Pediatric News

Two biomarkers could potentially indicate which children with SARS-CoV-2 infection will develop severe disease, according to research presented at the American Academy of Pediatrics 2021 National Conference.

“Most children with COVID-19 present with common symptoms, such as fever, vomiting, and abdominal pain, which are very similar to other common viruses,” said senior researcher Usha Sethuraman, MD, professor of pediatric emergency medicine at Central Michigan University in Detroit.

“It is impossible, in many instances, to predict which child, even after identification of SARS-CoV-2 infection, is going to develop severe consequences, such as multisystem inflammatory syndrome [MIS-C] or severe pneumonia,” she said in an interview.

“In fact, many of these kids have been sent home the first time around as they appeared clinically well, only to return a couple of days later in cardiogenic shock and requiring invasive interventions,” she added. “It would be invaluable to have the ability to know which child is likely to develop severe infection so appropriate disposition can be made and treatment initiated.”

In their prospective observational cohort study, Dr. Sethuraman and her colleagues collected saliva samples from children and adolescents when they were diagnosed with SARS-CoV-2 infection. They assessed the saliva for micro (mi)RNAs, which are small noncoding RNAs that help regulate gene expression and are “thought to play a role in the regulation of inflammation following an infection,” the researchers write in their poster.

Of the 129 young people assessed, 32 (25%) developed severe infection and 97 (75%) did not. The researchers defined severe infection as an MIS-C diagnosis, death in the 30 days after diagnosis, or the need for at least 2 L of oxygen, inotropes, mechanical ventilation, or extracorporeal membrane oxygenation.

The expression of 63 miRNAs was significantly different between young people who developed severe infection and those who did not (P < .05). In cases of severe disease, expression was downregulated for 38 of the 63 miRNAs (60%).

“A model of six miRNAs was able to discriminate between severe and nonsevere infections with high sensitivity and accuracy in a preliminary analysis,” Dr. Sethuraman reported. “While salivary miRNA has been shown in other studies to help differentiate persistent concussion in children, we did not expect them to be downregulated in children with severe COVID-19.”

The significant differences in miRNA expression in those with and without severe disease is “striking,” despite this being an interim analysis in a fairly small sample size, said Sindhu Mohandas, MD, a pediatric infectious disease specialist at Children’s Hospital Los Angeles.

“It will be interesting to see if these findings persist when larger numbers are analyzed,” she told this news organization. “Biomarkers that can predict potential severity can be very useful in making risk and management determinations. A child who has the biomarkers that indicate increased severity can be monitored more closely and complications can be preempted and prevented.”

The largest difference between severe and nonsevere cases was in the expression of miRNA 4495. In addition, miRNA 6125 appears to have prognostic potential, the researchers conclude. And three cytokines from saliva samples were elevated in cases of severe infection, but cytokine levels could not distinguish between severe and nonsevere infections, Dr. Sethuraman said.

If further research confirms these findings and determines that these miRNAs truly can provide insight into the likely course of an infection, it “would be a game changer, clinically,” she added, particularly because saliva samples are less invasive and less painful than blood draws.

The potential applications of these biomarkers could extend beyond children admitted to the hospital, Dr. Mohandas noted.

“For example, it would be a noninvasive and easy method to predict potential severity in a child seen in the emergency room and could help with deciding between observation, admission to the general floor, or admission to the ICU,” she told this news organization. “However, this test is not easily or routinely available at present, and cost and accessibility will be the main factors that will have to be overcome before it can be used for this purpose.”

These findings are preliminary, from a small sample, and require confirmation and validation, Dr. Sethuraman cautioned. And the team only analyzed saliva collected at diagnosis, so they have no data on potential changes in cytokines or miRNAs that occur as the disease progresses.

The next step is to “better characterize what happens with time to these profiles,” she explained. “The role of age, race, and gender differences in saliva biomarker profiles needs additional investigation as well.”

It would also be interesting to see whether varied expression of miRNAs “can help differentiate the various complications after COVID-19, like acute respiratory failure, MIS-C, and long COVID,” said Dr. Mohandas. “That would mean it could be used not only to potentially predict severity, but also to predict longer-term outcomes.”

This study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) program. Coauthor Steven D. Hicks, MD, PhD, reports being a paid consultant for Quadrant Biosciences.

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

Two biomarkers could potentially indicate which children with SARS-CoV-2 infection will develop severe disease, according to research presented at the American Academy of Pediatrics 2021 National Conference.

“Most children with COVID-19 present with common symptoms, such as fever, vomiting, and abdominal pain, which are very similar to other common viruses,” said senior researcher Usha Sethuraman, MD, professor of pediatric emergency medicine at Central Michigan University in Detroit.

“It is impossible, in many instances, to predict which child, even after identification of SARS-CoV-2 infection, is going to develop severe consequences, such as multisystem inflammatory syndrome [MIS-C] or severe pneumonia,” she said in an interview.

“In fact, many of these kids have been sent home the first time around as they appeared clinically well, only to return a couple of days later in cardiogenic shock and requiring invasive interventions,” she added. “It would be invaluable to have the ability to know which child is likely to develop severe infection so appropriate disposition can be made and treatment initiated.”

In their prospective observational cohort study, Dr. Sethuraman and her colleagues collected saliva samples from children and adolescents when they were diagnosed with SARS-CoV-2 infection. They assessed the saliva for micro (mi)RNAs, which are small noncoding RNAs that help regulate gene expression and are “thought to play a role in the regulation of inflammation following an infection,” the researchers write in their poster.

Of the 129 young people assessed, 32 (25%) developed severe infection and 97 (75%) did not. The researchers defined severe infection as an MIS-C diagnosis, death in the 30 days after diagnosis, or the need for at least 2 L of oxygen, inotropes, mechanical ventilation, or extracorporeal membrane oxygenation.

The expression of 63 miRNAs was significantly different between young people who developed severe infection and those who did not (P < .05). In cases of severe disease, expression was downregulated for 38 of the 63 miRNAs (60%).

“A model of six miRNAs was able to discriminate between severe and nonsevere infections with high sensitivity and accuracy in a preliminary analysis,” Dr. Sethuraman reported. “While salivary miRNA has been shown in other studies to help differentiate persistent concussion in children, we did not expect them to be downregulated in children with severe COVID-19.”

The significant differences in miRNA expression in those with and without severe disease is “striking,” despite this being an interim analysis in a fairly small sample size, said Sindhu Mohandas, MD, a pediatric infectious disease specialist at Children’s Hospital Los Angeles.

“It will be interesting to see if these findings persist when larger numbers are analyzed,” she told this news organization. “Biomarkers that can predict potential severity can be very useful in making risk and management determinations. A child who has the biomarkers that indicate increased severity can be monitored more closely and complications can be preempted and prevented.”

The largest difference between severe and nonsevere cases was in the expression of miRNA 4495. In addition, miRNA 6125 appears to have prognostic potential, the researchers conclude. And three cytokines from saliva samples were elevated in cases of severe infection, but cytokine levels could not distinguish between severe and nonsevere infections, Dr. Sethuraman said.

If further research confirms these findings and determines that these miRNAs truly can provide insight into the likely course of an infection, it “would be a game changer, clinically,” she added, particularly because saliva samples are less invasive and less painful than blood draws.

The potential applications of these biomarkers could extend beyond children admitted to the hospital, Dr. Mohandas noted.

“For example, it would be a noninvasive and easy method to predict potential severity in a child seen in the emergency room and could help with deciding between observation, admission to the general floor, or admission to the ICU,” she told this news organization. “However, this test is not easily or routinely available at present, and cost and accessibility will be the main factors that will have to be overcome before it can be used for this purpose.”

These findings are preliminary, from a small sample, and require confirmation and validation, Dr. Sethuraman cautioned. And the team only analyzed saliva collected at diagnosis, so they have no data on potential changes in cytokines or miRNAs that occur as the disease progresses.

The next step is to “better characterize what happens with time to these profiles,” she explained. “The role of age, race, and gender differences in saliva biomarker profiles needs additional investigation as well.”

It would also be interesting to see whether varied expression of miRNAs “can help differentiate the various complications after COVID-19, like acute respiratory failure, MIS-C, and long COVID,” said Dr. Mohandas. “That would mean it could be used not only to potentially predict severity, but also to predict longer-term outcomes.”

This study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) program. Coauthor Steven D. Hicks, MD, PhD, reports being a paid consultant for Quadrant Biosciences.

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

Two biomarkers could potentially indicate which children with SARS-CoV-2 infection will develop severe disease, according to research presented at the American Academy of Pediatrics 2021 National Conference.

“Most children with COVID-19 present with common symptoms, such as fever, vomiting, and abdominal pain, which are very similar to other common viruses,” said senior researcher Usha Sethuraman, MD, professor of pediatric emergency medicine at Central Michigan University in Detroit.

“It is impossible, in many instances, to predict which child, even after identification of SARS-CoV-2 infection, is going to develop severe consequences, such as multisystem inflammatory syndrome [MIS-C] or severe pneumonia,” she said in an interview.

“In fact, many of these kids have been sent home the first time around as they appeared clinically well, only to return a couple of days later in cardiogenic shock and requiring invasive interventions,” she added. “It would be invaluable to have the ability to know which child is likely to develop severe infection so appropriate disposition can be made and treatment initiated.”

In their prospective observational cohort study, Dr. Sethuraman and her colleagues collected saliva samples from children and adolescents when they were diagnosed with SARS-CoV-2 infection. They assessed the saliva for micro (mi)RNAs, which are small noncoding RNAs that help regulate gene expression and are “thought to play a role in the regulation of inflammation following an infection,” the researchers write in their poster.

Of the 129 young people assessed, 32 (25%) developed severe infection and 97 (75%) did not. The researchers defined severe infection as an MIS-C diagnosis, death in the 30 days after diagnosis, or the need for at least 2 L of oxygen, inotropes, mechanical ventilation, or extracorporeal membrane oxygenation.

The expression of 63 miRNAs was significantly different between young people who developed severe infection and those who did not (P < .05). In cases of severe disease, expression was downregulated for 38 of the 63 miRNAs (60%).

“A model of six miRNAs was able to discriminate between severe and nonsevere infections with high sensitivity and accuracy in a preliminary analysis,” Dr. Sethuraman reported. “While salivary miRNA has been shown in other studies to help differentiate persistent concussion in children, we did not expect them to be downregulated in children with severe COVID-19.”

The significant differences in miRNA expression in those with and without severe disease is “striking,” despite this being an interim analysis in a fairly small sample size, said Sindhu Mohandas, MD, a pediatric infectious disease specialist at Children’s Hospital Los Angeles.

“It will be interesting to see if these findings persist when larger numbers are analyzed,” she told this news organization. “Biomarkers that can predict potential severity can be very useful in making risk and management determinations. A child who has the biomarkers that indicate increased severity can be monitored more closely and complications can be preempted and prevented.”

The largest difference between severe and nonsevere cases was in the expression of miRNA 4495. In addition, miRNA 6125 appears to have prognostic potential, the researchers conclude. And three cytokines from saliva samples were elevated in cases of severe infection, but cytokine levels could not distinguish between severe and nonsevere infections, Dr. Sethuraman said.

If further research confirms these findings and determines that these miRNAs truly can provide insight into the likely course of an infection, it “would be a game changer, clinically,” she added, particularly because saliva samples are less invasive and less painful than blood draws.

The potential applications of these biomarkers could extend beyond children admitted to the hospital, Dr. Mohandas noted.

“For example, it would be a noninvasive and easy method to predict potential severity in a child seen in the emergency room and could help with deciding between observation, admission to the general floor, or admission to the ICU,” she told this news organization. “However, this test is not easily or routinely available at present, and cost and accessibility will be the main factors that will have to be overcome before it can be used for this purpose.”

These findings are preliminary, from a small sample, and require confirmation and validation, Dr. Sethuraman cautioned. And the team only analyzed saliva collected at diagnosis, so they have no data on potential changes in cytokines or miRNAs that occur as the disease progresses.

The next step is to “better characterize what happens with time to these profiles,” she explained. “The role of age, race, and gender differences in saliva biomarker profiles needs additional investigation as well.”

It would also be interesting to see whether varied expression of miRNAs “can help differentiate the various complications after COVID-19, like acute respiratory failure, MIS-C, and long COVID,” said Dr. Mohandas. “That would mean it could be used not only to potentially predict severity, but also to predict longer-term outcomes.”

This study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) program. Coauthor Steven D. Hicks, MD, PhD, reports being a paid consultant for Quadrant Biosciences.

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

A U.S. Food and Drug Administration (FDA) advisory committee on Oct. 15 voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline.
 

Johnson &amp; Johnson

In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.

It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.

Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
 

Limited data

The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.

These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.

Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.

She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.

But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.

“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.

Who needs a second dose?

On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.

COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.

The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.

The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.

Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.

The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.

“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
 

Trying to avoid confusion

Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.

“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.

Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.

Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.

“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.

Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.

“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.

“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
 

This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.

A U.S. Food and Drug Administration (FDA) advisory committee on Oct. 15 voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline.
 

Johnson &amp; Johnson

In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.

It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.

Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
 

Limited data

The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.

These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.

Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.

She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.

But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.

“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.

Who needs a second dose?

On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.

COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.

The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.

The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.

Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.

The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.

“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
 

Trying to avoid confusion

Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.

“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.

Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.

Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.

“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.

Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.

“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.

“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
 

This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.

A U.S. Food and Drug Administration (FDA) advisory committee on Oct. 15 voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline.
 

Johnson &amp; Johnson

In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.

It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.

Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
 

Limited data

The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.

These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.

Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.

She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.

But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.

“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.

Who needs a second dose?

On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.

COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.

The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.

The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.

Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.

The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.

“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
 

Trying to avoid confusion

Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.

“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.

Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.

Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.

“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.

Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.

“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.

“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
 

This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.

Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.

Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.

“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”

This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)

“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”

In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.

Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
 

Insurer admits ‘challenges’ with claims processing

VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.

VCU cited several problems it said Anthem had created that slowed claims payments:

Any claim over a certain dollar limit requires an itemized bill.

Anthem requests detailed medical records prior to considering payment of even clean claims.

Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.

Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”

In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”

In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.

The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”

Some claims routinely downcoded

Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.

This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.

In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.

Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”

In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
 

‘Revenue-grab strategy’

Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.

“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.

The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.

The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”

A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
 

Challenge to practice economics

Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.

“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.

While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.

However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.

Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”

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

Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.

Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.

“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”

This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)

“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”

In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.

Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
 

Insurer admits ‘challenges’ with claims processing

VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.

VCU cited several problems it said Anthem had created that slowed claims payments:

Any claim over a certain dollar limit requires an itemized bill.

Anthem requests detailed medical records prior to considering payment of even clean claims.

Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.

Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”

In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”

In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.

The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”

Some claims routinely downcoded

Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.

This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.

In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.

Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”

In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
 

‘Revenue-grab strategy’

Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.

“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.

The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.

The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”

A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
 

Challenge to practice economics

Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.

“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.

While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.

However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.

Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”

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

Despite reporting record profits during the COVID-19 pandemic, major insurance companies are delaying claims payments and making it more difficult for hospitals and physicians to get paid the full amount of claims, observers and physicians say.

Kaiser Health News recently reported that hospitals, in particular, are affected by the slowdown in claims payments from Anthem Blue Cross, the nation’s second largest health insurer. The investigative piece did not focus on outpatient or independent practices. Research by this news organization shows that the health plans’ new policies are also reducing cash flow and raising costs for ambulatory care groups. In addition, it showed that other payers besides Anthem have engaged in the same practices.

“What we’ve seen is that with complex claims, such as those with -25 modifiers, plans are routinely requiring documentation,” Jim Donohue, senior manager and associate principal at ECG Management Consultants, said in an interview. “It’s not a denial, it’s a request for more information for medical records prior to processing payments. That has the effect of slowing down payments.”

This is exactly what one internal medicine group in the Southeast has noticed. The internist who heads the practice, who asked not to be identified, says that about 4-6 months ago, United, Humana, and other payers started to require documentation for prepayment review on a higher percentage of complex claims such as 99214 (established patient), 99204 (new patient), and claims with -25 modifiers. (The latter are appended to evaluation and management [E/M] claims in which patients had comorbidities that were addressed in the same visit as the main complaint.)

“That’s really frustrating, because you have to print out or take the record for that particular visit and computer fax it to them,” the practice leader notes. “And invariably, they’ll say they didn’t get a certain percentage of them. It’s our fault because they lost the claim.”

In the past, he says, health plans would occasionally ask for the note related to a complex visit where they saw issues, and they’ve always done random postpayment chart audits. But the percentage of prepayment reviews has significantly increased in recent months, he says.

Until a plan does this review, the claim can’t be processed because it’s not regarded as a clean claim. And this has implications for insurers’ compliance with laws that, in most states, require them to pay claims within 30-40 days of submission. (Medicare’s limit is 30 days.) According to Mr. Donohue, the clock doesn’t start ticking on this requirement unless and until a claim is clean. So by requiring documentation on complex claims, the plans can not only justify downcoding a claim, but can also delay payment without triggering state penalties.
 

Insurer admits ‘challenges’ with claims processing

VCU Health, a health system affiliated with Virginia Commonwealth University, recently filed a complaint against Anthem with Virginia’s insurance commissioner, asking that the Virginia Bureau of Insurance investigate the company’s claims-processing delays. The complaint claimed Anthem owes VCU more than $385 million, of which $171 million is over 90 days old. Much of that consists of commercial claims, which are subject to the state’s 40-day claims payment rule.

VCU cited several problems it said Anthem had created that slowed claims payments:

Any claim over a certain dollar limit requires an itemized bill.

Anthem requests detailed medical records prior to considering payment of even clean claims.

Documents must be uploaded to a web portal that has technical problems, and Anthem has lost some documents as a result.

Claims are being incorrectly processed for some professionals, “resulting in multi-million-dollar underpayments of anesthesia, nurse practitioners, pathology, and behavioral health providers.”

In addition, as the Kaiser Health News article points out, hospitals have blamed the increase in payment delays or denials partly on “preauthorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers.”

In response to an inquiry from this news organization, an Anthem spokesman admitted that some payments to providers have been delayed, partly because of changes in the company’s claims-processing system. “We recognize there have been some challenges as we work with care providers to update claims processing, and readjust and adapt to a new set of dynamics as we continue to manage the pandemic,” said the spokesman.

The Kaiser Health News piece reported that Anthem’s CFO had told stock analysts on a conference call that the company had slowed claims payments to build up its financial reserves during the pandemic – a statement that some physicians called “outrageous.” But the Anthem spokesman told this news organization the quote was taken out of context and that the CFO was talking not about reserves but about “days in claims payable.” The spokesman said, “The payment delays that the article focuses on are not the primary driver or even a material driver of the increase in our overall reserves or DCPs [defined contribution plans] relative to historical levels. In fact, the vast majority of our claims are being processed in a timely manner.”

Some claims routinely downcoded

Even if that were the case, it would not explain why some physicians are seeing their higher-cost claims routinely downcoded. Will Sawyer, MD, a family physician in Cincinnati, told this news organization, “Anthem has been downcoding relentlessly since October 2020.” More often than not, when his office submits a claim with a 99214 code (office visit, 30-39 minutes, moderate medical decision-making), it’s changed to 99213 (office visit, 20-29 minutes, low medical decision-making) before processing, he says.

This has resulted in a significant diminution of his income, he notes. Anthem pays him less than Medicare for E/M visits, and the downcoding reduces his payment from $86 to $68 for a complex visit that may have taken half an hour or more.

In some cases where his office manager has noticed the downcoding, Dr. Sawyer says, she has resubmitted the claim with a copy of the encounter form. But Anthem hasn’t budged. And the refiling effort takes a toll on his solo practice, which doesn’t have sufficient staff, as it is.

Dr. Sawyer acknowledges that he has sent in a higher percentage of complex claims in the past year than he did previously. But much of that is the result of two factors beyond his control: First, many patients avoided coming into the office early in the pandemic, and when they returned, their preventive and chronic care needs were greater. Second, he says, “There are many comorbidities and mental health aspects, which exacerbate many issues and become an issue. We’re not dealing with engines here; they’re human beings. And it takes time.”

In response to Dr. Sawyer’s comments, Anthem said that it uses “analytical tools to review evaluation and management (E/M) codes during the claims adjudication and processing process.” Physicians who believe that certain claims should not have been downcoded can dispute these decisions; they must supply a statement explaining why they disagree with the decision along with documentation to support their statement, the company said. Anthem added that it reviews claims to lower costs for its members.
 

‘Revenue-grab strategy’

Dr. Sawyer believes that what Anthem is doing to him and other physicians reflects its desire to increase profits by netting extra revenue and keeping physicians’ money while it delays payments to them – a practice known in the trade as “the float.” Moreover, he says, the company depends on many practices not keeping track of their finances during the pandemic.

“When practices are running at warp speed, trying to keep people healthy and getting burned out, they aren’t paying as close attention to the details of payment. It’s an absolute revenue-grab strategy that’s unconscionable,” says Dr. Sawyer.

The Southeast internist also thinks that insurance companies other than Anthem – including United and Humana – are profiting from the float. Besides delaying his payments with gratuitous demands for documentation, he said, they also downcode many claims, forcing the practice to refile the claims and appeal. That forces the practice to pay overtime or bring on more claims staff, which raises administrative costs.

The plans’ strategy, the internist says, is this: “If they downcode millions of claims, a certain number of physicians will give up without appealing, and they’ll raise their profits.”

A United spokesperson said in an interview, “We pay claims appropriately under members’ plans and within the required time frame.” Humana had not responded to this news organization’s request for comment at press time.
 

Challenge to practice economics

Insurer policies that delay payments or downcode claims, ECG’s Mr. Donohue points out, are especially harmful to primary care and other ambulatory practices that have many small-dollar claims.

“That’s where it’s challenging, because it’s not like a $10,000 case where you add $100 to it [to meet records requests]. You’re talking about something that’s relatively low dollar, where the practice makes a small surplus, and when you add administrative costs, it can change the economics,” he says.

While the economic burden on ambulatory care practices may be greater, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), said that the payment delays and demands for documentation – along with prior authorization – particularly affect inpatient care. The health plans are questioning big-ticket items more than ever, he said, and most of those services occur in hospitals.

However, the greater level of insurer scrutiny also affects physicians who treat patients in the hospital, including surgeons and emergency department physicians who contract with the facilities, he adds.

Mr. Gilberg views the current situation as an exacerbation of the health plan policies that physicians have long struggled with. “It’s not new to have insurers play the float and not pay claims on time. Unfortunately, this is something that medical practices are used to.”

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

Children in foster care are far more likely to be prescribed psychotropic medication, compared with children who are not in foster care, an analysis of Medicaid claims data shows.

Different rates of mental health disorders in these groups do not fully explain the “alarming trend,” which persists across psychotropic medication classes, said study author Rachael J. Keefe, MD, MPH.

Misdiagnosis, overprescribing, and frequent transitions to new doctors may contribute to this phenomenon, doctors suggested.

Dr. Keefe, with Baylor College of Medicine, Houston, and colleagues analyzed Medicaid claims data from two managed care organizations to compare the prevalence of psychotropic medication use among children in foster care versus children insured by Medicaid but not in foster care. The study focused on claims from the same region in southeast Texas between July 2014 and June 2016.

The researchers included 388,914 children in Medicaid and 8,426 children in foster care in their analysis. They excluded children with a seizure or epilepsy diagnosis.

About 8% of children not in foster care received psychotropic medications, compared with 35% of those in foster care.

Children in foster care were 27 times more likely to receive antipsychotic medication (21.2% of children in foster care vs. 0.8% of children not in foster care) and twice as likely to receive antianxiety medication (6% vs. 3%).

For children in foster care, the rate of alpha-agonist use was 15 times higher, the rate of antidepressant use was 13 times higher, the rate of mood stabilizer use was 26 times higher, and the rate of stimulant use was 6 times higher.

The researchers have a limited understanding of the full context in which these medications were prescribed, and psychotropic medications have a role in the treatment of children in foster care, Dr. Keefe acknowledged.

“We have to be careful not to have a knee-jerk reaction” and inappropriately withhold medication from children in foster care, she said in an interview.

But overprescribing has been a concern. Dr. Keefe leads a foster care clinical service at Texas Children’s Hospital in Houston.

“The overprescribing of psychotropic medications to children in foster care is something I feel every day in my clinical practice, but it’s different to see it on paper,” Dr. Keefe said in a news release highlighting the research, which she presented on Oct. 11 at the annual meeting of the American Academy of Pediatrics. “It’s especially shocking to see these dramatic differences in children of preschool and elementary age.”

Misdiagnosis can be a common problem among children in foster care, said Danielle Shaw, MD, a child and adolescent psychiatrist in Camarillo, Calif., during a question-and-answer period following the presentation.

“I see incorrect diagnoses very frequently,” Dr. Shaw said. “The history of trauma or [adverse childhood experiences] is not even included in the assessment. Mood lability from trauma is misdiagnosed as bipolar disorder, despite not meeting criteria. This will justify the use of antipsychotic medication and mood stabilizers. Flashbacks can be mistaken for a psychotic disorder, which again justifies the use of antipsychotic medication.”

Children in foster care have experienced numerous traumatic experiences that affect brain development and the hypothalamic-pituitary-adrenal axis, Dr. Keefe said.

“Although from previous research we know that children in foster care are more likely to carry mental health and developmental disorder diagnoses, this does not account for the significant difference in prescribing practices in this population,” Dr. Keefe said in an interview.

Although the study focused on data in Texas, Dr. Keefe expects similar patterns exist in other regions, based on anecdotal reports. “I work with foster care pediatricians across the country, and many have seen similar concerning trends within their own clinical practices,” she said.

The use of appropriate therapies, minimizing transitions between providers, improved record keeping, the development of deprescribing algorithms, and placement of children in foster care in long-term homes as early as possible are measures that potentially could reduce inappropriate psychotropic prescribing for children in foster care, Dr. Keefe suggested.

The research was funded by a Texas Medical Center Health Policy Research Grant. The study authors and Dr. Shaw had no relevant financial disclosures.

[email protected]

Children in foster care are far more likely to be prescribed psychotropic medication, compared with children who are not in foster care, an analysis of Medicaid claims data shows.

Different rates of mental health disorders in these groups do not fully explain the “alarming trend,” which persists across psychotropic medication classes, said study author Rachael J. Keefe, MD, MPH.

Misdiagnosis, overprescribing, and frequent transitions to new doctors may contribute to this phenomenon, doctors suggested.

Dr. Keefe, with Baylor College of Medicine, Houston, and colleagues analyzed Medicaid claims data from two managed care organizations to compare the prevalence of psychotropic medication use among children in foster care versus children insured by Medicaid but not in foster care. The study focused on claims from the same region in southeast Texas between July 2014 and June 2016.

The researchers included 388,914 children in Medicaid and 8,426 children in foster care in their analysis. They excluded children with a seizure or epilepsy diagnosis.

About 8% of children not in foster care received psychotropic medications, compared with 35% of those in foster care.

Children in foster care were 27 times more likely to receive antipsychotic medication (21.2% of children in foster care vs. 0.8% of children not in foster care) and twice as likely to receive antianxiety medication (6% vs. 3%).

For children in foster care, the rate of alpha-agonist use was 15 times higher, the rate of antidepressant use was 13 times higher, the rate of mood stabilizer use was 26 times higher, and the rate of stimulant use was 6 times higher.

The researchers have a limited understanding of the full context in which these medications were prescribed, and psychotropic medications have a role in the treatment of children in foster care, Dr. Keefe acknowledged.

“We have to be careful not to have a knee-jerk reaction” and inappropriately withhold medication from children in foster care, she said in an interview.

But overprescribing has been a concern. Dr. Keefe leads a foster care clinical service at Texas Children’s Hospital in Houston.

“The overprescribing of psychotropic medications to children in foster care is something I feel every day in my clinical practice, but it’s different to see it on paper,” Dr. Keefe said in a news release highlighting the research, which she presented on Oct. 11 at the annual meeting of the American Academy of Pediatrics. “It’s especially shocking to see these dramatic differences in children of preschool and elementary age.”

Misdiagnosis can be a common problem among children in foster care, said Danielle Shaw, MD, a child and adolescent psychiatrist in Camarillo, Calif., during a question-and-answer period following the presentation.

“I see incorrect diagnoses very frequently,” Dr. Shaw said. “The history of trauma or [adverse childhood experiences] is not even included in the assessment. Mood lability from trauma is misdiagnosed as bipolar disorder, despite not meeting criteria. This will justify the use of antipsychotic medication and mood stabilizers. Flashbacks can be mistaken for a psychotic disorder, which again justifies the use of antipsychotic medication.”

Children in foster care have experienced numerous traumatic experiences that affect brain development and the hypothalamic-pituitary-adrenal axis, Dr. Keefe said.

“Although from previous research we know that children in foster care are more likely to carry mental health and developmental disorder diagnoses, this does not account for the significant difference in prescribing practices in this population,” Dr. Keefe said in an interview.

Although the study focused on data in Texas, Dr. Keefe expects similar patterns exist in other regions, based on anecdotal reports. “I work with foster care pediatricians across the country, and many have seen similar concerning trends within their own clinical practices,” she said.

The use of appropriate therapies, minimizing transitions between providers, improved record keeping, the development of deprescribing algorithms, and placement of children in foster care in long-term homes as early as possible are measures that potentially could reduce inappropriate psychotropic prescribing for children in foster care, Dr. Keefe suggested.

The research was funded by a Texas Medical Center Health Policy Research Grant. The study authors and Dr. Shaw had no relevant financial disclosures.

[email protected]

Children in foster care are far more likely to be prescribed psychotropic medication, compared with children who are not in foster care, an analysis of Medicaid claims data shows.

Different rates of mental health disorders in these groups do not fully explain the “alarming trend,” which persists across psychotropic medication classes, said study author Rachael J. Keefe, MD, MPH.

Misdiagnosis, overprescribing, and frequent transitions to new doctors may contribute to this phenomenon, doctors suggested.

Dr. Keefe, with Baylor College of Medicine, Houston, and colleagues analyzed Medicaid claims data from two managed care organizations to compare the prevalence of psychotropic medication use among children in foster care versus children insured by Medicaid but not in foster care. The study focused on claims from the same region in southeast Texas between July 2014 and June 2016.

The researchers included 388,914 children in Medicaid and 8,426 children in foster care in their analysis. They excluded children with a seizure or epilepsy diagnosis.

About 8% of children not in foster care received psychotropic medications, compared with 35% of those in foster care.

Children in foster care were 27 times more likely to receive antipsychotic medication (21.2% of children in foster care vs. 0.8% of children not in foster care) and twice as likely to receive antianxiety medication (6% vs. 3%).

For children in foster care, the rate of alpha-agonist use was 15 times higher, the rate of antidepressant use was 13 times higher, the rate of mood stabilizer use was 26 times higher, and the rate of stimulant use was 6 times higher.

The researchers have a limited understanding of the full context in which these medications were prescribed, and psychotropic medications have a role in the treatment of children in foster care, Dr. Keefe acknowledged.

“We have to be careful not to have a knee-jerk reaction” and inappropriately withhold medication from children in foster care, she said in an interview.

But overprescribing has been a concern. Dr. Keefe leads a foster care clinical service at Texas Children’s Hospital in Houston.

“The overprescribing of psychotropic medications to children in foster care is something I feel every day in my clinical practice, but it’s different to see it on paper,” Dr. Keefe said in a news release highlighting the research, which she presented on Oct. 11 at the annual meeting of the American Academy of Pediatrics. “It’s especially shocking to see these dramatic differences in children of preschool and elementary age.”

Misdiagnosis can be a common problem among children in foster care, said Danielle Shaw, MD, a child and adolescent psychiatrist in Camarillo, Calif., during a question-and-answer period following the presentation.

“I see incorrect diagnoses very frequently,” Dr. Shaw said. “The history of trauma or [adverse childhood experiences] is not even included in the assessment. Mood lability from trauma is misdiagnosed as bipolar disorder, despite not meeting criteria. This will justify the use of antipsychotic medication and mood stabilizers. Flashbacks can be mistaken for a psychotic disorder, which again justifies the use of antipsychotic medication.”

Children in foster care have experienced numerous traumatic experiences that affect brain development and the hypothalamic-pituitary-adrenal axis, Dr. Keefe said.

“Although from previous research we know that children in foster care are more likely to carry mental health and developmental disorder diagnoses, this does not account for the significant difference in prescribing practices in this population,” Dr. Keefe said in an interview.

Although the study focused on data in Texas, Dr. Keefe expects similar patterns exist in other regions, based on anecdotal reports. “I work with foster care pediatricians across the country, and many have seen similar concerning trends within their own clinical practices,” she said.

The use of appropriate therapies, minimizing transitions between providers, improved record keeping, the development of deprescribing algorithms, and placement of children in foster care in long-term homes as early as possible are measures that potentially could reduce inappropriate psychotropic prescribing for children in foster care, Dr. Keefe suggested.

The research was funded by a Texas Medical Center Health Policy Research Grant. The study authors and Dr. Shaw had no relevant financial disclosures.

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Many pediatric patients with headache experienced increased headache frequency, increased anxiety, and worsening mood through the first year of the COVID-19 pandemic, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.

“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.

Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.

The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).

Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).

Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.

The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.

The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
 

Pandemic effects mixed

Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”

He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”

On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.

He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.

No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.

Many pediatric patients with headache experienced increased headache frequency, increased anxiety, and worsening mood through the first year of the COVID-19 pandemic, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.

“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.

Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.

The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).

Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).

Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.

The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.

The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
 

Pandemic effects mixed

Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”

He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”

On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.

He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.

No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.

Many pediatric patients with headache experienced increased headache frequency, increased anxiety, and worsening mood through the first year of the COVID-19 pandemic, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.

“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.

Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.

The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).

Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).

Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.

The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.

The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
 

Pandemic effects mixed

Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”

He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”

On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.

He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.

No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.

The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.

The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”

While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.

“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”

The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.

Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.

Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.

Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.

“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”

The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.

There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.

The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.

To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.

The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.

However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.

“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.

Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.

“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.

The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.

The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”

While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.

“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”

The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.

Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.

Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.

Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.

“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”

The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.

There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.

The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.

To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.

The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.

However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.

“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.

Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.

“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.

The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.

The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”

While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.

“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”

The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.

Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.

Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.

Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.

“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”

The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.

There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.

The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.

To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.

The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.

However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.

“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.

Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.

“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

Transgender and nonbinary young people experienced less depression and fewer suicidal thoughts after a year of gender-affirming care with hormones or puberty blockers, according to new research.

“Given the high rates of adverse mental health comorbidities, these data provide critical evidence that expansion of gender-affirming care can save lives,” said David J. Inwards-Breland, MD, MPH, chief of adolescent and young adult medicine and codirector of the Center for Gender-Affirming Care at Rady Children’s Hospital in San Diego, during his presentation.

The findings, presented October 11 at the American Academy of Pediatrics 2021 National Conference, were not at all surprising to Cora Breuner, MD, MPH, professor of pediatrics at Seattle Children’s Hospital.

“The younger we can provide gender-affirming care, the less likely they’re going to have depression, and then the negative outcomes from untreated depression, which includes suicide intent or even suicide completion,” Dr. Breuner told this news organization. “It’s so obvious that we are saving lives by providing gender-affirming care.”

For their study, Dr. Inwards-Breland and his colleagues tracked depression, anxiety, and suicidality in 104 trans and nonbinary people 13 to 21 years of age who received care at the Seattle Children’s gender clinic between August 2017 and June 2018.

The study population consisted of 63 transgender male or male participants, 27 transgender female or female participants, 10 nonbinary participants, and four participants who had not defined their gender identity. Of this cohort, 62.5% were receiving mental health therapy, and 34.7% reported some substance use.

Participants completed the nine-item Patient Health Questionnaire (PHQ-9) and the seven-item Generalized Anxiety Disorder scale (GAD-7) at baseline and then at 3, 6, and 12 months. The researchers defined severe depression and severe anxiety as a score of 10 or greater on either scale.

At baseline, 56.7% of the participants had moderate to severe depression, 43.3% reported thoughts of self-harm or suicidal in the previous 2 weeks, and 50.0% had moderate to severe anxiety.

After 12 months of care, participants experienced a 60% decrease in depression (adjusted odds ratio, 0.4) and a 73% decrease in suicidality (aOR, 0.27), after adjustment for temporal trends and sex assigned at birth, race/ethnicity, level of parental support, ongoing mental health therapy, substance use, and victimization, including bullying, interpersonal violence, neglect, and abuse.

Although the decline in depression and suicidality after gender-affirming treatment was not a surprise, “those drops are huge,” Dr. Inwards-Breland said in an interview.

He said he attributes the improvement to a health care system that “affirms who these young people are” and enables changes that allow their outward appearance to reflect “who they know they are inside.”

There were no significant changes in anxiety during the study period. “Anxiety, I think, is just a little harder to treat, and it takes a little longer to treat,” he explained. And a lot of factors can trigger anxiety, and those can continue during treatment.

The slow pace of changes to gender identity can have an effect on people’s moods. “Since they’re not happening quickly, these young people are still being misgendered, they’re still seeing the body that they don’t feel like they should have, and they have to go to school and go out in public. I think that continues to fuel anxiety with a lot of these young people.”

Family support is important in reducing depression and suicidal thoughts in this population. Parents will often see positive changes after their child receives gender-affirming care, which can help contribute to positive changes in parents’ attitudes, Dr. Inwards-Breland said.

Such changes reinforce “that protective factor of connectedness with family,” he noted. “Families are crucial for any health care, and if there’s that connectedness with families, we know that, clinically, patients do better.”
 

Balancing risks

Although there are risks associated with gender-affirming hormones and puberty blockers, the risks of not receiving treatment must also be considered.

“Our young people are killing themselves,” he said. “Our young people are developing severe eating disorders that are killing them. Our young people are increasing their substance abuse, homelessness, depression. The list just goes on.”

For trans-masculine and nonbinary masculine patients, the potential permanent changes of hormone therapy include a deeper voice, hair growth, enlargement of the clitoris, and, in some patients, the development of male pattern baldness. In trans and nonbinary feminine patients, potential long-term effects include breast development and an increased risk for fertility issues.

The consent forms required for young people who want gender-affirming hormones or puberty blockers are extensive, with every possible reversible and irreversible effect described in detail, Dr. Breuner said.

“Parents sign them because they want their child to stay alive,” she explained. “When you compare the cost of someone who has severe debilitating depression and dying by suicide with some of the risks associated with gender-affirming hormone therapy, that’s a no-brainer to me.”

This study is limited by the fact that screening tests, not diagnostic tests, were used to identify depression, anxiety, and suicidality, and the fact that the use of antidepression or antianxiety medications was not taken into account, Dr. Inwards-Breland acknowledged.

“I think future studies should look at a mental health evaluation and diagnosis by a mental health provider,” he added. And mental health, gender dysphoria, suicidality, and self-harm should be tracked over the course of treatment.

He also acknowledged the study’s selection bias. All participants sought care at a multidisciplinary gender clinic, so were likely to be privileged and to have supportive families. “There’s a good chance that if we had more trans and nonbinary youth of color, we may have different findings,” he said.

More qualitative research is needed to assess the effect of gender-affirming therapy on the mental health of these patients, Dr. Breuner said.

“Being able to finally come into who you think you are and enjoy expressing who you are in a gender-affirming way has to be positive in such a way that you’re not depressed anymore,” she added. “It has to be tragic for people who cannot stand the body they’re in and cannot talk about it to anybody or express themselves without fear of recourse, to the point that they would be so devastated that they’d want to die by suicide.”

This research was funded by the Seattle Children’s Center for Diversity and Health Equity and the Pacific Hospital Development and Port Authority. Dr. Inwards-Breland and Dr. Breuner have disclosed no relevant financial relationships.

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

Transgender and nonbinary young people experienced less depression and fewer suicidal thoughts after a year of gender-affirming care with hormones or puberty blockers, according to new research.

“Given the high rates of adverse mental health comorbidities, these data provide critical evidence that expansion of gender-affirming care can save lives,” said David J. Inwards-Breland, MD, MPH, chief of adolescent and young adult medicine and codirector of the Center for Gender-Affirming Care at Rady Children’s Hospital in San Diego, during his presentation.

The findings, presented October 11 at the American Academy of Pediatrics 2021 National Conference, were not at all surprising to Cora Breuner, MD, MPH, professor of pediatrics at Seattle Children’s Hospital.

“The younger we can provide gender-affirming care, the less likely they’re going to have depression, and then the negative outcomes from untreated depression, which includes suicide intent or even suicide completion,” Dr. Breuner told this news organization. “It’s so obvious that we are saving lives by providing gender-affirming care.”

For their study, Dr. Inwards-Breland and his colleagues tracked depression, anxiety, and suicidality in 104 trans and nonbinary people 13 to 21 years of age who received care at the Seattle Children’s gender clinic between August 2017 and June 2018.

The study population consisted of 63 transgender male or male participants, 27 transgender female or female participants, 10 nonbinary participants, and four participants who had not defined their gender identity. Of this cohort, 62.5% were receiving mental health therapy, and 34.7% reported some substance use.

Participants completed the nine-item Patient Health Questionnaire (PHQ-9) and the seven-item Generalized Anxiety Disorder scale (GAD-7) at baseline and then at 3, 6, and 12 months. The researchers defined severe depression and severe anxiety as a score of 10 or greater on either scale.

At baseline, 56.7% of the participants had moderate to severe depression, 43.3% reported thoughts of self-harm or suicidal in the previous 2 weeks, and 50.0% had moderate to severe anxiety.

After 12 months of care, participants experienced a 60% decrease in depression (adjusted odds ratio, 0.4) and a 73% decrease in suicidality (aOR, 0.27), after adjustment for temporal trends and sex assigned at birth, race/ethnicity, level of parental support, ongoing mental health therapy, substance use, and victimization, including bullying, interpersonal violence, neglect, and abuse.

Although the decline in depression and suicidality after gender-affirming treatment was not a surprise, “those drops are huge,” Dr. Inwards-Breland said in an interview.

He said he attributes the improvement to a health care system that “affirms who these young people are” and enables changes that allow their outward appearance to reflect “who they know they are inside.”

There were no significant changes in anxiety during the study period. “Anxiety, I think, is just a little harder to treat, and it takes a little longer to treat,” he explained. And a lot of factors can trigger anxiety, and those can continue during treatment.

The slow pace of changes to gender identity can have an effect on people’s moods. “Since they’re not happening quickly, these young people are still being misgendered, they’re still seeing the body that they don’t feel like they should have, and they have to go to school and go out in public. I think that continues to fuel anxiety with a lot of these young people.”

Family support is important in reducing depression and suicidal thoughts in this population. Parents will often see positive changes after their child receives gender-affirming care, which can help contribute to positive changes in parents’ attitudes, Dr. Inwards-Breland said.

Such changes reinforce “that protective factor of connectedness with family,” he noted. “Families are crucial for any health care, and if there’s that connectedness with families, we know that, clinically, patients do better.”
 

Balancing risks

Although there are risks associated with gender-affirming hormones and puberty blockers, the risks of not receiving treatment must also be considered.

“Our young people are killing themselves,” he said. “Our young people are developing severe eating disorders that are killing them. Our young people are increasing their substance abuse, homelessness, depression. The list just goes on.”

For trans-masculine and nonbinary masculine patients, the potential permanent changes of hormone therapy include a deeper voice, hair growth, enlargement of the clitoris, and, in some patients, the development of male pattern baldness. In trans and nonbinary feminine patients, potential long-term effects include breast development and an increased risk for fertility issues.

The consent forms required for young people who want gender-affirming hormones or puberty blockers are extensive, with every possible reversible and irreversible effect described in detail, Dr. Breuner said.

“Parents sign them because they want their child to stay alive,” she explained. “When you compare the cost of someone who has severe debilitating depression and dying by suicide with some of the risks associated with gender-affirming hormone therapy, that’s a no-brainer to me.”

This study is limited by the fact that screening tests, not diagnostic tests, were used to identify depression, anxiety, and suicidality, and the fact that the use of antidepression or antianxiety medications was not taken into account, Dr. Inwards-Breland acknowledged.

“I think future studies should look at a mental health evaluation and diagnosis by a mental health provider,” he added. And mental health, gender dysphoria, suicidality, and self-harm should be tracked over the course of treatment.

He also acknowledged the study’s selection bias. All participants sought care at a multidisciplinary gender clinic, so were likely to be privileged and to have supportive families. “There’s a good chance that if we had more trans and nonbinary youth of color, we may have different findings,” he said.

More qualitative research is needed to assess the effect of gender-affirming therapy on the mental health of these patients, Dr. Breuner said.

“Being able to finally come into who you think you are and enjoy expressing who you are in a gender-affirming way has to be positive in such a way that you’re not depressed anymore,” she added. “It has to be tragic for people who cannot stand the body they’re in and cannot talk about it to anybody or express themselves without fear of recourse, to the point that they would be so devastated that they’d want to die by suicide.”

This research was funded by the Seattle Children’s Center for Diversity and Health Equity and the Pacific Hospital Development and Port Authority. Dr. Inwards-Breland and Dr. Breuner have disclosed no relevant financial relationships.

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

Transgender and nonbinary young people experienced less depression and fewer suicidal thoughts after a year of gender-affirming care with hormones or puberty blockers, according to new research.

“Given the high rates of adverse mental health comorbidities, these data provide critical evidence that expansion of gender-affirming care can save lives,” said David J. Inwards-Breland, MD, MPH, chief of adolescent and young adult medicine and codirector of the Center for Gender-Affirming Care at Rady Children’s Hospital in San Diego, during his presentation.

The findings, presented October 11 at the American Academy of Pediatrics 2021 National Conference, were not at all surprising to Cora Breuner, MD, MPH, professor of pediatrics at Seattle Children’s Hospital.

“The younger we can provide gender-affirming care, the less likely they’re going to have depression, and then the negative outcomes from untreated depression, which includes suicide intent or even suicide completion,” Dr. Breuner told this news organization. “It’s so obvious that we are saving lives by providing gender-affirming care.”

For their study, Dr. Inwards-Breland and his colleagues tracked depression, anxiety, and suicidality in 104 trans and nonbinary people 13 to 21 years of age who received care at the Seattle Children’s gender clinic between August 2017 and June 2018.

The study population consisted of 63 transgender male or male participants, 27 transgender female or female participants, 10 nonbinary participants, and four participants who had not defined their gender identity. Of this cohort, 62.5% were receiving mental health therapy, and 34.7% reported some substance use.

Participants completed the nine-item Patient Health Questionnaire (PHQ-9) and the seven-item Generalized Anxiety Disorder scale (GAD-7) at baseline and then at 3, 6, and 12 months. The researchers defined severe depression and severe anxiety as a score of 10 or greater on either scale.

At baseline, 56.7% of the participants had moderate to severe depression, 43.3% reported thoughts of self-harm or suicidal in the previous 2 weeks, and 50.0% had moderate to severe anxiety.

After 12 months of care, participants experienced a 60% decrease in depression (adjusted odds ratio, 0.4) and a 73% decrease in suicidality (aOR, 0.27), after adjustment for temporal trends and sex assigned at birth, race/ethnicity, level of parental support, ongoing mental health therapy, substance use, and victimization, including bullying, interpersonal violence, neglect, and abuse.

Although the decline in depression and suicidality after gender-affirming treatment was not a surprise, “those drops are huge,” Dr. Inwards-Breland said in an interview.

He said he attributes the improvement to a health care system that “affirms who these young people are” and enables changes that allow their outward appearance to reflect “who they know they are inside.”

There were no significant changes in anxiety during the study period. “Anxiety, I think, is just a little harder to treat, and it takes a little longer to treat,” he explained. And a lot of factors can trigger anxiety, and those can continue during treatment.

The slow pace of changes to gender identity can have an effect on people’s moods. “Since they’re not happening quickly, these young people are still being misgendered, they’re still seeing the body that they don’t feel like they should have, and they have to go to school and go out in public. I think that continues to fuel anxiety with a lot of these young people.”

Family support is important in reducing depression and suicidal thoughts in this population. Parents will often see positive changes after their child receives gender-affirming care, which can help contribute to positive changes in parents’ attitudes, Dr. Inwards-Breland said.

Such changes reinforce “that protective factor of connectedness with family,” he noted. “Families are crucial for any health care, and if there’s that connectedness with families, we know that, clinically, patients do better.”
 

Balancing risks

Although there are risks associated with gender-affirming hormones and puberty blockers, the risks of not receiving treatment must also be considered.

“Our young people are killing themselves,” he said. “Our young people are developing severe eating disorders that are killing them. Our young people are increasing their substance abuse, homelessness, depression. The list just goes on.”

For trans-masculine and nonbinary masculine patients, the potential permanent changes of hormone therapy include a deeper voice, hair growth, enlargement of the clitoris, and, in some patients, the development of male pattern baldness. In trans and nonbinary feminine patients, potential long-term effects include breast development and an increased risk for fertility issues.

The consent forms required for young people who want gender-affirming hormones or puberty blockers are extensive, with every possible reversible and irreversible effect described in detail, Dr. Breuner said.

“Parents sign them because they want their child to stay alive,” she explained. “When you compare the cost of someone who has severe debilitating depression and dying by suicide with some of the risks associated with gender-affirming hormone therapy, that’s a no-brainer to me.”

This study is limited by the fact that screening tests, not diagnostic tests, were used to identify depression, anxiety, and suicidality, and the fact that the use of antidepression or antianxiety medications was not taken into account, Dr. Inwards-Breland acknowledged.

“I think future studies should look at a mental health evaluation and diagnosis by a mental health provider,” he added. And mental health, gender dysphoria, suicidality, and self-harm should be tracked over the course of treatment.

He also acknowledged the study’s selection bias. All participants sought care at a multidisciplinary gender clinic, so were likely to be privileged and to have supportive families. “There’s a good chance that if we had more trans and nonbinary youth of color, we may have different findings,” he said.

More qualitative research is needed to assess the effect of gender-affirming therapy on the mental health of these patients, Dr. Breuner said.

“Being able to finally come into who you think you are and enjoy expressing who you are in a gender-affirming way has to be positive in such a way that you’re not depressed anymore,” she added. “It has to be tragic for people who cannot stand the body they’re in and cannot talk about it to anybody or express themselves without fear of recourse, to the point that they would be so devastated that they’d want to die by suicide.”

This research was funded by the Seattle Children’s Center for Diversity and Health Equity and the Pacific Hospital Development and Port Authority. Dr. Inwards-Breland and Dr. Breuner have disclosed no relevant financial relationships.

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