COVID-19 is now a vaccine-preventable disease, but too many children remain unprotected.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. Ms. Ezell is a recent graduate from Indiana University Southeast with a Bachelor of Arts in English. They have no conflicts of interest.

References

1. Fleming-Dutra KE et al. Morb Mortal Wkly Rep. 2023;72:177-182.

2. Murthy BP et al. Morb Mortal Wkly Rep. 2023;72:183-9.

3. Lopes L et al. KFF COVID-19 vaccine monitor: July 2022. San Francisco: Kaiser Family Foundation, 2022.

4. Cadet K et al. J Child Neurol. 2022 Apr;37(5):410-5.

5. Antoon JW et al. Pediatrics. 2022 Nov 1;150(5):e2022058167.

Case: A 3-year-old girl presented to the emergency department after a brief seizure at home. She looked well on physical exam except for a fever of 103° F and thick rhinorrhea.

The intern on duty methodically worked through the standard list of questions. “Immunizations up to date?” she asked.

“Absolutely,” the child’s mom responded. “She’s had everything that’s recommended.”

“Including COVID-19 vaccine?” the intern prompted.

Dr. Kristina A. Bryant

“No.” The mom responded with a shake of her head. “We don’t do that vaccine.”

That mom is not alone. 

COVID-19 vaccines for children as young as 6 months were given emergency-use authorization by the Food and Drug Administration in June 2022 and in February 2023, the Advisory Committee on Immunization Practices included COVID-19 vaccine on the routine childhood immunization schedule.

COVID-19 vaccines are safe in young children, and they prevent the most severe outcomes associated with infection, including hospitalization. Newly released data confirm that the COVID-19 vaccines produced by Moderna and Pfizer also provide protection against symptomatic infection for at least 4 months after completion of the monovalent primary series. 

In a Morbidity and Mortality Weekly Report released on Feb. 17, 2023, the Centers for Disease Control and Prevention reported the results of a test-negative design case-control study that enrolled symptomatic children tested for SARS-CoV-2 infection through Feb. 5, 2023, as part of the Increasing Community Access to Testing (ICATT) program.1 ICATT provides SARS-CoV-2 testing to persons aged at least 3 years at pharmacy and community-based testing sites nationwide.

Two doses of monovalent Moderna vaccine (complete primary series) was 60% effective against symptomatic infection (95% confidence interval, 49%-68%) 2 weeks to 2 months after receipt of the second dose. Vaccine effectiveness dropped to 36% (95% CI, 15%-52%) 3-4 months after the second dose. Three doses of monovalent Pfizer-BioNTech vaccine (complete primary series) was 31% effective (95% CI, 7%-49%) at preventing symptomatic infection 2 weeks to 4 months after receipt of the third dose. A bivalent vaccine dose for eligible children is expected to provide more protection against currently circulating SARS-CoV-2 variants. 

Kymber Ezell, BA

Despite evidence of vaccine efficacy, very few parents are opting to protect their young children with the COVID-19 vaccine. The CDC reports that, as of March 1, 2023, only 8% of children under 2 years and 10.5% of children aged 2-4 years have initiated a COVID vaccine series. The American Academy of Pediatrics has emphasized that 15.0 million children between the ages of 6 months and 4 years have not yet received their first COVID-19 vaccine dose.

While the reasons underlying low COVID-19 vaccination rates in young children are complex, themes emerge. Socioeconomic disparities contributing to low vaccination rates in young children were highlighted in another recent MMWR article.2 Through Dec. 1, 2022, vaccination coverage was lower in rural counties (3.4%) than in urban counties (10.5%). Rates were lower in Black and Hispanic children than in White and Asian children. 

According to the CDC, high rates of poverty in Black and Hispanic communities may affect vaccination coverage by affecting caregivers’ access to vaccination sites or ability to leave work to take their child to be vaccinated. Pediatric care providers have repeatedly been identified by parents as a source of trusted vaccine information and a strong provider recommendation is associated with vaccination, but not all families are receiving vaccine advice. In a 2022 Kaiser Family Foundation survey, parents of young children with annual household incomes above $90,000 were more likely to talk to their pediatrician about a COVID-19 vaccine than families with lower incomes.3Vaccine hesitancy, fueled by general confusion and skepticism, is another factor contributing to low vaccination rates. Admittedly, the recommendations are complex and on March 14, 2023, the FDA again revised the emergency-use authorization for young children. Some caregivers continue to express concerns about vaccine side effects as well as the belief that the vaccine won’t prevent their child from getting sick. 

Kendall Purcell, MD, a pediatrician with Norton Children’s Medical Group in Louisville, Ky., recommends COVID-19 vaccination for her patients because it reduces the risk of severe disease. That factored into her own decision to vaccinate her 4-year-old son and 1-year-old daughter, but she hasn’t been able to convince the parents of all her patients. “Some feel that COVID-19 is not as severe for children, so the risks don’t outweigh the benefits when it comes to vaccinating their children.” Back to our case: In the ED the intern reviewed the laboratory testing she had ordered. She then sat down with the mother of the 3-year-old girl to discuss the diagnosis: febrile seizure associated with COVID-19 infection. Febrile seizures are a well-recognized but uncommon complication of COVID-19 in children. In a retrospective cohort study using electronic health record data, febrile seizures occurred in 0.5% of 8,854 children aged 0-5 years with COVID-19 infection.4 About 9% of these children required critical care services. In another cohort of hospitalized children, neurologic complications occurred in 7% of children hospitalized with COVID-19.5 Febrile and nonfebrile seizures were most commonly observed.

“I really thought COVID-19 was no big deal in young kids,” the mom said. “Parents need the facts.”

The facts are these: Through Dec. 2, 2022, more than 3 million cases of COVID-19 have been reported in children aged younger than 5 years. While COVID is generally less severe in young children than older adults, it is difficult to predict which children will become seriously ill. When children are hospitalized, one in four requires intensive care. COVID-19 is now a vaccine-preventable disease, but too many children remain unprotected.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. Ms. Ezell is a recent graduate from Indiana University Southeast with a Bachelor of Arts in English. They have no conflicts of interest.

References

1. Fleming-Dutra KE et al. Morb Mortal Wkly Rep. 2023;72:177-182.

2. Murthy BP et al. Morb Mortal Wkly Rep. 2023;72:183-9.

3. Lopes L et al. KFF COVID-19 vaccine monitor: July 2022. San Francisco: Kaiser Family Foundation, 2022.

4. Cadet K et al. J Child Neurol. 2022 Apr;37(5):410-5.

5. Antoon JW et al. Pediatrics. 2022 Nov 1;150(5):e2022058167.

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CSU in children: Study identifies biomarkers associated with responses to different treatments

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Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

Alex Nguyen


To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.

Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.

Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).

After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).

“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”

He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.

“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”

The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.
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Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

Alex Nguyen


To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.

Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.

Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).

After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).

“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”

He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.

“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”

The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.

Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

Alex Nguyen


To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.

Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.

Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).

After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).

“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”

He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.

“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”

The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.
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