Pediatrics

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

The frequency of showering or bathing and follow-up application of moisturizer appear to be more important factors associated with atopic dermatitis (AD) severity than the duration of showers or baths, results from a prospective observational study found.

Uros Rakita

“Patients may benefit most from counseling on showering or bathing once daily and regularly applying moisturizer after showering or bathing,” one of the study authors, Uros Rakita, MSc, told this news organization. “Recommending less than daily shower frequencies or counseling on specific shower durations may not be necessary.”

During a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium, Mr. Rakita, a fourth-year student at Chicago Medical School, North Chicago, presented findings from a prospective, practice-based dermatology study that investigated the longitudinal relationship between different bathing practices and AD severity to help inform patient counseling about optimal bathing practices.

“AD is a chronic, inflammatory skin condition with a diverse set of environmental triggers and exacerbating factors,” Mr. Rakita said during the meeting. “Maintaining adequate skin hydration, skin hygiene, and avoiding triggers are key aspects of AD management across all disease severities. Therefore, understanding optimal shower or bath and moisturizing practices is essential.” In fact, he added, “bathing has been shown to not only hydrate the skin, but also to improve symptoms, remove allergens, and decrease [Staphylococcus] aureus colonization. However, at the same time, concern exists for the potential of inappropriate shower or bathing frequency or durations, as well as inconsistent moisturizer application to worsen disease severity and potentially compromise disease management.”

He noted that current guidelines on bathing frequency and duration among AD patients lack consensus, are limited, and are largely based on studies of pediatric populations.

Mr. Rakita, along with primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, and Trisha Kaundinya, a medical student at Northwestern University, Chicago, prospectively evaluated 509 adults with AD who made an average of 2.3 visits at a single dermatology clinic between 2013 and 2020. At each visit, severity of AD signs and symptoms, as well as bathing and moisturizing practices, were assessed.

AD severity was assessed using the objective component of Scoring Atopic Dermatitis (o-SCORAD), intensity of pruritus in the past 3 days (SCORAD-itch), Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). The researchers constructed repeated measures regression models to examine associations of bathing and moisturizing practices with change in AD severity outcome measure scores over time. Multivariable models controlled for age, sex, and race.

In adjusted linear regression models, showering or bathing more than once a day versus once daily was associated with significantly higher scores for SCORAD-itch (0.74; P = .0456), o-SCORAD (4.27; P = .0171), EASI (4.20; P = .0028), POEM (2.61; P = .0021), and DLQI (2.77; P = .0004).

The researchers also found that consistent application of moisturizer after the shower or bath was associated with significantly lower scores for o-SCORAD (–7.22; P < .0001), EASI (–3.91; P = .001) and POEM (–2.68; P = .0002), compared against not applying moisturizer after a shower or bath. However, shower or bath duration of more than, compared against fewer than, 15 minutes was not associated with significantly lower scores for o-SCORAD (1.26; P = .2868), SCORAD-itch (0.17; P = .4987), EASI (0.85; P = .3454), POEM (0.24; P = .6627) or DLQI (–0.40; P = .4318).

“Interestingly, this pattern was present when the reference shower or bath durations were under 10 minutes as well as under 5 minutes,” Mr. Rakita said. “Also, shower or bath frequencies of less than daily, relative to daily frequencies, were not significantly related to longitudinal AD severity.”

Mr. Rakita acknowledged certain limitations of the study, including the fact that the researchers did not examine the potential influence of specific soap and moisturizing products, water hardness, or other bathing features such as water temperature and bath additives.

Lawrence J. Green, MD, who was asked to comment on the study, said that he was not surprised by the finding that moisturizing after bathing improved AD signs and symptoms. “On the other hand, a long-held belief that longer duration of shower/bath time worsens AD was not found to be true,” said Dr. Green, a dermatologist who practices in Rockville, Md., and is also clinical professor of dermatology at George Washington University.

“This provides useful information for practicing dermatologists who wish to provide evidenced-based education about moisturizing and bathing to their AD patients,” he said.

The study was supported by the Agency for Healthcare Research and Quality and the Dermatology Foundation. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies. There were no other disclosures.

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

The frequency of showering or bathing and follow-up application of moisturizer appear to be more important factors associated with atopic dermatitis (AD) severity than the duration of showers or baths, results from a prospective observational study found.

Uros Rakita

“Patients may benefit most from counseling on showering or bathing once daily and regularly applying moisturizer after showering or bathing,” one of the study authors, Uros Rakita, MSc, told this news organization. “Recommending less than daily shower frequencies or counseling on specific shower durations may not be necessary.”

During a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium, Mr. Rakita, a fourth-year student at Chicago Medical School, North Chicago, presented findings from a prospective, practice-based dermatology study that investigated the longitudinal relationship between different bathing practices and AD severity to help inform patient counseling about optimal bathing practices.

“AD is a chronic, inflammatory skin condition with a diverse set of environmental triggers and exacerbating factors,” Mr. Rakita said during the meeting. “Maintaining adequate skin hydration, skin hygiene, and avoiding triggers are key aspects of AD management across all disease severities. Therefore, understanding optimal shower or bath and moisturizing practices is essential.” In fact, he added, “bathing has been shown to not only hydrate the skin, but also to improve symptoms, remove allergens, and decrease [Staphylococcus] aureus colonization. However, at the same time, concern exists for the potential of inappropriate shower or bathing frequency or durations, as well as inconsistent moisturizer application to worsen disease severity and potentially compromise disease management.”

He noted that current guidelines on bathing frequency and duration among AD patients lack consensus, are limited, and are largely based on studies of pediatric populations.

Mr. Rakita, along with primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, and Trisha Kaundinya, a medical student at Northwestern University, Chicago, prospectively evaluated 509 adults with AD who made an average of 2.3 visits at a single dermatology clinic between 2013 and 2020. At each visit, severity of AD signs and symptoms, as well as bathing and moisturizing practices, were assessed.

AD severity was assessed using the objective component of Scoring Atopic Dermatitis (o-SCORAD), intensity of pruritus in the past 3 days (SCORAD-itch), Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). The researchers constructed repeated measures regression models to examine associations of bathing and moisturizing practices with change in AD severity outcome measure scores over time. Multivariable models controlled for age, sex, and race.

In adjusted linear regression models, showering or bathing more than once a day versus once daily was associated with significantly higher scores for SCORAD-itch (0.74; P = .0456), o-SCORAD (4.27; P = .0171), EASI (4.20; P = .0028), POEM (2.61; P = .0021), and DLQI (2.77; P = .0004).

The researchers also found that consistent application of moisturizer after the shower or bath was associated with significantly lower scores for o-SCORAD (–7.22; P < .0001), EASI (–3.91; P = .001) and POEM (–2.68; P = .0002), compared against not applying moisturizer after a shower or bath. However, shower or bath duration of more than, compared against fewer than, 15 minutes was not associated with significantly lower scores for o-SCORAD (1.26; P = .2868), SCORAD-itch (0.17; P = .4987), EASI (0.85; P = .3454), POEM (0.24; P = .6627) or DLQI (–0.40; P = .4318).

“Interestingly, this pattern was present when the reference shower or bath durations were under 10 minutes as well as under 5 minutes,” Mr. Rakita said. “Also, shower or bath frequencies of less than daily, relative to daily frequencies, were not significantly related to longitudinal AD severity.”

Mr. Rakita acknowledged certain limitations of the study, including the fact that the researchers did not examine the potential influence of specific soap and moisturizing products, water hardness, or other bathing features such as water temperature and bath additives.

Lawrence J. Green, MD, who was asked to comment on the study, said that he was not surprised by the finding that moisturizing after bathing improved AD signs and symptoms. “On the other hand, a long-held belief that longer duration of shower/bath time worsens AD was not found to be true,” said Dr. Green, a dermatologist who practices in Rockville, Md., and is also clinical professor of dermatology at George Washington University.

“This provides useful information for practicing dermatologists who wish to provide evidenced-based education about moisturizing and bathing to their AD patients,” he said.

The study was supported by the Agency for Healthcare Research and Quality and the Dermatology Foundation. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies. There were no other disclosures.

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

The frequency of showering or bathing and follow-up application of moisturizer appear to be more important factors associated with atopic dermatitis (AD) severity than the duration of showers or baths, results from a prospective observational study found.

Uros Rakita

“Patients may benefit most from counseling on showering or bathing once daily and regularly applying moisturizer after showering or bathing,” one of the study authors, Uros Rakita, MSc, told this news organization. “Recommending less than daily shower frequencies or counseling on specific shower durations may not be necessary.”

During a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium, Mr. Rakita, a fourth-year student at Chicago Medical School, North Chicago, presented findings from a prospective, practice-based dermatology study that investigated the longitudinal relationship between different bathing practices and AD severity to help inform patient counseling about optimal bathing practices.

“AD is a chronic, inflammatory skin condition with a diverse set of environmental triggers and exacerbating factors,” Mr. Rakita said during the meeting. “Maintaining adequate skin hydration, skin hygiene, and avoiding triggers are key aspects of AD management across all disease severities. Therefore, understanding optimal shower or bath and moisturizing practices is essential.” In fact, he added, “bathing has been shown to not only hydrate the skin, but also to improve symptoms, remove allergens, and decrease [Staphylococcus] aureus colonization. However, at the same time, concern exists for the potential of inappropriate shower or bathing frequency or durations, as well as inconsistent moisturizer application to worsen disease severity and potentially compromise disease management.”

He noted that current guidelines on bathing frequency and duration among AD patients lack consensus, are limited, and are largely based on studies of pediatric populations.

Mr. Rakita, along with primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, and Trisha Kaundinya, a medical student at Northwestern University, Chicago, prospectively evaluated 509 adults with AD who made an average of 2.3 visits at a single dermatology clinic between 2013 and 2020. At each visit, severity of AD signs and symptoms, as well as bathing and moisturizing practices, were assessed.

AD severity was assessed using the objective component of Scoring Atopic Dermatitis (o-SCORAD), intensity of pruritus in the past 3 days (SCORAD-itch), Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). The researchers constructed repeated measures regression models to examine associations of bathing and moisturizing practices with change in AD severity outcome measure scores over time. Multivariable models controlled for age, sex, and race.

In adjusted linear regression models, showering or bathing more than once a day versus once daily was associated with significantly higher scores for SCORAD-itch (0.74; P = .0456), o-SCORAD (4.27; P = .0171), EASI (4.20; P = .0028), POEM (2.61; P = .0021), and DLQI (2.77; P = .0004).

The researchers also found that consistent application of moisturizer after the shower or bath was associated with significantly lower scores for o-SCORAD (–7.22; P < .0001), EASI (–3.91; P = .001) and POEM (–2.68; P = .0002), compared against not applying moisturizer after a shower or bath. However, shower or bath duration of more than, compared against fewer than, 15 minutes was not associated with significantly lower scores for o-SCORAD (1.26; P = .2868), SCORAD-itch (0.17; P = .4987), EASI (0.85; P = .3454), POEM (0.24; P = .6627) or DLQI (–0.40; P = .4318).

“Interestingly, this pattern was present when the reference shower or bath durations were under 10 minutes as well as under 5 minutes,” Mr. Rakita said. “Also, shower or bath frequencies of less than daily, relative to daily frequencies, were not significantly related to longitudinal AD severity.”

Mr. Rakita acknowledged certain limitations of the study, including the fact that the researchers did not examine the potential influence of specific soap and moisturizing products, water hardness, or other bathing features such as water temperature and bath additives.

Lawrence J. Green, MD, who was asked to comment on the study, said that he was not surprised by the finding that moisturizing after bathing improved AD signs and symptoms. “On the other hand, a long-held belief that longer duration of shower/bath time worsens AD was not found to be true,” said Dr. Green, a dermatologist who practices in Rockville, Md., and is also clinical professor of dermatology at George Washington University.

“This provides useful information for practicing dermatologists who wish to provide evidenced-based education about moisturizing and bathing to their AD patients,” he said.

The study was supported by the Agency for Healthcare Research and Quality and the Dermatology Foundation. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies. There were no other disclosures.

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

The pandemic has created a hostile environment for pregnant people and their babies.

Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.

Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.

That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.

Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.

“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.

For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.

Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.

Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.

Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.

At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.

Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.

“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”

Learning from history

Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.

Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.

People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.

Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.

Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.

Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.

Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”

Damaging a fetal security system

The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.

That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.

But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.

Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.

Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.

Rewiring the immune system

In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.

In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.

The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.

Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.

“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”

Increasing the risk for boys

Boys could face higher risks from COVID, even before birth.

Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.

But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.

That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.

Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.

Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.

New research on COVID could help illuminate this vulnerability.

In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.

Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.

When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.

The sex of a fetus can influence its mother’s response to other illnesses, as well.

For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.

Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”

Boosting toxic stress

Rates of depression and stress among pregnant women have increased dramatically during the pandemic.

That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.

Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.

“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.

Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.

In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.

The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.

Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.

Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.

In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.

Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.

While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.

“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The pandemic has created a hostile environment for pregnant people and their babies.

Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.

Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.

That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.

Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.

“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.

For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.

Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.

Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.

Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.

At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.

Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.

“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”

Learning from history

Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.

Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.

People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.

Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.

Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.

Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.

Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”

Damaging a fetal security system

The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.

That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.

But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.

Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.

Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.

Rewiring the immune system

In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.

In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.

The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.

Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.

“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”

Increasing the risk for boys

Boys could face higher risks from COVID, even before birth.

Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.

But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.

That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.

Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.

Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.

New research on COVID could help illuminate this vulnerability.

In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.

Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.

When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.

The sex of a fetus can influence its mother’s response to other illnesses, as well.

For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.

Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”

Boosting toxic stress

Rates of depression and stress among pregnant women have increased dramatically during the pandemic.

That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.

Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.

“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.

Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.

In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.

The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.

Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.

Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.

In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.

Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.

While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.

“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The pandemic has created a hostile environment for pregnant people and their babies.

Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.

Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.

That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.

Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.

“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.

For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.

Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.

Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.

Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.

At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.

Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.

“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”

Learning from history

Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.

Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.

People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.

Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.

Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.

Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.

Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”

Damaging a fetal security system

The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.

That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.

But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.

Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.

Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.

Rewiring the immune system

In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.

In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.

The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.

Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.

“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”

Increasing the risk for boys

Boys could face higher risks from COVID, even before birth.

Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.

But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.

That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.

Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.

Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.

New research on COVID could help illuminate this vulnerability.

In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.

Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.

When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.

The sex of a fetus can influence its mother’s response to other illnesses, as well.

For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.

Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”

Boosting toxic stress

Rates of depression and stress among pregnant women have increased dramatically during the pandemic.

That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.

Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.

“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.

Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.

In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.

The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.

Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.

Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.

In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.

Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.

While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.

“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

New COVID-19 vaccinations in children were down by almost 24% in the last week as new cases rose by just 3.5%, based on new data.

That fairly low number suggests the latest case count from the American Academy of Pediatrics and the Children’s Hospital Association has not caught up yet to the reality of the Omicron variant, which has sent new cases climbing among all ages and now represents the majority of COVID-19 infections nationwide, the Centers for Disease Control and Prevention said.

Meanwhile, in the midst of the latest surge, the United States just passed yet another sobering COVID milestone: 1,000 deaths in children aged 17 and under. The total as of Dec. 20 was 1,015, according to the CDC, with the largest share, almost 32%, occurring in children less than 5 years of age.

The 3.5% increase in child cases brought the total to nearly 170,000 for the week of Dec. 10-16, the fifth such rise in the last 6 weeks and the 19th consecutive week with a count of over 100,000 dating back to mid-August. Regionally, the majority of that increase came in the Northeast, with a small rise in the South and decreases in the Midwest and West, the AAP and CHA said in their weekly COVID report.

At the state level, the largest percent increases in cases over the past 2 weeks were seen in Maine and New Hampshire, as well as Vermont, which has the nation’s highest vaccination rates for children aged 5-11 (51%) and 12-17 (84%), the AAP said in its vaccination trends report.

Nationally, new COVID vaccinations in children continue to trend downward. The number of children aged 5-17 years who had received at least one dose increased by about 498,000 for the week of Dec. 13-19, down from 654,000 (–23.9%) the previous week. Children aged 5-11 years still represented the largest share (22.7%) of all vaccine initiators in the last 2 weeks, but that proportion was 42.8% just before Thanksgiving, according to data from the CDC.

On a more positive note, children aged 5-11 made up 51% of all Americans who completed the vaccine regimen during the 2 weeks ending Dec. 20. The cumulative completion count is 3.6 million in that age group, along with almost 13.4 million children aged 12-17, and the CDC data show that 6.1 million children aged 5-11 and 15.9 million children aged 12-17 have received at least one dose.

On a less positive note, however, that means almost half (47%) of 12- to 17-year-olds still are not fully vaccinated and that over a third (37%) have received no vaccine at all, according to the COVID Data Tracker.

[email protected]

New COVID-19 vaccinations in children were down by almost 24% in the last week as new cases rose by just 3.5%, based on new data.

That fairly low number suggests the latest case count from the American Academy of Pediatrics and the Children’s Hospital Association has not caught up yet to the reality of the Omicron variant, which has sent new cases climbing among all ages and now represents the majority of COVID-19 infections nationwide, the Centers for Disease Control and Prevention said.

Meanwhile, in the midst of the latest surge, the United States just passed yet another sobering COVID milestone: 1,000 deaths in children aged 17 and under. The total as of Dec. 20 was 1,015, according to the CDC, with the largest share, almost 32%, occurring in children less than 5 years of age.

The 3.5% increase in child cases brought the total to nearly 170,000 for the week of Dec. 10-16, the fifth such rise in the last 6 weeks and the 19th consecutive week with a count of over 100,000 dating back to mid-August. Regionally, the majority of that increase came in the Northeast, with a small rise in the South and decreases in the Midwest and West, the AAP and CHA said in their weekly COVID report.

At the state level, the largest percent increases in cases over the past 2 weeks were seen in Maine and New Hampshire, as well as Vermont, which has the nation’s highest vaccination rates for children aged 5-11 (51%) and 12-17 (84%), the AAP said in its vaccination trends report.

Nationally, new COVID vaccinations in children continue to trend downward. The number of children aged 5-17 years who had received at least one dose increased by about 498,000 for the week of Dec. 13-19, down from 654,000 (–23.9%) the previous week. Children aged 5-11 years still represented the largest share (22.7%) of all vaccine initiators in the last 2 weeks, but that proportion was 42.8% just before Thanksgiving, according to data from the CDC.

On a more positive note, children aged 5-11 made up 51% of all Americans who completed the vaccine regimen during the 2 weeks ending Dec. 20. The cumulative completion count is 3.6 million in that age group, along with almost 13.4 million children aged 12-17, and the CDC data show that 6.1 million children aged 5-11 and 15.9 million children aged 12-17 have received at least one dose.

On a less positive note, however, that means almost half (47%) of 12- to 17-year-olds still are not fully vaccinated and that over a third (37%) have received no vaccine at all, according to the COVID Data Tracker.

[email protected]

New COVID-19 vaccinations in children were down by almost 24% in the last week as new cases rose by just 3.5%, based on new data.

That fairly low number suggests the latest case count from the American Academy of Pediatrics and the Children’s Hospital Association has not caught up yet to the reality of the Omicron variant, which has sent new cases climbing among all ages and now represents the majority of COVID-19 infections nationwide, the Centers for Disease Control and Prevention said.

Meanwhile, in the midst of the latest surge, the United States just passed yet another sobering COVID milestone: 1,000 deaths in children aged 17 and under. The total as of Dec. 20 was 1,015, according to the CDC, with the largest share, almost 32%, occurring in children less than 5 years of age.

The 3.5% increase in child cases brought the total to nearly 170,000 for the week of Dec. 10-16, the fifth such rise in the last 6 weeks and the 19th consecutive week with a count of over 100,000 dating back to mid-August. Regionally, the majority of that increase came in the Northeast, with a small rise in the South and decreases in the Midwest and West, the AAP and CHA said in their weekly COVID report.

At the state level, the largest percent increases in cases over the past 2 weeks were seen in Maine and New Hampshire, as well as Vermont, which has the nation’s highest vaccination rates for children aged 5-11 (51%) and 12-17 (84%), the AAP said in its vaccination trends report.

Nationally, new COVID vaccinations in children continue to trend downward. The number of children aged 5-17 years who had received at least one dose increased by about 498,000 for the week of Dec. 13-19, down from 654,000 (–23.9%) the previous week. Children aged 5-11 years still represented the largest share (22.7%) of all vaccine initiators in the last 2 weeks, but that proportion was 42.8% just before Thanksgiving, according to data from the CDC.

On a more positive note, children aged 5-11 made up 51% of all Americans who completed the vaccine regimen during the 2 weeks ending Dec. 20. The cumulative completion count is 3.6 million in that age group, along with almost 13.4 million children aged 12-17, and the CDC data show that 6.1 million children aged 5-11 and 15.9 million children aged 12-17 have received at least one dose.

On a less positive note, however, that means almost half (47%) of 12- to 17-year-olds still are not fully vaccinated and that over a third (37%) have received no vaccine at all, according to the COVID Data Tracker.

[email protected]

The impact of respiratory syncytial virus (RSV)will likely be greater in 2021 and 2022 in the United States than in previous years as a result of the ongoing COVID-19 pandemic, based on data from a simulation-modeling study involving approximately 19 million individuals.

Although RSV usually follows consistent patterns of timing and duration, the disease all but disappeared starting in March 2020 after the introduction of measures to mitigate the spread of COVID-19, Zhe Zheng, MBBS, of Yale University, New Haven, Conn., and colleagues wrote.

However, lifting of mitigation measures has resulted in emergence of RSV in various parts of the world in early 2021, and trends may be similar in the United States, but data are needed to plan for prophylaxis and hospital use, they noted.

In a study published in JAMA Network Open, the researchers developed a simulation model for epidemics of RSV based on historical data. They acquired inpatient records from New York during 2005-2014 and from California during 2003-2011. The primary clinical outcome was the estimated monthly hospitalizations for RSV.

The simulated study population was 19.45 million individuals. After evaluating several scenarios including continued low transmission associated with social distancing and other mitigation measures, the researchers focused on the likely scenario that introduction of RSV from other regions would likely spark RSV epidemics in the United States.

They determined that spring and summer 2021 would show an increase in hospitalizations for RSV. Overall, higher rates of virus introduction from other regions were associated with more intense spring and summer RSV epidemics, with the trade-off of smaller winter epidemics. In the model, the expected RSV epidemic in spring and summer 2021 in New York was small, with a peak incidence of 419 hospitalizations per 100,000 people in April; by contrast, for states with less seasonal variability, such as Florida, the model predicted a larger summer epidemic.

In the model, the mean age of hospitalization for children younger than 5 years for January 2022 was expected to be 1.17 years, compared with 0.84 years in January 2019, the researchers noted.

Across all age groups, the greatest relative increase in the incidence of RSV infection was predicted for children aged 1-4 years (ranging from 82% to 86%), as were lower respiratory infections (87%-101%) and hospitalization (99%-119%), compared with prepandemic levels.

Hospitalizations for children aged 1 year were predicted to double compared with prepandemic seasons; 707 per 100,000 children per year for 2021 and 2022 versus 355 per 100,000 children per year in a typical prepandemic season. However, the largest incidence of lower respiratory infections (30,075 per 100,000) was predicted for infants aged 3-5 months, and the largest incidence of hospitalizations (3,116 per 100,000) was predicted for infants younger than 3 months.

“Without virus importation, the risk of RSV infections across all age groups in the winter of 2021 and 2022 would be greater, as more susceptible individuals were spared from infections in the absence of summer epidemics,” the researchers noted.

The older mean hospitalization age seen in the model was similar to the reported median patient age in Australia both before the pandemic and during the reemergent RSV epidemic.

“This makes intuitive sense, since many children born in 2020 were spared from RSV infection due to the low virus activity; these children will be older when they get infected for the first time during the reemergent epidemics,” the researchers wrote. “Consequently, stakeholders should consider modifying prophylaxis guidelines to include high-risk infants less than 2 years of age for the 2021-2022 season.”

The study findings were limited by several factors including the lack of data on level of virus introduction or on the impact of lack of boosting on infants with only transplacentally acquired RSV antibodies, the researchers noted. Other limitations include the use of historical data and the lack of data on values outside those included in the model, as well as the inability to control for other factors that could influence RSV, such as vaccines or long-lasting antibodies.

However, the results suggest that the rate of imported infections is associated with RSV hospitalizations, and the model effectively captured the RSV epidemics in the United States in spring and summer 2021.

Models can guide clinical preparations

“Health care simulation modeling is a growing field, with very exciting implications,” Lenore Jarvis, MD, of George Washington University, Washington, said in an interview. The field has the potential ability to influence health care in a data-driven way, including, but not limited to, staffing and other hospital operations, as well as patient care decision-making. “In short, accurate modeling and predictions can help us to make informed health care decisions that can lead to increased quality of care, potential cost savings, and even to help save lives,” she said.

Although the details of transmission modeling were not mentioned in the study, the authors evaluated the performances of several models and scenarios. “Scenario 4, for example, was focused on in particular because it best captured the observed dynamics [for RSV] that emerged during the spring and summer of 2021,” Dr. Jarvis said.

“Pediatricians can speak to these trends firsthand. A decrease in expected RSV infections and hospitalizations in 2020, followed by an unprecedented and early increase in RSV infections and severity in 2021, and the factors that the authors account for make sense, such as reintroduction of RSV from other regions and low immunity in the population,” she said. “It also makes sense that, in these transmission modeling scenarios, the expected mean age of hospitalization because of RSV increased with a temporary (hopefully) increase in RSV hospitalizations in the 2021 season, and potentially the 2022 RSV season.”

As for additional research, Dr. Jarvis said she would like to see follow-up data on the RSV transmission modeling. “For example, with scenario 4, does this scenario continue to perform well in other time periods, such as the winter? If the modeling continues to be accurate during other periods of evaluation and reevaluation, this modeling could be very useful in helping pediatric clinics and hospitals to prepare for RSV care and hospital capacity management.”

The study was supported by grants to various researchers from the National Institute of Allergy and Infectious Diseases/National Institutes of Health, the National Center for Advancing Translational Science at the National Institutes of Health, and NIH Roadmap for Medical Research. Lead author Ms. Zheng had no financial conflicts to disclose. Her study coauthors disclosed relationships with companies including AbbVie, Merck, Pfizer, GlaxoSmithKline, MedImmune, and Janssen. Dr. Jarvis had no financial conflicts to disclose and serves on the Pediatric News editorial advisory board.

The impact of respiratory syncytial virus (RSV)will likely be greater in 2021 and 2022 in the United States than in previous years as a result of the ongoing COVID-19 pandemic, based on data from a simulation-modeling study involving approximately 19 million individuals.

Although RSV usually follows consistent patterns of timing and duration, the disease all but disappeared starting in March 2020 after the introduction of measures to mitigate the spread of COVID-19, Zhe Zheng, MBBS, of Yale University, New Haven, Conn., and colleagues wrote.

However, lifting of mitigation measures has resulted in emergence of RSV in various parts of the world in early 2021, and trends may be similar in the United States, but data are needed to plan for prophylaxis and hospital use, they noted.

In a study published in JAMA Network Open, the researchers developed a simulation model for epidemics of RSV based on historical data. They acquired inpatient records from New York during 2005-2014 and from California during 2003-2011. The primary clinical outcome was the estimated monthly hospitalizations for RSV.

The simulated study population was 19.45 million individuals. After evaluating several scenarios including continued low transmission associated with social distancing and other mitigation measures, the researchers focused on the likely scenario that introduction of RSV from other regions would likely spark RSV epidemics in the United States.

They determined that spring and summer 2021 would show an increase in hospitalizations for RSV. Overall, higher rates of virus introduction from other regions were associated with more intense spring and summer RSV epidemics, with the trade-off of smaller winter epidemics. In the model, the expected RSV epidemic in spring and summer 2021 in New York was small, with a peak incidence of 419 hospitalizations per 100,000 people in April; by contrast, for states with less seasonal variability, such as Florida, the model predicted a larger summer epidemic.

In the model, the mean age of hospitalization for children younger than 5 years for January 2022 was expected to be 1.17 years, compared with 0.84 years in January 2019, the researchers noted.

Across all age groups, the greatest relative increase in the incidence of RSV infection was predicted for children aged 1-4 years (ranging from 82% to 86%), as were lower respiratory infections (87%-101%) and hospitalization (99%-119%), compared with prepandemic levels.

Hospitalizations for children aged 1 year were predicted to double compared with prepandemic seasons; 707 per 100,000 children per year for 2021 and 2022 versus 355 per 100,000 children per year in a typical prepandemic season. However, the largest incidence of lower respiratory infections (30,075 per 100,000) was predicted for infants aged 3-5 months, and the largest incidence of hospitalizations (3,116 per 100,000) was predicted for infants younger than 3 months.

“Without virus importation, the risk of RSV infections across all age groups in the winter of 2021 and 2022 would be greater, as more susceptible individuals were spared from infections in the absence of summer epidemics,” the researchers noted.

The older mean hospitalization age seen in the model was similar to the reported median patient age in Australia both before the pandemic and during the reemergent RSV epidemic.

“This makes intuitive sense, since many children born in 2020 were spared from RSV infection due to the low virus activity; these children will be older when they get infected for the first time during the reemergent epidemics,” the researchers wrote. “Consequently, stakeholders should consider modifying prophylaxis guidelines to include high-risk infants less than 2 years of age for the 2021-2022 season.”

The study findings were limited by several factors including the lack of data on level of virus introduction or on the impact of lack of boosting on infants with only transplacentally acquired RSV antibodies, the researchers noted. Other limitations include the use of historical data and the lack of data on values outside those included in the model, as well as the inability to control for other factors that could influence RSV, such as vaccines or long-lasting antibodies.

However, the results suggest that the rate of imported infections is associated with RSV hospitalizations, and the model effectively captured the RSV epidemics in the United States in spring and summer 2021.

Models can guide clinical preparations

“Health care simulation modeling is a growing field, with very exciting implications,” Lenore Jarvis, MD, of George Washington University, Washington, said in an interview. The field has the potential ability to influence health care in a data-driven way, including, but not limited to, staffing and other hospital operations, as well as patient care decision-making. “In short, accurate modeling and predictions can help us to make informed health care decisions that can lead to increased quality of care, potential cost savings, and even to help save lives,” she said.

Although the details of transmission modeling were not mentioned in the study, the authors evaluated the performances of several models and scenarios. “Scenario 4, for example, was focused on in particular because it best captured the observed dynamics [for RSV] that emerged during the spring and summer of 2021,” Dr. Jarvis said.

“Pediatricians can speak to these trends firsthand. A decrease in expected RSV infections and hospitalizations in 2020, followed by an unprecedented and early increase in RSV infections and severity in 2021, and the factors that the authors account for make sense, such as reintroduction of RSV from other regions and low immunity in the population,” she said. “It also makes sense that, in these transmission modeling scenarios, the expected mean age of hospitalization because of RSV increased with a temporary (hopefully) increase in RSV hospitalizations in the 2021 season, and potentially the 2022 RSV season.”

As for additional research, Dr. Jarvis said she would like to see follow-up data on the RSV transmission modeling. “For example, with scenario 4, does this scenario continue to perform well in other time periods, such as the winter? If the modeling continues to be accurate during other periods of evaluation and reevaluation, this modeling could be very useful in helping pediatric clinics and hospitals to prepare for RSV care and hospital capacity management.”

The study was supported by grants to various researchers from the National Institute of Allergy and Infectious Diseases/National Institutes of Health, the National Center for Advancing Translational Science at the National Institutes of Health, and NIH Roadmap for Medical Research. Lead author Ms. Zheng had no financial conflicts to disclose. Her study coauthors disclosed relationships with companies including AbbVie, Merck, Pfizer, GlaxoSmithKline, MedImmune, and Janssen. Dr. Jarvis had no financial conflicts to disclose and serves on the Pediatric News editorial advisory board.

The impact of respiratory syncytial virus (RSV)will likely be greater in 2021 and 2022 in the United States than in previous years as a result of the ongoing COVID-19 pandemic, based on data from a simulation-modeling study involving approximately 19 million individuals.

Although RSV usually follows consistent patterns of timing and duration, the disease all but disappeared starting in March 2020 after the introduction of measures to mitigate the spread of COVID-19, Zhe Zheng, MBBS, of Yale University, New Haven, Conn., and colleagues wrote.

However, lifting of mitigation measures has resulted in emergence of RSV in various parts of the world in early 2021, and trends may be similar in the United States, but data are needed to plan for prophylaxis and hospital use, they noted.

In a study published in JAMA Network Open, the researchers developed a simulation model for epidemics of RSV based on historical data. They acquired inpatient records from New York during 2005-2014 and from California during 2003-2011. The primary clinical outcome was the estimated monthly hospitalizations for RSV.

The simulated study population was 19.45 million individuals. After evaluating several scenarios including continued low transmission associated with social distancing and other mitigation measures, the researchers focused on the likely scenario that introduction of RSV from other regions would likely spark RSV epidemics in the United States.

They determined that spring and summer 2021 would show an increase in hospitalizations for RSV. Overall, higher rates of virus introduction from other regions were associated with more intense spring and summer RSV epidemics, with the trade-off of smaller winter epidemics. In the model, the expected RSV epidemic in spring and summer 2021 in New York was small, with a peak incidence of 419 hospitalizations per 100,000 people in April; by contrast, for states with less seasonal variability, such as Florida, the model predicted a larger summer epidemic.

In the model, the mean age of hospitalization for children younger than 5 years for January 2022 was expected to be 1.17 years, compared with 0.84 years in January 2019, the researchers noted.

Across all age groups, the greatest relative increase in the incidence of RSV infection was predicted for children aged 1-4 years (ranging from 82% to 86%), as were lower respiratory infections (87%-101%) and hospitalization (99%-119%), compared with prepandemic levels.

Hospitalizations for children aged 1 year were predicted to double compared with prepandemic seasons; 707 per 100,000 children per year for 2021 and 2022 versus 355 per 100,000 children per year in a typical prepandemic season. However, the largest incidence of lower respiratory infections (30,075 per 100,000) was predicted for infants aged 3-5 months, and the largest incidence of hospitalizations (3,116 per 100,000) was predicted for infants younger than 3 months.

“Without virus importation, the risk of RSV infections across all age groups in the winter of 2021 and 2022 would be greater, as more susceptible individuals were spared from infections in the absence of summer epidemics,” the researchers noted.

The older mean hospitalization age seen in the model was similar to the reported median patient age in Australia both before the pandemic and during the reemergent RSV epidemic.

“This makes intuitive sense, since many children born in 2020 were spared from RSV infection due to the low virus activity; these children will be older when they get infected for the first time during the reemergent epidemics,” the researchers wrote. “Consequently, stakeholders should consider modifying prophylaxis guidelines to include high-risk infants less than 2 years of age for the 2021-2022 season.”

The study findings were limited by several factors including the lack of data on level of virus introduction or on the impact of lack of boosting on infants with only transplacentally acquired RSV antibodies, the researchers noted. Other limitations include the use of historical data and the lack of data on values outside those included in the model, as well as the inability to control for other factors that could influence RSV, such as vaccines or long-lasting antibodies.

However, the results suggest that the rate of imported infections is associated with RSV hospitalizations, and the model effectively captured the RSV epidemics in the United States in spring and summer 2021.

Models can guide clinical preparations

“Health care simulation modeling is a growing field, with very exciting implications,” Lenore Jarvis, MD, of George Washington University, Washington, said in an interview. The field has the potential ability to influence health care in a data-driven way, including, but not limited to, staffing and other hospital operations, as well as patient care decision-making. “In short, accurate modeling and predictions can help us to make informed health care decisions that can lead to increased quality of care, potential cost savings, and even to help save lives,” she said.

Although the details of transmission modeling were not mentioned in the study, the authors evaluated the performances of several models and scenarios. “Scenario 4, for example, was focused on in particular because it best captured the observed dynamics [for RSV] that emerged during the spring and summer of 2021,” Dr. Jarvis said.

“Pediatricians can speak to these trends firsthand. A decrease in expected RSV infections and hospitalizations in 2020, followed by an unprecedented and early increase in RSV infections and severity in 2021, and the factors that the authors account for make sense, such as reintroduction of RSV from other regions and low immunity in the population,” she said. “It also makes sense that, in these transmission modeling scenarios, the expected mean age of hospitalization because of RSV increased with a temporary (hopefully) increase in RSV hospitalizations in the 2021 season, and potentially the 2022 RSV season.”

As for additional research, Dr. Jarvis said she would like to see follow-up data on the RSV transmission modeling. “For example, with scenario 4, does this scenario continue to perform well in other time periods, such as the winter? If the modeling continues to be accurate during other periods of evaluation and reevaluation, this modeling could be very useful in helping pediatric clinics and hospitals to prepare for RSV care and hospital capacity management.”

The study was supported by grants to various researchers from the National Institute of Allergy and Infectious Diseases/National Institutes of Health, the National Center for Advancing Translational Science at the National Institutes of Health, and NIH Roadmap for Medical Research. Lead author Ms. Zheng had no financial conflicts to disclose. Her study coauthors disclosed relationships with companies including AbbVie, Merck, Pfizer, GlaxoSmithKline, MedImmune, and Janssen. Dr. Jarvis had no financial conflicts to disclose and serves on the Pediatric News editorial advisory board.

The amount of fat surrounding abdominal organs may help clinicians identify cardiovascular risk in young people with obesity, researchers have found.

Severely overweight children and young adults showed a subtle association between visceral fat and arterial stiffness independent of body mass index (BMI). The association was not present in those of healthy weight, possibly because their visceral fat stores are too small to have a detectable effect on cardiovascular health, according to the researchers, who reported their findings in the latest issue of Pediatric Obesity.

“Those kids with greater visceral fat had stiffer arteries, which can overtax and overstress the system and lead to unfortunate consequences in terms of cardiovascular health down the line,” senior author Joseph M. Kindler, PhD, an assistant professor of nutritional sciences at the University of Georgia, Athens, told this news organization.

The data came from cross-sectional measurements in 605 youth (67% female, 56% non-Black) aged 10-23 years at Cincinnati Children’s Hospital Medical Center. The sample included 236 individuals of healthy weight, 224 with obesity, and 145 with type 2 diabetes.    

Visceral fat was assessed with dual-energy x-ray absorptiometry (DXA), a widely used test of bone mineral density screening to assess fracture risk. Carotid-femoral pulse wave velocity (PWV) was used to gauge arterial stiffness, a subclinical sign of cardiovascular disease.

Visceral fat was associated with PWV in all three groups of study subjects (P < .05), the researchers found, whereas the amount of subcutaneous fat was linked to arterial stiffness in obese youth and those with obesity but not those whose weight was considered healthy.

The amount of fat was associated with an additional 1.6% of the variability in arterial stiffness in youth with obesity after accounting for BMI. Subcutaneous fat, meanwhile, did not appear to affect PWV, the researchers found. “In youth with healthy weight, visceral fat, subcutaneous fat, BMI, and waist circumference were not significantly associated with PWV in any analyses,” they write.

The researchers cited a paucity of data on the relationship between visceral fat and cardiovascular disease in children with obesity. Although BMI is a reliable and readily available indicator of risk for disease, DXA “might give us a little more information,” Dr. Kindler, a nutritionist and bone biologist, said. As for clinical use to supplement BMI and waist circumference, he said, “maybe there’s room for visceral fat, but we do need a lot more science to back those decisions down the line.”

For example, what normal visceral fat accumulation during childhood looks like is unknown, he said.

Rigorous longitudinal studies are needed to establish cause and effect, but the new findings offer “a potential connection between visceral fat and cardiovascular disease risk in youth in a relatively large sample,” Wei Shen, MD, MPH, the associate director of the body composition unit at the New York Obesity Nutrition Research Center at Columbia University, New York, said.

Ideally, said Dr. Shen, who was not involved in the latest study, it would be “more credible to use the most accurate measure of visceral fat, the volumetric measurement of visceral fat using MRI” to establish a causal relationship with cardiovascular risk. However, MRI is more expensive and less accessible than DXA. To assess visceral fat in the clinic, “waist circumference may still be a good choice, as it is so convenient to use,” she added.

Dr. Kindler and his colleagues highlighted the need to examine the effect of excess visceral fat as well as intrahepatic fat on youth with type 2 diabetes, who experience cardiovascular complications independent of whether they are obese. In the new study, the positive association between visceral fat and arterial stiffness did not differ between youth with obesity and normal glucose control and those with obesity and type 2 diabetes.

Funding came from the Endocrine Fellows Foundation, the National Institutes of Health, and the University of Georgia Obesity Initiative. Dr. Kindler and Dr. Shen have disclosed no relevant financial relationships.

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

The amount of fat surrounding abdominal organs may help clinicians identify cardiovascular risk in young people with obesity, researchers have found.

Severely overweight children and young adults showed a subtle association between visceral fat and arterial stiffness independent of body mass index (BMI). The association was not present in those of healthy weight, possibly because their visceral fat stores are too small to have a detectable effect on cardiovascular health, according to the researchers, who reported their findings in the latest issue of Pediatric Obesity.

“Those kids with greater visceral fat had stiffer arteries, which can overtax and overstress the system and lead to unfortunate consequences in terms of cardiovascular health down the line,” senior author Joseph M. Kindler, PhD, an assistant professor of nutritional sciences at the University of Georgia, Athens, told this news organization.

The data came from cross-sectional measurements in 605 youth (67% female, 56% non-Black) aged 10-23 years at Cincinnati Children’s Hospital Medical Center. The sample included 236 individuals of healthy weight, 224 with obesity, and 145 with type 2 diabetes.    

Visceral fat was assessed with dual-energy x-ray absorptiometry (DXA), a widely used test of bone mineral density screening to assess fracture risk. Carotid-femoral pulse wave velocity (PWV) was used to gauge arterial stiffness, a subclinical sign of cardiovascular disease.

Visceral fat was associated with PWV in all three groups of study subjects (P < .05), the researchers found, whereas the amount of subcutaneous fat was linked to arterial stiffness in obese youth and those with obesity but not those whose weight was considered healthy.

The amount of fat was associated with an additional 1.6% of the variability in arterial stiffness in youth with obesity after accounting for BMI. Subcutaneous fat, meanwhile, did not appear to affect PWV, the researchers found. “In youth with healthy weight, visceral fat, subcutaneous fat, BMI, and waist circumference were not significantly associated with PWV in any analyses,” they write.

The researchers cited a paucity of data on the relationship between visceral fat and cardiovascular disease in children with obesity. Although BMI is a reliable and readily available indicator of risk for disease, DXA “might give us a little more information,” Dr. Kindler, a nutritionist and bone biologist, said. As for clinical use to supplement BMI and waist circumference, he said, “maybe there’s room for visceral fat, but we do need a lot more science to back those decisions down the line.”

For example, what normal visceral fat accumulation during childhood looks like is unknown, he said.

Rigorous longitudinal studies are needed to establish cause and effect, but the new findings offer “a potential connection between visceral fat and cardiovascular disease risk in youth in a relatively large sample,” Wei Shen, MD, MPH, the associate director of the body composition unit at the New York Obesity Nutrition Research Center at Columbia University, New York, said.

Ideally, said Dr. Shen, who was not involved in the latest study, it would be “more credible to use the most accurate measure of visceral fat, the volumetric measurement of visceral fat using MRI” to establish a causal relationship with cardiovascular risk. However, MRI is more expensive and less accessible than DXA. To assess visceral fat in the clinic, “waist circumference may still be a good choice, as it is so convenient to use,” she added.

Dr. Kindler and his colleagues highlighted the need to examine the effect of excess visceral fat as well as intrahepatic fat on youth with type 2 diabetes, who experience cardiovascular complications independent of whether they are obese. In the new study, the positive association between visceral fat and arterial stiffness did not differ between youth with obesity and normal glucose control and those with obesity and type 2 diabetes.

Funding came from the Endocrine Fellows Foundation, the National Institutes of Health, and the University of Georgia Obesity Initiative. Dr. Kindler and Dr. Shen have disclosed no relevant financial relationships.

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

The amount of fat surrounding abdominal organs may help clinicians identify cardiovascular risk in young people with obesity, researchers have found.

Severely overweight children and young adults showed a subtle association between visceral fat and arterial stiffness independent of body mass index (BMI). The association was not present in those of healthy weight, possibly because their visceral fat stores are too small to have a detectable effect on cardiovascular health, according to the researchers, who reported their findings in the latest issue of Pediatric Obesity.

“Those kids with greater visceral fat had stiffer arteries, which can overtax and overstress the system and lead to unfortunate consequences in terms of cardiovascular health down the line,” senior author Joseph M. Kindler, PhD, an assistant professor of nutritional sciences at the University of Georgia, Athens, told this news organization.

The data came from cross-sectional measurements in 605 youth (67% female, 56% non-Black) aged 10-23 years at Cincinnati Children’s Hospital Medical Center. The sample included 236 individuals of healthy weight, 224 with obesity, and 145 with type 2 diabetes.    

Visceral fat was assessed with dual-energy x-ray absorptiometry (DXA), a widely used test of bone mineral density screening to assess fracture risk. Carotid-femoral pulse wave velocity (PWV) was used to gauge arterial stiffness, a subclinical sign of cardiovascular disease.

Visceral fat was associated with PWV in all three groups of study subjects (P < .05), the researchers found, whereas the amount of subcutaneous fat was linked to arterial stiffness in obese youth and those with obesity but not those whose weight was considered healthy.

The amount of fat was associated with an additional 1.6% of the variability in arterial stiffness in youth with obesity after accounting for BMI. Subcutaneous fat, meanwhile, did not appear to affect PWV, the researchers found. “In youth with healthy weight, visceral fat, subcutaneous fat, BMI, and waist circumference were not significantly associated with PWV in any analyses,” they write.

The researchers cited a paucity of data on the relationship between visceral fat and cardiovascular disease in children with obesity. Although BMI is a reliable and readily available indicator of risk for disease, DXA “might give us a little more information,” Dr. Kindler, a nutritionist and bone biologist, said. As for clinical use to supplement BMI and waist circumference, he said, “maybe there’s room for visceral fat, but we do need a lot more science to back those decisions down the line.”

For example, what normal visceral fat accumulation during childhood looks like is unknown, he said.

Rigorous longitudinal studies are needed to establish cause and effect, but the new findings offer “a potential connection between visceral fat and cardiovascular disease risk in youth in a relatively large sample,” Wei Shen, MD, MPH, the associate director of the body composition unit at the New York Obesity Nutrition Research Center at Columbia University, New York, said.

Ideally, said Dr. Shen, who was not involved in the latest study, it would be “more credible to use the most accurate measure of visceral fat, the volumetric measurement of visceral fat using MRI” to establish a causal relationship with cardiovascular risk. However, MRI is more expensive and less accessible than DXA. To assess visceral fat in the clinic, “waist circumference may still be a good choice, as it is so convenient to use,” she added.

Dr. Kindler and his colleagues highlighted the need to examine the effect of excess visceral fat as well as intrahepatic fat on youth with type 2 diabetes, who experience cardiovascular complications independent of whether they are obese. In the new study, the positive association between visceral fat and arterial stiffness did not differ between youth with obesity and normal glucose control and those with obesity and type 2 diabetes.

Funding came from the Endocrine Fellows Foundation, the National Institutes of Health, and the University of Georgia Obesity Initiative. Dr. Kindler and Dr. Shen have disclosed no relevant financial relationships.

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

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

• Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
• Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
• Consider including virologic testing in the diagnostic workup of sexually active youth.
• Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
• Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
• Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
• For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

• Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
• Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
• Consider including virologic testing in the diagnostic workup of sexually active youth.
• Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
• Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
• Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
• For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

• Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
• Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
• Consider including virologic testing in the diagnostic workup of sexually active youth.
• Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
• Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
• Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
• For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

Voxelotor for hemolytic anemia in sickle cell disease can now be used in children from 4 years old and is also available as a child-friendly, grape-flavored tablet for oral suspension to make it easier for them to take.

The indication had previously been for patients 12 years old and up, the FDA said in an announcement.

Voxelotor (Oxbryta) was originally approved for sickle cell disease in November 2019 and was described as the first drug that directly inhibits sickle hemoglobin polymerization, the root cause of the disease. It binds and stabilizes hemoglobin to prevent red blood cells from sickling and being destroyed.

Approval for the new indication of use in children down to age 4 was based on data from a phase 2 trial that involved 45 children aged 4-11 years; the results show that 36% had an increase in hemoglobin greater than 1 g/dL by week 24, the FDA said.

“Complications of [sickle cell disease] that can cause irreversible organ damage are known to begin in the first few years of life, which is why earlier intervention is critical,” commented Ted Love, MD, president and CEO of Global Blood Therapeutics, the manufacturer, in a press release.

The company is studying voxelotor in children as young as 9 months old.

The agent was granted an accelerated approval by the FDA, so continued approval depends on additional data to confirm that increases in hemoglobin have clinical benefit.

With the new approvals, voxelotor is now available in 500-mg tablets and the 300-mg tablets for oral suspension. Dosing for ages 12 years and up is 1,500 mg once daily. Dosing for children 4 to up to 12 years old is weight based.

The most common side effects are headache, vomiting, diarrhea, abdominal pain, nausea, rash, and fever.

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

Voxelotor for hemolytic anemia in sickle cell disease can now be used in children from 4 years old and is also available as a child-friendly, grape-flavored tablet for oral suspension to make it easier for them to take.

The indication had previously been for patients 12 years old and up, the FDA said in an announcement.

Voxelotor (Oxbryta) was originally approved for sickle cell disease in November 2019 and was described as the first drug that directly inhibits sickle hemoglobin polymerization, the root cause of the disease. It binds and stabilizes hemoglobin to prevent red blood cells from sickling and being destroyed.

Approval for the new indication of use in children down to age 4 was based on data from a phase 2 trial that involved 45 children aged 4-11 years; the results show that 36% had an increase in hemoglobin greater than 1 g/dL by week 24, the FDA said.

“Complications of [sickle cell disease] that can cause irreversible organ damage are known to begin in the first few years of life, which is why earlier intervention is critical,” commented Ted Love, MD, president and CEO of Global Blood Therapeutics, the manufacturer, in a press release.

The company is studying voxelotor in children as young as 9 months old.

The agent was granted an accelerated approval by the FDA, so continued approval depends on additional data to confirm that increases in hemoglobin have clinical benefit.

With the new approvals, voxelotor is now available in 500-mg tablets and the 300-mg tablets for oral suspension. Dosing for ages 12 years and up is 1,500 mg once daily. Dosing for children 4 to up to 12 years old is weight based.

The most common side effects are headache, vomiting, diarrhea, abdominal pain, nausea, rash, and fever.

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

Voxelotor for hemolytic anemia in sickle cell disease can now be used in children from 4 years old and is also available as a child-friendly, grape-flavored tablet for oral suspension to make it easier for them to take.

The indication had previously been for patients 12 years old and up, the FDA said in an announcement.

Voxelotor (Oxbryta) was originally approved for sickle cell disease in November 2019 and was described as the first drug that directly inhibits sickle hemoglobin polymerization, the root cause of the disease. It binds and stabilizes hemoglobin to prevent red blood cells from sickling and being destroyed.

Approval for the new indication of use in children down to age 4 was based on data from a phase 2 trial that involved 45 children aged 4-11 years; the results show that 36% had an increase in hemoglobin greater than 1 g/dL by week 24, the FDA said.

“Complications of [sickle cell disease] that can cause irreversible organ damage are known to begin in the first few years of life, which is why earlier intervention is critical,” commented Ted Love, MD, president and CEO of Global Blood Therapeutics, the manufacturer, in a press release.

The company is studying voxelotor in children as young as 9 months old.

The agent was granted an accelerated approval by the FDA, so continued approval depends on additional data to confirm that increases in hemoglobin have clinical benefit.

With the new approvals, voxelotor is now available in 500-mg tablets and the 300-mg tablets for oral suspension. Dosing for ages 12 years and up is 1,500 mg once daily. Dosing for children 4 to up to 12 years old is weight based.

The most common side effects are headache, vomiting, diarrhea, abdominal pain, nausea, rash, and fever.

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

The Centers for Disease Control and Prevention has announced that students who are exposed to the coronavirus can still attend school as long as they continue to test negative for the virus in the following days.

The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.

“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.

When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.

In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.

“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”

In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.

The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.

Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.

In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.

The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.

In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.

The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.

Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.

“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.

“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.

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

The Centers for Disease Control and Prevention has announced that students who are exposed to the coronavirus can still attend school as long as they continue to test negative for the virus in the following days.

The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.

“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.

When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.

In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.

“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”

In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.

The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.

Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.

In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.

The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.

In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.

The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.

Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.

“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.

“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.

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

The Centers for Disease Control and Prevention has announced that students who are exposed to the coronavirus can still attend school as long as they continue to test negative for the virus in the following days.

The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.

“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.

When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.

In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.

“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”

In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.

The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.

Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.

In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.

The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.

In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.

The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.

Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.

“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.

“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.

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