Pediatric News

There is insufficient evidence to recommend for or against the use of synbiotics to prevent or treat common gastrointestinal disorders in infants and children.

That’s the conclusion of a position paper from the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) special interest group on gut microbiota and modifications and its working group for pre- and probiotics.

Based on their review of available data, the group could not offer a recommendation on use of any specific synbiotic preparation for treatment of acute gastroenteritis, Helicobacter pylori (H. pylori) infection, inflammatory bowel disease (IBD), infantile colic, functional abdominal pain, irritable bowel syndrome (IBS), or constipation.

No recommendation can be formulated on their use in the prevention of food allergies, the group also says.

The same goes for prevention of necrotizing enterocolitis (NEC) in preterm infants and newborns with cyanotic congenital heart disease, as well as prevention of food allergies.

The position paper was published online in the Journal of Pediatric Gastroenterology and Nutrition.
 

Few studies, major limitations

A synbiotic mixture comprises probiotics and prebiotics selectively utilized by host microorganisms that confers a health benefit on the host.

While the number of studies evaluating the effect of different synbiotics is increasing, the results to date are “ambiguous,” report first author Iva Hojsak, with Children’s Hospital Zagreb, Croatia, and colleagues. Well-designed studies using the same outcome measures for specific clinical indications are needed to allow comparison between studies, they write.

To gauge their effect on pediatric GI disorders, the group searched the literature for studies in English that compared the use of synbiotics, in all delivery vehicles and formulations, at any dose, with no synbiotic (placebo or no treatment or other interventions).

They found very few studies that addressed the specific indications of interest, ranging from two randomized controlled trials (RCTs) each for infantile colic and IBD to five RCTs for acute gastroenteritis. 

There were only two indications (acute gastroenteritis and H. pylori) where two synbiotic preparations were tested.

The studies often included a limited number of participants, had significant methodological biases, scarcely reported on side effects or adverse events, and reported different outcomes, making inter-study comparisons tough.

“Comparison of studies was further limited by the synbiotic preparation used, where dose effect was not assessed,” the group writes. Also, few studies used the same synbiotic preparation for a specific clinical indication or the same amount of live bacteria and prebiotic in the preparation.

The authors made note of the newly stringent recommendations for direct evidence proposed by the International Scientific Association for Probiotics and Prebiotics, which state RCTs need to compare the synergistic synbiotic combination, the substrate alone, the live microorganisms alone, and a control.
 

Outside experts weigh in

Offering outside perspective, Gail Cresci, PhD, microbiome researcher, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s Hospital, said what’s “most notable with this review is that there is an issue with studies that incorporate a prebiotic and probiotic, in that there is much heterogeneity with the probiotic strains and prebiotic substrates that are investigated.”

Dr. Cresci also noted that “both pre- and probiotics have specific mechanisms of action based on the substrate and strain, respectively, so to pull the trials together and analyze as a ‘synbiotic’ treating all the combinations the same is not accurate [and] also limits the ability to do meta-analyses and make recommendations in a position paper.”

Geoffrey Preidis, MD, PhD, spokesperson for the American Gastroenterological Association (AGA), also reviewed the paper for this news organization.

He noted that few studies tested the exact same synbiotic preparation for a given clinical indication.

“For the majority of GI disorders examined in this review, the total number of studies testing a particular synbiotic formulation is exactly one. Clinical recommendations rarely can be made based on the results of a single trial,” said Dr. Preidis, a pediatric gastroenterologist with Texas Children’s Hospital, Houston.

“Perhaps most importantly, most studies do not report safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” he noted.

“Millions of Americans take probiotics. They are the third most commonly used dietary supplement behind vitamins and minerals,” Dr. Preidis added. “Prebiotics and synbiotics also are increasing in popularity. They can be found almost everywhere – in supermarkets, drugstores, health food stores, and online – in pill or powder form and in some foods and beverages.

None of these products have been approved by the [U.S. Food and Drug Administration] to treat, cure, or prevent any disease. In most circumstances, there is not enough clinical evidence to suggest a clear value to be gained for most consumers,” he said.

Dr. Preidis said he agrees with the conclusions of this “thoughtfully written position paper” on whether synbiotics have a role in the management of GI disorders in children.

“Synbiotics should not be given routinely to infants or children to manage GI disorders at this time,” he said in an interview. “Potential beneficial effects are not yet confirmed in multiple well-designed, adequately powered trials that test the same synbiotic combination and dose, measure the same outcomes, and rigorously document all adverse effects.”

This research had no specific funding. Dr. Hojsak received payment/honorarium for lectures from BioGaia, Nutricia, Biocodex, AbelaPharm, Nestle, Abbott, Sandoz, Oktal Pharma, and Takeda. Dr. Cresci and Dr. Preidis report no relevant disclosures.

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

There is insufficient evidence to recommend for or against the use of synbiotics to prevent or treat common gastrointestinal disorders in infants and children.

That’s the conclusion of a position paper from the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) special interest group on gut microbiota and modifications and its working group for pre- and probiotics.

Based on their review of available data, the group could not offer a recommendation on use of any specific synbiotic preparation for treatment of acute gastroenteritis, Helicobacter pylori (H. pylori) infection, inflammatory bowel disease (IBD), infantile colic, functional abdominal pain, irritable bowel syndrome (IBS), or constipation.

No recommendation can be formulated on their use in the prevention of food allergies, the group also says.

The same goes for prevention of necrotizing enterocolitis (NEC) in preterm infants and newborns with cyanotic congenital heart disease, as well as prevention of food allergies.

The position paper was published online in the Journal of Pediatric Gastroenterology and Nutrition.
 

Few studies, major limitations

A synbiotic mixture comprises probiotics and prebiotics selectively utilized by host microorganisms that confers a health benefit on the host.

While the number of studies evaluating the effect of different synbiotics is increasing, the results to date are “ambiguous,” report first author Iva Hojsak, with Children’s Hospital Zagreb, Croatia, and colleagues. Well-designed studies using the same outcome measures for specific clinical indications are needed to allow comparison between studies, they write.

To gauge their effect on pediatric GI disorders, the group searched the literature for studies in English that compared the use of synbiotics, in all delivery vehicles and formulations, at any dose, with no synbiotic (placebo or no treatment or other interventions).

They found very few studies that addressed the specific indications of interest, ranging from two randomized controlled trials (RCTs) each for infantile colic and IBD to five RCTs for acute gastroenteritis. 

There were only two indications (acute gastroenteritis and H. pylori) where two synbiotic preparations were tested.

The studies often included a limited number of participants, had significant methodological biases, scarcely reported on side effects or adverse events, and reported different outcomes, making inter-study comparisons tough.

“Comparison of studies was further limited by the synbiotic preparation used, where dose effect was not assessed,” the group writes. Also, few studies used the same synbiotic preparation for a specific clinical indication or the same amount of live bacteria and prebiotic in the preparation.

The authors made note of the newly stringent recommendations for direct evidence proposed by the International Scientific Association for Probiotics and Prebiotics, which state RCTs need to compare the synergistic synbiotic combination, the substrate alone, the live microorganisms alone, and a control.
 

Outside experts weigh in

Offering outside perspective, Gail Cresci, PhD, microbiome researcher, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s Hospital, said what’s “most notable with this review is that there is an issue with studies that incorporate a prebiotic and probiotic, in that there is much heterogeneity with the probiotic strains and prebiotic substrates that are investigated.”

Dr. Cresci also noted that “both pre- and probiotics have specific mechanisms of action based on the substrate and strain, respectively, so to pull the trials together and analyze as a ‘synbiotic’ treating all the combinations the same is not accurate [and] also limits the ability to do meta-analyses and make recommendations in a position paper.”

Geoffrey Preidis, MD, PhD, spokesperson for the American Gastroenterological Association (AGA), also reviewed the paper for this news organization.

He noted that few studies tested the exact same synbiotic preparation for a given clinical indication.

“For the majority of GI disorders examined in this review, the total number of studies testing a particular synbiotic formulation is exactly one. Clinical recommendations rarely can be made based on the results of a single trial,” said Dr. Preidis, a pediatric gastroenterologist with Texas Children’s Hospital, Houston.

“Perhaps most importantly, most studies do not report safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” he noted.

“Millions of Americans take probiotics. They are the third most commonly used dietary supplement behind vitamins and minerals,” Dr. Preidis added. “Prebiotics and synbiotics also are increasing in popularity. They can be found almost everywhere – in supermarkets, drugstores, health food stores, and online – in pill or powder form and in some foods and beverages.

None of these products have been approved by the [U.S. Food and Drug Administration] to treat, cure, or prevent any disease. In most circumstances, there is not enough clinical evidence to suggest a clear value to be gained for most consumers,” he said.

Dr. Preidis said he agrees with the conclusions of this “thoughtfully written position paper” on whether synbiotics have a role in the management of GI disorders in children.

“Synbiotics should not be given routinely to infants or children to manage GI disorders at this time,” he said in an interview. “Potential beneficial effects are not yet confirmed in multiple well-designed, adequately powered trials that test the same synbiotic combination and dose, measure the same outcomes, and rigorously document all adverse effects.”

This research had no specific funding. Dr. Hojsak received payment/honorarium for lectures from BioGaia, Nutricia, Biocodex, AbelaPharm, Nestle, Abbott, Sandoz, Oktal Pharma, and Takeda. Dr. Cresci and Dr. Preidis report no relevant disclosures.

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

There is insufficient evidence to recommend for or against the use of synbiotics to prevent or treat common gastrointestinal disorders in infants and children.

That’s the conclusion of a position paper from the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) special interest group on gut microbiota and modifications and its working group for pre- and probiotics.

Based on their review of available data, the group could not offer a recommendation on use of any specific synbiotic preparation for treatment of acute gastroenteritis, Helicobacter pylori (H. pylori) infection, inflammatory bowel disease (IBD), infantile colic, functional abdominal pain, irritable bowel syndrome (IBS), or constipation.

No recommendation can be formulated on their use in the prevention of food allergies, the group also says.

The same goes for prevention of necrotizing enterocolitis (NEC) in preterm infants and newborns with cyanotic congenital heart disease, as well as prevention of food allergies.

The position paper was published online in the Journal of Pediatric Gastroenterology and Nutrition.
 

Few studies, major limitations

A synbiotic mixture comprises probiotics and prebiotics selectively utilized by host microorganisms that confers a health benefit on the host.

While the number of studies evaluating the effect of different synbiotics is increasing, the results to date are “ambiguous,” report first author Iva Hojsak, with Children’s Hospital Zagreb, Croatia, and colleagues. Well-designed studies using the same outcome measures for specific clinical indications are needed to allow comparison between studies, they write.

To gauge their effect on pediatric GI disorders, the group searched the literature for studies in English that compared the use of synbiotics, in all delivery vehicles and formulations, at any dose, with no synbiotic (placebo or no treatment or other interventions).

They found very few studies that addressed the specific indications of interest, ranging from two randomized controlled trials (RCTs) each for infantile colic and IBD to five RCTs for acute gastroenteritis. 

There were only two indications (acute gastroenteritis and H. pylori) where two synbiotic preparations were tested.

The studies often included a limited number of participants, had significant methodological biases, scarcely reported on side effects or adverse events, and reported different outcomes, making inter-study comparisons tough.

“Comparison of studies was further limited by the synbiotic preparation used, where dose effect was not assessed,” the group writes. Also, few studies used the same synbiotic preparation for a specific clinical indication or the same amount of live bacteria and prebiotic in the preparation.

The authors made note of the newly stringent recommendations for direct evidence proposed by the International Scientific Association for Probiotics and Prebiotics, which state RCTs need to compare the synergistic synbiotic combination, the substrate alone, the live microorganisms alone, and a control.
 

Outside experts weigh in

Offering outside perspective, Gail Cresci, PhD, microbiome researcher, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s Hospital, said what’s “most notable with this review is that there is an issue with studies that incorporate a prebiotic and probiotic, in that there is much heterogeneity with the probiotic strains and prebiotic substrates that are investigated.”

Dr. Cresci also noted that “both pre- and probiotics have specific mechanisms of action based on the substrate and strain, respectively, so to pull the trials together and analyze as a ‘synbiotic’ treating all the combinations the same is not accurate [and] also limits the ability to do meta-analyses and make recommendations in a position paper.”

Geoffrey Preidis, MD, PhD, spokesperson for the American Gastroenterological Association (AGA), also reviewed the paper for this news organization.

He noted that few studies tested the exact same synbiotic preparation for a given clinical indication.

“For the majority of GI disorders examined in this review, the total number of studies testing a particular synbiotic formulation is exactly one. Clinical recommendations rarely can be made based on the results of a single trial,” said Dr. Preidis, a pediatric gastroenterologist with Texas Children’s Hospital, Houston.

“Perhaps most importantly, most studies do not report safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” he noted.

“Millions of Americans take probiotics. They are the third most commonly used dietary supplement behind vitamins and minerals,” Dr. Preidis added. “Prebiotics and synbiotics also are increasing in popularity. They can be found almost everywhere – in supermarkets, drugstores, health food stores, and online – in pill or powder form and in some foods and beverages.

None of these products have been approved by the [U.S. Food and Drug Administration] to treat, cure, or prevent any disease. In most circumstances, there is not enough clinical evidence to suggest a clear value to be gained for most consumers,” he said.

Dr. Preidis said he agrees with the conclusions of this “thoughtfully written position paper” on whether synbiotics have a role in the management of GI disorders in children.

“Synbiotics should not be given routinely to infants or children to manage GI disorders at this time,” he said in an interview. “Potential beneficial effects are not yet confirmed in multiple well-designed, adequately powered trials that test the same synbiotic combination and dose, measure the same outcomes, and rigorously document all adverse effects.”

This research had no specific funding. Dr. Hojsak received payment/honorarium for lectures from BioGaia, Nutricia, Biocodex, AbelaPharm, Nestle, Abbott, Sandoz, Oktal Pharma, and Takeda. Dr. Cresci and Dr. Preidis report no relevant disclosures.

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

The Food and Drug Administration has sent warning letters to three companies, including Amazon, for selling mole and skin tag removal products that have not been approved by the agency, according to a press release issued on Aug. 9.

In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.

The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.

The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.

Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.

Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.

The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.

The Food and Drug Administration has sent warning letters to three companies, including Amazon, for selling mole and skin tag removal products that have not been approved by the agency, according to a press release issued on Aug. 9.

In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.

The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.

The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.

Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.

Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.

The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.

The Food and Drug Administration has sent warning letters to three companies, including Amazon, for selling mole and skin tag removal products that have not been approved by the agency, according to a press release issued on Aug. 9.

In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.

The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.

The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.

Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.

Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.

The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.

Patients with rheumatic and musculoskeletal diseases may need additional vaccines or different versions of vaccines they were not previously recommended to receive, according to updated guidelines from the American College of Rheumatology (ACR) on vaccinations for these patients. The new guidelines pertain to routine vaccinations for adults and children and are based on the most current evidence. They include recommendations on whether to hold certain medications before or after vaccination. They do not include recommendations regarding COVID-19 vaccines.

For guidance on COVID-19 vaccine timing and frequency, the ACR directs physicians to the CDC’s recommendations for people with mild or severe immunosuppression and the ACR’s previous clinical guidance summary on the topic, last revised in February 2022. The recommendations in the new guidance differ from ACR’s guidance on COVID-19 vaccines on whether and when to hold immunosuppressive medications when patients receive nonlive vaccines. The new guidelines now align more closely with those of EULAR, the Infectious Diseases Society of America, and the CDC’s recommendations for human papillomavirus (HPV), pneumococcal, and shingles vaccines.

MarianVejcik/Getty Images

Vaccinations in this population are particularly important because “a leading cause of morbidity and mortality in those with rheumatic diseases is infections, due to the detrimental impact immunosuppression has on the ability for the patient to properly clear the pathogen,” Alfred Kim, MD, PhD, professor of rheumatology at Washington University, St. Louis, told this news organization. While immunosuppressive medications are the most common reason patients with these conditions may have impaired immune function, “some of our patients with autoimmune disease also have a preexisting immunodeficiency that can inherently blunt immune responses to either infection or vaccination,” Dr. Kim explained.

“The authors of the guidelines have done a really nice job of making distinct recommendations based on the mechanism of action of various immunosuppressive medications,” Dr. Kim said. “This helps simplify the process of deciding the timing of vaccination for the health provider, especially for those on multiple immunosuppressives who represent an important proportion of our patients with rheumatic diseases.”

The main change to the guidelines for children, aside from those related to flu vaccination, is in regard to rotavirus vaccination for infants exposed to tumor necrosis factor (TNF) inhibitors or rituximab in utero. Infants prenatally exposed to rituximab should not receive the rotavirus vaccine until they are older than 6 months. Those exposed prenatally to TNF inhibitors should receive the rotavirus vaccine on time, according to the CDC schedule for all infants.

The new rotavirus recommendations follow data showing that immune responses to rotavirus are blunted in those with infliximab exposure, according to Dr. Kim.

“Thus, this poses a serious theoretical risk in newborns with mothers on [a TNF inhibitor] of ineffective clearance of rotavirus infections,” Dr. Kim said in an interview. “While rotavirus infections are quite common with typically self-limiting disease, sometimes requiring hydration to counteract diarrhea-induced dehydration, this can become severe in these newborns that have [a TNF inhibitor] in their system.”

For adults, the ACR issued the following expanded indications for four vaccines for patients currently taking immunosuppressive medication:

• Patients aged 18 and older should receive the recombinant zoster vaccine against shingles.
• For patients aged 27-44 who weren’t previously vaccinated against HPV, the HPV vaccine is “conditionally recommended.”
• Patients younger than 65 should receive the pneumococcal vaccine.
• Patients aged 19-64 are conditionally recommended to receive the high-dose or adjuvanted flu vaccine rather than the regular-dose flu vaccine.

The guidelines also conditionally recommend that all patients aged 65 and older who have rheumatic or musculoskeletal diseases receive the high-dose or adjuvanted flu vaccine, regardless of whether they are taking immunosuppressive medication. Another new conditional recommendation is to give multiple vaccinations to patients on the same day, rather than give individual vaccines on different days.

The guidelines make conditional recommendations regarding flu and nonlive attenuated vaccines for those taking methotrexate, rituximab, or glucocorticoids. Methotrexate should be held for 2 weeks after flu vaccination as long as disease activity allows it, but patients who are taking methotrexate should continue taking it for any other nonlive attenuated vaccinations.

“Non-rheumatology providers, such as general pediatricians and internists, are encouraged to give the influenza vaccination and then consult with the patient’s rheumatology provider about holding methotrexate to avoid a missed vaccination opportunity,” the guidelines state.

Patients taking rituximab should receive the flu vaccine on schedule and continue taking rituximab. However, for these patients, the guidelines recommend to “delay any subsequent rituximab dosing for at least two weeks after influenza vaccination if disease activity allows.”

“Because of the relatively short time period between the rollout of the influenza vaccine and its season, we can’t always wait to time the B-cell depletion dosage,” Dr. Kim said. “Also, it is not always easy to synchronize the patient’s B-cell depletion dosing schedule to the influenza vaccine rollout. Thus, we now just recommend getting the influenza vaccine regardless of the patient’s last B-cell depletion dosage despite its known strong attenuation of optimal immune responses.”

For other nonlive attenuated vaccines, providers should time vaccination for when the next rituximab dose is due and then hold the drug for at least 2 weeks thereafter, providing time for the B cells to mount a response before rituximab depletes B cells again.

Patients taking less than 20 mg of prednisone daily should still receive the flu vaccine and other nonlive attenuated vaccines. Those taking 20 mg or more of prednisone each day should still receive the flu vaccine, but other vaccines should be deferred until their dose of glucocorticoids has been tapered down to less than 20 mg daily.

Patients taking all other immunosuppressive medications should continue taking them for the flu vaccine and other nonlive attenuated vaccinations, but it is conditionally recommended that live attenuated vaccines be deferred. For any patient with a rheumatic and musculoskeletal disease, regardless of disease activity, it is conditionally recommended that all routine nonlive attenuated vaccines be administered.

For live attenuated virus vaccines, the ACR provides a chart on which immunosuppressive medications to hold and for how long. Glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, calcineurin inhibitors, and oral cyclophosphamide should all be held 4 weeks before and 4 weeks after administration of a live attenuated vaccine. For those taking JAK inhibitors, the medication should be halted 1 week before administration of a live vaccine and should continue to be withheld for 4 weeks after.

For most other biologics, the ACR recommends holding the medication for one dosing interval before the live vaccine and 4 weeks thereafter. The main exception is rituximab, which should be held for 6 months before a live vaccine and then for 4 more weeks thereafter.

For patients receiving intravenous immunoglobulin, the drug should be held for 8-11 months before they are administered a live attenuated vaccine, depending on the dosage, and then 4 weeks after vaccination, regardless of dosage.

To reassure people with rheumatic disease who may have anxiety or concerns about receiving immunizations, whether taking immunosuppressive medication or not, Dr. Kim said it’s important to provide lots of education to patients.

“Fear and emotion have replaced facts, and data as a leading factor in decision-making, as seen with COVID-19,” Dr. Kim said. “The reality is that a small minority of people will have any issues with most vaccines, which include disease flares, adverse events, or acquisition of an autoimmune disease. We are not saying there is zero risk, rather, that the risk is quite small. This is where shared decision-making between the health care provider and the patient must be done effectively to enable the patient to properly weigh risk versus benefit.”

Dr. Kim has relationships with GlaxoSmithKline, Aurinia Pharmaceuticals, Kypha, Pfizer, Alexion Pharmaceuticals, AstraZeneca, Exagen Diagnostics, and Foghorn Therapeutics.

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

Patients with rheumatic and musculoskeletal diseases may need additional vaccines or different versions of vaccines they were not previously recommended to receive, according to updated guidelines from the American College of Rheumatology (ACR) on vaccinations for these patients. The new guidelines pertain to routine vaccinations for adults and children and are based on the most current evidence. They include recommendations on whether to hold certain medications before or after vaccination. They do not include recommendations regarding COVID-19 vaccines.

For guidance on COVID-19 vaccine timing and frequency, the ACR directs physicians to the CDC’s recommendations for people with mild or severe immunosuppression and the ACR’s previous clinical guidance summary on the topic, last revised in February 2022. The recommendations in the new guidance differ from ACR’s guidance on COVID-19 vaccines on whether and when to hold immunosuppressive medications when patients receive nonlive vaccines. The new guidelines now align more closely with those of EULAR, the Infectious Diseases Society of America, and the CDC’s recommendations for human papillomavirus (HPV), pneumococcal, and shingles vaccines.

MarianVejcik/Getty Images

Vaccinations in this population are particularly important because “a leading cause of morbidity and mortality in those with rheumatic diseases is infections, due to the detrimental impact immunosuppression has on the ability for the patient to properly clear the pathogen,” Alfred Kim, MD, PhD, professor of rheumatology at Washington University, St. Louis, told this news organization. While immunosuppressive medications are the most common reason patients with these conditions may have impaired immune function, “some of our patients with autoimmune disease also have a preexisting immunodeficiency that can inherently blunt immune responses to either infection or vaccination,” Dr. Kim explained.

“The authors of the guidelines have done a really nice job of making distinct recommendations based on the mechanism of action of various immunosuppressive medications,” Dr. Kim said. “This helps simplify the process of deciding the timing of vaccination for the health provider, especially for those on multiple immunosuppressives who represent an important proportion of our patients with rheumatic diseases.”

The main change to the guidelines for children, aside from those related to flu vaccination, is in regard to rotavirus vaccination for infants exposed to tumor necrosis factor (TNF) inhibitors or rituximab in utero. Infants prenatally exposed to rituximab should not receive the rotavirus vaccine until they are older than 6 months. Those exposed prenatally to TNF inhibitors should receive the rotavirus vaccine on time, according to the CDC schedule for all infants.

The new rotavirus recommendations follow data showing that immune responses to rotavirus are blunted in those with infliximab exposure, according to Dr. Kim.

“Thus, this poses a serious theoretical risk in newborns with mothers on [a TNF inhibitor] of ineffective clearance of rotavirus infections,” Dr. Kim said in an interview. “While rotavirus infections are quite common with typically self-limiting disease, sometimes requiring hydration to counteract diarrhea-induced dehydration, this can become severe in these newborns that have [a TNF inhibitor] in their system.”

For adults, the ACR issued the following expanded indications for four vaccines for patients currently taking immunosuppressive medication:

• Patients aged 18 and older should receive the recombinant zoster vaccine against shingles.
• For patients aged 27-44 who weren’t previously vaccinated against HPV, the HPV vaccine is “conditionally recommended.”
• Patients younger than 65 should receive the pneumococcal vaccine.
• Patients aged 19-64 are conditionally recommended to receive the high-dose or adjuvanted flu vaccine rather than the regular-dose flu vaccine.

The guidelines also conditionally recommend that all patients aged 65 and older who have rheumatic or musculoskeletal diseases receive the high-dose or adjuvanted flu vaccine, regardless of whether they are taking immunosuppressive medication. Another new conditional recommendation is to give multiple vaccinations to patients on the same day, rather than give individual vaccines on different days.

The guidelines make conditional recommendations regarding flu and nonlive attenuated vaccines for those taking methotrexate, rituximab, or glucocorticoids. Methotrexate should be held for 2 weeks after flu vaccination as long as disease activity allows it, but patients who are taking methotrexate should continue taking it for any other nonlive attenuated vaccinations.

“Non-rheumatology providers, such as general pediatricians and internists, are encouraged to give the influenza vaccination and then consult with the patient’s rheumatology provider about holding methotrexate to avoid a missed vaccination opportunity,” the guidelines state.

Patients taking rituximab should receive the flu vaccine on schedule and continue taking rituximab. However, for these patients, the guidelines recommend to “delay any subsequent rituximab dosing for at least two weeks after influenza vaccination if disease activity allows.”

“Because of the relatively short time period between the rollout of the influenza vaccine and its season, we can’t always wait to time the B-cell depletion dosage,” Dr. Kim said. “Also, it is not always easy to synchronize the patient’s B-cell depletion dosing schedule to the influenza vaccine rollout. Thus, we now just recommend getting the influenza vaccine regardless of the patient’s last B-cell depletion dosage despite its known strong attenuation of optimal immune responses.”

For other nonlive attenuated vaccines, providers should time vaccination for when the next rituximab dose is due and then hold the drug for at least 2 weeks thereafter, providing time for the B cells to mount a response before rituximab depletes B cells again.

Patients taking less than 20 mg of prednisone daily should still receive the flu vaccine and other nonlive attenuated vaccines. Those taking 20 mg or more of prednisone each day should still receive the flu vaccine, but other vaccines should be deferred until their dose of glucocorticoids has been tapered down to less than 20 mg daily.

Patients taking all other immunosuppressive medications should continue taking them for the flu vaccine and other nonlive attenuated vaccinations, but it is conditionally recommended that live attenuated vaccines be deferred. For any patient with a rheumatic and musculoskeletal disease, regardless of disease activity, it is conditionally recommended that all routine nonlive attenuated vaccines be administered.

For live attenuated virus vaccines, the ACR provides a chart on which immunosuppressive medications to hold and for how long. Glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, calcineurin inhibitors, and oral cyclophosphamide should all be held 4 weeks before and 4 weeks after administration of a live attenuated vaccine. For those taking JAK inhibitors, the medication should be halted 1 week before administration of a live vaccine and should continue to be withheld for 4 weeks after.

For most other biologics, the ACR recommends holding the medication for one dosing interval before the live vaccine and 4 weeks thereafter. The main exception is rituximab, which should be held for 6 months before a live vaccine and then for 4 more weeks thereafter.

For patients receiving intravenous immunoglobulin, the drug should be held for 8-11 months before they are administered a live attenuated vaccine, depending on the dosage, and then 4 weeks after vaccination, regardless of dosage.

To reassure people with rheumatic disease who may have anxiety or concerns about receiving immunizations, whether taking immunosuppressive medication or not, Dr. Kim said it’s important to provide lots of education to patients.

“Fear and emotion have replaced facts, and data as a leading factor in decision-making, as seen with COVID-19,” Dr. Kim said. “The reality is that a small minority of people will have any issues with most vaccines, which include disease flares, adverse events, or acquisition of an autoimmune disease. We are not saying there is zero risk, rather, that the risk is quite small. This is where shared decision-making between the health care provider and the patient must be done effectively to enable the patient to properly weigh risk versus benefit.”

Dr. Kim has relationships with GlaxoSmithKline, Aurinia Pharmaceuticals, Kypha, Pfizer, Alexion Pharmaceuticals, AstraZeneca, Exagen Diagnostics, and Foghorn Therapeutics.

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

Patients with rheumatic and musculoskeletal diseases may need additional vaccines or different versions of vaccines they were not previously recommended to receive, according to updated guidelines from the American College of Rheumatology (ACR) on vaccinations for these patients. The new guidelines pertain to routine vaccinations for adults and children and are based on the most current evidence. They include recommendations on whether to hold certain medications before or after vaccination. They do not include recommendations regarding COVID-19 vaccines.

For guidance on COVID-19 vaccine timing and frequency, the ACR directs physicians to the CDC’s recommendations for people with mild or severe immunosuppression and the ACR’s previous clinical guidance summary on the topic, last revised in February 2022. The recommendations in the new guidance differ from ACR’s guidance on COVID-19 vaccines on whether and when to hold immunosuppressive medications when patients receive nonlive vaccines. The new guidelines now align more closely with those of EULAR, the Infectious Diseases Society of America, and the CDC’s recommendations for human papillomavirus (HPV), pneumococcal, and shingles vaccines.

MarianVejcik/Getty Images

Vaccinations in this population are particularly important because “a leading cause of morbidity and mortality in those with rheumatic diseases is infections, due to the detrimental impact immunosuppression has on the ability for the patient to properly clear the pathogen,” Alfred Kim, MD, PhD, professor of rheumatology at Washington University, St. Louis, told this news organization. While immunosuppressive medications are the most common reason patients with these conditions may have impaired immune function, “some of our patients with autoimmune disease also have a preexisting immunodeficiency that can inherently blunt immune responses to either infection or vaccination,” Dr. Kim explained.

“The authors of the guidelines have done a really nice job of making distinct recommendations based on the mechanism of action of various immunosuppressive medications,” Dr. Kim said. “This helps simplify the process of deciding the timing of vaccination for the health provider, especially for those on multiple immunosuppressives who represent an important proportion of our patients with rheumatic diseases.”

The main change to the guidelines for children, aside from those related to flu vaccination, is in regard to rotavirus vaccination for infants exposed to tumor necrosis factor (TNF) inhibitors or rituximab in utero. Infants prenatally exposed to rituximab should not receive the rotavirus vaccine until they are older than 6 months. Those exposed prenatally to TNF inhibitors should receive the rotavirus vaccine on time, according to the CDC schedule for all infants.

The new rotavirus recommendations follow data showing that immune responses to rotavirus are blunted in those with infliximab exposure, according to Dr. Kim.

“Thus, this poses a serious theoretical risk in newborns with mothers on [a TNF inhibitor] of ineffective clearance of rotavirus infections,” Dr. Kim said in an interview. “While rotavirus infections are quite common with typically self-limiting disease, sometimes requiring hydration to counteract diarrhea-induced dehydration, this can become severe in these newborns that have [a TNF inhibitor] in their system.”

For adults, the ACR issued the following expanded indications for four vaccines for patients currently taking immunosuppressive medication:

• Patients aged 18 and older should receive the recombinant zoster vaccine against shingles.
• For patients aged 27-44 who weren’t previously vaccinated against HPV, the HPV vaccine is “conditionally recommended.”
• Patients younger than 65 should receive the pneumococcal vaccine.
• Patients aged 19-64 are conditionally recommended to receive the high-dose or adjuvanted flu vaccine rather than the regular-dose flu vaccine.

The guidelines also conditionally recommend that all patients aged 65 and older who have rheumatic or musculoskeletal diseases receive the high-dose or adjuvanted flu vaccine, regardless of whether they are taking immunosuppressive medication. Another new conditional recommendation is to give multiple vaccinations to patients on the same day, rather than give individual vaccines on different days.

The guidelines make conditional recommendations regarding flu and nonlive attenuated vaccines for those taking methotrexate, rituximab, or glucocorticoids. Methotrexate should be held for 2 weeks after flu vaccination as long as disease activity allows it, but patients who are taking methotrexate should continue taking it for any other nonlive attenuated vaccinations.

“Non-rheumatology providers, such as general pediatricians and internists, are encouraged to give the influenza vaccination and then consult with the patient’s rheumatology provider about holding methotrexate to avoid a missed vaccination opportunity,” the guidelines state.

Patients taking rituximab should receive the flu vaccine on schedule and continue taking rituximab. However, for these patients, the guidelines recommend to “delay any subsequent rituximab dosing for at least two weeks after influenza vaccination if disease activity allows.”

“Because of the relatively short time period between the rollout of the influenza vaccine and its season, we can’t always wait to time the B-cell depletion dosage,” Dr. Kim said. “Also, it is not always easy to synchronize the patient’s B-cell depletion dosing schedule to the influenza vaccine rollout. Thus, we now just recommend getting the influenza vaccine regardless of the patient’s last B-cell depletion dosage despite its known strong attenuation of optimal immune responses.”

For other nonlive attenuated vaccines, providers should time vaccination for when the next rituximab dose is due and then hold the drug for at least 2 weeks thereafter, providing time for the B cells to mount a response before rituximab depletes B cells again.

Patients taking less than 20 mg of prednisone daily should still receive the flu vaccine and other nonlive attenuated vaccines. Those taking 20 mg or more of prednisone each day should still receive the flu vaccine, but other vaccines should be deferred until their dose of glucocorticoids has been tapered down to less than 20 mg daily.

Patients taking all other immunosuppressive medications should continue taking them for the flu vaccine and other nonlive attenuated vaccinations, but it is conditionally recommended that live attenuated vaccines be deferred. For any patient with a rheumatic and musculoskeletal disease, regardless of disease activity, it is conditionally recommended that all routine nonlive attenuated vaccines be administered.

For live attenuated virus vaccines, the ACR provides a chart on which immunosuppressive medications to hold and for how long. Glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, calcineurin inhibitors, and oral cyclophosphamide should all be held 4 weeks before and 4 weeks after administration of a live attenuated vaccine. For those taking JAK inhibitors, the medication should be halted 1 week before administration of a live vaccine and should continue to be withheld for 4 weeks after.

For most other biologics, the ACR recommends holding the medication for one dosing interval before the live vaccine and 4 weeks thereafter. The main exception is rituximab, which should be held for 6 months before a live vaccine and then for 4 more weeks thereafter.

For patients receiving intravenous immunoglobulin, the drug should be held for 8-11 months before they are administered a live attenuated vaccine, depending on the dosage, and then 4 weeks after vaccination, regardless of dosage.

To reassure people with rheumatic disease who may have anxiety or concerns about receiving immunizations, whether taking immunosuppressive medication or not, Dr. Kim said it’s important to provide lots of education to patients.

“Fear and emotion have replaced facts, and data as a leading factor in decision-making, as seen with COVID-19,” Dr. Kim said. “The reality is that a small minority of people will have any issues with most vaccines, which include disease flares, adverse events, or acquisition of an autoimmune disease. We are not saying there is zero risk, rather, that the risk is quite small. This is where shared decision-making between the health care provider and the patient must be done effectively to enable the patient to properly weigh risk versus benefit.”

Dr. Kim has relationships with GlaxoSmithKline, Aurinia Pharmaceuticals, Kypha, Pfizer, Alexion Pharmaceuticals, AstraZeneca, Exagen Diagnostics, and Foghorn Therapeutics.

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

Healthy children who are underweight in the first 2 years of life continue with a lower-than-average body mass index and height-for-age through age 10, according to new research.

The association was most pronounced for girls, as well as for children with lower growth rates, write the authors of the prospective Canadian cohort study published in JAMA Network Open.

The findings “highlight the importance of preventing underweight in early life,” because this can have “lasting effects” in later childhood, senior author Jonathon L. Maguire, MD, from St Michael’s Hospital Pediatric Clinic, and the University of Toronto said in an interview.
 

Methods and results

The study recruited 5,803 healthy children, mean age 4.07 months, between February 2008 and September 2020 during well-child visits at clinics in The Applied Research Group for Kids! (TARGet Kids!) practice-based research network in Canada. The study’s exclusion criteria included a premature birth, or a health condition affecting growth.

The primary outcome of the study was the child’s age- and sex-adjusted weight, also known as the body mass index z score (zBMI), between the ages of 2 and 10 years.

At baseline, a total of 550 children (9.5%) were classified as underweight, based on the World Health Organization definition of zBMI less than –2. Underweight children were more likely to be younger, have lower birth weight, and to report Asian maternal ethnicity, the researchers observed.

The study found that, compared with children with normal weight, those who were underweight in the first 2 years had lower zBMI at ages 5 and 10 years (–0.49 and –0.39 respectively). This meant that at 10 years old, they were a mean of 1.23 kg lighter than 10-year-olds who had been normal weight at age 2 years.

Height-for-age z score (HAZ) was also lower for underweight 2-year-olds (–0.24), making them a mean of 0.68 cm shorter than normal-weight 2-year-olds. This difference was attenuated at age 5 years.

Growth rate modified the association of underweight with both zBMI and HAZ. Among children who were underweight in the first 2 years, those with lower growth rate had lower zBMI at 10 years (–0.64) compared with those with average (–0.38) or high growth rate (0.11). Similarly, children who were underweight and had a lower growth rate at age 2 years also a lower HAZ at age 10 years (–0.12), compared with those with average (0.02) or high growth rates (0.16). These effects were more pronounced in girls.
 

Increased health risks linked with chronic underweight

This study did not assess the reasons for early underweight, Dr. Maguire commented in an interview. But, he cited challenges with dietary transitions as a possible explanation.

“Considerable dietary changes happen around 2 years of age with increasing diversity of foods as children transition from primarily liquid foods to primarily solid foods,” he noted.

Asked for comment on the study, Colleen Spees, PhD, associate professor in the division of medical dietetics and director of Hope lab at the Ohio State University, Columbus, said that “at age 10, it’s not surprising to see a lower zBMI and height-for-age in those that were underweight at age 2 with poor growth trajectories.”

Although, this is the first study she is aware of to document these findings in a Canadian cohort, “the results align with what we know about low birth weight and underweight infants and children in terms of linear growth trajectories from child stunting studies,” Dr. Spees said.

She said child stunting, which is more common in less developed countries where children have lower birth weights and greater socioeconomic and environmental risk factors, is defined by the WHO as impaired linear growth with adverse functional consequences.

“In short, a chronic underweight status in infants and young children can lead to greater risk of malnutrition, vitamin and mineral deficiencies, decreased immune function, as well as physical growth and development issues,” she said. “Hence, the most recent 2020-2025 Dietary Guidelines for Americans now includes both pregnancy, breastfeeding, and the first 2 years of life (referred to as the “first 1,000 days”) in their recommendations.”

She added that, if caregivers are concerned about their child’s weight, they should consult with their pediatrician to rule out any medical issues. If no medical issues are identified, they should ask for a referral to a pediatric dietitian.

The study was funded by the Canadian Institute of Health Research. Dr Maguire reported receiving grants from the CIHR, Physician Services, Ontario SPOR Support Unit, and Dairy Farmers of Canada during the conduct of the study and nonfinancial support from DDrops outside the submitted work. Other authors of the paper reported receiving grants from various institutions. Dr. Spees reported no relevant disclosures.

Healthy children who are underweight in the first 2 years of life continue with a lower-than-average body mass index and height-for-age through age 10, according to new research.

The association was most pronounced for girls, as well as for children with lower growth rates, write the authors of the prospective Canadian cohort study published in JAMA Network Open.

The findings “highlight the importance of preventing underweight in early life,” because this can have “lasting effects” in later childhood, senior author Jonathon L. Maguire, MD, from St Michael’s Hospital Pediatric Clinic, and the University of Toronto said in an interview.
 

Methods and results

The study recruited 5,803 healthy children, mean age 4.07 months, between February 2008 and September 2020 during well-child visits at clinics in The Applied Research Group for Kids! (TARGet Kids!) practice-based research network in Canada. The study’s exclusion criteria included a premature birth, or a health condition affecting growth.

The primary outcome of the study was the child’s age- and sex-adjusted weight, also known as the body mass index z score (zBMI), between the ages of 2 and 10 years.

At baseline, a total of 550 children (9.5%) were classified as underweight, based on the World Health Organization definition of zBMI less than –2. Underweight children were more likely to be younger, have lower birth weight, and to report Asian maternal ethnicity, the researchers observed.

The study found that, compared with children with normal weight, those who were underweight in the first 2 years had lower zBMI at ages 5 and 10 years (–0.49 and –0.39 respectively). This meant that at 10 years old, they were a mean of 1.23 kg lighter than 10-year-olds who had been normal weight at age 2 years.

Height-for-age z score (HAZ) was also lower for underweight 2-year-olds (–0.24), making them a mean of 0.68 cm shorter than normal-weight 2-year-olds. This difference was attenuated at age 5 years.

Growth rate modified the association of underweight with both zBMI and HAZ. Among children who were underweight in the first 2 years, those with lower growth rate had lower zBMI at 10 years (–0.64) compared with those with average (–0.38) or high growth rate (0.11). Similarly, children who were underweight and had a lower growth rate at age 2 years also a lower HAZ at age 10 years (–0.12), compared with those with average (0.02) or high growth rates (0.16). These effects were more pronounced in girls.
 

Increased health risks linked with chronic underweight

This study did not assess the reasons for early underweight, Dr. Maguire commented in an interview. But, he cited challenges with dietary transitions as a possible explanation.

“Considerable dietary changes happen around 2 years of age with increasing diversity of foods as children transition from primarily liquid foods to primarily solid foods,” he noted.

Asked for comment on the study, Colleen Spees, PhD, associate professor in the division of medical dietetics and director of Hope lab at the Ohio State University, Columbus, said that “at age 10, it’s not surprising to see a lower zBMI and height-for-age in those that were underweight at age 2 with poor growth trajectories.”

Although, this is the first study she is aware of to document these findings in a Canadian cohort, “the results align with what we know about low birth weight and underweight infants and children in terms of linear growth trajectories from child stunting studies,” Dr. Spees said.

She said child stunting, which is more common in less developed countries where children have lower birth weights and greater socioeconomic and environmental risk factors, is defined by the WHO as impaired linear growth with adverse functional consequences.

“In short, a chronic underweight status in infants and young children can lead to greater risk of malnutrition, vitamin and mineral deficiencies, decreased immune function, as well as physical growth and development issues,” she said. “Hence, the most recent 2020-2025 Dietary Guidelines for Americans now includes both pregnancy, breastfeeding, and the first 2 years of life (referred to as the “first 1,000 days”) in their recommendations.”

She added that, if caregivers are concerned about their child’s weight, they should consult with their pediatrician to rule out any medical issues. If no medical issues are identified, they should ask for a referral to a pediatric dietitian.

The study was funded by the Canadian Institute of Health Research. Dr Maguire reported receiving grants from the CIHR, Physician Services, Ontario SPOR Support Unit, and Dairy Farmers of Canada during the conduct of the study and nonfinancial support from DDrops outside the submitted work. Other authors of the paper reported receiving grants from various institutions. Dr. Spees reported no relevant disclosures.

Healthy children who are underweight in the first 2 years of life continue with a lower-than-average body mass index and height-for-age through age 10, according to new research.

The association was most pronounced for girls, as well as for children with lower growth rates, write the authors of the prospective Canadian cohort study published in JAMA Network Open.

The findings “highlight the importance of preventing underweight in early life,” because this can have “lasting effects” in later childhood, senior author Jonathon L. Maguire, MD, from St Michael’s Hospital Pediatric Clinic, and the University of Toronto said in an interview.
 

Methods and results

The study recruited 5,803 healthy children, mean age 4.07 months, between February 2008 and September 2020 during well-child visits at clinics in The Applied Research Group for Kids! (TARGet Kids!) practice-based research network in Canada. The study’s exclusion criteria included a premature birth, or a health condition affecting growth.

The primary outcome of the study was the child’s age- and sex-adjusted weight, also known as the body mass index z score (zBMI), between the ages of 2 and 10 years.

At baseline, a total of 550 children (9.5%) were classified as underweight, based on the World Health Organization definition of zBMI less than –2. Underweight children were more likely to be younger, have lower birth weight, and to report Asian maternal ethnicity, the researchers observed.

The study found that, compared with children with normal weight, those who were underweight in the first 2 years had lower zBMI at ages 5 and 10 years (–0.49 and –0.39 respectively). This meant that at 10 years old, they were a mean of 1.23 kg lighter than 10-year-olds who had been normal weight at age 2 years.

Height-for-age z score (HAZ) was also lower for underweight 2-year-olds (–0.24), making them a mean of 0.68 cm shorter than normal-weight 2-year-olds. This difference was attenuated at age 5 years.

Growth rate modified the association of underweight with both zBMI and HAZ. Among children who were underweight in the first 2 years, those with lower growth rate had lower zBMI at 10 years (–0.64) compared with those with average (–0.38) or high growth rate (0.11). Similarly, children who were underweight and had a lower growth rate at age 2 years also a lower HAZ at age 10 years (–0.12), compared with those with average (0.02) or high growth rates (0.16). These effects were more pronounced in girls.
 

Increased health risks linked with chronic underweight

This study did not assess the reasons for early underweight, Dr. Maguire commented in an interview. But, he cited challenges with dietary transitions as a possible explanation.

“Considerable dietary changes happen around 2 years of age with increasing diversity of foods as children transition from primarily liquid foods to primarily solid foods,” he noted.

Asked for comment on the study, Colleen Spees, PhD, associate professor in the division of medical dietetics and director of Hope lab at the Ohio State University, Columbus, said that “at age 10, it’s not surprising to see a lower zBMI and height-for-age in those that were underweight at age 2 with poor growth trajectories.”

Although, this is the first study she is aware of to document these findings in a Canadian cohort, “the results align with what we know about low birth weight and underweight infants and children in terms of linear growth trajectories from child stunting studies,” Dr. Spees said.

She said child stunting, which is more common in less developed countries where children have lower birth weights and greater socioeconomic and environmental risk factors, is defined by the WHO as impaired linear growth with adverse functional consequences.

“In short, a chronic underweight status in infants and young children can lead to greater risk of malnutrition, vitamin and mineral deficiencies, decreased immune function, as well as physical growth and development issues,” she said. “Hence, the most recent 2020-2025 Dietary Guidelines for Americans now includes both pregnancy, breastfeeding, and the first 2 years of life (referred to as the “first 1,000 days”) in their recommendations.”

She added that, if caregivers are concerned about their child’s weight, they should consult with their pediatrician to rule out any medical issues. If no medical issues are identified, they should ask for a referral to a pediatric dietitian.

The study was funded by the Canadian Institute of Health Research. Dr Maguire reported receiving grants from the CIHR, Physician Services, Ontario SPOR Support Unit, and Dairy Farmers of Canada during the conduct of the study and nonfinancial support from DDrops outside the submitted work. Other authors of the paper reported receiving grants from various institutions. Dr. Spees reported no relevant disclosures.

A variety of treatments, most already commercially available, are under investigation for treating the constellation of overlapping symptoms associated with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), “long COVID,” and dysautonomia.

At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, speakers presented data for a variety of approaches to ease symptoms common across postviral conditions, such as extreme fatigue, postexertional malaise (“crash”), cognitive dysfunction (“brain fog”), orthostatic intolerance including postural orthostatic tachycardia syndrome (POTS), and chronic pain. Most of the modalities are already commercially available for other indications, although some are costly and not covered by payers for these conditions.

“Both post–acute COVID-19 syndrome and ME/CFS are forms of postinfectious viral syndromes and they have overlapping symptoms. ... In the past, patients were told ‘you have chronic fatigue syndrome but there’s nothing we can do for it.’ That certainly is not the case. There aren’t cures, but there are many management techniques to improve symptoms,” Charles W. Lapp, MD, medical director of the Hunter-Hopkins Center, Charlotte, N.C., said in an interview.

A current mainstay of treatment for ME/CFS – including that triggered by COVID-19 – is activity pacing, in which patients learn to stay within their “energy envelopes” in order to avoid postexertional malaise, a worsening of all symptoms with exertion. The use of “graded exercise” is no longer recommended, per U.K. and U.S. guidelines.

Data for the following approaches were presented at the IACFS/ME conference:
 

Pyridostigmine (mestinon, others)

Pyridostigmine, an acetylcholinesterase inhibitor, is approved for the treatment of muscle weakness resulting from myasthenia gravis and is available in generic form. It has previously been shown to produce significant improvement in both symptom burden and heart rate response in POTS.

At the IACFS/ME conference, David M. Systrom, MD, a pulmonary and critical care medicine specialist at Brigham and Women’s Hospital and director of the Massachusetts General Hospital Cardiopulmonary laboratory, both in Boston, summarized his group’s study in patients with ME/CFS using pyridostigmine as both a potential treatment for improving exercise capacity and a proof-of-concept that neurovascular dysregulation underlies exertional intolerance in the condition.

A total of 45 patients were randomized to 60 mg oral pyridostigmine or placebo after an invasive cardiopulmonary exercise test, and a second test performed 50 minutes later. Peak VO₂ increased after pyridostigmine but decreased after placebo (+13.3 mL/min vs. –40.2 mL/min, P < .05). Cardiac output and right atrial pressure were also significantly improved with pyridostigmine and worse with placebo.

“We suggest that treatable neurovascular dysregulation underlies acute exercise intolerance in ME/CFS. ... Pyridostigmine may be a useful repurposed off-label treatment [for] a subset of patients with exercise intolerance,” Dr. Systrom said.

Asked to comment, Dr. Lapp said: “We’ve used Mestinon for years because it helps with POTS and also with neurally mediated hypotension. Systrom is taking it to a new level because he’s shown that it increases preload to the heart.” However, he noted that it’s unclear whether the drug will help patients who don’t have POTS specifically. On the other hand, patients rarely experience side effects from the drug.

Since the generic tablets come only in 60-mg doses, and the starting dose is 30 mg three times a day, he advised cutting the tablets in half during titration up to 60 mg three times a day.
 

Oxaloacetate (benaGene)

David Lyons Kaufman, MD, of the Center for Complex Diseases, Mountain View, Calif., summarized data from his group’s recently published open-label, nonrandomized, “proof-of-concept” study on use of the commercially available nutritional supplement anhydrous enol-oxaloacetate for treating mental and physical fatigue in 76 patients with longstanding ME/CFS and 43 with long-COVID fatigue.

Oxaloacetate is a major step in the Krebs cycle within the mitochondria that are depleted in patients with ME/CFS. It is also an energy metabolite that has multiple effects in cells and mitochondria, Dr. Kaufman explained.

Doses ranging from 500 mg twice daily up to 1,000 mg three times a day were given for 6 weeks. Up to 33% of the patients with ME/CFS and up to 46.8% of the long-COVID group achieved clinical efficacy as measured by physical and mental fatigue scores, compared with just 5.9% of historical ME/CFS controls. All doses showed highly significant improvements.

The only adverse effects were occasional dyspepsia, which was avoided by taking the supplement with food, and insomnia, resolved by having them dose at breakfast and lunch, Dr. Kaufman said.

Following those preliminary data, there is now an ongoing 90-day, randomized, placebo-controlled clinical trial of 80 patients with ME/CFS using 2,000 mg anhydrous enol-oxaloacetate per day. Endpoints include multiple objective measures.

“We have a health care crisis with long COVID, and we’ve had this smoldering crisis with ME/CFS for decades that’s never been addressed. ME/CFS and long COVID, if not identical, are certainly overlapping. ... We have to pursue these translational medicine pilot studies as rapidly as possible,” Dr. Kaufman remarked.

Dr. Lapp told this news organization that it makes sense to use constituents of the Krebs cycle to improve mitochondrial function, but the problem with oxaloacetate is its cost. Dr. Kaufman mentioned that based on the preliminary trial, the therapeutic “sweet spot” appeared to be 1,000 mg twice daily. The manufacturer’s website lists the price for a single bottle of 30 250-mg capsules at $49, or $42 if purchased via a monthly subscription.

“It’s a benign drug, and it’s over the counter. I would give it to any patient who’s got a big wallet,” Dr. Lapp quipped, adding: “If they’ve got the money, they can order it tonight.”
 

Inspiritol

Inspiritol is an investigational “nebulized, inhaled, multimechanism medication designed to treat the major symptoms of respiratory distress with antioxidant, anti-inflammatory, and broad-spectrum antiviral and antibacterial properties. Inspiritol is composed of both endogenously produced and naturally occurring, well-tolerated biochemicals,” according to the company website.

The hypothesis, Liisa K. Selin, MD, PhD, professor of pathology at the University of Massachusetts, Worcester, said at the meeting, is that “ME/CFS and long COVID-19 result from an aberrant response to an immunological trigger like infection, which results in a permanently dysregulated immune system as a result of overactivation of CD8 T cells and subsequent exhaustion.”

Inspiritol, containing five antioxidants, acts as an immune modulator to reverse the CD8 T cell exhaustion and improve symptoms. Administration by inhaler delivers it directly to the brain from the lung. It was originally designed for use in chronic obstructive pulmonary disease and asthma and has shown efficacy for acute COVID-19, Dr. Selin said.

In a preliminary study, four patients with ME/CFS and five with long COVID have been treated with Inspiritol for 2-15 months, and all have self-reported improved symptoms. Cough has been the only reported side effect.

The company is pursuing an Investigational New Drug Application for the product with the Food and Drug Administration and has several patents pending. Dr. Lapp called Inspiritol “very interesting,” and said that reversal of CD8 “exhaustion” also would appear to be a promising approach. However, he noted, “the problem is that we don’t know what’s in it.”
 

Stellate ganglion block

Injection of local anesthetic near the stellate ganglion to block activity of the entire cervical sympathetic chain has been used for nearly a century to treat a variety of sympathetically mediated conditions, including complex regional pain syndrome (CRPS), shingles, and phantom-limb pain. More recently, it has been used in a variety of other conditions, including PTSD, Raynaud’s disease, menopausal hot flashes, and hyperhidrosis.

Insurance companies typically cover it for CRPS, neuropathic upper-extremity pain, hyperhidrosis, and Raynaud’s, said Luke Liu, MD, an anesthesiologist who is founder and chief executive officer of Alaska-based pain management company Neuroversion.

Deborah Duricka, PhD, also with Neuroversion, presented results from a now-published case series of 11 patients with long COVID who underwent stellate ganglion block by a board-certified anesthesiologist, first on one side at the level of C6, then on the contralateral side the following day.

Clinically meaningful benefits were seen in at least five of the patients in fatigue, memory problems, problems concentrating, rapid heartbeat, orthostatic intolerance, sleep problems, postexertional malaise, anxiety, and depression.

The hypothetical mechanism, she said, is that “sympathetic block prevents sympathetically driven vasoconstriction in carotid and vertebral arteries.”

Dr. Liu presented another case series of five patients with ME/CFS who underwent the procedure with ultrasound guidance, again on one side and the other side the next day. All had upper-limb autonomic issues such as Raynaud’s and/or neuropathic pain that had been refractory to more conventional treatments.

All five patients reported improvements in symptoms of ME/CFS, including energy level, cognition, pain, and postexertional malaise. One patient reported “feeling well for the first time in decades.” However, that patient relapsed after a mild viral illness 3.5 months after treatment. Some of the patients have required further treatments.

Dr. Lapp commented that, although the procedure is generally safe when performed by an experienced clinician, “Any time you do an injection like that, there’s a high risk that you could nick an artery or a vein or hit an essential nerve in the neck. That’s why it has to be done under fluoroscopy or ultrasound.”

He said he’s had a few patients undergo the procedure, mostly for CRPS, and they seem to have benefited from it. “It might increase cerebral blood flow and preload to the heart, so it might decrease ME/CFS symptoms and help with POTS as well.”

Nonetheless, Dr. Lapp said he wouldn’t consider stellate ganglion block as first-line treatment for ME/CFS or long COVID. “I think it would be for the treatment-resistant patient, when you’ve gone through all the treatments that we know and addressed all the comorbidities and they’re still not getting better.”

But, he added, it is a standard procedure. “Any pain clinic can do a stellate block.”
 

Transcutaneous auricular vagus nerve stimulation

Nicola Clague-Baker, PhD, a physiotherapist at the University of Liverpool (England), presented findings from an international survey of people with ME/CFS regarding their experience with transcutaneous auricular vagus nerve stimulation (taVNS) to manage their autonomic symptoms. The technique involves stimulation of the autonomic nervous system via the vagus nerve using electrodes applied to part of the ear. The theory is that the technique stimulates the parasympathetic nervous system and improves autonomic balance.

Two small previous trials showing benefit of vagus nerve stimulation for people with ME/CFS used more invasive and less comfortable methods of applying the stimulation rather than to the ear, Dr. Clague-Baker and colleagues noted in a poster. It has also been used successfully in treating POTS, another conference speaker noted.

A total of 131 people with ME/CFS (called simply “ME” in the United Kingdom) responded to a survey advertised on social media and websites. The majority (60%) were from the United Kingdom while the rest were from Europe, Australia, and North America. Most were female, and slightly more than half had lived with ME for 10 or more years.

The majority (72%) were still using taVNS, while 28% had stopped using it. Only 9% had used the modality for longer than a year. Respondents identified more than 30 benefits in symptoms and activities, with improvements in postexertional malaise (39%) and brain fog (37%) being the most common. One reported significant reduction in constipation.

However, respondents also mentioned more than 20 short- and long-term negatives, including headaches (15%) and long-term irritation at the site (9%). One participant reported a “big improvement in neuropathic pain, but not so much for muscles and joints.”

Overall, 80% reported that they would continue using taVNS and 67% said they would recommend it to others with ME, and 56% said that the system was mildly to very beneficial.

Dr. Lapp noted that several types of transcutaneous electrical nerve stimulation units with ear clips are sold online, and he’s seen them work well for migraine treatment. However, he cautioned that some patients have had side effects from the treatment, such as headaches and dizziness. “It’s putting an electrical current through your brain. In my mind, it’s another last-ditch measure.”

Dr. Lapp reported no financial disclosures.

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

A variety of treatments, most already commercially available, are under investigation for treating the constellation of overlapping symptoms associated with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), “long COVID,” and dysautonomia.

At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, speakers presented data for a variety of approaches to ease symptoms common across postviral conditions, such as extreme fatigue, postexertional malaise (“crash”), cognitive dysfunction (“brain fog”), orthostatic intolerance including postural orthostatic tachycardia syndrome (POTS), and chronic pain. Most of the modalities are already commercially available for other indications, although some are costly and not covered by payers for these conditions.

“Both post–acute COVID-19 syndrome and ME/CFS are forms of postinfectious viral syndromes and they have overlapping symptoms. ... In the past, patients were told ‘you have chronic fatigue syndrome but there’s nothing we can do for it.’ That certainly is not the case. There aren’t cures, but there are many management techniques to improve symptoms,” Charles W. Lapp, MD, medical director of the Hunter-Hopkins Center, Charlotte, N.C., said in an interview.

A current mainstay of treatment for ME/CFS – including that triggered by COVID-19 – is activity pacing, in which patients learn to stay within their “energy envelopes” in order to avoid postexertional malaise, a worsening of all symptoms with exertion. The use of “graded exercise” is no longer recommended, per U.K. and U.S. guidelines.

Data for the following approaches were presented at the IACFS/ME conference:
 

Pyridostigmine (mestinon, others)

Pyridostigmine, an acetylcholinesterase inhibitor, is approved for the treatment of muscle weakness resulting from myasthenia gravis and is available in generic form. It has previously been shown to produce significant improvement in both symptom burden and heart rate response in POTS.

At the IACFS/ME conference, David M. Systrom, MD, a pulmonary and critical care medicine specialist at Brigham and Women’s Hospital and director of the Massachusetts General Hospital Cardiopulmonary laboratory, both in Boston, summarized his group’s study in patients with ME/CFS using pyridostigmine as both a potential treatment for improving exercise capacity and a proof-of-concept that neurovascular dysregulation underlies exertional intolerance in the condition.

A total of 45 patients were randomized to 60 mg oral pyridostigmine or placebo after an invasive cardiopulmonary exercise test, and a second test performed 50 minutes later. Peak VO₂ increased after pyridostigmine but decreased after placebo (+13.3 mL/min vs. –40.2 mL/min, P < .05). Cardiac output and right atrial pressure were also significantly improved with pyridostigmine and worse with placebo.

“We suggest that treatable neurovascular dysregulation underlies acute exercise intolerance in ME/CFS. ... Pyridostigmine may be a useful repurposed off-label treatment [for] a subset of patients with exercise intolerance,” Dr. Systrom said.

Asked to comment, Dr. Lapp said: “We’ve used Mestinon for years because it helps with POTS and also with neurally mediated hypotension. Systrom is taking it to a new level because he’s shown that it increases preload to the heart.” However, he noted that it’s unclear whether the drug will help patients who don’t have POTS specifically. On the other hand, patients rarely experience side effects from the drug.

Since the generic tablets come only in 60-mg doses, and the starting dose is 30 mg three times a day, he advised cutting the tablets in half during titration up to 60 mg three times a day.
 

Oxaloacetate (benaGene)

David Lyons Kaufman, MD, of the Center for Complex Diseases, Mountain View, Calif., summarized data from his group’s recently published open-label, nonrandomized, “proof-of-concept” study on use of the commercially available nutritional supplement anhydrous enol-oxaloacetate for treating mental and physical fatigue in 76 patients with longstanding ME/CFS and 43 with long-COVID fatigue.

Oxaloacetate is a major step in the Krebs cycle within the mitochondria that are depleted in patients with ME/CFS. It is also an energy metabolite that has multiple effects in cells and mitochondria, Dr. Kaufman explained.

Doses ranging from 500 mg twice daily up to 1,000 mg three times a day were given for 6 weeks. Up to 33% of the patients with ME/CFS and up to 46.8% of the long-COVID group achieved clinical efficacy as measured by physical and mental fatigue scores, compared with just 5.9% of historical ME/CFS controls. All doses showed highly significant improvements.

The only adverse effects were occasional dyspepsia, which was avoided by taking the supplement with food, and insomnia, resolved by having them dose at breakfast and lunch, Dr. Kaufman said.

Following those preliminary data, there is now an ongoing 90-day, randomized, placebo-controlled clinical trial of 80 patients with ME/CFS using 2,000 mg anhydrous enol-oxaloacetate per day. Endpoints include multiple objective measures.

“We have a health care crisis with long COVID, and we’ve had this smoldering crisis with ME/CFS for decades that’s never been addressed. ME/CFS and long COVID, if not identical, are certainly overlapping. ... We have to pursue these translational medicine pilot studies as rapidly as possible,” Dr. Kaufman remarked.

Dr. Lapp told this news organization that it makes sense to use constituents of the Krebs cycle to improve mitochondrial function, but the problem with oxaloacetate is its cost. Dr. Kaufman mentioned that based on the preliminary trial, the therapeutic “sweet spot” appeared to be 1,000 mg twice daily. The manufacturer’s website lists the price for a single bottle of 30 250-mg capsules at $49, or $42 if purchased via a monthly subscription.

“It’s a benign drug, and it’s over the counter. I would give it to any patient who’s got a big wallet,” Dr. Lapp quipped, adding: “If they’ve got the money, they can order it tonight.”
 

Inspiritol

Inspiritol is an investigational “nebulized, inhaled, multimechanism medication designed to treat the major symptoms of respiratory distress with antioxidant, anti-inflammatory, and broad-spectrum antiviral and antibacterial properties. Inspiritol is composed of both endogenously produced and naturally occurring, well-tolerated biochemicals,” according to the company website.

The hypothesis, Liisa K. Selin, MD, PhD, professor of pathology at the University of Massachusetts, Worcester, said at the meeting, is that “ME/CFS and long COVID-19 result from an aberrant response to an immunological trigger like infection, which results in a permanently dysregulated immune system as a result of overactivation of CD8 T cells and subsequent exhaustion.”

Inspiritol, containing five antioxidants, acts as an immune modulator to reverse the CD8 T cell exhaustion and improve symptoms. Administration by inhaler delivers it directly to the brain from the lung. It was originally designed for use in chronic obstructive pulmonary disease and asthma and has shown efficacy for acute COVID-19, Dr. Selin said.

In a preliminary study, four patients with ME/CFS and five with long COVID have been treated with Inspiritol for 2-15 months, and all have self-reported improved symptoms. Cough has been the only reported side effect.

The company is pursuing an Investigational New Drug Application for the product with the Food and Drug Administration and has several patents pending. Dr. Lapp called Inspiritol “very interesting,” and said that reversal of CD8 “exhaustion” also would appear to be a promising approach. However, he noted, “the problem is that we don’t know what’s in it.”
 

Stellate ganglion block

Injection of local anesthetic near the stellate ganglion to block activity of the entire cervical sympathetic chain has been used for nearly a century to treat a variety of sympathetically mediated conditions, including complex regional pain syndrome (CRPS), shingles, and phantom-limb pain. More recently, it has been used in a variety of other conditions, including PTSD, Raynaud’s disease, menopausal hot flashes, and hyperhidrosis.

Insurance companies typically cover it for CRPS, neuropathic upper-extremity pain, hyperhidrosis, and Raynaud’s, said Luke Liu, MD, an anesthesiologist who is founder and chief executive officer of Alaska-based pain management company Neuroversion.

Deborah Duricka, PhD, also with Neuroversion, presented results from a now-published case series of 11 patients with long COVID who underwent stellate ganglion block by a board-certified anesthesiologist, first on one side at the level of C6, then on the contralateral side the following day.

Clinically meaningful benefits were seen in at least five of the patients in fatigue, memory problems, problems concentrating, rapid heartbeat, orthostatic intolerance, sleep problems, postexertional malaise, anxiety, and depression.

The hypothetical mechanism, she said, is that “sympathetic block prevents sympathetically driven vasoconstriction in carotid and vertebral arteries.”

Dr. Liu presented another case series of five patients with ME/CFS who underwent the procedure with ultrasound guidance, again on one side and the other side the next day. All had upper-limb autonomic issues such as Raynaud’s and/or neuropathic pain that had been refractory to more conventional treatments.

All five patients reported improvements in symptoms of ME/CFS, including energy level, cognition, pain, and postexertional malaise. One patient reported “feeling well for the first time in decades.” However, that patient relapsed after a mild viral illness 3.5 months after treatment. Some of the patients have required further treatments.

Dr. Lapp commented that, although the procedure is generally safe when performed by an experienced clinician, “Any time you do an injection like that, there’s a high risk that you could nick an artery or a vein or hit an essential nerve in the neck. That’s why it has to be done under fluoroscopy or ultrasound.”

He said he’s had a few patients undergo the procedure, mostly for CRPS, and they seem to have benefited from it. “It might increase cerebral blood flow and preload to the heart, so it might decrease ME/CFS symptoms and help with POTS as well.”

Nonetheless, Dr. Lapp said he wouldn’t consider stellate ganglion block as first-line treatment for ME/CFS or long COVID. “I think it would be for the treatment-resistant patient, when you’ve gone through all the treatments that we know and addressed all the comorbidities and they’re still not getting better.”

But, he added, it is a standard procedure. “Any pain clinic can do a stellate block.”
 

Transcutaneous auricular vagus nerve stimulation

Nicola Clague-Baker, PhD, a physiotherapist at the University of Liverpool (England), presented findings from an international survey of people with ME/CFS regarding their experience with transcutaneous auricular vagus nerve stimulation (taVNS) to manage their autonomic symptoms. The technique involves stimulation of the autonomic nervous system via the vagus nerve using electrodes applied to part of the ear. The theory is that the technique stimulates the parasympathetic nervous system and improves autonomic balance.

Two small previous trials showing benefit of vagus nerve stimulation for people with ME/CFS used more invasive and less comfortable methods of applying the stimulation rather than to the ear, Dr. Clague-Baker and colleagues noted in a poster. It has also been used successfully in treating POTS, another conference speaker noted.

A total of 131 people with ME/CFS (called simply “ME” in the United Kingdom) responded to a survey advertised on social media and websites. The majority (60%) were from the United Kingdom while the rest were from Europe, Australia, and North America. Most were female, and slightly more than half had lived with ME for 10 or more years.

The majority (72%) were still using taVNS, while 28% had stopped using it. Only 9% had used the modality for longer than a year. Respondents identified more than 30 benefits in symptoms and activities, with improvements in postexertional malaise (39%) and brain fog (37%) being the most common. One reported significant reduction in constipation.

However, respondents also mentioned more than 20 short- and long-term negatives, including headaches (15%) and long-term irritation at the site (9%). One participant reported a “big improvement in neuropathic pain, but not so much for muscles and joints.”

Overall, 80% reported that they would continue using taVNS and 67% said they would recommend it to others with ME, and 56% said that the system was mildly to very beneficial.

Dr. Lapp noted that several types of transcutaneous electrical nerve stimulation units with ear clips are sold online, and he’s seen them work well for migraine treatment. However, he cautioned that some patients have had side effects from the treatment, such as headaches and dizziness. “It’s putting an electrical current through your brain. In my mind, it’s another last-ditch measure.”

Dr. Lapp reported no financial disclosures.

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

A variety of treatments, most already commercially available, are under investigation for treating the constellation of overlapping symptoms associated with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), “long COVID,” and dysautonomia.

At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, speakers presented data for a variety of approaches to ease symptoms common across postviral conditions, such as extreme fatigue, postexertional malaise (“crash”), cognitive dysfunction (“brain fog”), orthostatic intolerance including postural orthostatic tachycardia syndrome (POTS), and chronic pain. Most of the modalities are already commercially available for other indications, although some are costly and not covered by payers for these conditions.

“Both post–acute COVID-19 syndrome and ME/CFS are forms of postinfectious viral syndromes and they have overlapping symptoms. ... In the past, patients were told ‘you have chronic fatigue syndrome but there’s nothing we can do for it.’ That certainly is not the case. There aren’t cures, but there are many management techniques to improve symptoms,” Charles W. Lapp, MD, medical director of the Hunter-Hopkins Center, Charlotte, N.C., said in an interview.

A current mainstay of treatment for ME/CFS – including that triggered by COVID-19 – is activity pacing, in which patients learn to stay within their “energy envelopes” in order to avoid postexertional malaise, a worsening of all symptoms with exertion. The use of “graded exercise” is no longer recommended, per U.K. and U.S. guidelines.

Data for the following approaches were presented at the IACFS/ME conference:
 

Pyridostigmine (mestinon, others)

Pyridostigmine, an acetylcholinesterase inhibitor, is approved for the treatment of muscle weakness resulting from myasthenia gravis and is available in generic form. It has previously been shown to produce significant improvement in both symptom burden and heart rate response in POTS.

At the IACFS/ME conference, David M. Systrom, MD, a pulmonary and critical care medicine specialist at Brigham and Women’s Hospital and director of the Massachusetts General Hospital Cardiopulmonary laboratory, both in Boston, summarized his group’s study in patients with ME/CFS using pyridostigmine as both a potential treatment for improving exercise capacity and a proof-of-concept that neurovascular dysregulation underlies exertional intolerance in the condition.

A total of 45 patients were randomized to 60 mg oral pyridostigmine or placebo after an invasive cardiopulmonary exercise test, and a second test performed 50 minutes later. Peak VO₂ increased after pyridostigmine but decreased after placebo (+13.3 mL/min vs. –40.2 mL/min, P < .05). Cardiac output and right atrial pressure were also significantly improved with pyridostigmine and worse with placebo.

“We suggest that treatable neurovascular dysregulation underlies acute exercise intolerance in ME/CFS. ... Pyridostigmine may be a useful repurposed off-label treatment [for] a subset of patients with exercise intolerance,” Dr. Systrom said.

Asked to comment, Dr. Lapp said: “We’ve used Mestinon for years because it helps with POTS and also with neurally mediated hypotension. Systrom is taking it to a new level because he’s shown that it increases preload to the heart.” However, he noted that it’s unclear whether the drug will help patients who don’t have POTS specifically. On the other hand, patients rarely experience side effects from the drug.

Since the generic tablets come only in 60-mg doses, and the starting dose is 30 mg three times a day, he advised cutting the tablets in half during titration up to 60 mg three times a day.
 

Oxaloacetate (benaGene)

David Lyons Kaufman, MD, of the Center for Complex Diseases, Mountain View, Calif., summarized data from his group’s recently published open-label, nonrandomized, “proof-of-concept” study on use of the commercially available nutritional supplement anhydrous enol-oxaloacetate for treating mental and physical fatigue in 76 patients with longstanding ME/CFS and 43 with long-COVID fatigue.

Oxaloacetate is a major step in the Krebs cycle within the mitochondria that are depleted in patients with ME/CFS. It is also an energy metabolite that has multiple effects in cells and mitochondria, Dr. Kaufman explained.

Doses ranging from 500 mg twice daily up to 1,000 mg three times a day were given for 6 weeks. Up to 33% of the patients with ME/CFS and up to 46.8% of the long-COVID group achieved clinical efficacy as measured by physical and mental fatigue scores, compared with just 5.9% of historical ME/CFS controls. All doses showed highly significant improvements.

The only adverse effects were occasional dyspepsia, which was avoided by taking the supplement with food, and insomnia, resolved by having them dose at breakfast and lunch, Dr. Kaufman said.

Following those preliminary data, there is now an ongoing 90-day, randomized, placebo-controlled clinical trial of 80 patients with ME/CFS using 2,000 mg anhydrous enol-oxaloacetate per day. Endpoints include multiple objective measures.

“We have a health care crisis with long COVID, and we’ve had this smoldering crisis with ME/CFS for decades that’s never been addressed. ME/CFS and long COVID, if not identical, are certainly overlapping. ... We have to pursue these translational medicine pilot studies as rapidly as possible,” Dr. Kaufman remarked.

Dr. Lapp told this news organization that it makes sense to use constituents of the Krebs cycle to improve mitochondrial function, but the problem with oxaloacetate is its cost. Dr. Kaufman mentioned that based on the preliminary trial, the therapeutic “sweet spot” appeared to be 1,000 mg twice daily. The manufacturer’s website lists the price for a single bottle of 30 250-mg capsules at $49, or $42 if purchased via a monthly subscription.

“It’s a benign drug, and it’s over the counter. I would give it to any patient who’s got a big wallet,” Dr. Lapp quipped, adding: “If they’ve got the money, they can order it tonight.”
 

Inspiritol

Inspiritol is an investigational “nebulized, inhaled, multimechanism medication designed to treat the major symptoms of respiratory distress with antioxidant, anti-inflammatory, and broad-spectrum antiviral and antibacterial properties. Inspiritol is composed of both endogenously produced and naturally occurring, well-tolerated biochemicals,” according to the company website.

The hypothesis, Liisa K. Selin, MD, PhD, professor of pathology at the University of Massachusetts, Worcester, said at the meeting, is that “ME/CFS and long COVID-19 result from an aberrant response to an immunological trigger like infection, which results in a permanently dysregulated immune system as a result of overactivation of CD8 T cells and subsequent exhaustion.”

Inspiritol, containing five antioxidants, acts as an immune modulator to reverse the CD8 T cell exhaustion and improve symptoms. Administration by inhaler delivers it directly to the brain from the lung. It was originally designed for use in chronic obstructive pulmonary disease and asthma and has shown efficacy for acute COVID-19, Dr. Selin said.

In a preliminary study, four patients with ME/CFS and five with long COVID have been treated with Inspiritol for 2-15 months, and all have self-reported improved symptoms. Cough has been the only reported side effect.

The company is pursuing an Investigational New Drug Application for the product with the Food and Drug Administration and has several patents pending. Dr. Lapp called Inspiritol “very interesting,” and said that reversal of CD8 “exhaustion” also would appear to be a promising approach. However, he noted, “the problem is that we don’t know what’s in it.”
 

Stellate ganglion block

Injection of local anesthetic near the stellate ganglion to block activity of the entire cervical sympathetic chain has been used for nearly a century to treat a variety of sympathetically mediated conditions, including complex regional pain syndrome (CRPS), shingles, and phantom-limb pain. More recently, it has been used in a variety of other conditions, including PTSD, Raynaud’s disease, menopausal hot flashes, and hyperhidrosis.

Insurance companies typically cover it for CRPS, neuropathic upper-extremity pain, hyperhidrosis, and Raynaud’s, said Luke Liu, MD, an anesthesiologist who is founder and chief executive officer of Alaska-based pain management company Neuroversion.

Deborah Duricka, PhD, also with Neuroversion, presented results from a now-published case series of 11 patients with long COVID who underwent stellate ganglion block by a board-certified anesthesiologist, first on one side at the level of C6, then on the contralateral side the following day.

Clinically meaningful benefits were seen in at least five of the patients in fatigue, memory problems, problems concentrating, rapid heartbeat, orthostatic intolerance, sleep problems, postexertional malaise, anxiety, and depression.

The hypothetical mechanism, she said, is that “sympathetic block prevents sympathetically driven vasoconstriction in carotid and vertebral arteries.”

Dr. Liu presented another case series of five patients with ME/CFS who underwent the procedure with ultrasound guidance, again on one side and the other side the next day. All had upper-limb autonomic issues such as Raynaud’s and/or neuropathic pain that had been refractory to more conventional treatments.

All five patients reported improvements in symptoms of ME/CFS, including energy level, cognition, pain, and postexertional malaise. One patient reported “feeling well for the first time in decades.” However, that patient relapsed after a mild viral illness 3.5 months after treatment. Some of the patients have required further treatments.

Dr. Lapp commented that, although the procedure is generally safe when performed by an experienced clinician, “Any time you do an injection like that, there’s a high risk that you could nick an artery or a vein or hit an essential nerve in the neck. That’s why it has to be done under fluoroscopy or ultrasound.”

He said he’s had a few patients undergo the procedure, mostly for CRPS, and they seem to have benefited from it. “It might increase cerebral blood flow and preload to the heart, so it might decrease ME/CFS symptoms and help with POTS as well.”

Nonetheless, Dr. Lapp said he wouldn’t consider stellate ganglion block as first-line treatment for ME/CFS or long COVID. “I think it would be for the treatment-resistant patient, when you’ve gone through all the treatments that we know and addressed all the comorbidities and they’re still not getting better.”

But, he added, it is a standard procedure. “Any pain clinic can do a stellate block.”
 

Transcutaneous auricular vagus nerve stimulation

Nicola Clague-Baker, PhD, a physiotherapist at the University of Liverpool (England), presented findings from an international survey of people with ME/CFS regarding their experience with transcutaneous auricular vagus nerve stimulation (taVNS) to manage their autonomic symptoms. The technique involves stimulation of the autonomic nervous system via the vagus nerve using electrodes applied to part of the ear. The theory is that the technique stimulates the parasympathetic nervous system and improves autonomic balance.

Two small previous trials showing benefit of vagus nerve stimulation for people with ME/CFS used more invasive and less comfortable methods of applying the stimulation rather than to the ear, Dr. Clague-Baker and colleagues noted in a poster. It has also been used successfully in treating POTS, another conference speaker noted.

A total of 131 people with ME/CFS (called simply “ME” in the United Kingdom) responded to a survey advertised on social media and websites. The majority (60%) were from the United Kingdom while the rest were from Europe, Australia, and North America. Most were female, and slightly more than half had lived with ME for 10 or more years.

The majority (72%) were still using taVNS, while 28% had stopped using it. Only 9% had used the modality for longer than a year. Respondents identified more than 30 benefits in symptoms and activities, with improvements in postexertional malaise (39%) and brain fog (37%) being the most common. One reported significant reduction in constipation.

However, respondents also mentioned more than 20 short- and long-term negatives, including headaches (15%) and long-term irritation at the site (9%). One participant reported a “big improvement in neuropathic pain, but not so much for muscles and joints.”

Overall, 80% reported that they would continue using taVNS and 67% said they would recommend it to others with ME, and 56% said that the system was mildly to very beneficial.

Dr. Lapp noted that several types of transcutaneous electrical nerve stimulation units with ear clips are sold online, and he’s seen them work well for migraine treatment. However, he cautioned that some patients have had side effects from the treatment, such as headaches and dizziness. “It’s putting an electrical current through your brain. In my mind, it’s another last-ditch measure.”

Dr. Lapp reported no financial disclosures.

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

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. 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.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. 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.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. 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.

Topical ruxolitinib appears to quickly relieve itch in Black patients with atopic dermatitis (AD), an industry-sponsored analysis of pooled data from two studies suggests.

“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.

AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.

Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.

Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.  

FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.

Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows: 

• Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
• At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
• At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
• Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.

Ruxolitinib may be an alternative to systemic immunosuppressives

Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”

Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.

“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.

Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”

The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.

“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.

All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.

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

Topical ruxolitinib appears to quickly relieve itch in Black patients with atopic dermatitis (AD), an industry-sponsored analysis of pooled data from two studies suggests.

“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.

AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.

Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.

Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.  

FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.

Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows: 

• Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
• At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
• At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
• Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.

Ruxolitinib may be an alternative to systemic immunosuppressives

Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”

Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.

“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.

Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”

The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.

“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.

All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.

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

Topical ruxolitinib appears to quickly relieve itch in Black patients with atopic dermatitis (AD), an industry-sponsored analysis of pooled data from two studies suggests.

“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.

AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.

Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.

Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.  

FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.

Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows: 

• Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
• At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
• At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
• Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.

Ruxolitinib may be an alternative to systemic immunosuppressives

Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”

Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.

“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.

Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”

The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.

“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.

All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.

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

Most vaccines don’t come as one-shot deals. A series of boosters is needed to step up immunity to COVID-19, tetanus, and other infectious threats over time.

But what if you could receive just one shot that boosts itself whenever you need a bump in protection?

Researchers at the Massachusetts Institute of Technology (MIT) have developed microparticles that could be used to create self-boosting vaccines that deliver their contents at carefully set time points. In a new study published in the journal Science Advances, the scientists describe how they tune the particles to release the goods at the right time and offer insights on how they can keep the particles stable until then.
 

How self-boosting vaccines could work

The team developed tiny particles that look like coffee cups – except instead of your favorite brew, they’re filled with vaccine.

“You can put the lid on, and then inject it into the body, and once the lid breaks, whatever is in there is released,” says study author Ana Jaklenec, PhD, a research scientist at MIT’s Koch Institute for Integrative Cancer Research.

To make the tiny cups, the researchers use various polymers already used in medical applications, such as dissolvable stitches. Then they fill the cups with vaccine material that is dried and combined with sugars and other stabilizers.

The particles can be made in various shapes and fine-tuned using polymers with different properties. Some polymers last longer in the body than others, so their choice helps determine how long everything will stay stable under the skin after the injection and when the particles will release their cargo. It could be days or months after the injection.

One challenge is that as the particles open, the environment around them becomes more acidic. The team is working on ways to curb that acidity to make the vaccine material more stable.

“We have ongoing research that has produced some really, really exciting results about their stability and [shows] that you’re able to maintain really sensitive vaccines, stable for a good period of time,” says study author Morteza Sarmadi, PhD, a research specialist at the Koch Institute.
 

The potential public health impact

This research, funded by the Bill & Melinda Gates Foundation, started with the developing world in mind.

“The intent was actually helping people in the developing world, because a lot of times, people don’t come back for a second injection,” says study author Robert Langer, ScD, the David H. Koch Institute professor at MIT.

But a one-shot plan could benefit the developed world, too. One reason is that self-boosting vaccines could help those who get one achieve higher antibody responses than they would with just one dose. That could mean more protection for the person and the population, because as people develop stronger immunity, germs may have less of a chance to evolve and spread.

Take the COVID-19 pandemic, for example. Only 67% of Americans are fully vaccinated, and most people eligible for first and second boosters haven’t gotten them. New variants, such as the recent Omicron ones, continue to emerge and infect.

“I think those variants would have had a lot less chance to come about if everybody that had gotten vaccinated the first time got repeat injections, which they didn’t,” says Dr. Langer.

Self-boosting vaccines could also benefit infants, children who fear shots, and older adults who have a hard time getting health care.

Also, because the vaccine material is encapsulated and its release can be staggered, this technology might help people receive multiple vaccines at the same time that must now be given separately.
 

What comes next

The team is testing self-boosting polio and hepatitis vaccines in non-human primates. A small trial in healthy humans might follow within the next few years.

“We think that there’s really high potential for this technology, and we hope it can be developed and get to the human phase very soon,” says Dr. Jaklenec.

In smaller animal models, they are exploring the potential of self-boosting mRNA vaccines. They’re also working with scientists who are studying HIV vaccines.

“There has been some recent progress where very complex regimens seem to be working, but they’re not practical,” says Dr. Jaklenec. “And so, this is where this particular technology could be useful, because you have to prime and boost with different things, and this allows you to do that.”

This system could also extend beyond vaccines and be used to deliver cancer therapies, hormones, and biologics in a shot.

Through new work with researchers at Georgia Tech University, the team will study the potential of giving self-boosting vaccines through 3D-printed microneedles. These vaccines, which would stick on your skin like a bandage, could be self-administered and deployed globally in response to local outbreaks.

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

Most vaccines don’t come as one-shot deals. A series of boosters is needed to step up immunity to COVID-19, tetanus, and other infectious threats over time.

But what if you could receive just one shot that boosts itself whenever you need a bump in protection?

Researchers at the Massachusetts Institute of Technology (MIT) have developed microparticles that could be used to create self-boosting vaccines that deliver their contents at carefully set time points. In a new study published in the journal Science Advances, the scientists describe how they tune the particles to release the goods at the right time and offer insights on how they can keep the particles stable until then.
 

How self-boosting vaccines could work

The team developed tiny particles that look like coffee cups – except instead of your favorite brew, they’re filled with vaccine.

“You can put the lid on, and then inject it into the body, and once the lid breaks, whatever is in there is released,” says study author Ana Jaklenec, PhD, a research scientist at MIT’s Koch Institute for Integrative Cancer Research.

To make the tiny cups, the researchers use various polymers already used in medical applications, such as dissolvable stitches. Then they fill the cups with vaccine material that is dried and combined with sugars and other stabilizers.

The particles can be made in various shapes and fine-tuned using polymers with different properties. Some polymers last longer in the body than others, so their choice helps determine how long everything will stay stable under the skin after the injection and when the particles will release their cargo. It could be days or months after the injection.

One challenge is that as the particles open, the environment around them becomes more acidic. The team is working on ways to curb that acidity to make the vaccine material more stable.

“We have ongoing research that has produced some really, really exciting results about their stability and [shows] that you’re able to maintain really sensitive vaccines, stable for a good period of time,” says study author Morteza Sarmadi, PhD, a research specialist at the Koch Institute.
 

The potential public health impact

This research, funded by the Bill & Melinda Gates Foundation, started with the developing world in mind.

“The intent was actually helping people in the developing world, because a lot of times, people don’t come back for a second injection,” says study author Robert Langer, ScD, the David H. Koch Institute professor at MIT.

But a one-shot plan could benefit the developed world, too. One reason is that self-boosting vaccines could help those who get one achieve higher antibody responses than they would with just one dose. That could mean more protection for the person and the population, because as people develop stronger immunity, germs may have less of a chance to evolve and spread.

Take the COVID-19 pandemic, for example. Only 67% of Americans are fully vaccinated, and most people eligible for first and second boosters haven’t gotten them. New variants, such as the recent Omicron ones, continue to emerge and infect.

“I think those variants would have had a lot less chance to come about if everybody that had gotten vaccinated the first time got repeat injections, which they didn’t,” says Dr. Langer.

Self-boosting vaccines could also benefit infants, children who fear shots, and older adults who have a hard time getting health care.

Also, because the vaccine material is encapsulated and its release can be staggered, this technology might help people receive multiple vaccines at the same time that must now be given separately.
 

What comes next

The team is testing self-boosting polio and hepatitis vaccines in non-human primates. A small trial in healthy humans might follow within the next few years.

“We think that there’s really high potential for this technology, and we hope it can be developed and get to the human phase very soon,” says Dr. Jaklenec.

In smaller animal models, they are exploring the potential of self-boosting mRNA vaccines. They’re also working with scientists who are studying HIV vaccines.

“There has been some recent progress where very complex regimens seem to be working, but they’re not practical,” says Dr. Jaklenec. “And so, this is where this particular technology could be useful, because you have to prime and boost with different things, and this allows you to do that.”

This system could also extend beyond vaccines and be used to deliver cancer therapies, hormones, and biologics in a shot.

Through new work with researchers at Georgia Tech University, the team will study the potential of giving self-boosting vaccines through 3D-printed microneedles. These vaccines, which would stick on your skin like a bandage, could be self-administered and deployed globally in response to local outbreaks.

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

Most vaccines don’t come as one-shot deals. A series of boosters is needed to step up immunity to COVID-19, tetanus, and other infectious threats over time.

But what if you could receive just one shot that boosts itself whenever you need a bump in protection?

Researchers at the Massachusetts Institute of Technology (MIT) have developed microparticles that could be used to create self-boosting vaccines that deliver their contents at carefully set time points. In a new study published in the journal Science Advances, the scientists describe how they tune the particles to release the goods at the right time and offer insights on how they can keep the particles stable until then.
 

How self-boosting vaccines could work

The team developed tiny particles that look like coffee cups – except instead of your favorite brew, they’re filled with vaccine.

“You can put the lid on, and then inject it into the body, and once the lid breaks, whatever is in there is released,” says study author Ana Jaklenec, PhD, a research scientist at MIT’s Koch Institute for Integrative Cancer Research.

To make the tiny cups, the researchers use various polymers already used in medical applications, such as dissolvable stitches. Then they fill the cups with vaccine material that is dried and combined with sugars and other stabilizers.

The particles can be made in various shapes and fine-tuned using polymers with different properties. Some polymers last longer in the body than others, so their choice helps determine how long everything will stay stable under the skin after the injection and when the particles will release their cargo. It could be days or months after the injection.

One challenge is that as the particles open, the environment around them becomes more acidic. The team is working on ways to curb that acidity to make the vaccine material more stable.

“We have ongoing research that has produced some really, really exciting results about their stability and [shows] that you’re able to maintain really sensitive vaccines, stable for a good period of time,” says study author Morteza Sarmadi, PhD, a research specialist at the Koch Institute.
 

The potential public health impact

This research, funded by the Bill & Melinda Gates Foundation, started with the developing world in mind.

“The intent was actually helping people in the developing world, because a lot of times, people don’t come back for a second injection,” says study author Robert Langer, ScD, the David H. Koch Institute professor at MIT.

But a one-shot plan could benefit the developed world, too. One reason is that self-boosting vaccines could help those who get one achieve higher antibody responses than they would with just one dose. That could mean more protection for the person and the population, because as people develop stronger immunity, germs may have less of a chance to evolve and spread.

Take the COVID-19 pandemic, for example. Only 67% of Americans are fully vaccinated, and most people eligible for first and second boosters haven’t gotten them. New variants, such as the recent Omicron ones, continue to emerge and infect.

“I think those variants would have had a lot less chance to come about if everybody that had gotten vaccinated the first time got repeat injections, which they didn’t,” says Dr. Langer.

Self-boosting vaccines could also benefit infants, children who fear shots, and older adults who have a hard time getting health care.

Also, because the vaccine material is encapsulated and its release can be staggered, this technology might help people receive multiple vaccines at the same time that must now be given separately.
 

What comes next

The team is testing self-boosting polio and hepatitis vaccines in non-human primates. A small trial in healthy humans might follow within the next few years.

“We think that there’s really high potential for this technology, and we hope it can be developed and get to the human phase very soon,” says Dr. Jaklenec.

In smaller animal models, they are exploring the potential of self-boosting mRNA vaccines. They’re also working with scientists who are studying HIV vaccines.

“There has been some recent progress where very complex regimens seem to be working, but they’re not practical,” says Dr. Jaklenec. “And so, this is where this particular technology could be useful, because you have to prime and boost with different things, and this allows you to do that.”

This system could also extend beyond vaccines and be used to deliver cancer therapies, hormones, and biologics in a shot.

Through new work with researchers at Georgia Tech University, the team will study the potential of giving self-boosting vaccines through 3D-printed microneedles. These vaccines, which would stick on your skin like a bandage, could be self-administered and deployed globally in response to local outbreaks.

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

Researchers from the Centers for Disease Control and Prevention report that children and teenagers with long COVID have about twice the risk of getting serious outcomes, compared to others without COVID.

Heart inflammation; a blood clot in the lung; or a blood clot in the lower leg, thigh, or pelvis were the most common bad outcomes in a new study. Even though the risk was higher for these and some other serious events, the overall numbers were small.

“Many of these conditions were rare or uncommon among children in this analysis, but even a small increase in these conditions is notable,” a CDC new release stated.

The investigators said their findings stress the importance of COVID-19 vaccination in Americans under the age of 18.

The study was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Less is known about long COVID in children

Lyudmyla Kompaniyets, PhD, and colleagues noted that most research on long COVID to date has been done in adults, so little information is available about the risks to Americans ages 17 and younger.

To learn more, they compared post–COVID-19 symptoms and conditions between 781,419 children and teenagers with confirmed COVID-19 to another 2,344,257 without COVID-19. They looked at medical claims and laboratory data for these children and teenagers from March 1, 2020, through Jan. 31, 2022, to see who got any of 15 specific outcomes linked to long COVID-19.

Long COVID was defined as a condition where symptoms that last for or begin at least 4 weeks after a COVID-19 diagnosis.

Compared to children with no history of a COVID-19 diagnosis, the long COVID-19 group was 101% more likely to have an acute pulmonary embolism, 99% more likely to have myocarditis or cardiomyopathy, 87% more likely to have a venous thromboembolic event, 32% more likely to have acute and unspecified renal failure, and 23% more likely to have type 1 diabetes.

“This report points to the fact that the risks of COVID infection itself, both in terms of the acute effects, MIS-C [multisystem inflammatory syndrome in children], as well as the long-term effects, are real, are concerning, and are potentially very serious,” said Stuart Berger, MD, chair of the American Academy of Pediatrics Section on Cardiology and Cardiac Surgery.

“The message that we should take away from this is that we should be very keen on all the methods of prevention for COVID, especially the vaccine,” said Dr. Berger, chief of cardiology in the department of pediatrics at Northwestern University in Chicago.


 

A ‘wake-up call’

The study findings are “sobering” and are “a reminder of the seriousness of COVID infection,” says Gregory Poland, MD, an infectious disease expert at the Mayo Clinic in Rochester, Minn.

“When you look in particular at the more serious complications from COVID in this young age group, those are life-altering complications that will have consequences and ramifications throughout their lives,” he said.

“I would take this as a serious wake-up call to parents [at a time when] the immunization rates in younger children are so pitifully low,” Dr. Poland said.
 

Still early days

The study is suggestive but not definitive, said Peter Katona, MD, professor of medicine and infectious diseases expert at the UCLA Fielding School of Public Health.

It’s still too early to draw conclusions about long COVID, including in children, because many questions remain, he said: Should long COVID be defined as symptoms at 1 month or 3 months after infection? How do you define brain fog?

Dr. Katona and colleagues are studying long COVID intervention among students at UCLA to answer some of these questions, including the incidence and effect of early intervention.

The study had “at least seven limitations,” the researchers noted. Among them was the use of medical claims data that noted long COVID outcomes but not how severe they were; some people in the no COVID group might have had the illness but not been diagnosed; and the researchers did not adjust for vaccination status.

Dr. Poland noted that the study was done during surges in COVID variants including Delta and Omicron. In other words, any long COVID effects linked to more recent variants such as BA.5 or BA.2.75 are unknown.

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

Researchers from the Centers for Disease Control and Prevention report that children and teenagers with long COVID have about twice the risk of getting serious outcomes, compared to others without COVID.

Heart inflammation; a blood clot in the lung; or a blood clot in the lower leg, thigh, or pelvis were the most common bad outcomes in a new study. Even though the risk was higher for these and some other serious events, the overall numbers were small.

“Many of these conditions were rare or uncommon among children in this analysis, but even a small increase in these conditions is notable,” a CDC new release stated.

The investigators said their findings stress the importance of COVID-19 vaccination in Americans under the age of 18.

The study was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Less is known about long COVID in children

Lyudmyla Kompaniyets, PhD, and colleagues noted that most research on long COVID to date has been done in adults, so little information is available about the risks to Americans ages 17 and younger.

To learn more, they compared post–COVID-19 symptoms and conditions between 781,419 children and teenagers with confirmed COVID-19 to another 2,344,257 without COVID-19. They looked at medical claims and laboratory data for these children and teenagers from March 1, 2020, through Jan. 31, 2022, to see who got any of 15 specific outcomes linked to long COVID-19.

Long COVID was defined as a condition where symptoms that last for or begin at least 4 weeks after a COVID-19 diagnosis.

Compared to children with no history of a COVID-19 diagnosis, the long COVID-19 group was 101% more likely to have an acute pulmonary embolism, 99% more likely to have myocarditis or cardiomyopathy, 87% more likely to have a venous thromboembolic event, 32% more likely to have acute and unspecified renal failure, and 23% more likely to have type 1 diabetes.

“This report points to the fact that the risks of COVID infection itself, both in terms of the acute effects, MIS-C [multisystem inflammatory syndrome in children], as well as the long-term effects, are real, are concerning, and are potentially very serious,” said Stuart Berger, MD, chair of the American Academy of Pediatrics Section on Cardiology and Cardiac Surgery.

“The message that we should take away from this is that we should be very keen on all the methods of prevention for COVID, especially the vaccine,” said Dr. Berger, chief of cardiology in the department of pediatrics at Northwestern University in Chicago.


 

A ‘wake-up call’

The study findings are “sobering” and are “a reminder of the seriousness of COVID infection,” says Gregory Poland, MD, an infectious disease expert at the Mayo Clinic in Rochester, Minn.

“When you look in particular at the more serious complications from COVID in this young age group, those are life-altering complications that will have consequences and ramifications throughout their lives,” he said.

“I would take this as a serious wake-up call to parents [at a time when] the immunization rates in younger children are so pitifully low,” Dr. Poland said.
 

Still early days

The study is suggestive but not definitive, said Peter Katona, MD, professor of medicine and infectious diseases expert at the UCLA Fielding School of Public Health.

It’s still too early to draw conclusions about long COVID, including in children, because many questions remain, he said: Should long COVID be defined as symptoms at 1 month or 3 months after infection? How do you define brain fog?

Dr. Katona and colleagues are studying long COVID intervention among students at UCLA to answer some of these questions, including the incidence and effect of early intervention.

The study had “at least seven limitations,” the researchers noted. Among them was the use of medical claims data that noted long COVID outcomes but not how severe they were; some people in the no COVID group might have had the illness but not been diagnosed; and the researchers did not adjust for vaccination status.

Dr. Poland noted that the study was done during surges in COVID variants including Delta and Omicron. In other words, any long COVID effects linked to more recent variants such as BA.5 or BA.2.75 are unknown.

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

Researchers from the Centers for Disease Control and Prevention report that children and teenagers with long COVID have about twice the risk of getting serious outcomes, compared to others without COVID.

Heart inflammation; a blood clot in the lung; or a blood clot in the lower leg, thigh, or pelvis were the most common bad outcomes in a new study. Even though the risk was higher for these and some other serious events, the overall numbers were small.

“Many of these conditions were rare or uncommon among children in this analysis, but even a small increase in these conditions is notable,” a CDC new release stated.

The investigators said their findings stress the importance of COVID-19 vaccination in Americans under the age of 18.

The study was published online in the CDC’s Morbidity and Mortality Weekly Report.
 

Less is known about long COVID in children

Lyudmyla Kompaniyets, PhD, and colleagues noted that most research on long COVID to date has been done in adults, so little information is available about the risks to Americans ages 17 and younger.

To learn more, they compared post–COVID-19 symptoms and conditions between 781,419 children and teenagers with confirmed COVID-19 to another 2,344,257 without COVID-19. They looked at medical claims and laboratory data for these children and teenagers from March 1, 2020, through Jan. 31, 2022, to see who got any of 15 specific outcomes linked to long COVID-19.

Long COVID was defined as a condition where symptoms that last for or begin at least 4 weeks after a COVID-19 diagnosis.

Compared to children with no history of a COVID-19 diagnosis, the long COVID-19 group was 101% more likely to have an acute pulmonary embolism, 99% more likely to have myocarditis or cardiomyopathy, 87% more likely to have a venous thromboembolic event, 32% more likely to have acute and unspecified renal failure, and 23% more likely to have type 1 diabetes.

“This report points to the fact that the risks of COVID infection itself, both in terms of the acute effects, MIS-C [multisystem inflammatory syndrome in children], as well as the long-term effects, are real, are concerning, and are potentially very serious,” said Stuart Berger, MD, chair of the American Academy of Pediatrics Section on Cardiology and Cardiac Surgery.

“The message that we should take away from this is that we should be very keen on all the methods of prevention for COVID, especially the vaccine,” said Dr. Berger, chief of cardiology in the department of pediatrics at Northwestern University in Chicago.


 

A ‘wake-up call’

The study findings are “sobering” and are “a reminder of the seriousness of COVID infection,” says Gregory Poland, MD, an infectious disease expert at the Mayo Clinic in Rochester, Minn.

“When you look in particular at the more serious complications from COVID in this young age group, those are life-altering complications that will have consequences and ramifications throughout their lives,” he said.

“I would take this as a serious wake-up call to parents [at a time when] the immunization rates in younger children are so pitifully low,” Dr. Poland said.
 

Still early days

The study is suggestive but not definitive, said Peter Katona, MD, professor of medicine and infectious diseases expert at the UCLA Fielding School of Public Health.

It’s still too early to draw conclusions about long COVID, including in children, because many questions remain, he said: Should long COVID be defined as symptoms at 1 month or 3 months after infection? How do you define brain fog?

Dr. Katona and colleagues are studying long COVID intervention among students at UCLA to answer some of these questions, including the incidence and effect of early intervention.

The study had “at least seven limitations,” the researchers noted. Among them was the use of medical claims data that noted long COVID outcomes but not how severe they were; some people in the no COVID group might have had the illness but not been diagnosed; and the researchers did not adjust for vaccination status.

Dr. Poland noted that the study was done during surges in COVID variants including Delta and Omicron. In other words, any long COVID effects linked to more recent variants such as BA.5 or BA.2.75 are unknown.

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

After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.

Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.

Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.

“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital. 

Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.

Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”

Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.

As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.

More than 9,000 high school athletes are treated for heat-related illnesses every year.

Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.

Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.

Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.

Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.

Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.

They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.

To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.

“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
 

Warning signs and solutions

Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.

Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.

For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.

Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.

Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.

More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.

The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
 

A lopsided risk

People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.

A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.

The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.

“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.

Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.

The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.

Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.

“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.

Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.

The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.

But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.

The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.

The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.

The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.

The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.

Giving people better ways to conceptualize heat is critical, she said.

“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”

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.

After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.

Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.

Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.

“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital. 

Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.

Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”

Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.

As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.

More than 9,000 high school athletes are treated for heat-related illnesses every year.

Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.

Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.

Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.

Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.

Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.

They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.

To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.

“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
 

Warning signs and solutions

Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.

Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.

For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.

Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.

Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.

More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.

The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
 

A lopsided risk

People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.

A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.

The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.

“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.

Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.

The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.

Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.

“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.

Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.

The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.

But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.

The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.

The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.

The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.

The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.

Giving people better ways to conceptualize heat is critical, she said.

“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”

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.

After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.

Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.

Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.

“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital. 

Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.

Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”

Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.

As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.

More than 9,000 high school athletes are treated for heat-related illnesses every year.

Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.

Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.

Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.

Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.

Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.

They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.

To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.

“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
 

Warning signs and solutions

Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.

Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.

For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.

Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.

Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.

More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.

The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
 

A lopsided risk

People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.

A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.

The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.

“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.

Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.

The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.

Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.

“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.

Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.

The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.

But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.

The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.

The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.

The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.

The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.

Giving people better ways to conceptualize heat is critical, she said.

“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”

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.