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An online survey captured mixed information about people’s willingness to undergo surgery during a viral pandemic in relation to the vaccine status of the patient and staff. The findings showcase opportunities for public education and “skillful messaging,” researchers report.

In survey scenarios that asked people to imagine their vaccination status, people were more willing to undergo surgery if it was lifesaving, rather than elective, especially if vaccinated. The prospect of no hospital stay tipped the scales further toward surgery. The vaccination status of hospital staff played only a minor role in decision making, according to the study, which was published in Vaccine.

But as a post hoc analysis revealed, it was participants who were not vaccinated against COVID-19 in real life who were more willing to undergo surgery, compared with those who had one or two shots.

In either case, too many people were unwilling to undergo lifesaving surgery, even though the risk of hospital-acquired COVID-19 is low. “Making this choice for an actual health problem would result in an unacceptably high rate of potential morbidity attributable to pandemic-related fears, the authors wrote.

In an unusual approach, the researchers used Amazon’s Mechanical Turk to electronically recruit 2,006 adults. The participants answered a 26-item survey about a hypothetical surgery in an unnamed pandemic with different combinations of vaccine status for patient and staff.

Coauthor and anesthesiologist Keith J. Ruskin, MD, of the University of Chicago, told this news organization that they “wanted to make this timeless” and independent of COVID “so that when the next thing came about, the paper would still be relevant.”

The researchers were surprised by the findings at the extreme ends of attitudes toward surgery. Some were still willing to have elective surgery with (hypothetically) unvaccinated patients and staff.

“And people at the other end, even though they are vaccinated, the hospital staff is vaccinated, and the surgery is lifesaving, they absolutely won’t have surgery,” Dr. Ruskin said.

He viewed these two groups as opportunities for education. “You can present information in the most positive light to get them to do the right thing with what’s best for themselves,” he said.

As an example, Dr. Ruskin pointed to an ad in Illinois. “It’s not only people saying I’m getting vaccinated for myself and my family, but there are people who said I got vaccinated and I still got COVID, but it could have been much worse. Please, if you’re on the fence, just get vaccinated,” he said.

Coauthor Anna Clebone Ruskin, MD, an anesthesiologist at the University of Chicago, said, “Humans are programmed to see things in extremes. With surgery, people tend to think of surgery as a monolith – surgery is all good, or surgery is all bad, where there is a huge in between. So we saw those extremes. ... Seeing that dichotomy with people on either end was pretty surprising.

“Getting surgery is not always good. Getting surgery is not always bad. It’s a risk-versus-benefit analysis and educating the public to consider the risks and benefits of medical decisions, in general, would be enormously beneficial,” she said.

A post hoc analysis found that “participants who were not actually vaccinated against COVID-19 were generally more willing to undergo surgery compared to those who had one vaccination or two vaccinations,” the authors wrote.

In a second post hoc finding, participants who reported high wariness of vaccines were generally more likely to be willing to undergo surgery. Notably, 15% of participants “were unwilling to undergo lifesaving surgery during a pandemic even when they and the health care staff were vaccinated,” the authors wrote.

Dr. Keith J. Ruskin hypothesized about this result, saying, “What we think is that potentially actually getting vaccinated against COVID-19 may indicate that you have a lower risk tolerance. So you may be less likely to do anything you perceive to be risky if you’re vaccinated against COVID-19.”

The authors stated that “the risk of hospital-acquired COVID-19 even prior to vaccination is vanishingly small.” The risk of nosocomial COVID varies among different studies. An EPIC-based study between April 2020 and October 2021 found the risk to be 1.8%; EPIC describes the fears of a patient catching COVID at a hospital as “likely unfounded.”

In the United Kingdom, the risk was as high as 24% earlier in the pandemic and then declined to approximately 5% a year ago. Omicron also brought more infections. Rates varied significantly among hospitals – and, notably, the risk of death from a nosocomial COVID infection was 21% in April-September 2020.

Emily Landon, MD, an epidemiologist and executive medical director for infection prevention and control at the University of Chicago Medicine, told this news organization that the study’s data were collected during Delta, a “time when we thought that this was a pandemic of the unvaccinated. But there was serious politicization of the vaccine.”

Dr. Landon said one of the study’s strengths was the large number of participants. A limitation was, “You’re going to have less participants who are generally poor and indigent, and fewer old participants, probably because they’re less likely to respond to an online survey.

“But the most interesting results are that people who were wary of vaccines or who hadn’t been vaccinated, were much more willing to undergo surgical procedures in the time of a pandemic, regardless of status, which reflects the fact that not being vaccinated correlates with not worrying much about COVID. Vaccinated individuals had a lot more wariness about undergoing surgical procedures during a pandemic.”

It appeared “individuals who were vaccinated in real life [were] worried about staff vaccination,” Dr. Landon noted. She concluded, “I think it supports the need for mandatory vaccinations in health care workers.”

The study has implications for hospital vaccination policies and practices. In Cumberland, Md., when COVID was high and vaccines first became available, the Maryland Hospital Association said that all health care staff should be vaccinated. The local hospital, UPMC–Western Maryland Hospital, refused.

Two months later, the local news reporter, Teresa McMinn, wrote, “While Maryland’s largest hospital systems have ‘led by example by mandating vaccines for all of their hospital staff,’ other facilities – including UPMC Western Maryland and Garrett Regional Medical Center – have taken no such action even though it’s been 8 months since vaccines were made available to health care workers.”

The hospital would not tell patients whether staff were vaccinated, either. An ongoing concern for members of the community is the lack of communication with UPMC, which erodes trust in the health system – the only hospital available in this rural community.

This vaccine study supports that the vaccination status of the staff may influence some patients’ decision on whether to have surgery.

The Ruskins and Dr. Landon have disclosed no relevant financial relationships.

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

An online survey captured mixed information about people’s willingness to undergo surgery during a viral pandemic in relation to the vaccine status of the patient and staff. The findings showcase opportunities for public education and “skillful messaging,” researchers report.

In survey scenarios that asked people to imagine their vaccination status, people were more willing to undergo surgery if it was lifesaving, rather than elective, especially if vaccinated. The prospect of no hospital stay tipped the scales further toward surgery. The vaccination status of hospital staff played only a minor role in decision making, according to the study, which was published in Vaccine.

But as a post hoc analysis revealed, it was participants who were not vaccinated against COVID-19 in real life who were more willing to undergo surgery, compared with those who had one or two shots.

In either case, too many people were unwilling to undergo lifesaving surgery, even though the risk of hospital-acquired COVID-19 is low. “Making this choice for an actual health problem would result in an unacceptably high rate of potential morbidity attributable to pandemic-related fears, the authors wrote.

In an unusual approach, the researchers used Amazon’s Mechanical Turk to electronically recruit 2,006 adults. The participants answered a 26-item survey about a hypothetical surgery in an unnamed pandemic with different combinations of vaccine status for patient and staff.

Coauthor and anesthesiologist Keith J. Ruskin, MD, of the University of Chicago, told this news organization that they “wanted to make this timeless” and independent of COVID “so that when the next thing came about, the paper would still be relevant.”

The researchers were surprised by the findings at the extreme ends of attitudes toward surgery. Some were still willing to have elective surgery with (hypothetically) unvaccinated patients and staff.

“And people at the other end, even though they are vaccinated, the hospital staff is vaccinated, and the surgery is lifesaving, they absolutely won’t have surgery,” Dr. Ruskin said.

He viewed these two groups as opportunities for education. “You can present information in the most positive light to get them to do the right thing with what’s best for themselves,” he said.

As an example, Dr. Ruskin pointed to an ad in Illinois. “It’s not only people saying I’m getting vaccinated for myself and my family, but there are people who said I got vaccinated and I still got COVID, but it could have been much worse. Please, if you’re on the fence, just get vaccinated,” he said.

Coauthor Anna Clebone Ruskin, MD, an anesthesiologist at the University of Chicago, said, “Humans are programmed to see things in extremes. With surgery, people tend to think of surgery as a monolith – surgery is all good, or surgery is all bad, where there is a huge in between. So we saw those extremes. ... Seeing that dichotomy with people on either end was pretty surprising.

“Getting surgery is not always good. Getting surgery is not always bad. It’s a risk-versus-benefit analysis and educating the public to consider the risks and benefits of medical decisions, in general, would be enormously beneficial,” she said.

A post hoc analysis found that “participants who were not actually vaccinated against COVID-19 were generally more willing to undergo surgery compared to those who had one vaccination or two vaccinations,” the authors wrote.

In a second post hoc finding, participants who reported high wariness of vaccines were generally more likely to be willing to undergo surgery. Notably, 15% of participants “were unwilling to undergo lifesaving surgery during a pandemic even when they and the health care staff were vaccinated,” the authors wrote.

Dr. Keith J. Ruskin hypothesized about this result, saying, “What we think is that potentially actually getting vaccinated against COVID-19 may indicate that you have a lower risk tolerance. So you may be less likely to do anything you perceive to be risky if you’re vaccinated against COVID-19.”

The authors stated that “the risk of hospital-acquired COVID-19 even prior to vaccination is vanishingly small.” The risk of nosocomial COVID varies among different studies. An EPIC-based study between April 2020 and October 2021 found the risk to be 1.8%; EPIC describes the fears of a patient catching COVID at a hospital as “likely unfounded.”

In the United Kingdom, the risk was as high as 24% earlier in the pandemic and then declined to approximately 5% a year ago. Omicron also brought more infections. Rates varied significantly among hospitals – and, notably, the risk of death from a nosocomial COVID infection was 21% in April-September 2020.

Emily Landon, MD, an epidemiologist and executive medical director for infection prevention and control at the University of Chicago Medicine, told this news organization that the study’s data were collected during Delta, a “time when we thought that this was a pandemic of the unvaccinated. But there was serious politicization of the vaccine.”

Dr. Landon said one of the study’s strengths was the large number of participants. A limitation was, “You’re going to have less participants who are generally poor and indigent, and fewer old participants, probably because they’re less likely to respond to an online survey.

“But the most interesting results are that people who were wary of vaccines or who hadn’t been vaccinated, were much more willing to undergo surgical procedures in the time of a pandemic, regardless of status, which reflects the fact that not being vaccinated correlates with not worrying much about COVID. Vaccinated individuals had a lot more wariness about undergoing surgical procedures during a pandemic.”

It appeared “individuals who were vaccinated in real life [were] worried about staff vaccination,” Dr. Landon noted. She concluded, “I think it supports the need for mandatory vaccinations in health care workers.”

The study has implications for hospital vaccination policies and practices. In Cumberland, Md., when COVID was high and vaccines first became available, the Maryland Hospital Association said that all health care staff should be vaccinated. The local hospital, UPMC–Western Maryland Hospital, refused.

Two months later, the local news reporter, Teresa McMinn, wrote, “While Maryland’s largest hospital systems have ‘led by example by mandating vaccines for all of their hospital staff,’ other facilities – including UPMC Western Maryland and Garrett Regional Medical Center – have taken no such action even though it’s been 8 months since vaccines were made available to health care workers.”

The hospital would not tell patients whether staff were vaccinated, either. An ongoing concern for members of the community is the lack of communication with UPMC, which erodes trust in the health system – the only hospital available in this rural community.

This vaccine study supports that the vaccination status of the staff may influence some patients’ decision on whether to have surgery.

The Ruskins and Dr. Landon have disclosed no relevant financial relationships.

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

An online survey captured mixed information about people’s willingness to undergo surgery during a viral pandemic in relation to the vaccine status of the patient and staff. The findings showcase opportunities for public education and “skillful messaging,” researchers report.

In survey scenarios that asked people to imagine their vaccination status, people were more willing to undergo surgery if it was lifesaving, rather than elective, especially if vaccinated. The prospect of no hospital stay tipped the scales further toward surgery. The vaccination status of hospital staff played only a minor role in decision making, according to the study, which was published in Vaccine.

But as a post hoc analysis revealed, it was participants who were not vaccinated against COVID-19 in real life who were more willing to undergo surgery, compared with those who had one or two shots.

In either case, too many people were unwilling to undergo lifesaving surgery, even though the risk of hospital-acquired COVID-19 is low. “Making this choice for an actual health problem would result in an unacceptably high rate of potential morbidity attributable to pandemic-related fears, the authors wrote.

In an unusual approach, the researchers used Amazon’s Mechanical Turk to electronically recruit 2,006 adults. The participants answered a 26-item survey about a hypothetical surgery in an unnamed pandemic with different combinations of vaccine status for patient and staff.

Coauthor and anesthesiologist Keith J. Ruskin, MD, of the University of Chicago, told this news organization that they “wanted to make this timeless” and independent of COVID “so that when the next thing came about, the paper would still be relevant.”

The researchers were surprised by the findings at the extreme ends of attitudes toward surgery. Some were still willing to have elective surgery with (hypothetically) unvaccinated patients and staff.

“And people at the other end, even though they are vaccinated, the hospital staff is vaccinated, and the surgery is lifesaving, they absolutely won’t have surgery,” Dr. Ruskin said.

He viewed these two groups as opportunities for education. “You can present information in the most positive light to get them to do the right thing with what’s best for themselves,” he said.

As an example, Dr. Ruskin pointed to an ad in Illinois. “It’s not only people saying I’m getting vaccinated for myself and my family, but there are people who said I got vaccinated and I still got COVID, but it could have been much worse. Please, if you’re on the fence, just get vaccinated,” he said.

Coauthor Anna Clebone Ruskin, MD, an anesthesiologist at the University of Chicago, said, “Humans are programmed to see things in extremes. With surgery, people tend to think of surgery as a monolith – surgery is all good, or surgery is all bad, where there is a huge in between. So we saw those extremes. ... Seeing that dichotomy with people on either end was pretty surprising.

“Getting surgery is not always good. Getting surgery is not always bad. It’s a risk-versus-benefit analysis and educating the public to consider the risks and benefits of medical decisions, in general, would be enormously beneficial,” she said.

A post hoc analysis found that “participants who were not actually vaccinated against COVID-19 were generally more willing to undergo surgery compared to those who had one vaccination or two vaccinations,” the authors wrote.

In a second post hoc finding, participants who reported high wariness of vaccines were generally more likely to be willing to undergo surgery. Notably, 15% of participants “were unwilling to undergo lifesaving surgery during a pandemic even when they and the health care staff were vaccinated,” the authors wrote.

Dr. Keith J. Ruskin hypothesized about this result, saying, “What we think is that potentially actually getting vaccinated against COVID-19 may indicate that you have a lower risk tolerance. So you may be less likely to do anything you perceive to be risky if you’re vaccinated against COVID-19.”

The authors stated that “the risk of hospital-acquired COVID-19 even prior to vaccination is vanishingly small.” The risk of nosocomial COVID varies among different studies. An EPIC-based study between April 2020 and October 2021 found the risk to be 1.8%; EPIC describes the fears of a patient catching COVID at a hospital as “likely unfounded.”

In the United Kingdom, the risk was as high as 24% earlier in the pandemic and then declined to approximately 5% a year ago. Omicron also brought more infections. Rates varied significantly among hospitals – and, notably, the risk of death from a nosocomial COVID infection was 21% in April-September 2020.

Emily Landon, MD, an epidemiologist and executive medical director for infection prevention and control at the University of Chicago Medicine, told this news organization that the study’s data were collected during Delta, a “time when we thought that this was a pandemic of the unvaccinated. But there was serious politicization of the vaccine.”

Dr. Landon said one of the study’s strengths was the large number of participants. A limitation was, “You’re going to have less participants who are generally poor and indigent, and fewer old participants, probably because they’re less likely to respond to an online survey.

“But the most interesting results are that people who were wary of vaccines or who hadn’t been vaccinated, were much more willing to undergo surgical procedures in the time of a pandemic, regardless of status, which reflects the fact that not being vaccinated correlates with not worrying much about COVID. Vaccinated individuals had a lot more wariness about undergoing surgical procedures during a pandemic.”

It appeared “individuals who were vaccinated in real life [were] worried about staff vaccination,” Dr. Landon noted. She concluded, “I think it supports the need for mandatory vaccinations in health care workers.”

The study has implications for hospital vaccination policies and practices. In Cumberland, Md., when COVID was high and vaccines first became available, the Maryland Hospital Association said that all health care staff should be vaccinated. The local hospital, UPMC–Western Maryland Hospital, refused.

Two months later, the local news reporter, Teresa McMinn, wrote, “While Maryland’s largest hospital systems have ‘led by example by mandating vaccines for all of their hospital staff,’ other facilities – including UPMC Western Maryland and Garrett Regional Medical Center – have taken no such action even though it’s been 8 months since vaccines were made available to health care workers.”

The hospital would not tell patients whether staff were vaccinated, either. An ongoing concern for members of the community is the lack of communication with UPMC, which erodes trust in the health system – the only hospital available in this rural community.

This vaccine study supports that the vaccination status of the staff may influence some patients’ decision on whether to have surgery.

The Ruskins and Dr. Landon have disclosed no relevant financial relationships.

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

During the first year of the pandemic, profound changes in screen use and sleep timing occurred among U.S. adolescents as a result of spending more time using electronic devices, going to bed later, and getting up later, compared with before the pandemic, new research indicates.

The excessive screen time negatively affected sleep, said lead investigator Orsolya Kiss, PhD, with the Center for Health Sciences at SRI International, Menlo Park, Calif.

And what’s “concerning,” she told this news organization, is that there is no indication of any spontaneous decline in screen use in 2021, when there were fewer restrictions.

Dr. Kiss said she is “very much interested to see what future studies will show.”

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Sleep takes a pandemic hit

“Adolescents and families have turned to online activities and social platforms more than ever before to maintain wellbeing, [to] connect with friends and family, and for online schooling,” Dr. Kiss said in a conference statement.

She and her colleagues examined longitudinal data from 5,027 adolescents aged 11-14 years who are participating in the ongoing Adolescent Brain Cognitive Development (ABCD) study.

As part of the study, participants reported sleep and daily screen time use prior to and at six time points during the first year of the pandemic (May 2020 to March 2021).

During the first year of the pandemic, relative to before the pandemic, recreational screen time was dramatically higher, with adolescents spending about 45 minutes more on social media and 20 minutes more playing video games, Dr. Kiss reported.

The jump in screen time was coupled with changes in sleep patterns.

Adolescents’ wake up times were delayed about 1.5 hours during May and August 2020, relative to prepandemic levels. The delay was partly due to summer break; wake-up times returned to earlier times in the fall of 2020.

During all pandemic assessments, bedtimes were delayed by about 1 hour, even when the new school year started. This was particularly the case in older adolescents and girls.

The findings highlight the need to promote “balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change,” the authors wrote in their conference abstract.
 

Mental illness risk

In an interview, Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, noted that “during adolescence, the tendency to become more of a night owl naturally worsens, and when kids have no sleep schedule imposed on them, these patterns become exacerbated.”

Dr. Benca, who was not involved in the study, also noted that altered sleep patterns are risk factors for psychiatric illness.

“Adolescence, in particular, is so critical for brain development, and it really raises the question of whether sleep disturbances in adolescence or poor sleep patterns are contributing to the increase psychiatric epidemic we’re seeing in adolescents and children these days,” said Dr. Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, N.C.

Also weighing in on the study, journalist and author Lisa Lewis, MS, based in Southern California, said, “It’s not surprising that tech use and social media – which is such an important part of their social worlds – went up during the pandemic.”

Ms. Lewis, a parent of two teenagers, played a key role in California’s new healthy school start times law, the first of its kind in the nation, and is the author of the newly released book, The Sleep-Deprived Teen (Mango Publishing).

“Far too many adolescents aren’t getting anywhere close to the 8-10 hours of nightly sleep they need,” Ms. Lewis said in an interview.

She noted that the the American Academy of Pediatrics recommends no tech use an hour before bed.

“And there are other house rules parents can implement, such as charging all devices in a central location, like the kitchen. Making sleep a priority helps teens, but it helps parents too: No one functions well when they’re sleep-deprived,” Ms. Lewis added.

Support for the study was provided by the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals. Ms. Lewis has no relevant disclosures.

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

During the first year of the pandemic, profound changes in screen use and sleep timing occurred among U.S. adolescents as a result of spending more time using electronic devices, going to bed later, and getting up later, compared with before the pandemic, new research indicates.

The excessive screen time negatively affected sleep, said lead investigator Orsolya Kiss, PhD, with the Center for Health Sciences at SRI International, Menlo Park, Calif.

And what’s “concerning,” she told this news organization, is that there is no indication of any spontaneous decline in screen use in 2021, when there were fewer restrictions.

Dr. Kiss said she is “very much interested to see what future studies will show.”

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Sleep takes a pandemic hit

“Adolescents and families have turned to online activities and social platforms more than ever before to maintain wellbeing, [to] connect with friends and family, and for online schooling,” Dr. Kiss said in a conference statement.

She and her colleagues examined longitudinal data from 5,027 adolescents aged 11-14 years who are participating in the ongoing Adolescent Brain Cognitive Development (ABCD) study.

As part of the study, participants reported sleep and daily screen time use prior to and at six time points during the first year of the pandemic (May 2020 to March 2021).

During the first year of the pandemic, relative to before the pandemic, recreational screen time was dramatically higher, with adolescents spending about 45 minutes more on social media and 20 minutes more playing video games, Dr. Kiss reported.

The jump in screen time was coupled with changes in sleep patterns.

Adolescents’ wake up times were delayed about 1.5 hours during May and August 2020, relative to prepandemic levels. The delay was partly due to summer break; wake-up times returned to earlier times in the fall of 2020.

During all pandemic assessments, bedtimes were delayed by about 1 hour, even when the new school year started. This was particularly the case in older adolescents and girls.

The findings highlight the need to promote “balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change,” the authors wrote in their conference abstract.
 

Mental illness risk

In an interview, Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, noted that “during adolescence, the tendency to become more of a night owl naturally worsens, and when kids have no sleep schedule imposed on them, these patterns become exacerbated.”

Dr. Benca, who was not involved in the study, also noted that altered sleep patterns are risk factors for psychiatric illness.

“Adolescence, in particular, is so critical for brain development, and it really raises the question of whether sleep disturbances in adolescence or poor sleep patterns are contributing to the increase psychiatric epidemic we’re seeing in adolescents and children these days,” said Dr. Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, N.C.

Also weighing in on the study, journalist and author Lisa Lewis, MS, based in Southern California, said, “It’s not surprising that tech use and social media – which is such an important part of their social worlds – went up during the pandemic.”

Ms. Lewis, a parent of two teenagers, played a key role in California’s new healthy school start times law, the first of its kind in the nation, and is the author of the newly released book, The Sleep-Deprived Teen (Mango Publishing).

“Far too many adolescents aren’t getting anywhere close to the 8-10 hours of nightly sleep they need,” Ms. Lewis said in an interview.

She noted that the the American Academy of Pediatrics recommends no tech use an hour before bed.

“And there are other house rules parents can implement, such as charging all devices in a central location, like the kitchen. Making sleep a priority helps teens, but it helps parents too: No one functions well when they’re sleep-deprived,” Ms. Lewis added.

Support for the study was provided by the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals. Ms. Lewis has no relevant disclosures.

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

During the first year of the pandemic, profound changes in screen use and sleep timing occurred among U.S. adolescents as a result of spending more time using electronic devices, going to bed later, and getting up later, compared with before the pandemic, new research indicates.

The excessive screen time negatively affected sleep, said lead investigator Orsolya Kiss, PhD, with the Center for Health Sciences at SRI International, Menlo Park, Calif.

And what’s “concerning,” she told this news organization, is that there is no indication of any spontaneous decline in screen use in 2021, when there were fewer restrictions.

Dr. Kiss said she is “very much interested to see what future studies will show.”

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Sleep takes a pandemic hit

“Adolescents and families have turned to online activities and social platforms more than ever before to maintain wellbeing, [to] connect with friends and family, and for online schooling,” Dr. Kiss said in a conference statement.

She and her colleagues examined longitudinal data from 5,027 adolescents aged 11-14 years who are participating in the ongoing Adolescent Brain Cognitive Development (ABCD) study.

As part of the study, participants reported sleep and daily screen time use prior to and at six time points during the first year of the pandemic (May 2020 to March 2021).

During the first year of the pandemic, relative to before the pandemic, recreational screen time was dramatically higher, with adolescents spending about 45 minutes more on social media and 20 minutes more playing video games, Dr. Kiss reported.

The jump in screen time was coupled with changes in sleep patterns.

Adolescents’ wake up times were delayed about 1.5 hours during May and August 2020, relative to prepandemic levels. The delay was partly due to summer break; wake-up times returned to earlier times in the fall of 2020.

During all pandemic assessments, bedtimes were delayed by about 1 hour, even when the new school year started. This was particularly the case in older adolescents and girls.

The findings highlight the need to promote “balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change,” the authors wrote in their conference abstract.
 

Mental illness risk

In an interview, Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, noted that “during adolescence, the tendency to become more of a night owl naturally worsens, and when kids have no sleep schedule imposed on them, these patterns become exacerbated.”

Dr. Benca, who was not involved in the study, also noted that altered sleep patterns are risk factors for psychiatric illness.

“Adolescence, in particular, is so critical for brain development, and it really raises the question of whether sleep disturbances in adolescence or poor sleep patterns are contributing to the increase psychiatric epidemic we’re seeing in adolescents and children these days,” said Dr. Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, N.C.

Also weighing in on the study, journalist and author Lisa Lewis, MS, based in Southern California, said, “It’s not surprising that tech use and social media – which is such an important part of their social worlds – went up during the pandemic.”

Ms. Lewis, a parent of two teenagers, played a key role in California’s new healthy school start times law, the first of its kind in the nation, and is the author of the newly released book, The Sleep-Deprived Teen (Mango Publishing).

“Far too many adolescents aren’t getting anywhere close to the 8-10 hours of nightly sleep they need,” Ms. Lewis said in an interview.

She noted that the the American Academy of Pediatrics recommends no tech use an hour before bed.

“And there are other house rules parents can implement, such as charging all devices in a central location, like the kitchen. Making sleep a priority helps teens, but it helps parents too: No one functions well when they’re sleep-deprived,” Ms. Lewis added.

Support for the study was provided by the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals. Ms. Lewis has no relevant disclosures.

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

COVID-19 infection during pregnancy has been linked to a small but significant effect on infant neurodevelopment, suggests a small-scale analysis that points to the need for further study and monitoring during pregnancy.

The study included 24 pregnant women, half of whom had COVID-19 during pregnancy, and their offspring. It showed impairments at 6 weeks of age on the social interactive dimension of a neonatal assessment.

“Not all babies born to mothers infected with COVID show neurodevelopmental differences, but our data show that their risk is increased in comparison to those not exposed to COVID in the womb. We need a bigger study to confirm the exact extent of the difference,” said lead researcher Rosa Ayesa Arriola, PhD, Valdecilla Research Institute (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, Spain, in a release.

The findings were presented at the virtual European Psychiatric Association 2022 Congress.
 

Differing responses to cuddling

Coauthor Águeda Castro Quintas, PhD student, Network Centre for Biomedical Research in Mental Health, University of Barcelona, explained that the tests showed the children born to mothers who had COVID-19 during pregnancy reacted “slightly differently to being held, or cuddled.”

“We need to note that these are preliminary results, but this is part of a project following a larger sample of 100 mothers and their babies,” she added. The authors plan to compare their results with those from a similar study.

The group will also monitor infant language and motor development aged between 18 and 42 months.

“This is an ongoing project, and we are at an early stage,” Ms. Castro Quintas said. “We don’t know if these effects will result in any longer-term issues,” but longer-term observation “may help us understand this.”

“Of course, in babies who are so young, there are several things we just can’t measure, such as language skills or cognition,” added coinvestigator Nerea San Martín González, department of evolutionary biology, ecology and environmental sciences, University of Barcelona.

While emphasizing the need for larger sample sizes, she said that “in the meantime, we need to stress the importance of medical monitoring to facilitate a healthy pregnancy.”

The researchers note that the consequences of the COVID-19 pandemic for the newborns of affected mothers remain “unknown.”

However, previous studies of other infections during pregnancy suggest that offspring could be “especially vulnerable,”as the pathophysiological mechanisms of the infection, such as cytokine storms and microcoagulation, “could clearly compromise fetal neurodevelopment.”

To investigate further, they examined the neurodevelopment of infants born both immediately before and during the COVID-19 pandemic, from 2017 to 2021.

Twenty-one women who had COVID-19 during pregnancy were matched with 21 healthy controls. They were studied both during pregnancy and in the postpartum period, completing hormonal and other biochemical tests, salivary tests, movement assessments, and psychological questionnaires, adjusted for various factors.

The team also administered the Brazelton Neonatal Behavioural Assessment Scale (NBAS) to the offspring at 6 weeks of age to evaluate neurologic, social, and behavioral aspects of function.

“We have been especially sensitive in how we have conducted these tests,” said Ms. Castro Quintas. “Each mother and baby were closely examined by clinicians with expert training in the field and in the tests.”

Among those offspring exposed to COVID-19 during pregnancy, there was a significant decrease in scores on the social interactive dimension of the NBAS, particularly if infection occurred before week 20 of gestation.

Other NBAS subscales were not associated with maternal COVID-19 during pregnancy.
 

More research needed

Commenting on the findings, Livio Provenzi, PhD, a psychologist and researcher in developmental psychobiology at the University of Pavia (Italy), noted there is a “great need” to study the direct and indirect effect of the COVID-19 pandemic on parents and their children. “Pregnancy is a period of life which shapes much of our subsequent development, and exposure to adversity in pregnancy can leave long-lasting biological footprints.”

Dr. Provenzi, who was not involved in the study, added in the release that the findings reinforce “evidence of epigenetic alterations in infants born from mothers exposed to pandemic-related stress during pregnancy.

“It shows we need more large-scale, international research to allow us to understand the developmental effects of this health emergency and to deliver better quality of care to parents and infants.”

The study was funded by the Spanish Ministry of Economy and Competitiveness, Instituto de Salud Carlos III through the University of Barcelona multicenter project and the Government of Cantabria. No relevant financial relationships were declared.

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

COVID-19 infection during pregnancy has been linked to a small but significant effect on infant neurodevelopment, suggests a small-scale analysis that points to the need for further study and monitoring during pregnancy.

The study included 24 pregnant women, half of whom had COVID-19 during pregnancy, and their offspring. It showed impairments at 6 weeks of age on the social interactive dimension of a neonatal assessment.

“Not all babies born to mothers infected with COVID show neurodevelopmental differences, but our data show that their risk is increased in comparison to those not exposed to COVID in the womb. We need a bigger study to confirm the exact extent of the difference,” said lead researcher Rosa Ayesa Arriola, PhD, Valdecilla Research Institute (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, Spain, in a release.

The findings were presented at the virtual European Psychiatric Association 2022 Congress.
 

Differing responses to cuddling

Coauthor Águeda Castro Quintas, PhD student, Network Centre for Biomedical Research in Mental Health, University of Barcelona, explained that the tests showed the children born to mothers who had COVID-19 during pregnancy reacted “slightly differently to being held, or cuddled.”

“We need to note that these are preliminary results, but this is part of a project following a larger sample of 100 mothers and their babies,” she added. The authors plan to compare their results with those from a similar study.

The group will also monitor infant language and motor development aged between 18 and 42 months.

“This is an ongoing project, and we are at an early stage,” Ms. Castro Quintas said. “We don’t know if these effects will result in any longer-term issues,” but longer-term observation “may help us understand this.”

“Of course, in babies who are so young, there are several things we just can’t measure, such as language skills or cognition,” added coinvestigator Nerea San Martín González, department of evolutionary biology, ecology and environmental sciences, University of Barcelona.

While emphasizing the need for larger sample sizes, she said that “in the meantime, we need to stress the importance of medical monitoring to facilitate a healthy pregnancy.”

The researchers note that the consequences of the COVID-19 pandemic for the newborns of affected mothers remain “unknown.”

However, previous studies of other infections during pregnancy suggest that offspring could be “especially vulnerable,”as the pathophysiological mechanisms of the infection, such as cytokine storms and microcoagulation, “could clearly compromise fetal neurodevelopment.”

To investigate further, they examined the neurodevelopment of infants born both immediately before and during the COVID-19 pandemic, from 2017 to 2021.

Twenty-one women who had COVID-19 during pregnancy were matched with 21 healthy controls. They were studied both during pregnancy and in the postpartum period, completing hormonal and other biochemical tests, salivary tests, movement assessments, and psychological questionnaires, adjusted for various factors.

The team also administered the Brazelton Neonatal Behavioural Assessment Scale (NBAS) to the offspring at 6 weeks of age to evaluate neurologic, social, and behavioral aspects of function.

“We have been especially sensitive in how we have conducted these tests,” said Ms. Castro Quintas. “Each mother and baby were closely examined by clinicians with expert training in the field and in the tests.”

Among those offspring exposed to COVID-19 during pregnancy, there was a significant decrease in scores on the social interactive dimension of the NBAS, particularly if infection occurred before week 20 of gestation.

Other NBAS subscales were not associated with maternal COVID-19 during pregnancy.
 

More research needed

Commenting on the findings, Livio Provenzi, PhD, a psychologist and researcher in developmental psychobiology at the University of Pavia (Italy), noted there is a “great need” to study the direct and indirect effect of the COVID-19 pandemic on parents and their children. “Pregnancy is a period of life which shapes much of our subsequent development, and exposure to adversity in pregnancy can leave long-lasting biological footprints.”

Dr. Provenzi, who was not involved in the study, added in the release that the findings reinforce “evidence of epigenetic alterations in infants born from mothers exposed to pandemic-related stress during pregnancy.

“It shows we need more large-scale, international research to allow us to understand the developmental effects of this health emergency and to deliver better quality of care to parents and infants.”

The study was funded by the Spanish Ministry of Economy and Competitiveness, Instituto de Salud Carlos III through the University of Barcelona multicenter project and the Government of Cantabria. No relevant financial relationships were declared.

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

COVID-19 infection during pregnancy has been linked to a small but significant effect on infant neurodevelopment, suggests a small-scale analysis that points to the need for further study and monitoring during pregnancy.

The study included 24 pregnant women, half of whom had COVID-19 during pregnancy, and their offspring. It showed impairments at 6 weeks of age on the social interactive dimension of a neonatal assessment.

“Not all babies born to mothers infected with COVID show neurodevelopmental differences, but our data show that their risk is increased in comparison to those not exposed to COVID in the womb. We need a bigger study to confirm the exact extent of the difference,” said lead researcher Rosa Ayesa Arriola, PhD, Valdecilla Research Institute (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, Spain, in a release.

The findings were presented at the virtual European Psychiatric Association 2022 Congress.
 

Differing responses to cuddling

Coauthor Águeda Castro Quintas, PhD student, Network Centre for Biomedical Research in Mental Health, University of Barcelona, explained that the tests showed the children born to mothers who had COVID-19 during pregnancy reacted “slightly differently to being held, or cuddled.”

“We need to note that these are preliminary results, but this is part of a project following a larger sample of 100 mothers and their babies,” she added. The authors plan to compare their results with those from a similar study.

The group will also monitor infant language and motor development aged between 18 and 42 months.

“This is an ongoing project, and we are at an early stage,” Ms. Castro Quintas said. “We don’t know if these effects will result in any longer-term issues,” but longer-term observation “may help us understand this.”

“Of course, in babies who are so young, there are several things we just can’t measure, such as language skills or cognition,” added coinvestigator Nerea San Martín González, department of evolutionary biology, ecology and environmental sciences, University of Barcelona.

While emphasizing the need for larger sample sizes, she said that “in the meantime, we need to stress the importance of medical monitoring to facilitate a healthy pregnancy.”

The researchers note that the consequences of the COVID-19 pandemic for the newborns of affected mothers remain “unknown.”

However, previous studies of other infections during pregnancy suggest that offspring could be “especially vulnerable,”as the pathophysiological mechanisms of the infection, such as cytokine storms and microcoagulation, “could clearly compromise fetal neurodevelopment.”

To investigate further, they examined the neurodevelopment of infants born both immediately before and during the COVID-19 pandemic, from 2017 to 2021.

Twenty-one women who had COVID-19 during pregnancy were matched with 21 healthy controls. They were studied both during pregnancy and in the postpartum period, completing hormonal and other biochemical tests, salivary tests, movement assessments, and psychological questionnaires, adjusted for various factors.

The team also administered the Brazelton Neonatal Behavioural Assessment Scale (NBAS) to the offspring at 6 weeks of age to evaluate neurologic, social, and behavioral aspects of function.

“We have been especially sensitive in how we have conducted these tests,” said Ms. Castro Quintas. “Each mother and baby were closely examined by clinicians with expert training in the field and in the tests.”

Among those offspring exposed to COVID-19 during pregnancy, there was a significant decrease in scores on the social interactive dimension of the NBAS, particularly if infection occurred before week 20 of gestation.

Other NBAS subscales were not associated with maternal COVID-19 during pregnancy.
 

More research needed

Commenting on the findings, Livio Provenzi, PhD, a psychologist and researcher in developmental psychobiology at the University of Pavia (Italy), noted there is a “great need” to study the direct and indirect effect of the COVID-19 pandemic on parents and their children. “Pregnancy is a period of life which shapes much of our subsequent development, and exposure to adversity in pregnancy can leave long-lasting biological footprints.”

Dr. Provenzi, who was not involved in the study, added in the release that the findings reinforce “evidence of epigenetic alterations in infants born from mothers exposed to pandemic-related stress during pregnancy.

“It shows we need more large-scale, international research to allow us to understand the developmental effects of this health emergency and to deliver better quality of care to parents and infants.”

The study was funded by the Spanish Ministry of Economy and Competitiveness, Instituto de Salud Carlos III through the University of Barcelona multicenter project and the Government of Cantabria. No relevant financial relationships were declared.

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

Moderate to severe sleep disturbances and severe fatigue affect up to 40% of patients with long COVID, or post-acute sequelae of SARS-CoV-2 infection (PASC). Such disturbances are especially common among Black people, new research shows.

The “high” prevalence of moderate to severe sleep disturbances is “alarming,” study investigator Cinthya Pena Orbea, MD, sleep specialist at the Cleveland Clinic, said in an interview.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.

Dr. Pena and colleagues analyzed data on 962 patients with PASC seen at the Cleveland Clinic ReCOVer Clinic between February 2021 and April 2022.

More than two-thirds of patients (67.2%) reported at least moderate fatigue, while 21.8% reported severe fatigue, Dr. Pena reported.

In addition, 41.3% reported at least moderate sleep disturbances, while 8% of patients reported severe sleep disturbances, including insomnia, “which may impair quality of life,” Dr. Pena said.

Obesity, mood disorders, and Black race emerged as contributors to problems with sleep and fatigue after COVID.

Notably, after adjusting for demographics, Black race conferred threefold higher odds of moderate to severe sleep disturbances.

“We don’t know why this is, and one of our next steps is to better understand race-specific determinants of sleep disturbances after COVID and create targeted interventions,” Dr. Pena said.

How long after COVID the fatigue and sleep problems last “remains uncertain,” Dr. Pena acknowledged. However, in her clinical experience with therapy, patients’ sleep and fatigue may improve after 6 or 8 months.

Ruth Benca, MD, PhD, cochair of the Alliance for Sleep, is not surprised by the Cleveland Clinic findings.

“Sleep disturbances and fatigue are part of the sequelae of COVID,” Dr. Benca, who was not involved in the study, said in an interview.

“We know that people who have had COVID have more trouble sleeping afterwards. There is the COVID insomnia created in all of us just out of our worries, fears, isolation, and stress. And then there’s an actual impact of having the infection itself on worsening sleep,” said Dr. Benca, with Wake Forest University and Atrium Health Wake Forest Baptist, both in Winston-Salem, N.C.

The study had no specific funding. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals.

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

Moderate to severe sleep disturbances and severe fatigue affect up to 40% of patients with long COVID, or post-acute sequelae of SARS-CoV-2 infection (PASC). Such disturbances are especially common among Black people, new research shows.

The “high” prevalence of moderate to severe sleep disturbances is “alarming,” study investigator Cinthya Pena Orbea, MD, sleep specialist at the Cleveland Clinic, said in an interview.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.

Dr. Pena and colleagues analyzed data on 962 patients with PASC seen at the Cleveland Clinic ReCOVer Clinic between February 2021 and April 2022.

More than two-thirds of patients (67.2%) reported at least moderate fatigue, while 21.8% reported severe fatigue, Dr. Pena reported.

In addition, 41.3% reported at least moderate sleep disturbances, while 8% of patients reported severe sleep disturbances, including insomnia, “which may impair quality of life,” Dr. Pena said.

Obesity, mood disorders, and Black race emerged as contributors to problems with sleep and fatigue after COVID.

Notably, after adjusting for demographics, Black race conferred threefold higher odds of moderate to severe sleep disturbances.

“We don’t know why this is, and one of our next steps is to better understand race-specific determinants of sleep disturbances after COVID and create targeted interventions,” Dr. Pena said.

How long after COVID the fatigue and sleep problems last “remains uncertain,” Dr. Pena acknowledged. However, in her clinical experience with therapy, patients’ sleep and fatigue may improve after 6 or 8 months.

Ruth Benca, MD, PhD, cochair of the Alliance for Sleep, is not surprised by the Cleveland Clinic findings.

“Sleep disturbances and fatigue are part of the sequelae of COVID,” Dr. Benca, who was not involved in the study, said in an interview.

“We know that people who have had COVID have more trouble sleeping afterwards. There is the COVID insomnia created in all of us just out of our worries, fears, isolation, and stress. And then there’s an actual impact of having the infection itself on worsening sleep,” said Dr. Benca, with Wake Forest University and Atrium Health Wake Forest Baptist, both in Winston-Salem, N.C.

The study had no specific funding. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals.

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

Moderate to severe sleep disturbances and severe fatigue affect up to 40% of patients with long COVID, or post-acute sequelae of SARS-CoV-2 infection (PASC). Such disturbances are especially common among Black people, new research shows.

The “high” prevalence of moderate to severe sleep disturbances is “alarming,” study investigator Cinthya Pena Orbea, MD, sleep specialist at the Cleveland Clinic, said in an interview.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.

Dr. Pena and colleagues analyzed data on 962 patients with PASC seen at the Cleveland Clinic ReCOVer Clinic between February 2021 and April 2022.

More than two-thirds of patients (67.2%) reported at least moderate fatigue, while 21.8% reported severe fatigue, Dr. Pena reported.

In addition, 41.3% reported at least moderate sleep disturbances, while 8% of patients reported severe sleep disturbances, including insomnia, “which may impair quality of life,” Dr. Pena said.

Obesity, mood disorders, and Black race emerged as contributors to problems with sleep and fatigue after COVID.

Notably, after adjusting for demographics, Black race conferred threefold higher odds of moderate to severe sleep disturbances.

“We don’t know why this is, and one of our next steps is to better understand race-specific determinants of sleep disturbances after COVID and create targeted interventions,” Dr. Pena said.

How long after COVID the fatigue and sleep problems last “remains uncertain,” Dr. Pena acknowledged. However, in her clinical experience with therapy, patients’ sleep and fatigue may improve after 6 or 8 months.

Ruth Benca, MD, PhD, cochair of the Alliance for Sleep, is not surprised by the Cleveland Clinic findings.

“Sleep disturbances and fatigue are part of the sequelae of COVID,” Dr. Benca, who was not involved in the study, said in an interview.

“We know that people who have had COVID have more trouble sleeping afterwards. There is the COVID insomnia created in all of us just out of our worries, fears, isolation, and stress. And then there’s an actual impact of having the infection itself on worsening sleep,” said Dr. Benca, with Wake Forest University and Atrium Health Wake Forest Baptist, both in Winston-Salem, N.C.

The study had no specific funding. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals.

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

A federal advisory panel strongly supported a bid for Novavax to win U.S. emergency authorization for its COVID-19 vaccine, which is based on a more traditional, protein-based approach than the cutting-edge technology used in mRNA-based shots.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted almost unanimously June 7 in favor of Novavax’s two-dose COVID-19 vaccine for those 18 or older – despite some concerns over rare events of myocarditis and pericarditis.

The tally was 21 “yes” votes, without any “no” votes, but one abstention from a panelist who then offered a largely positive take on this vaccine.

Panelist Bruce Gellin, MD, explained at the end of the meeting that he would have cast a conditional vote in favor of the Novavax vaccine, called NVX-CoV2373, had that been an option. Dr. Gellin, chief of global public health strategy for the Rockefeller Foundation and a vaccine expert, said he didn’t want his abstention to be considered as signaling opposition to the Novavax shot.

Instead, he said, he expects FDA officials will gather more data and evidence about the Novavax vaccine, especially in relation to certain manufacturing issues, before making its decision on the company’s application.

Earlier in the day, a top FDA vaccine reviewer, Doran Fink, MD, PhD, noted that there were important manufacturing differences between the Novavax vaccine supply used in different projects, complicating efforts to assess the company’s application for emergency use authorization (EUA).

But Dr. Fink noted that the FDA staff already had made a convincing case in its briefing document, with enough evidence for an initial conditional clearance to be found in available data.

The FDA is not bound to follow the suggestions of its advisory committees but it often does.
 

Using the ‘bully pulpit’

At the beginning of the meeting, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said he was seizing the “bully pulpit” in addressing the need to persuade more people in the United States to take shots against COVID-19.

About 67% of people in the United States aged 18 and older are fully vaccinated, but only about 50% of those in this group have had a first booster, according to the Centers for Disease Control and Prevention.

The two-dose mRNA vaccines from Pfizer and Moderna have been the subject of intense misinformation campaigns on social media, despite efforts by the FDA and other public health officials to convey the message about their strong benefit-risk profile. The FDA in May limited the authorized use of Johnson & Johnson’s single-dose COVID-19 shot, which is based on a different technology, because of concerns about rare and potentially life-threatening blood clots.

Novavax has been described as a more traditional vaccine – a protein subunit shot similar to one people have long received for protection against influenza, pertussis (whooping cough), diphtheria, and tetanus.

“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Dr. Marks said. “We do have a problem with vaccine uptake that is very serious in the United States. And anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do.”

Dr. Marks offered these remarks in answer to an FDA panelist’s question about the need to consider an EUA for yet another vaccine.

EUAs are special clearances the FDA can grant in connection with public health emergencies such as the pandemic. The FDA used EUAs for the initial December 2020 clearances of the Pfizer-BioNTech and Moderna vaccines. It has since granted normal approvals for both of these mRNA-based vaccines, based on larger bodies of evidence gathered and submitted by their developers.

During the meeting, the FDA panelists in general appeared comfortable with the idea of granting another EUA for a vaccine. There was agreement that the shot appeared to work in key tests, although these were done before the rise of the Omicron variant.

In a key test, known as study 301, the Novavax vaccine was judged to be 90.4% effective. In the study, 17 of the 17,272 people who got the Novavax vaccine developed COVID-19, compared with 79 of the 8,385 in the placebo group.

Panelists expressed disappointment with the lack of information about how the shot would work now.

“We’re looking at the efficacy against strains that don’t exist any longer,” said panelist Eric J. Rubin, MD, PhD, a Harvard professor and editor of the New England Journal of Medicine.

Still, Dr. Rubin added that he agreed with the argument the FDA’s Dr. Marks had made earlier for an EUA for the Novavax vaccine.

“If there really is a population of patients who are willing to take this and not willing to take the existing vaccines, I think it’s pretty compelling,” Dr. Rubin said.

Other FDA panelists were skeptical of this argument. Jay Portnoy, MD, who was listed on the FDA roster as the panel’s consumer representative, said he has close friends who are vaccine skeptics.

“Their hesitancy is more ideological than technological,” said Dr. Portnoy of Children’s Mercy Hospital, Kansas City, Mo. “So I really doubt that this vaccine is going to crack that nut, but perhaps some individuals would get this when they wouldn’t get the other ones.”
 

Myocarditis, pericarditis

The Novavax vaccine is already authorized in other countries, including Canada. Novavax in February announced that it had begun shipping its first doses of the vaccine to European Union member states. The vaccine can be moved through existing vaccine supply and cold chain channels instead of requiring complex new delivery procedures.

That could prove an advantage in time, said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville.

“Who knows even with supply chain challenges down the road, it will be nice to have options going forward,” Dr. Nelson said. 

As with other COVID-19 vaccines, clinicians and researchers are still working to understand the potential risk for inflammation of heart muscle and nearby tissue with vaccination. Most patients with myocarditis or pericarditis who sought medical care for these conditions responded well to medicine and rest and felt better quickly, the CDC says on its website. They usually return to their normal daily activities after their symptoms improve.

At the June 7 meeting, Dr. Nelson said there may be cases of myocarditis that go undetected.

“Our signals are those who get admitted to the emergency room and the hospital,” he said. “I’m quite convinced that there are others who are experiencing cardiac events of lesser severity that are worthy of being studied, both from mechanistic and outcomes standpoints. So we have a lot of work to do.”

In looking at results for an initial pool of 40,000 people who received the Novavax vaccine, there were five reported cases of myocarditis or pericarditis developing within 20 days of people getting the shot, the FDA staff said in its presentation on safety.

In a briefing document released ahead of the advisory committee meeting, the FDA staff flagged this number of cases in a relatively small database as a concern, noting it “could be higher than reported during postauthorization use of mRNA COVID-19 vaccines (for which no cases were identified in preauthorization evaluation).”

Novavax officials took a somewhat unusual step of responding in public. The Gaithersburg, Md.–based company on June 3 issued a statement saying researchers had come to “expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk.”

The data from the company’s placebo-controlled studies show that, overall, in its clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%), Novavax said.

At the June 7 meeting, FDA panelists including Dr. Nelson, and Paul A. Offit, MD, of Children’s Hospital of Philadelphia, urged continued study to try to determine whether and how the vaccines could trigger myocarditis. Investments made now in pursuing these questions related to COVID-19 shots may pay off later, Dr. Offit said.

“We can use that knowledge to make safer vaccines for a disease that is going to be with us for decades, if not longer,” he said.

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

A federal advisory panel strongly supported a bid for Novavax to win U.S. emergency authorization for its COVID-19 vaccine, which is based on a more traditional, protein-based approach than the cutting-edge technology used in mRNA-based shots.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted almost unanimously June 7 in favor of Novavax’s two-dose COVID-19 vaccine for those 18 or older – despite some concerns over rare events of myocarditis and pericarditis.

The tally was 21 “yes” votes, without any “no” votes, but one abstention from a panelist who then offered a largely positive take on this vaccine.

Panelist Bruce Gellin, MD, explained at the end of the meeting that he would have cast a conditional vote in favor of the Novavax vaccine, called NVX-CoV2373, had that been an option. Dr. Gellin, chief of global public health strategy for the Rockefeller Foundation and a vaccine expert, said he didn’t want his abstention to be considered as signaling opposition to the Novavax shot.

Instead, he said, he expects FDA officials will gather more data and evidence about the Novavax vaccine, especially in relation to certain manufacturing issues, before making its decision on the company’s application.

Earlier in the day, a top FDA vaccine reviewer, Doran Fink, MD, PhD, noted that there were important manufacturing differences between the Novavax vaccine supply used in different projects, complicating efforts to assess the company’s application for emergency use authorization (EUA).

But Dr. Fink noted that the FDA staff already had made a convincing case in its briefing document, with enough evidence for an initial conditional clearance to be found in available data.

The FDA is not bound to follow the suggestions of its advisory committees but it often does.
 

Using the ‘bully pulpit’

At the beginning of the meeting, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said he was seizing the “bully pulpit” in addressing the need to persuade more people in the United States to take shots against COVID-19.

About 67% of people in the United States aged 18 and older are fully vaccinated, but only about 50% of those in this group have had a first booster, according to the Centers for Disease Control and Prevention.

The two-dose mRNA vaccines from Pfizer and Moderna have been the subject of intense misinformation campaigns on social media, despite efforts by the FDA and other public health officials to convey the message about their strong benefit-risk profile. The FDA in May limited the authorized use of Johnson & Johnson’s single-dose COVID-19 shot, which is based on a different technology, because of concerns about rare and potentially life-threatening blood clots.

Novavax has been described as a more traditional vaccine – a protein subunit shot similar to one people have long received for protection against influenza, pertussis (whooping cough), diphtheria, and tetanus.

“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Dr. Marks said. “We do have a problem with vaccine uptake that is very serious in the United States. And anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do.”

Dr. Marks offered these remarks in answer to an FDA panelist’s question about the need to consider an EUA for yet another vaccine.

EUAs are special clearances the FDA can grant in connection with public health emergencies such as the pandemic. The FDA used EUAs for the initial December 2020 clearances of the Pfizer-BioNTech and Moderna vaccines. It has since granted normal approvals for both of these mRNA-based vaccines, based on larger bodies of evidence gathered and submitted by their developers.

During the meeting, the FDA panelists in general appeared comfortable with the idea of granting another EUA for a vaccine. There was agreement that the shot appeared to work in key tests, although these were done before the rise of the Omicron variant.

In a key test, known as study 301, the Novavax vaccine was judged to be 90.4% effective. In the study, 17 of the 17,272 people who got the Novavax vaccine developed COVID-19, compared with 79 of the 8,385 in the placebo group.

Panelists expressed disappointment with the lack of information about how the shot would work now.

“We’re looking at the efficacy against strains that don’t exist any longer,” said panelist Eric J. Rubin, MD, PhD, a Harvard professor and editor of the New England Journal of Medicine.

Still, Dr. Rubin added that he agreed with the argument the FDA’s Dr. Marks had made earlier for an EUA for the Novavax vaccine.

“If there really is a population of patients who are willing to take this and not willing to take the existing vaccines, I think it’s pretty compelling,” Dr. Rubin said.

Other FDA panelists were skeptical of this argument. Jay Portnoy, MD, who was listed on the FDA roster as the panel’s consumer representative, said he has close friends who are vaccine skeptics.

“Their hesitancy is more ideological than technological,” said Dr. Portnoy of Children’s Mercy Hospital, Kansas City, Mo. “So I really doubt that this vaccine is going to crack that nut, but perhaps some individuals would get this when they wouldn’t get the other ones.”
 

Myocarditis, pericarditis

The Novavax vaccine is already authorized in other countries, including Canada. Novavax in February announced that it had begun shipping its first doses of the vaccine to European Union member states. The vaccine can be moved through existing vaccine supply and cold chain channels instead of requiring complex new delivery procedures.

That could prove an advantage in time, said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville.

“Who knows even with supply chain challenges down the road, it will be nice to have options going forward,” Dr. Nelson said. 

As with other COVID-19 vaccines, clinicians and researchers are still working to understand the potential risk for inflammation of heart muscle and nearby tissue with vaccination. Most patients with myocarditis or pericarditis who sought medical care for these conditions responded well to medicine and rest and felt better quickly, the CDC says on its website. They usually return to their normal daily activities after their symptoms improve.

At the June 7 meeting, Dr. Nelson said there may be cases of myocarditis that go undetected.

“Our signals are those who get admitted to the emergency room and the hospital,” he said. “I’m quite convinced that there are others who are experiencing cardiac events of lesser severity that are worthy of being studied, both from mechanistic and outcomes standpoints. So we have a lot of work to do.”

In looking at results for an initial pool of 40,000 people who received the Novavax vaccine, there were five reported cases of myocarditis or pericarditis developing within 20 days of people getting the shot, the FDA staff said in its presentation on safety.

In a briefing document released ahead of the advisory committee meeting, the FDA staff flagged this number of cases in a relatively small database as a concern, noting it “could be higher than reported during postauthorization use of mRNA COVID-19 vaccines (for which no cases were identified in preauthorization evaluation).”

Novavax officials took a somewhat unusual step of responding in public. The Gaithersburg, Md.–based company on June 3 issued a statement saying researchers had come to “expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk.”

The data from the company’s placebo-controlled studies show that, overall, in its clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%), Novavax said.

At the June 7 meeting, FDA panelists including Dr. Nelson, and Paul A. Offit, MD, of Children’s Hospital of Philadelphia, urged continued study to try to determine whether and how the vaccines could trigger myocarditis. Investments made now in pursuing these questions related to COVID-19 shots may pay off later, Dr. Offit said.

“We can use that knowledge to make safer vaccines for a disease that is going to be with us for decades, if not longer,” he said.

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

A federal advisory panel strongly supported a bid for Novavax to win U.S. emergency authorization for its COVID-19 vaccine, which is based on a more traditional, protein-based approach than the cutting-edge technology used in mRNA-based shots.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted almost unanimously June 7 in favor of Novavax’s two-dose COVID-19 vaccine for those 18 or older – despite some concerns over rare events of myocarditis and pericarditis.

The tally was 21 “yes” votes, without any “no” votes, but one abstention from a panelist who then offered a largely positive take on this vaccine.

Panelist Bruce Gellin, MD, explained at the end of the meeting that he would have cast a conditional vote in favor of the Novavax vaccine, called NVX-CoV2373, had that been an option. Dr. Gellin, chief of global public health strategy for the Rockefeller Foundation and a vaccine expert, said he didn’t want his abstention to be considered as signaling opposition to the Novavax shot.

Instead, he said, he expects FDA officials will gather more data and evidence about the Novavax vaccine, especially in relation to certain manufacturing issues, before making its decision on the company’s application.

Earlier in the day, a top FDA vaccine reviewer, Doran Fink, MD, PhD, noted that there were important manufacturing differences between the Novavax vaccine supply used in different projects, complicating efforts to assess the company’s application for emergency use authorization (EUA).

But Dr. Fink noted that the FDA staff already had made a convincing case in its briefing document, with enough evidence for an initial conditional clearance to be found in available data.

The FDA is not bound to follow the suggestions of its advisory committees but it often does.
 

Using the ‘bully pulpit’

At the beginning of the meeting, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said he was seizing the “bully pulpit” in addressing the need to persuade more people in the United States to take shots against COVID-19.

About 67% of people in the United States aged 18 and older are fully vaccinated, but only about 50% of those in this group have had a first booster, according to the Centers for Disease Control and Prevention.

The two-dose mRNA vaccines from Pfizer and Moderna have been the subject of intense misinformation campaigns on social media, despite efforts by the FDA and other public health officials to convey the message about their strong benefit-risk profile. The FDA in May limited the authorized use of Johnson & Johnson’s single-dose COVID-19 shot, which is based on a different technology, because of concerns about rare and potentially life-threatening blood clots.

Novavax has been described as a more traditional vaccine – a protein subunit shot similar to one people have long received for protection against influenza, pertussis (whooping cough), diphtheria, and tetanus.

“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Dr. Marks said. “We do have a problem with vaccine uptake that is very serious in the United States. And anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do.”

Dr. Marks offered these remarks in answer to an FDA panelist’s question about the need to consider an EUA for yet another vaccine.

EUAs are special clearances the FDA can grant in connection with public health emergencies such as the pandemic. The FDA used EUAs for the initial December 2020 clearances of the Pfizer-BioNTech and Moderna vaccines. It has since granted normal approvals for both of these mRNA-based vaccines, based on larger bodies of evidence gathered and submitted by their developers.

During the meeting, the FDA panelists in general appeared comfortable with the idea of granting another EUA for a vaccine. There was agreement that the shot appeared to work in key tests, although these were done before the rise of the Omicron variant.

In a key test, known as study 301, the Novavax vaccine was judged to be 90.4% effective. In the study, 17 of the 17,272 people who got the Novavax vaccine developed COVID-19, compared with 79 of the 8,385 in the placebo group.

Panelists expressed disappointment with the lack of information about how the shot would work now.

“We’re looking at the efficacy against strains that don’t exist any longer,” said panelist Eric J. Rubin, MD, PhD, a Harvard professor and editor of the New England Journal of Medicine.

Still, Dr. Rubin added that he agreed with the argument the FDA’s Dr. Marks had made earlier for an EUA for the Novavax vaccine.

“If there really is a population of patients who are willing to take this and not willing to take the existing vaccines, I think it’s pretty compelling,” Dr. Rubin said.

Other FDA panelists were skeptical of this argument. Jay Portnoy, MD, who was listed on the FDA roster as the panel’s consumer representative, said he has close friends who are vaccine skeptics.

“Their hesitancy is more ideological than technological,” said Dr. Portnoy of Children’s Mercy Hospital, Kansas City, Mo. “So I really doubt that this vaccine is going to crack that nut, but perhaps some individuals would get this when they wouldn’t get the other ones.”
 

Myocarditis, pericarditis

The Novavax vaccine is already authorized in other countries, including Canada. Novavax in February announced that it had begun shipping its first doses of the vaccine to European Union member states. The vaccine can be moved through existing vaccine supply and cold chain channels instead of requiring complex new delivery procedures.

That could prove an advantage in time, said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville.

“Who knows even with supply chain challenges down the road, it will be nice to have options going forward,” Dr. Nelson said. 

As with other COVID-19 vaccines, clinicians and researchers are still working to understand the potential risk for inflammation of heart muscle and nearby tissue with vaccination. Most patients with myocarditis or pericarditis who sought medical care for these conditions responded well to medicine and rest and felt better quickly, the CDC says on its website. They usually return to their normal daily activities after their symptoms improve.

At the June 7 meeting, Dr. Nelson said there may be cases of myocarditis that go undetected.

“Our signals are those who get admitted to the emergency room and the hospital,” he said. “I’m quite convinced that there are others who are experiencing cardiac events of lesser severity that are worthy of being studied, both from mechanistic and outcomes standpoints. So we have a lot of work to do.”

In looking at results for an initial pool of 40,000 people who received the Novavax vaccine, there were five reported cases of myocarditis or pericarditis developing within 20 days of people getting the shot, the FDA staff said in its presentation on safety.

In a briefing document released ahead of the advisory committee meeting, the FDA staff flagged this number of cases in a relatively small database as a concern, noting it “could be higher than reported during postauthorization use of mRNA COVID-19 vaccines (for which no cases were identified in preauthorization evaluation).”

Novavax officials took a somewhat unusual step of responding in public. The Gaithersburg, Md.–based company on June 3 issued a statement saying researchers had come to “expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk.”

The data from the company’s placebo-controlled studies show that, overall, in its clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%), Novavax said.

At the June 7 meeting, FDA panelists including Dr. Nelson, and Paul A. Offit, MD, of Children’s Hospital of Philadelphia, urged continued study to try to determine whether and how the vaccines could trigger myocarditis. Investments made now in pursuing these questions related to COVID-19 shots may pay off later, Dr. Offit said.

“We can use that knowledge to make safer vaccines for a disease that is going to be with us for decades, if not longer,” he said.

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

The first decline in COVID-19 cases among children since early April may have been holiday related, but the shortened week also brought news about vaccination for the youngest children.

The Food and Drug Administration has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, so vaccination could begin as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Dr. Jha said at a White House press briefing June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

Decline may just be underreporting

Over on the incidence side of the pandemic, the total number of cases reported for the week of May 27 to June 2 was about 87,000, a drop of 22% from May 20-26 and the first decline after 7 straight weeks of increases. “Testing and reporting may have been affected by the holiday weekend [since] states may change their reporting schedules, which may cause irregularities in trends,” the American Academy of Pediatrics and the Children’s Hospital association said in their latest COVID report.

The decline in new cases was not spread uniformly across the four major regions of the United States. The count actually went up in the West for the week of May 27 to June 2, while the South saw the largest decline. The Midwest and Northeast, meanwhile, saw new cases drop for the second straight week, the AAP and CHA said.

The cumulative number of COVID-19 cases in children was up to 13.45 million as of June 2, with children representing 18.9% of all cases since the start of the pandemic, according to the two organizations. The Centers for Disease Control and Prevention reported figures of 13.14 million and 17.5% on June 6.

The AAP/CHA estimates, however, are based on state data that have become increasingly hard to obtain and subject to inconsistency. “Shortages of COVID-19 tests during surges and the increasing use of COVID-19 home tests likely affect the undercounting of COVID-19 cases,” they noted, and “at times when COVID-19 transmission is low, states might reduce the frequency information is updated.”
 

Vaccinations held steady over the holiday

The ongoing vaccination effort in children aged 5 years and older did not show a Memorial Day drop-off, as initial vaccinations held at 43,000 in 5- to 11-year-olds and at 27,000 in 12- to 17-year-olds for a second consecutive week. That number has ranged from 34,000 to 70,000 for the younger children and from 25,000 to 47,000 for the older group since mid-March, the AAP said in a separate weekly report.

Despite weekly vaccine initiations that have been roughly double those of the older children for months, the 5- to 11-year-olds are still only at 36.0% coverage with at least one dose, compared with 69.5% for the 12- to-17-year-olds. Full vaccination for the two age groups comes in at 29.3% and 59.6%, respectively, as of June 6, according to the CDC’s COVID Data Tracker.
 

The first decline in COVID-19 cases among children since early April may have been holiday related, but the shortened week also brought news about vaccination for the youngest children.

The Food and Drug Administration has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, so vaccination could begin as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Dr. Jha said at a White House press briefing June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

Decline may just be underreporting

Over on the incidence side of the pandemic, the total number of cases reported for the week of May 27 to June 2 was about 87,000, a drop of 22% from May 20-26 and the first decline after 7 straight weeks of increases. “Testing and reporting may have been affected by the holiday weekend [since] states may change their reporting schedules, which may cause irregularities in trends,” the American Academy of Pediatrics and the Children’s Hospital association said in their latest COVID report.

The decline in new cases was not spread uniformly across the four major regions of the United States. The count actually went up in the West for the week of May 27 to June 2, while the South saw the largest decline. The Midwest and Northeast, meanwhile, saw new cases drop for the second straight week, the AAP and CHA said.

The cumulative number of COVID-19 cases in children was up to 13.45 million as of June 2, with children representing 18.9% of all cases since the start of the pandemic, according to the two organizations. The Centers for Disease Control and Prevention reported figures of 13.14 million and 17.5% on June 6.

The AAP/CHA estimates, however, are based on state data that have become increasingly hard to obtain and subject to inconsistency. “Shortages of COVID-19 tests during surges and the increasing use of COVID-19 home tests likely affect the undercounting of COVID-19 cases,” they noted, and “at times when COVID-19 transmission is low, states might reduce the frequency information is updated.”
 

Vaccinations held steady over the holiday

The ongoing vaccination effort in children aged 5 years and older did not show a Memorial Day drop-off, as initial vaccinations held at 43,000 in 5- to 11-year-olds and at 27,000 in 12- to 17-year-olds for a second consecutive week. That number has ranged from 34,000 to 70,000 for the younger children and from 25,000 to 47,000 for the older group since mid-March, the AAP said in a separate weekly report.

Despite weekly vaccine initiations that have been roughly double those of the older children for months, the 5- to 11-year-olds are still only at 36.0% coverage with at least one dose, compared with 69.5% for the 12- to-17-year-olds. Full vaccination for the two age groups comes in at 29.3% and 59.6%, respectively, as of June 6, according to the CDC’s COVID Data Tracker.
 

The first decline in COVID-19 cases among children since early April may have been holiday related, but the shortened week also brought news about vaccination for the youngest children.

The Food and Drug Administration has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, so vaccination could begin as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Dr. Jha said at a White House press briefing June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

Decline may just be underreporting

Over on the incidence side of the pandemic, the total number of cases reported for the week of May 27 to June 2 was about 87,000, a drop of 22% from May 20-26 and the first decline after 7 straight weeks of increases. “Testing and reporting may have been affected by the holiday weekend [since] states may change their reporting schedules, which may cause irregularities in trends,” the American Academy of Pediatrics and the Children’s Hospital association said in their latest COVID report.

The decline in new cases was not spread uniformly across the four major regions of the United States. The count actually went up in the West for the week of May 27 to June 2, while the South saw the largest decline. The Midwest and Northeast, meanwhile, saw new cases drop for the second straight week, the AAP and CHA said.

The cumulative number of COVID-19 cases in children was up to 13.45 million as of June 2, with children representing 18.9% of all cases since the start of the pandemic, according to the two organizations. The Centers for Disease Control and Prevention reported figures of 13.14 million and 17.5% on June 6.

The AAP/CHA estimates, however, are based on state data that have become increasingly hard to obtain and subject to inconsistency. “Shortages of COVID-19 tests during surges and the increasing use of COVID-19 home tests likely affect the undercounting of COVID-19 cases,” they noted, and “at times when COVID-19 transmission is low, states might reduce the frequency information is updated.”
 

Vaccinations held steady over the holiday

The ongoing vaccination effort in children aged 5 years and older did not show a Memorial Day drop-off, as initial vaccinations held at 43,000 in 5- to 11-year-olds and at 27,000 in 12- to 17-year-olds for a second consecutive week. That number has ranged from 34,000 to 70,000 for the younger children and from 25,000 to 47,000 for the older group since mid-March, the AAP said in a separate weekly report.

Despite weekly vaccine initiations that have been roughly double those of the older children for months, the 5- to 11-year-olds are still only at 36.0% coverage with at least one dose, compared with 69.5% for the 12- to-17-year-olds. Full vaccination for the two age groups comes in at 29.3% and 59.6%, respectively, as of June 6, according to the CDC’s COVID Data Tracker.
 

COPENHAGEN – Most patients with immune-mediated inflammatory diseases (IMID) should not be considered at high risk for severe COVID-19 breakthrough infections, but those on anti-CD20 therapy are the exception, data from a large prospective, cohort study show.

“Overall, the data are reassuring, with conventional risk factors, such as age, and comorbidities seeming to be more important regarding risk of severe COVID-19 breakthrough infections than rheumatic disease or immunosuppressant medication,” said Laura Boekel, MD, from Amsterdam UMC, who presented the study at the annual European Congress of Rheumatology.

peterschreiber_media/iStock/Getty Images

But, she added, there was an exception for anti-CD20 therapy. “This is especially relevant for patients with conventional risk factors that might accumulate, and rheumatologists might want to consider alternative treatment options if possible. It is important to inform patients about the risks of anti-CD20.”

Another study, presented during the same session at the congress by Rebecca Hasseli, MD, from the University of Giessen (Germany) saw no deaths and no COVID-19 related complications in a cohort of triple-vaccinated patients with inflammatory rheumatic diseases, despite a higher median age and a higher rate of comorbidities compared to double-vaccinated and unvaccinated cohorts.

Ingrid Jyssum, MD, from Diakonhjemmet Hospital, Oslo, who presented results of the Nor-vaC study investigating the impact of different DMARDs on the immunogenicity of a third COVID-19 vaccine dose, welcomed the research by Dr. Boekel and Dr. Hasseli.

“The findings of Hasseli are interesting in the light of our data on serological response after the third dose, with a lack of breakthrough infections after three doses corresponding well to the robust antibody response that we found in our cohort,” she remarked. “This is very reassuring for our patients. Our own work together with the findings of Hasseli and Boekel demonstrate that additional vaccine doses are important to keep this population well protected against severe COVID-19 infections.”

The Nor-vaC study was conducted with a cohort of 1,100 patients with inflammatory joint and bowel diseases. “These patients had attenuated antibody responses after two vaccine doses; however, we found that a third vaccine dose brought the humoral response in patients up to the antibody levels that healthy controls had after two doses,” said Dr. Jyssum. “In addition, we found that the decline in antibodies after the third dose was less than the decline seen after the second dose. Importantly, the third dose was safe in our patients, with no new safety issues.”
 

Breakthrough infections and immunosuppressants

“Like the rest of the world, we were wondering if our patients were at increased risk of COVID-19, and if the immunosuppressants used by these patients influenced their risk,” said Dr. Boekel.

The researchers compared both the incidence and severity of COVID-19 breakthrough infections with the SARS-CoV-2 Delta variant in a population of fully vaccinated IMID patients taking immunosuppressants and controls (IMID patients not taking immunosuppressants and healthy controls).

Two large ongoing, prospective, multicenter cohort studies provided pooled data collected between February and December 2021 using digital questionnaires, standardized electronic case record forms, and medical files.

Finger-prick tests were used to collect blood samples that were analyzed after vaccination against SARS-CoV-2 for anti–receptor-binding domain (RBD) antibodies, and antinucleocapsid antibodies to identify asymptomatic breakthrough infections. Any associations between antibodies and the incidence of breakthrough infections were generated, and results were adjusted for sex, cardiovascular disease, chronic pulmonary disease, obesity, and vaccine type.

The analysis included 3,207 IMID patients taking immunosuppressants, and 1,810 controls (985 IMID patients not on immunosuppressants and 825 healthy controls).

Initially, Dr. Boekel and her colleagues looked at incidence of infections and hospitalizations prior to vaccination, and then after vaccination, which was the main aim of the study.

Prior to vaccination, hospitalization risk for COVID-19 was somewhat higher for IMID patients overall compared with controls, reported Dr. Boekel. “But those treated with anti-CD20 therapy, demonstrated much greater risk for severe disease.”

After the SARS-CoV-2 vaccination campaign began, the researchers then looked at how immunosuppressants influenced humoral response to SARS-CoV-2 vaccination.

“Anti-CD20 therapy showed the greatest impact on humoral immune response after SARS-CoV-2 vaccination,” said Dr. Boekel. Other immunosuppressant drugs had variable effects on humoral and cellular immunity. 

Once they had established that immunosuppressant drugs impaired immune responses to SARS-CoV-2 vaccination, the researchers wanted to determine if this affected clinical outcomes. Blood samples taken 28 days after the second vaccination enabled Dr. Boekel and her colleagues to see if antibody production was associated with breakthrough infections.   

Breakthrough infections were seen in 5% of patients on immunosuppressants, 5% of patients not on immunosuppressants, and 4% of healthy controls. Also, asymptomatic COVID-19 breakthrough cases were comparable between IMID patients taking immunosuppressants and controls, at 10% in each group.

“We saw that the incidence [of getting COVID-19] was comparable between groups, independent of whether they were receiving immunosuppressants or not, or healthy controls. However, if they developed antibodies against the two vaccinations the chance of getting infected was lower,” reported Dr. Boekel.

Hospitalization (severe disease) rates were also comparable between groups. “Patients with rheumatic diseases, even when treated with immunosuppressants were not at increased risk of severe disease from Delta breakthrough infections,” added the researcher. “Cases that were hospitalized were mainly elderly and those with comorbidities, for example cardiovascular disease and cardiopulmonary disease.”

Hospital admissions were 5.4% in patients on immunosuppressants, 5.7% in those not on immunosuppressants, and 6% in health controls.

However, once again, there was one exception, Dr. Boekel stressed. “Patients treated with anti-CD20 therapy were at increased risk of severe disease and hospitalization.”

Omicron variant has a different transmissibility than Delta, so the researchers continued the study looking at the Omicron variant. The data “were mostly reassuring,” said Dr. Boekel. “As expected, hospitalization rates decreased overall, with the exception of patients on anti-CD20 therapy where, despite overall reduced pathogenicity, patients remain at increased risk.”

She said that they were awaiting long-term data so the data reflect only short-term immunity against Omicron. “However, we included many elderly and patients with comorbidities, so this made the analysis very sensitive to detect severe cases,” she added.

Breakthrough infection among double- and triple-vaccinated patients

A lower rate of COVID-19 related complications and deaths were seen in patients who were triple-vaccinated against SARS-CoV-2, than in double-vaccinated or unvaccinated patients, despite the former having more comorbidities and use of rituximab (Rituxan), said Dr. Hasseli.

“These data support the recommendation of booster vaccination to reduce COVID-19-related mortality in patients with inflammatory rheumatic diseases [IRDs],” she said.

“A small number of COVID-19 cases were seen in patients with IRD after vaccinations, and in a few cases, hospitalizations were required. Breakthrough infections were mostly seen in patients on B-cell depletion therapy,” she added.

Dr. Hasseli and her colleagues looked at the characteristics and outcomes of SARS-CoV-2 breakthrough infections among double- and triple-vaccinated patients with IRD.

“We wanted to understand if patients with IRD are protected in the same way as the general population following vaccination, given that these patients receive drugs that might impair the immune response,” she explained.

Data for analysis were drawn from the German COVID-19-IRD registry covering February 2021 and January 2022, and patients who were double- or triple- vaccinated against COVID-19 either 14 days or more prior to a SARS-CoV-2 infection were included. Type of IRD, vaccine, immunomodulation, comorbidities, and outcome of the infection were compared with 737 unvaccinated IRD patients with COVID-19. Those with prior COVID-19 were excluded.

Cases were stratified by vaccinations status: unvaccinated (1,388 patients, median age 57 years); double vaccinated (462, 56 years) and triple vaccinated (301, 53 years). Body mass index was similar across groups (25-26 kg/m²), and time between SARS-CoV-2 infection and last vaccination was 156 days in double-vaccinated patients, and 62 days in triple-vaccinated patients.

Patients had rheumatoid arthritis in 44.7% and 44.4% of unvaccinated and double-vaccinated patients respectively, but fewer triple-vaccinated patients had RA (37.2%). Triple vaccination was seen in 32.2% of patients with spondyloarthritis, 16.6% connective tissue diseases, 5.3% other vasculitis, and 3.3% ANCA-associated vasculitis. Of triple-vaccinated patients, 26.2% were treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors, and 6.3% with rituximab, while 5.3% were not on immunomodulation. At least 25% were treated with glucocorticoids, reported Dr. Hasseli.

“Arterial hypertension and diabetes, that might be risk factors for COVID-19, were less frequently reported in triple-vaccinated patients. More patients in the double-vaccinated group [42.9%] than the triple-vaccinated [23.8%] reported absence of relevant comorbidities,” she said.

COVID-19 related complications were less often reported in double- and triple-vaccinated groups with hospitalizations at 9.5% and 4.3% in double and triple-vaccinated people respectively.

Dr. Boekel and Dr. Hasseli report no relevant conflicts of interest.

COPENHAGEN – Most patients with immune-mediated inflammatory diseases (IMID) should not be considered at high risk for severe COVID-19 breakthrough infections, but those on anti-CD20 therapy are the exception, data from a large prospective, cohort study show.

“Overall, the data are reassuring, with conventional risk factors, such as age, and comorbidities seeming to be more important regarding risk of severe COVID-19 breakthrough infections than rheumatic disease or immunosuppressant medication,” said Laura Boekel, MD, from Amsterdam UMC, who presented the study at the annual European Congress of Rheumatology.

peterschreiber_media/iStock/Getty Images

But, she added, there was an exception for anti-CD20 therapy. “This is especially relevant for patients with conventional risk factors that might accumulate, and rheumatologists might want to consider alternative treatment options if possible. It is important to inform patients about the risks of anti-CD20.”

Another study, presented during the same session at the congress by Rebecca Hasseli, MD, from the University of Giessen (Germany) saw no deaths and no COVID-19 related complications in a cohort of triple-vaccinated patients with inflammatory rheumatic diseases, despite a higher median age and a higher rate of comorbidities compared to double-vaccinated and unvaccinated cohorts.

Ingrid Jyssum, MD, from Diakonhjemmet Hospital, Oslo, who presented results of the Nor-vaC study investigating the impact of different DMARDs on the immunogenicity of a third COVID-19 vaccine dose, welcomed the research by Dr. Boekel and Dr. Hasseli.

“The findings of Hasseli are interesting in the light of our data on serological response after the third dose, with a lack of breakthrough infections after three doses corresponding well to the robust antibody response that we found in our cohort,” she remarked. “This is very reassuring for our patients. Our own work together with the findings of Hasseli and Boekel demonstrate that additional vaccine doses are important to keep this population well protected against severe COVID-19 infections.”

The Nor-vaC study was conducted with a cohort of 1,100 patients with inflammatory joint and bowel diseases. “These patients had attenuated antibody responses after two vaccine doses; however, we found that a third vaccine dose brought the humoral response in patients up to the antibody levels that healthy controls had after two doses,” said Dr. Jyssum. “In addition, we found that the decline in antibodies after the third dose was less than the decline seen after the second dose. Importantly, the third dose was safe in our patients, with no new safety issues.”
 

Breakthrough infections and immunosuppressants

“Like the rest of the world, we were wondering if our patients were at increased risk of COVID-19, and if the immunosuppressants used by these patients influenced their risk,” said Dr. Boekel.

The researchers compared both the incidence and severity of COVID-19 breakthrough infections with the SARS-CoV-2 Delta variant in a population of fully vaccinated IMID patients taking immunosuppressants and controls (IMID patients not taking immunosuppressants and healthy controls).

Two large ongoing, prospective, multicenter cohort studies provided pooled data collected between February and December 2021 using digital questionnaires, standardized electronic case record forms, and medical files.

Finger-prick tests were used to collect blood samples that were analyzed after vaccination against SARS-CoV-2 for anti–receptor-binding domain (RBD) antibodies, and antinucleocapsid antibodies to identify asymptomatic breakthrough infections. Any associations between antibodies and the incidence of breakthrough infections were generated, and results were adjusted for sex, cardiovascular disease, chronic pulmonary disease, obesity, and vaccine type.

The analysis included 3,207 IMID patients taking immunosuppressants, and 1,810 controls (985 IMID patients not on immunosuppressants and 825 healthy controls).

Initially, Dr. Boekel and her colleagues looked at incidence of infections and hospitalizations prior to vaccination, and then after vaccination, which was the main aim of the study.

Prior to vaccination, hospitalization risk for COVID-19 was somewhat higher for IMID patients overall compared with controls, reported Dr. Boekel. “But those treated with anti-CD20 therapy, demonstrated much greater risk for severe disease.”

After the SARS-CoV-2 vaccination campaign began, the researchers then looked at how immunosuppressants influenced humoral response to SARS-CoV-2 vaccination.

“Anti-CD20 therapy showed the greatest impact on humoral immune response after SARS-CoV-2 vaccination,” said Dr. Boekel. Other immunosuppressant drugs had variable effects on humoral and cellular immunity. 

Once they had established that immunosuppressant drugs impaired immune responses to SARS-CoV-2 vaccination, the researchers wanted to determine if this affected clinical outcomes. Blood samples taken 28 days after the second vaccination enabled Dr. Boekel and her colleagues to see if antibody production was associated with breakthrough infections.   

Breakthrough infections were seen in 5% of patients on immunosuppressants, 5% of patients not on immunosuppressants, and 4% of healthy controls. Also, asymptomatic COVID-19 breakthrough cases were comparable between IMID patients taking immunosuppressants and controls, at 10% in each group.

“We saw that the incidence [of getting COVID-19] was comparable between groups, independent of whether they were receiving immunosuppressants or not, or healthy controls. However, if they developed antibodies against the two vaccinations the chance of getting infected was lower,” reported Dr. Boekel.

Hospitalization (severe disease) rates were also comparable between groups. “Patients with rheumatic diseases, even when treated with immunosuppressants were not at increased risk of severe disease from Delta breakthrough infections,” added the researcher. “Cases that were hospitalized were mainly elderly and those with comorbidities, for example cardiovascular disease and cardiopulmonary disease.”

Hospital admissions were 5.4% in patients on immunosuppressants, 5.7% in those not on immunosuppressants, and 6% in health controls.

However, once again, there was one exception, Dr. Boekel stressed. “Patients treated with anti-CD20 therapy were at increased risk of severe disease and hospitalization.”

Omicron variant has a different transmissibility than Delta, so the researchers continued the study looking at the Omicron variant. The data “were mostly reassuring,” said Dr. Boekel. “As expected, hospitalization rates decreased overall, with the exception of patients on anti-CD20 therapy where, despite overall reduced pathogenicity, patients remain at increased risk.”

She said that they were awaiting long-term data so the data reflect only short-term immunity against Omicron. “However, we included many elderly and patients with comorbidities, so this made the analysis very sensitive to detect severe cases,” she added.

Breakthrough infection among double- and triple-vaccinated patients

A lower rate of COVID-19 related complications and deaths were seen in patients who were triple-vaccinated against SARS-CoV-2, than in double-vaccinated or unvaccinated patients, despite the former having more comorbidities and use of rituximab (Rituxan), said Dr. Hasseli.

“These data support the recommendation of booster vaccination to reduce COVID-19-related mortality in patients with inflammatory rheumatic diseases [IRDs],” she said.

“A small number of COVID-19 cases were seen in patients with IRD after vaccinations, and in a few cases, hospitalizations were required. Breakthrough infections were mostly seen in patients on B-cell depletion therapy,” she added.

Dr. Hasseli and her colleagues looked at the characteristics and outcomes of SARS-CoV-2 breakthrough infections among double- and triple-vaccinated patients with IRD.

“We wanted to understand if patients with IRD are protected in the same way as the general population following vaccination, given that these patients receive drugs that might impair the immune response,” she explained.

Data for analysis were drawn from the German COVID-19-IRD registry covering February 2021 and January 2022, and patients who were double- or triple- vaccinated against COVID-19 either 14 days or more prior to a SARS-CoV-2 infection were included. Type of IRD, vaccine, immunomodulation, comorbidities, and outcome of the infection were compared with 737 unvaccinated IRD patients with COVID-19. Those with prior COVID-19 were excluded.

Cases were stratified by vaccinations status: unvaccinated (1,388 patients, median age 57 years); double vaccinated (462, 56 years) and triple vaccinated (301, 53 years). Body mass index was similar across groups (25-26 kg/m²), and time between SARS-CoV-2 infection and last vaccination was 156 days in double-vaccinated patients, and 62 days in triple-vaccinated patients.

Patients had rheumatoid arthritis in 44.7% and 44.4% of unvaccinated and double-vaccinated patients respectively, but fewer triple-vaccinated patients had RA (37.2%). Triple vaccination was seen in 32.2% of patients with spondyloarthritis, 16.6% connective tissue diseases, 5.3% other vasculitis, and 3.3% ANCA-associated vasculitis. Of triple-vaccinated patients, 26.2% were treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors, and 6.3% with rituximab, while 5.3% were not on immunomodulation. At least 25% were treated with glucocorticoids, reported Dr. Hasseli.

“Arterial hypertension and diabetes, that might be risk factors for COVID-19, were less frequently reported in triple-vaccinated patients. More patients in the double-vaccinated group [42.9%] than the triple-vaccinated [23.8%] reported absence of relevant comorbidities,” she said.

COVID-19 related complications were less often reported in double- and triple-vaccinated groups with hospitalizations at 9.5% and 4.3% in double and triple-vaccinated people respectively.

Dr. Boekel and Dr. Hasseli report no relevant conflicts of interest.

COPENHAGEN – Most patients with immune-mediated inflammatory diseases (IMID) should not be considered at high risk for severe COVID-19 breakthrough infections, but those on anti-CD20 therapy are the exception, data from a large prospective, cohort study show.

“Overall, the data are reassuring, with conventional risk factors, such as age, and comorbidities seeming to be more important regarding risk of severe COVID-19 breakthrough infections than rheumatic disease or immunosuppressant medication,” said Laura Boekel, MD, from Amsterdam UMC, who presented the study at the annual European Congress of Rheumatology.

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But, she added, there was an exception for anti-CD20 therapy. “This is especially relevant for patients with conventional risk factors that might accumulate, and rheumatologists might want to consider alternative treatment options if possible. It is important to inform patients about the risks of anti-CD20.”

Another study, presented during the same session at the congress by Rebecca Hasseli, MD, from the University of Giessen (Germany) saw no deaths and no COVID-19 related complications in a cohort of triple-vaccinated patients with inflammatory rheumatic diseases, despite a higher median age and a higher rate of comorbidities compared to double-vaccinated and unvaccinated cohorts.

Ingrid Jyssum, MD, from Diakonhjemmet Hospital, Oslo, who presented results of the Nor-vaC study investigating the impact of different DMARDs on the immunogenicity of a third COVID-19 vaccine dose, welcomed the research by Dr. Boekel and Dr. Hasseli.

“The findings of Hasseli are interesting in the light of our data on serological response after the third dose, with a lack of breakthrough infections after three doses corresponding well to the robust antibody response that we found in our cohort,” she remarked. “This is very reassuring for our patients. Our own work together with the findings of Hasseli and Boekel demonstrate that additional vaccine doses are important to keep this population well protected against severe COVID-19 infections.”

The Nor-vaC study was conducted with a cohort of 1,100 patients with inflammatory joint and bowel diseases. “These patients had attenuated antibody responses after two vaccine doses; however, we found that a third vaccine dose brought the humoral response in patients up to the antibody levels that healthy controls had after two doses,” said Dr. Jyssum. “In addition, we found that the decline in antibodies after the third dose was less than the decline seen after the second dose. Importantly, the third dose was safe in our patients, with no new safety issues.”
 

Breakthrough infections and immunosuppressants

“Like the rest of the world, we were wondering if our patients were at increased risk of COVID-19, and if the immunosuppressants used by these patients influenced their risk,” said Dr. Boekel.

The researchers compared both the incidence and severity of COVID-19 breakthrough infections with the SARS-CoV-2 Delta variant in a population of fully vaccinated IMID patients taking immunosuppressants and controls (IMID patients not taking immunosuppressants and healthy controls).

Two large ongoing, prospective, multicenter cohort studies provided pooled data collected between February and December 2021 using digital questionnaires, standardized electronic case record forms, and medical files.

Finger-prick tests were used to collect blood samples that were analyzed after vaccination against SARS-CoV-2 for anti–receptor-binding domain (RBD) antibodies, and antinucleocapsid antibodies to identify asymptomatic breakthrough infections. Any associations between antibodies and the incidence of breakthrough infections were generated, and results were adjusted for sex, cardiovascular disease, chronic pulmonary disease, obesity, and vaccine type.

The analysis included 3,207 IMID patients taking immunosuppressants, and 1,810 controls (985 IMID patients not on immunosuppressants and 825 healthy controls).

Initially, Dr. Boekel and her colleagues looked at incidence of infections and hospitalizations prior to vaccination, and then after vaccination, which was the main aim of the study.

Prior to vaccination, hospitalization risk for COVID-19 was somewhat higher for IMID patients overall compared with controls, reported Dr. Boekel. “But those treated with anti-CD20 therapy, demonstrated much greater risk for severe disease.”

After the SARS-CoV-2 vaccination campaign began, the researchers then looked at how immunosuppressants influenced humoral response to SARS-CoV-2 vaccination.

“Anti-CD20 therapy showed the greatest impact on humoral immune response after SARS-CoV-2 vaccination,” said Dr. Boekel. Other immunosuppressant drugs had variable effects on humoral and cellular immunity. 

Once they had established that immunosuppressant drugs impaired immune responses to SARS-CoV-2 vaccination, the researchers wanted to determine if this affected clinical outcomes. Blood samples taken 28 days after the second vaccination enabled Dr. Boekel and her colleagues to see if antibody production was associated with breakthrough infections.   

Breakthrough infections were seen in 5% of patients on immunosuppressants, 5% of patients not on immunosuppressants, and 4% of healthy controls. Also, asymptomatic COVID-19 breakthrough cases were comparable between IMID patients taking immunosuppressants and controls, at 10% in each group.

“We saw that the incidence [of getting COVID-19] was comparable between groups, independent of whether they were receiving immunosuppressants or not, or healthy controls. However, if they developed antibodies against the two vaccinations the chance of getting infected was lower,” reported Dr. Boekel.

Hospitalization (severe disease) rates were also comparable between groups. “Patients with rheumatic diseases, even when treated with immunosuppressants were not at increased risk of severe disease from Delta breakthrough infections,” added the researcher. “Cases that were hospitalized were mainly elderly and those with comorbidities, for example cardiovascular disease and cardiopulmonary disease.”

Hospital admissions were 5.4% in patients on immunosuppressants, 5.7% in those not on immunosuppressants, and 6% in health controls.

However, once again, there was one exception, Dr. Boekel stressed. “Patients treated with anti-CD20 therapy were at increased risk of severe disease and hospitalization.”

Omicron variant has a different transmissibility than Delta, so the researchers continued the study looking at the Omicron variant. The data “were mostly reassuring,” said Dr. Boekel. “As expected, hospitalization rates decreased overall, with the exception of patients on anti-CD20 therapy where, despite overall reduced pathogenicity, patients remain at increased risk.”

She said that they were awaiting long-term data so the data reflect only short-term immunity against Omicron. “However, we included many elderly and patients with comorbidities, so this made the analysis very sensitive to detect severe cases,” she added.

Breakthrough infection among double- and triple-vaccinated patients

A lower rate of COVID-19 related complications and deaths were seen in patients who were triple-vaccinated against SARS-CoV-2, than in double-vaccinated or unvaccinated patients, despite the former having more comorbidities and use of rituximab (Rituxan), said Dr. Hasseli.

“These data support the recommendation of booster vaccination to reduce COVID-19-related mortality in patients with inflammatory rheumatic diseases [IRDs],” she said.

“A small number of COVID-19 cases were seen in patients with IRD after vaccinations, and in a few cases, hospitalizations were required. Breakthrough infections were mostly seen in patients on B-cell depletion therapy,” she added.

Dr. Hasseli and her colleagues looked at the characteristics and outcomes of SARS-CoV-2 breakthrough infections among double- and triple-vaccinated patients with IRD.

“We wanted to understand if patients with IRD are protected in the same way as the general population following vaccination, given that these patients receive drugs that might impair the immune response,” she explained.

Data for analysis were drawn from the German COVID-19-IRD registry covering February 2021 and January 2022, and patients who were double- or triple- vaccinated against COVID-19 either 14 days or more prior to a SARS-CoV-2 infection were included. Type of IRD, vaccine, immunomodulation, comorbidities, and outcome of the infection were compared with 737 unvaccinated IRD patients with COVID-19. Those with prior COVID-19 were excluded.

Cases were stratified by vaccinations status: unvaccinated (1,388 patients, median age 57 years); double vaccinated (462, 56 years) and triple vaccinated (301, 53 years). Body mass index was similar across groups (25-26 kg/m²), and time between SARS-CoV-2 infection and last vaccination was 156 days in double-vaccinated patients, and 62 days in triple-vaccinated patients.

Patients had rheumatoid arthritis in 44.7% and 44.4% of unvaccinated and double-vaccinated patients respectively, but fewer triple-vaccinated patients had RA (37.2%). Triple vaccination was seen in 32.2% of patients with spondyloarthritis, 16.6% connective tissue diseases, 5.3% other vasculitis, and 3.3% ANCA-associated vasculitis. Of triple-vaccinated patients, 26.2% were treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors, and 6.3% with rituximab, while 5.3% were not on immunomodulation. At least 25% were treated with glucocorticoids, reported Dr. Hasseli.

“Arterial hypertension and diabetes, that might be risk factors for COVID-19, were less frequently reported in triple-vaccinated patients. More patients in the double-vaccinated group [42.9%] than the triple-vaccinated [23.8%] reported absence of relevant comorbidities,” she said.

COVID-19 related complications were less often reported in double- and triple-vaccinated groups with hospitalizations at 9.5% and 4.3% in double and triple-vaccinated people respectively.

Dr. Boekel and Dr. Hasseli report no relevant conflicts of interest.

NATIONAL HARBOR, MD. – While patients with multiple sclerosis (MS) don’t seem to be more likely to be infected with COVID-19, a neurologist told colleagues, the jury is still out over whether they face a higher mortality risk, especially if they take certain disease-modifying therapies (DMTs)

In regard to MS overall, “the data is conflicting, but any increased risk of mortality appears to be slight. And it appears to be chiefly the consequences associated with comorbidities as seen in other populations,” Joseph R. Berger, MD, said at the John F. Kurtzke Memorial Lecture at the annual meeting of the Consortium of Multiple Sclerosis Centers. “If you’re old, if you’re infirm, if you have obesity and cardiovascular disease and underlying pulmonary disease, you’re at risk of dying yourself. It’s not so much the MS,” said Dr. Berger, professor of neurology at the Hospital of the University of Pennsylvania and chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia.

Dr. Berger had his own COVID-19 story to tell: He couldn’t attend the conference in person because he was quarantining in Portugal since he tested positive. At press time, he was faring well but had reported 4 days of intense back pain.

In regard to MS and COVID-19, Dr. Berger said consistent research suggests that patients with MS aren’t at higher risk of COVID infection, although hospitalization may be more common. There may be a very small increase in risk of MS relapse in patients with COVID-19, he said, but pseudorelapses are far more common. As for mortality, he highlighted a 2021 pooled analysis of 18 studies with 5,634 patients that suggested they had a crude death rate of 1.97%, standardized lethality ratio of 1.24, and a 24% increased risk of death.

Dr. Berger is skeptical of these findings, however, in light of overall death rate numbers. Early on in the pandemic, the fatality rate in China was estimated at 2.3%.

He said he’s more convinced by a retrospective 2021 German COVID-19 study that compared 551 patients with MS to 156,973 other patients and found lower rates of ICU admission (17.1% in patients with MS vs. 22.7% in those without it), ventilation (9.8% vs. 14.5%), and in‐hospital mortality (11.1% vs. 19.3%).

Meanwhile, a 2021 systematic review found no increase in mortality among 4,310 patients with MS (3% death rate, 20.7% hospitalization), but the death risk was highest among those on no DMTs and those taking anti-CD20 monoclonal antibodies. The COViMS Registry has reported similar findings regarding the anti-CD20 drugs rituximab and ocrelizumab, Dr. Berger noted, and a pooled study of Italian and French data links the monoclonal antibodies to more severe COVID. A 2021 aggregated study also linked the antibodies to increased risk of hospitalization and ICU admission.

“Anti-CD20 monoclonal antibodies appear to increase the risk of hospitalization and perhaps the acquisition of the virus, ICU admission, maybe death,” he said, with rituximab appearing to pose the most risk, followed by ocrelizumab and ofatumumab. “And it appears that the platform [older] therapies may be associated with lesser mortality.”

As for nondrug factors, Dr. Berger said, studies have linked higher risk to age, male sex, and comorbidities.

COVID-19 vaccines are another area of concern, he said. “The recommendation is to administer vaccination prior to the initiation of the anti-CD20s, alemtuzumab, and cladribine, and wait a period of time. Three months is ideal, maybe a little longer, because it appears that the antibody response seems to be best as your CD19 count starts to return.”

Finally, Dr. Berger noted that “passive vaccination” is now available via Evusheld (tixagevimab and cilgavimab) as a preexposure treatment for people with moderate to severe immune compromise who may not mount an effective immune response to COVID-19 vaccination or those who are allergic.

Dr. Berger reported multiple disclosures.

NATIONAL HARBOR, MD. – While patients with multiple sclerosis (MS) don’t seem to be more likely to be infected with COVID-19, a neurologist told colleagues, the jury is still out over whether they face a higher mortality risk, especially if they take certain disease-modifying therapies (DMTs)

In regard to MS overall, “the data is conflicting, but any increased risk of mortality appears to be slight. And it appears to be chiefly the consequences associated with comorbidities as seen in other populations,” Joseph R. Berger, MD, said at the John F. Kurtzke Memorial Lecture at the annual meeting of the Consortium of Multiple Sclerosis Centers. “If you’re old, if you’re infirm, if you have obesity and cardiovascular disease and underlying pulmonary disease, you’re at risk of dying yourself. It’s not so much the MS,” said Dr. Berger, professor of neurology at the Hospital of the University of Pennsylvania and chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia.

Dr. Berger had his own COVID-19 story to tell: He couldn’t attend the conference in person because he was quarantining in Portugal since he tested positive. At press time, he was faring well but had reported 4 days of intense back pain.

In regard to MS and COVID-19, Dr. Berger said consistent research suggests that patients with MS aren’t at higher risk of COVID infection, although hospitalization may be more common. There may be a very small increase in risk of MS relapse in patients with COVID-19, he said, but pseudorelapses are far more common. As for mortality, he highlighted a 2021 pooled analysis of 18 studies with 5,634 patients that suggested they had a crude death rate of 1.97%, standardized lethality ratio of 1.24, and a 24% increased risk of death.

Dr. Berger is skeptical of these findings, however, in light of overall death rate numbers. Early on in the pandemic, the fatality rate in China was estimated at 2.3%.

He said he’s more convinced by a retrospective 2021 German COVID-19 study that compared 551 patients with MS to 156,973 other patients and found lower rates of ICU admission (17.1% in patients with MS vs. 22.7% in those without it), ventilation (9.8% vs. 14.5%), and in‐hospital mortality (11.1% vs. 19.3%).

Meanwhile, a 2021 systematic review found no increase in mortality among 4,310 patients with MS (3% death rate, 20.7% hospitalization), but the death risk was highest among those on no DMTs and those taking anti-CD20 monoclonal antibodies. The COViMS Registry has reported similar findings regarding the anti-CD20 drugs rituximab and ocrelizumab, Dr. Berger noted, and a pooled study of Italian and French data links the monoclonal antibodies to more severe COVID. A 2021 aggregated study also linked the antibodies to increased risk of hospitalization and ICU admission.

“Anti-CD20 monoclonal antibodies appear to increase the risk of hospitalization and perhaps the acquisition of the virus, ICU admission, maybe death,” he said, with rituximab appearing to pose the most risk, followed by ocrelizumab and ofatumumab. “And it appears that the platform [older] therapies may be associated with lesser mortality.”

As for nondrug factors, Dr. Berger said, studies have linked higher risk to age, male sex, and comorbidities.

COVID-19 vaccines are another area of concern, he said. “The recommendation is to administer vaccination prior to the initiation of the anti-CD20s, alemtuzumab, and cladribine, and wait a period of time. Three months is ideal, maybe a little longer, because it appears that the antibody response seems to be best as your CD19 count starts to return.”

Finally, Dr. Berger noted that “passive vaccination” is now available via Evusheld (tixagevimab and cilgavimab) as a preexposure treatment for people with moderate to severe immune compromise who may not mount an effective immune response to COVID-19 vaccination or those who are allergic.

Dr. Berger reported multiple disclosures.

NATIONAL HARBOR, MD. – While patients with multiple sclerosis (MS) don’t seem to be more likely to be infected with COVID-19, a neurologist told colleagues, the jury is still out over whether they face a higher mortality risk, especially if they take certain disease-modifying therapies (DMTs)

In regard to MS overall, “the data is conflicting, but any increased risk of mortality appears to be slight. And it appears to be chiefly the consequences associated with comorbidities as seen in other populations,” Joseph R. Berger, MD, said at the John F. Kurtzke Memorial Lecture at the annual meeting of the Consortium of Multiple Sclerosis Centers. “If you’re old, if you’re infirm, if you have obesity and cardiovascular disease and underlying pulmonary disease, you’re at risk of dying yourself. It’s not so much the MS,” said Dr. Berger, professor of neurology at the Hospital of the University of Pennsylvania and chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia.

Dr. Berger had his own COVID-19 story to tell: He couldn’t attend the conference in person because he was quarantining in Portugal since he tested positive. At press time, he was faring well but had reported 4 days of intense back pain.

In regard to MS and COVID-19, Dr. Berger said consistent research suggests that patients with MS aren’t at higher risk of COVID infection, although hospitalization may be more common. There may be a very small increase in risk of MS relapse in patients with COVID-19, he said, but pseudorelapses are far more common. As for mortality, he highlighted a 2021 pooled analysis of 18 studies with 5,634 patients that suggested they had a crude death rate of 1.97%, standardized lethality ratio of 1.24, and a 24% increased risk of death.

Dr. Berger is skeptical of these findings, however, in light of overall death rate numbers. Early on in the pandemic, the fatality rate in China was estimated at 2.3%.

He said he’s more convinced by a retrospective 2021 German COVID-19 study that compared 551 patients with MS to 156,973 other patients and found lower rates of ICU admission (17.1% in patients with MS vs. 22.7% in those without it), ventilation (9.8% vs. 14.5%), and in‐hospital mortality (11.1% vs. 19.3%).

Meanwhile, a 2021 systematic review found no increase in mortality among 4,310 patients with MS (3% death rate, 20.7% hospitalization), but the death risk was highest among those on no DMTs and those taking anti-CD20 monoclonal antibodies. The COViMS Registry has reported similar findings regarding the anti-CD20 drugs rituximab and ocrelizumab, Dr. Berger noted, and a pooled study of Italian and French data links the monoclonal antibodies to more severe COVID. A 2021 aggregated study also linked the antibodies to increased risk of hospitalization and ICU admission.

“Anti-CD20 monoclonal antibodies appear to increase the risk of hospitalization and perhaps the acquisition of the virus, ICU admission, maybe death,” he said, with rituximab appearing to pose the most risk, followed by ocrelizumab and ofatumumab. “And it appears that the platform [older] therapies may be associated with lesser mortality.”

As for nondrug factors, Dr. Berger said, studies have linked higher risk to age, male sex, and comorbidities.

COVID-19 vaccines are another area of concern, he said. “The recommendation is to administer vaccination prior to the initiation of the anti-CD20s, alemtuzumab, and cladribine, and wait a period of time. Three months is ideal, maybe a little longer, because it appears that the antibody response seems to be best as your CD19 count starts to return.”

Finally, Dr. Berger noted that “passive vaccination” is now available via Evusheld (tixagevimab and cilgavimab) as a preexposure treatment for people with moderate to severe immune compromise who may not mount an effective immune response to COVID-19 vaccination or those who are allergic.

Dr. Berger reported multiple disclosures.

Patients with multiple sclerosis (MS) treated with the B-cell-depleting medication rituximab who have not yet been vaccinated against COVID-19 should get the initial vaccination as soon as possible but wait to get a booster shot until B-cell levels increase, new research suggests.

In a prospective cohort study, 90% of patients taking rituximab whose B-cell level was at least 40 cells/mcL had a sufficient antibody response to the Pfizer vaccine, whereas among those with lower levels, the antibody response was significantly lower.

Results also showed a wide variation in the length of time needed for adequate B-cell restoration. Some patients needed a year or longer for levels to become adequate.

The findings led the hospital where the study was conducted to suspend rituximab therapy until patients could be vaccinated. The findings also prompted researchers to call for new guidelines on vaccine scheduling that are based on B-cell levels and not on the current criteria of length of time since last treatment.

“It’s meaningless to just go by some recommendation covering time since the last treatment,” study investigator Joachim Burman, MD, PhD, a consultant neurologist at Uppsala University Hospital and an associate professor at Uppsala University, both in Sweden, told this news organization.

“It’s misleading and potentially harmful for patients,” Dr. Burman said.

The findings were published online  in JAMA Network Open.
 

Finding the cutoff

Drugs such as rituximab target CD20, a protein found on the surface of B cells, resulting in B-cell depletion.

Rituximab is the most common MS therapy used in Sweden. The drug is approved in the United States to treat rheumatoid arthritis and some forms of cancer, but it is not approved for treatment of MS.

Prior research showed that antibody response to COVID-19 vaccines was lower in patients receiving B-cell therapy than in the general population. That was not altogether surprising, given the fact that studies have found a similarly weakened antibody response to other vaccines.

But before now, there was no known B-cell threshold sufficient to mount an acceptable antibody response following COVID vaccination.

Researchers enrolled 67 patients in the study. Of those patients, 60 had received rituximab treatment, and seven had not.

Approximately 6 months after the last rituximab dose, the B-cell count was lower than 10/mcL for 40% of patients. In that group, rituximab treatment duration was the only factor significantly associated with slower B-cell mobilization (median duration, 4.0 years, vs. 2.1; P = .002).
 

Close monitoring needed

Six weeks after vaccination with tozinameran, the mRNA vaccine manufactured by Pfizer, 28% of patients failed to generate a sufficient antibody response. Among those patients, the median B-cell count was 22/mcL, versus 51/mcL for the remainder of the cohort (P < .001).

A cutoff value of 40/mcL rendered adequate levels of anti-spike immunoglobulin G antibodies in 90% of patients and a strong response in anti-RBD antibodies in 72%.

Study participants did register an adequate T-cell response to the vaccine, suggesting at least some level of protection.

Because MS patients are at increased risk for serious illness from SARS-CoV-2 infection, the investigators recommend that patients with MS receive their initial COVID vaccines as soon as possible – but that they should hold off on receiving a booster until their B-cell counts reach 40/mcL.

Regarding when a clinician should re-vaccinate, “the results from our study strongly suggest that you should not do that right away or just follow some generic guideline,” Dr. Burman said.

“You should closely monitor the B-cell values, and re-vaccinate once those B- cells hit the level of 40 cells/mcL” he added.

Dr. Burman said he would expect that their findings would hold with the other mRNA vaccine and with any other B-cell therapy.
 

Too soon for B-cell measures?

Commenting for this news organization, Robert J. Fox, MD, staff neurologist at the Mellen Center for MS and vice-chair for research at the Neurological Institute at Cleveland Clinic, Ohio, said the B-cell threshold identified in the study is much higher than what is typically seen in patients who undergo treatment with ocrelizumab, an anti-CD20 B-cell therapy approved in the United States for treating MS.

“Decisions about treatment interval need to balance efficacy in treating MS with safety, including response to vaccines,” said Dr. Fox, who was not involved with the research.

“Given the unknown efficacy of these extended intervals, I don’t think we’re at the point of making management recommendations based upon B-cell counts,” he added.

And yet, Uppsala University Hospital, where the study was conducted, and other centers in Sweden decided to do just that. They suspended administering rituximab to patients with MS until the patients were vaccinated. For patients newly diagnosed with MS, therapy was initiated using another disease-modifying treatment, and for those who were due for a rituximab infusion, that treatment was delayed.

Only one patient experienced a mild MS relapse during the rituximab suspension, and that case went into remission within a week, Dr. Burman reported.

“Ever since the Bar-Or report showing that the humeral response to vaccines is markedly diminished in MS patients treated with anti-CD20 therapies, clinicians have been struggling to balance those safety concerns related to anti-CD20 monoclonal antibody treatments and the clinical benefit of this treatment class,” Dr. Fox said.

“Given the uncharted waters of the COVID pandemic, clinicians made judgments and decisions as best they could, given the paucity of data,” he noted.

“At this point, we don’t know which decisions were right or wrong, but I certainly don’t think we should judge clinicians for making decisions the best they could.”

The study was funded by the Engkvist Foundation, the Marianne and Marcus Wallenberg Foundation, and the Swedish Society for Medical Research. Dr. Burman reported no relevant financial relationships. Dr. Fox has received consulting fees from Genentech/Roche, Biogen, and other companies that promote MS therapies.

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

Patients with multiple sclerosis (MS) treated with the B-cell-depleting medication rituximab who have not yet been vaccinated against COVID-19 should get the initial vaccination as soon as possible but wait to get a booster shot until B-cell levels increase, new research suggests.

In a prospective cohort study, 90% of patients taking rituximab whose B-cell level was at least 40 cells/mcL had a sufficient antibody response to the Pfizer vaccine, whereas among those with lower levels, the antibody response was significantly lower.

Results also showed a wide variation in the length of time needed for adequate B-cell restoration. Some patients needed a year or longer for levels to become adequate.

The findings led the hospital where the study was conducted to suspend rituximab therapy until patients could be vaccinated. The findings also prompted researchers to call for new guidelines on vaccine scheduling that are based on B-cell levels and not on the current criteria of length of time since last treatment.

“It’s meaningless to just go by some recommendation covering time since the last treatment,” study investigator Joachim Burman, MD, PhD, a consultant neurologist at Uppsala University Hospital and an associate professor at Uppsala University, both in Sweden, told this news organization.

“It’s misleading and potentially harmful for patients,” Dr. Burman said.

The findings were published online  in JAMA Network Open.
 

Finding the cutoff

Drugs such as rituximab target CD20, a protein found on the surface of B cells, resulting in B-cell depletion.

Rituximab is the most common MS therapy used in Sweden. The drug is approved in the United States to treat rheumatoid arthritis and some forms of cancer, but it is not approved for treatment of MS.

Prior research showed that antibody response to COVID-19 vaccines was lower in patients receiving B-cell therapy than in the general population. That was not altogether surprising, given the fact that studies have found a similarly weakened antibody response to other vaccines.

But before now, there was no known B-cell threshold sufficient to mount an acceptable antibody response following COVID vaccination.

Researchers enrolled 67 patients in the study. Of those patients, 60 had received rituximab treatment, and seven had not.

Approximately 6 months after the last rituximab dose, the B-cell count was lower than 10/mcL for 40% of patients. In that group, rituximab treatment duration was the only factor significantly associated with slower B-cell mobilization (median duration, 4.0 years, vs. 2.1; P = .002).
 

Close monitoring needed

Six weeks after vaccination with tozinameran, the mRNA vaccine manufactured by Pfizer, 28% of patients failed to generate a sufficient antibody response. Among those patients, the median B-cell count was 22/mcL, versus 51/mcL for the remainder of the cohort (P < .001).

A cutoff value of 40/mcL rendered adequate levels of anti-spike immunoglobulin G antibodies in 90% of patients and a strong response in anti-RBD antibodies in 72%.

Study participants did register an adequate T-cell response to the vaccine, suggesting at least some level of protection.

Because MS patients are at increased risk for serious illness from SARS-CoV-2 infection, the investigators recommend that patients with MS receive their initial COVID vaccines as soon as possible – but that they should hold off on receiving a booster until their B-cell counts reach 40/mcL.

Regarding when a clinician should re-vaccinate, “the results from our study strongly suggest that you should not do that right away or just follow some generic guideline,” Dr. Burman said.

“You should closely monitor the B-cell values, and re-vaccinate once those B- cells hit the level of 40 cells/mcL” he added.

Dr. Burman said he would expect that their findings would hold with the other mRNA vaccine and with any other B-cell therapy.
 

Too soon for B-cell measures?

Commenting for this news organization, Robert J. Fox, MD, staff neurologist at the Mellen Center for MS and vice-chair for research at the Neurological Institute at Cleveland Clinic, Ohio, said the B-cell threshold identified in the study is much higher than what is typically seen in patients who undergo treatment with ocrelizumab, an anti-CD20 B-cell therapy approved in the United States for treating MS.

“Decisions about treatment interval need to balance efficacy in treating MS with safety, including response to vaccines,” said Dr. Fox, who was not involved with the research.

“Given the unknown efficacy of these extended intervals, I don’t think we’re at the point of making management recommendations based upon B-cell counts,” he added.

And yet, Uppsala University Hospital, where the study was conducted, and other centers in Sweden decided to do just that. They suspended administering rituximab to patients with MS until the patients were vaccinated. For patients newly diagnosed with MS, therapy was initiated using another disease-modifying treatment, and for those who were due for a rituximab infusion, that treatment was delayed.

Only one patient experienced a mild MS relapse during the rituximab suspension, and that case went into remission within a week, Dr. Burman reported.

“Ever since the Bar-Or report showing that the humeral response to vaccines is markedly diminished in MS patients treated with anti-CD20 therapies, clinicians have been struggling to balance those safety concerns related to anti-CD20 monoclonal antibody treatments and the clinical benefit of this treatment class,” Dr. Fox said.

“Given the uncharted waters of the COVID pandemic, clinicians made judgments and decisions as best they could, given the paucity of data,” he noted.

“At this point, we don’t know which decisions were right or wrong, but I certainly don’t think we should judge clinicians for making decisions the best they could.”

The study was funded by the Engkvist Foundation, the Marianne and Marcus Wallenberg Foundation, and the Swedish Society for Medical Research. Dr. Burman reported no relevant financial relationships. Dr. Fox has received consulting fees from Genentech/Roche, Biogen, and other companies that promote MS therapies.

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

Patients with multiple sclerosis (MS) treated with the B-cell-depleting medication rituximab who have not yet been vaccinated against COVID-19 should get the initial vaccination as soon as possible but wait to get a booster shot until B-cell levels increase, new research suggests.

In a prospective cohort study, 90% of patients taking rituximab whose B-cell level was at least 40 cells/mcL had a sufficient antibody response to the Pfizer vaccine, whereas among those with lower levels, the antibody response was significantly lower.

Results also showed a wide variation in the length of time needed for adequate B-cell restoration. Some patients needed a year or longer for levels to become adequate.

The findings led the hospital where the study was conducted to suspend rituximab therapy until patients could be vaccinated. The findings also prompted researchers to call for new guidelines on vaccine scheduling that are based on B-cell levels and not on the current criteria of length of time since last treatment.

“It’s meaningless to just go by some recommendation covering time since the last treatment,” study investigator Joachim Burman, MD, PhD, a consultant neurologist at Uppsala University Hospital and an associate professor at Uppsala University, both in Sweden, told this news organization.

“It’s misleading and potentially harmful for patients,” Dr. Burman said.

The findings were published online  in JAMA Network Open.
 

Finding the cutoff

Drugs such as rituximab target CD20, a protein found on the surface of B cells, resulting in B-cell depletion.

Rituximab is the most common MS therapy used in Sweden. The drug is approved in the United States to treat rheumatoid arthritis and some forms of cancer, but it is not approved for treatment of MS.

Prior research showed that antibody response to COVID-19 vaccines was lower in patients receiving B-cell therapy than in the general population. That was not altogether surprising, given the fact that studies have found a similarly weakened antibody response to other vaccines.

But before now, there was no known B-cell threshold sufficient to mount an acceptable antibody response following COVID vaccination.

Researchers enrolled 67 patients in the study. Of those patients, 60 had received rituximab treatment, and seven had not.

Approximately 6 months after the last rituximab dose, the B-cell count was lower than 10/mcL for 40% of patients. In that group, rituximab treatment duration was the only factor significantly associated with slower B-cell mobilization (median duration, 4.0 years, vs. 2.1; P = .002).
 

Close monitoring needed

Six weeks after vaccination with tozinameran, the mRNA vaccine manufactured by Pfizer, 28% of patients failed to generate a sufficient antibody response. Among those patients, the median B-cell count was 22/mcL, versus 51/mcL for the remainder of the cohort (P < .001).

A cutoff value of 40/mcL rendered adequate levels of anti-spike immunoglobulin G antibodies in 90% of patients and a strong response in anti-RBD antibodies in 72%.

Study participants did register an adequate T-cell response to the vaccine, suggesting at least some level of protection.

Because MS patients are at increased risk for serious illness from SARS-CoV-2 infection, the investigators recommend that patients with MS receive their initial COVID vaccines as soon as possible – but that they should hold off on receiving a booster until their B-cell counts reach 40/mcL.

Regarding when a clinician should re-vaccinate, “the results from our study strongly suggest that you should not do that right away or just follow some generic guideline,” Dr. Burman said.

“You should closely monitor the B-cell values, and re-vaccinate once those B- cells hit the level of 40 cells/mcL” he added.

Dr. Burman said he would expect that their findings would hold with the other mRNA vaccine and with any other B-cell therapy.
 

Too soon for B-cell measures?

Commenting for this news organization, Robert J. Fox, MD, staff neurologist at the Mellen Center for MS and vice-chair for research at the Neurological Institute at Cleveland Clinic, Ohio, said the B-cell threshold identified in the study is much higher than what is typically seen in patients who undergo treatment with ocrelizumab, an anti-CD20 B-cell therapy approved in the United States for treating MS.

“Decisions about treatment interval need to balance efficacy in treating MS with safety, including response to vaccines,” said Dr. Fox, who was not involved with the research.

“Given the unknown efficacy of these extended intervals, I don’t think we’re at the point of making management recommendations based upon B-cell counts,” he added.

And yet, Uppsala University Hospital, where the study was conducted, and other centers in Sweden decided to do just that. They suspended administering rituximab to patients with MS until the patients were vaccinated. For patients newly diagnosed with MS, therapy was initiated using another disease-modifying treatment, and for those who were due for a rituximab infusion, that treatment was delayed.

Only one patient experienced a mild MS relapse during the rituximab suspension, and that case went into remission within a week, Dr. Burman reported.

“Ever since the Bar-Or report showing that the humeral response to vaccines is markedly diminished in MS patients treated with anti-CD20 therapies, clinicians have been struggling to balance those safety concerns related to anti-CD20 monoclonal antibody treatments and the clinical benefit of this treatment class,” Dr. Fox said.

“Given the uncharted waters of the COVID pandemic, clinicians made judgments and decisions as best they could, given the paucity of data,” he noted.

“At this point, we don’t know which decisions were right or wrong, but I certainly don’t think we should judge clinicians for making decisions the best they could.”

The study was funded by the Engkvist Foundation, the Marianne and Marcus Wallenberg Foundation, and the Swedish Society for Medical Research. Dr. Burman reported no relevant financial relationships. Dr. Fox has received consulting fees from Genentech/Roche, Biogen, and other companies that promote MS therapies.

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

The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.

Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.

Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said. 

The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.  

If the FDA gives them the green light, the CDC will then weigh in.

“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.

“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”

Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.

The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.

Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.

Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.

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

The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.

Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.

Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said. 

The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.  

If the FDA gives them the green light, the CDC will then weigh in.

“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.

“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”

Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.

The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.

Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.

Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.

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

The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.

Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.

Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said. 

The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.  

If the FDA gives them the green light, the CDC will then weigh in.

“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.

“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”

Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.

The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.

Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.

Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.

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