MDedge Infectious Disease

Although enrollment into lung cancer clinical trials fell during the early months of the COVID-19 pandemic, it increased after a number of mitigation strategies were introduced.

These strategies should now be maintained, say experts, in order to improve enrollment and access to trials and to ensure that trials are more pragmatic and streamlined.

These were the findings from a survey sent to 173 sites of clinical trials in 45 countries around the world. The findings were presented recently at the World Conference on Lung Cancer (WCLC) 2021. The meeting and the survey were organized by the International Association for the Study of Lung Cancer (IASLC).

Responses to the survey revealed that enrollment into lung cancer trials fell by 43% during the early months of the pandemic. Patients stopped attending clinics, and some trials were suspended.

Patients were less willing to visit clinical trial sites, and lockdown restrictions made travel difficult.

Organizers of clinical trials responded by implementing mitigation strategies, such as changing monitoring requirements, increasing use of telehealth, and using local non-study facilities for laboratory and radiology services.

These measures led to an increase in trial enrollment toward the end of 2020, the survey results show.

“The COVID-19 pandemic created many challenges [that led to] reductions in lung cancer clinical trial enrollment,” commented study presenter Matthew P. Smeltzer, PhD, from the Division of Epidemiology, Biostatistics, and Environmental Health, University of Memphis.

The employment of mitigation strategies allowed the removal of “barriers,” and although the pandemic “worsened, trial enrollment began to improve due in part to these strategies,” Dr. Smeltzer said.

Many of these measures were successful and should be maintained, he suggested. Strategies include allowing telehealth visits, performing testing at local laboratories, using local radiology services, mailing experimental agents “where possible,” and allowing flexibility in trial schedules.

This is a “very important” study, commented Marina Garassino, MD, professor of medicine, hematology, and oncology, the University of Chicago Medicine, in her discussion of the abstract.

Irrespective of the pandemic, the regulation and the bureaucracy of clinical trials hinder participation by patients and physicians, she said.

Many of the mitigation strategies highlighted by the survey were similar to recommendations on the conduct of clinical trials published by the American Society of Clinical Oncology during the pandemic. Those recommendations emphasize the use of telehealth and offsite strategies to help with patient monitoring, she noted.

The findings from the survey show that it is possible to conduct more “streamlined and pragmatic trials,” she said.

“More flexible approaches should be approved by the sponsors of clinical trials and global regulatory bodies,” she added.

However, she expressed concern that “with the telehealth visits, we can create some disparities.”

“We have to remember that lung cancer patients are sometimes a very old population, and they are not digitally evolved,” she commented.

Commenting on Twitter, Jennifer C. King, PhD, chief scientific officer at the GO2 Foundation for Lung Cancer, in Washington, D.C., agreed that many of the mitigation strategies identified in the study “are good for patients all of the time, not just during a pandemic.”

Impact on lung cancer clinical trials

The survey, which included 64 questions, was intended to assess the impact of the COVID pandemic on lung cancer clinical trials.

Most of the survey responses came from sites in Europe (37.6%); 21.4% came from Asia, 13.3% came from the United States, and 7.5% came from Canada.

The team found that enrollment into lung cancer trials declined by 43% in 2020 compared to 2019, at an incidence rate ratio of 0.57 (P = .0115).

The largest decreases in enrollment were between April and August 2020, Dr. Smeltzer noted. However, in the last quarter of 2020 (October to December), the differences in enrollment were significantly smaller (P = .0160), despite a marked increase in global COVID-19 cases per month, he added.

The most common challenges faced by clinical trial sites during the pandemic were the following: There were fewer eligible patients (cited by 67% of respondents); compliance protocol was worse (61%); trials were suspended (60%); there was a lack of research staff (48%); and there were institutional closures (39%).

Regarding patient-related challenges, 67% of sites cited less willingness to visit the site. Other challenges included less ability to travel (cited by 60%), reduced access to the trial site (52%), quarantining because of exposure to COVID-19 (40%), and SARS-CoV-2 infection (26%).

Concerns of patients included the following: Fear of SARS-CoV-2 infection, which was cited by 83%; travel restrictions (47%); securing transportation (38%); and access to the laboratory/radiology services (14%).

“Patient willingness to visit the site was a consistent barrier reported across Europe, the U.S., and Canada,” said Dr. Smeltzer, although the effect was smaller in North America, he added.

Regarding mitigation strategies that were employed during the pandemic to combat the challenges and concerns, the team found that the most common measure was the modification of monitoring requirements, used by 44% of sites.

This was followed by the use of telehealth visits (43% sites), the use of laboratories at non-study facilities ( 27%), and alterations to the number of required visits (25%).

Other mitigation strategies included use of mail-order medications, (24%), using radiology services at a non-study site (20%), and altering the trial schedules (19%).

The most effective mitigation strategies were felt to be those that allowed flexibility with respect to location. These measures included use of remote monitoring, remote diagnostics, telehealth visits, and modified symptom monitoring.

Effective strategies that increased flexibility in time were delayed visits, delayed assessments, and changes to the Institutional Review Board.

The study was funded by the IASLC, which received industry support to conduct the project. Dr. Smeltzer reported no relevant financial relationships. Dr. Garassino has relationships with AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Ignyta, Incyte, MedImmune, Mirati, MSD International, Novartis, Pfizer, Regeneron, Roche, Takeda, and Seattle Genetics.

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

Although enrollment into lung cancer clinical trials fell during the early months of the COVID-19 pandemic, it increased after a number of mitigation strategies were introduced.

These strategies should now be maintained, say experts, in order to improve enrollment and access to trials and to ensure that trials are more pragmatic and streamlined.

These were the findings from a survey sent to 173 sites of clinical trials in 45 countries around the world. The findings were presented recently at the World Conference on Lung Cancer (WCLC) 2021. The meeting and the survey were organized by the International Association for the Study of Lung Cancer (IASLC).

Responses to the survey revealed that enrollment into lung cancer trials fell by 43% during the early months of the pandemic. Patients stopped attending clinics, and some trials were suspended.

Patients were less willing to visit clinical trial sites, and lockdown restrictions made travel difficult.

Organizers of clinical trials responded by implementing mitigation strategies, such as changing monitoring requirements, increasing use of telehealth, and using local non-study facilities for laboratory and radiology services.

These measures led to an increase in trial enrollment toward the end of 2020, the survey results show.

“The COVID-19 pandemic created many challenges [that led to] reductions in lung cancer clinical trial enrollment,” commented study presenter Matthew P. Smeltzer, PhD, from the Division of Epidemiology, Biostatistics, and Environmental Health, University of Memphis.

The employment of mitigation strategies allowed the removal of “barriers,” and although the pandemic “worsened, trial enrollment began to improve due in part to these strategies,” Dr. Smeltzer said.

Many of these measures were successful and should be maintained, he suggested. Strategies include allowing telehealth visits, performing testing at local laboratories, using local radiology services, mailing experimental agents “where possible,” and allowing flexibility in trial schedules.

This is a “very important” study, commented Marina Garassino, MD, professor of medicine, hematology, and oncology, the University of Chicago Medicine, in her discussion of the abstract.

Irrespective of the pandemic, the regulation and the bureaucracy of clinical trials hinder participation by patients and physicians, she said.

Many of the mitigation strategies highlighted by the survey were similar to recommendations on the conduct of clinical trials published by the American Society of Clinical Oncology during the pandemic. Those recommendations emphasize the use of telehealth and offsite strategies to help with patient monitoring, she noted.

The findings from the survey show that it is possible to conduct more “streamlined and pragmatic trials,” she said.

“More flexible approaches should be approved by the sponsors of clinical trials and global regulatory bodies,” she added.

However, she expressed concern that “with the telehealth visits, we can create some disparities.”

“We have to remember that lung cancer patients are sometimes a very old population, and they are not digitally evolved,” she commented.

Commenting on Twitter, Jennifer C. King, PhD, chief scientific officer at the GO2 Foundation for Lung Cancer, in Washington, D.C., agreed that many of the mitigation strategies identified in the study “are good for patients all of the time, not just during a pandemic.”

Impact on lung cancer clinical trials

The survey, which included 64 questions, was intended to assess the impact of the COVID pandemic on lung cancer clinical trials.

Most of the survey responses came from sites in Europe (37.6%); 21.4% came from Asia, 13.3% came from the United States, and 7.5% came from Canada.

The team found that enrollment into lung cancer trials declined by 43% in 2020 compared to 2019, at an incidence rate ratio of 0.57 (P = .0115).

The largest decreases in enrollment were between April and August 2020, Dr. Smeltzer noted. However, in the last quarter of 2020 (October to December), the differences in enrollment were significantly smaller (P = .0160), despite a marked increase in global COVID-19 cases per month, he added.

The most common challenges faced by clinical trial sites during the pandemic were the following: There were fewer eligible patients (cited by 67% of respondents); compliance protocol was worse (61%); trials were suspended (60%); there was a lack of research staff (48%); and there were institutional closures (39%).

Regarding patient-related challenges, 67% of sites cited less willingness to visit the site. Other challenges included less ability to travel (cited by 60%), reduced access to the trial site (52%), quarantining because of exposure to COVID-19 (40%), and SARS-CoV-2 infection (26%).

Concerns of patients included the following: Fear of SARS-CoV-2 infection, which was cited by 83%; travel restrictions (47%); securing transportation (38%); and access to the laboratory/radiology services (14%).

“Patient willingness to visit the site was a consistent barrier reported across Europe, the U.S., and Canada,” said Dr. Smeltzer, although the effect was smaller in North America, he added.

Regarding mitigation strategies that were employed during the pandemic to combat the challenges and concerns, the team found that the most common measure was the modification of monitoring requirements, used by 44% of sites.

This was followed by the use of telehealth visits (43% sites), the use of laboratories at non-study facilities ( 27%), and alterations to the number of required visits (25%).

Other mitigation strategies included use of mail-order medications, (24%), using radiology services at a non-study site (20%), and altering the trial schedules (19%).

The most effective mitigation strategies were felt to be those that allowed flexibility with respect to location. These measures included use of remote monitoring, remote diagnostics, telehealth visits, and modified symptom monitoring.

Effective strategies that increased flexibility in time were delayed visits, delayed assessments, and changes to the Institutional Review Board.

The study was funded by the IASLC, which received industry support to conduct the project. Dr. Smeltzer reported no relevant financial relationships. Dr. Garassino has relationships with AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Ignyta, Incyte, MedImmune, Mirati, MSD International, Novartis, Pfizer, Regeneron, Roche, Takeda, and Seattle Genetics.

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

Although enrollment into lung cancer clinical trials fell during the early months of the COVID-19 pandemic, it increased after a number of mitigation strategies were introduced.

These strategies should now be maintained, say experts, in order to improve enrollment and access to trials and to ensure that trials are more pragmatic and streamlined.

These were the findings from a survey sent to 173 sites of clinical trials in 45 countries around the world. The findings were presented recently at the World Conference on Lung Cancer (WCLC) 2021. The meeting and the survey were organized by the International Association for the Study of Lung Cancer (IASLC).

Responses to the survey revealed that enrollment into lung cancer trials fell by 43% during the early months of the pandemic. Patients stopped attending clinics, and some trials were suspended.

Patients were less willing to visit clinical trial sites, and lockdown restrictions made travel difficult.

Organizers of clinical trials responded by implementing mitigation strategies, such as changing monitoring requirements, increasing use of telehealth, and using local non-study facilities for laboratory and radiology services.

These measures led to an increase in trial enrollment toward the end of 2020, the survey results show.

“The COVID-19 pandemic created many challenges [that led to] reductions in lung cancer clinical trial enrollment,” commented study presenter Matthew P. Smeltzer, PhD, from the Division of Epidemiology, Biostatistics, and Environmental Health, University of Memphis.

The employment of mitigation strategies allowed the removal of “barriers,” and although the pandemic “worsened, trial enrollment began to improve due in part to these strategies,” Dr. Smeltzer said.

Many of these measures were successful and should be maintained, he suggested. Strategies include allowing telehealth visits, performing testing at local laboratories, using local radiology services, mailing experimental agents “where possible,” and allowing flexibility in trial schedules.

This is a “very important” study, commented Marina Garassino, MD, professor of medicine, hematology, and oncology, the University of Chicago Medicine, in her discussion of the abstract.

Irrespective of the pandemic, the regulation and the bureaucracy of clinical trials hinder participation by patients and physicians, she said.

Many of the mitigation strategies highlighted by the survey were similar to recommendations on the conduct of clinical trials published by the American Society of Clinical Oncology during the pandemic. Those recommendations emphasize the use of telehealth and offsite strategies to help with patient monitoring, she noted.

The findings from the survey show that it is possible to conduct more “streamlined and pragmatic trials,” she said.

“More flexible approaches should be approved by the sponsors of clinical trials and global regulatory bodies,” she added.

However, she expressed concern that “with the telehealth visits, we can create some disparities.”

“We have to remember that lung cancer patients are sometimes a very old population, and they are not digitally evolved,” she commented.

Commenting on Twitter, Jennifer C. King, PhD, chief scientific officer at the GO2 Foundation for Lung Cancer, in Washington, D.C., agreed that many of the mitigation strategies identified in the study “are good for patients all of the time, not just during a pandemic.”

Impact on lung cancer clinical trials

The survey, which included 64 questions, was intended to assess the impact of the COVID pandemic on lung cancer clinical trials.

Most of the survey responses came from sites in Europe (37.6%); 21.4% came from Asia, 13.3% came from the United States, and 7.5% came from Canada.

The team found that enrollment into lung cancer trials declined by 43% in 2020 compared to 2019, at an incidence rate ratio of 0.57 (P = .0115).

The largest decreases in enrollment were between April and August 2020, Dr. Smeltzer noted. However, in the last quarter of 2020 (October to December), the differences in enrollment were significantly smaller (P = .0160), despite a marked increase in global COVID-19 cases per month, he added.

The most common challenges faced by clinical trial sites during the pandemic were the following: There were fewer eligible patients (cited by 67% of respondents); compliance protocol was worse (61%); trials were suspended (60%); there was a lack of research staff (48%); and there were institutional closures (39%).

Regarding patient-related challenges, 67% of sites cited less willingness to visit the site. Other challenges included less ability to travel (cited by 60%), reduced access to the trial site (52%), quarantining because of exposure to COVID-19 (40%), and SARS-CoV-2 infection (26%).

Concerns of patients included the following: Fear of SARS-CoV-2 infection, which was cited by 83%; travel restrictions (47%); securing transportation (38%); and access to the laboratory/radiology services (14%).

“Patient willingness to visit the site was a consistent barrier reported across Europe, the U.S., and Canada,” said Dr. Smeltzer, although the effect was smaller in North America, he added.

Regarding mitigation strategies that were employed during the pandemic to combat the challenges and concerns, the team found that the most common measure was the modification of monitoring requirements, used by 44% of sites.

This was followed by the use of telehealth visits (43% sites), the use of laboratories at non-study facilities ( 27%), and alterations to the number of required visits (25%).

Other mitigation strategies included use of mail-order medications, (24%), using radiology services at a non-study site (20%), and altering the trial schedules (19%).

The most effective mitigation strategies were felt to be those that allowed flexibility with respect to location. These measures included use of remote monitoring, remote diagnostics, telehealth visits, and modified symptom monitoring.

Effective strategies that increased flexibility in time were delayed visits, delayed assessments, and changes to the Institutional Review Board.

The study was funded by the IASLC, which received industry support to conduct the project. Dr. Smeltzer reported no relevant financial relationships. Dr. Garassino has relationships with AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Ignyta, Incyte, MedImmune, Mirati, MSD International, Novartis, Pfizer, Regeneron, Roche, Takeda, and Seattle Genetics.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

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

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

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

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

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

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

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

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

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

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.

“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.

“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.

“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Long-term symptoms, like those linked with COVID-19, were common in people who had even just a single positive test, new Centers for Disease Control and Prevention data show.

The data show that symptoms in this group – including fatigue, cough, and headache – tended to last for more than a month. 

Frequency of symptoms in people with a positive test was 1.5 times higher, compared with people whose tests had always been negative, according to the research published in the CDC’s latest Morbidity and Mortality Weekly Report.

Lead author Valentine Wanga, PhD, with the CDC’s COVID-19 response team, and colleagues conducted a non–probability-based internet panel survey of about 6,000 U.S. adults to assess long-term symptoms often associated with COVID-19 among those who had ever tested positive or always tested negative for COVID-19 between January 2020 and April 2021.

William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., said in an interview that this research “establishes more securely than before that you don’t have to be hospitalized with COVID in order to develop long COVID symptoms.”

That’s better known among infectious disease experts, he said, but added that “this survey really gives a firm database for that.”
 

Study results

The study’s results showed that, compared with respondents who had a negative test result, those who received a positive result reported a significantly higher prevalence of any long-term symptom (65.9% vs. 42.9%), fatigue (22.5% vs. 12.0%), change in sense of smell or taste (17.3% vs. 1.7%), shortness of breath (15.5% vs. 5.2%), cough (14.5% vs. 4.9%), and headache (13.8% vs. 9.9%).

More people who had a positive test result (76.2%) reported persistence for more than a month of at least one initially occurring symptom, compared with those whose test results were always negative (69.6%).

The numbers are further proof, Dr. Schaffner said, that COVID not only will be an acute stressor on the health care system but patients with long COVID will need help with managing care for the long term.

“We still don’t know what the COVID virus does that results in these long COVID symptoms,” he said. Vanderbilt and many other institutions have developed “long COVID” centers as a testament to how important the problem is.

Long COVID symptoms are not well understood and most studies have looked at the effects from patients who had been hospitalized with COVID-19.

In this survey, respondents self-reported whether they had ever had a positive SARS-CoV-2 test result (698), always received a negative test result (2,437), or never were tested for SARS-CoV-2 (2,750).

Compared with those who always tested negative, a larger proportion of those who tested positive (28.7% vs. 15.7%) reported believing that receiving a COVID-19 vaccine made their long-term symptoms better. No difference was found in reported beliefs that a vaccine made long-term symptoms worse.

Dr. Schaffner said he found that survey result interesting, but said that is not backed up by current data and would need further study.

“I would treat that with great caution,” he said. “I’m not dismissing it, but you can’t take that at face value. All of us who get sick and those of us who care for people who are sick – if there’s an intervention, we all hope for the best. We’re being optimistic. It’s when you do a randomized, double-blind, placebo-controlled study that you can find out whether your instincts or hopes were correct.”

The authors said that findings can inform public health preparedness, help guide care for people with post-COVID conditions, and help make the case for vaccines.

The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

Long-term symptoms, like those linked with COVID-19, were common in people who had even just a single positive test, new Centers for Disease Control and Prevention data show.

The data show that symptoms in this group – including fatigue, cough, and headache – tended to last for more than a month. 

Frequency of symptoms in people with a positive test was 1.5 times higher, compared with people whose tests had always been negative, according to the research published in the CDC’s latest Morbidity and Mortality Weekly Report.

Lead author Valentine Wanga, PhD, with the CDC’s COVID-19 response team, and colleagues conducted a non–probability-based internet panel survey of about 6,000 U.S. adults to assess long-term symptoms often associated with COVID-19 among those who had ever tested positive or always tested negative for COVID-19 between January 2020 and April 2021.

William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., said in an interview that this research “establishes more securely than before that you don’t have to be hospitalized with COVID in order to develop long COVID symptoms.”

That’s better known among infectious disease experts, he said, but added that “this survey really gives a firm database for that.”
 

Study results

The study’s results showed that, compared with respondents who had a negative test result, those who received a positive result reported a significantly higher prevalence of any long-term symptom (65.9% vs. 42.9%), fatigue (22.5% vs. 12.0%), change in sense of smell or taste (17.3% vs. 1.7%), shortness of breath (15.5% vs. 5.2%), cough (14.5% vs. 4.9%), and headache (13.8% vs. 9.9%).

More people who had a positive test result (76.2%) reported persistence for more than a month of at least one initially occurring symptom, compared with those whose test results were always negative (69.6%).

The numbers are further proof, Dr. Schaffner said, that COVID not only will be an acute stressor on the health care system but patients with long COVID will need help with managing care for the long term.

“We still don’t know what the COVID virus does that results in these long COVID symptoms,” he said. Vanderbilt and many other institutions have developed “long COVID” centers as a testament to how important the problem is.

Long COVID symptoms are not well understood and most studies have looked at the effects from patients who had been hospitalized with COVID-19.

In this survey, respondents self-reported whether they had ever had a positive SARS-CoV-2 test result (698), always received a negative test result (2,437), or never were tested for SARS-CoV-2 (2,750).

Compared with those who always tested negative, a larger proportion of those who tested positive (28.7% vs. 15.7%) reported believing that receiving a COVID-19 vaccine made their long-term symptoms better. No difference was found in reported beliefs that a vaccine made long-term symptoms worse.

Dr. Schaffner said he found that survey result interesting, but said that is not backed up by current data and would need further study.

“I would treat that with great caution,” he said. “I’m not dismissing it, but you can’t take that at face value. All of us who get sick and those of us who care for people who are sick – if there’s an intervention, we all hope for the best. We’re being optimistic. It’s when you do a randomized, double-blind, placebo-controlled study that you can find out whether your instincts or hopes were correct.”

The authors said that findings can inform public health preparedness, help guide care for people with post-COVID conditions, and help make the case for vaccines.

The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

Long-term symptoms, like those linked with COVID-19, were common in people who had even just a single positive test, new Centers for Disease Control and Prevention data show.

The data show that symptoms in this group – including fatigue, cough, and headache – tended to last for more than a month. 

Frequency of symptoms in people with a positive test was 1.5 times higher, compared with people whose tests had always been negative, according to the research published in the CDC’s latest Morbidity and Mortality Weekly Report.

Lead author Valentine Wanga, PhD, with the CDC’s COVID-19 response team, and colleagues conducted a non–probability-based internet panel survey of about 6,000 U.S. adults to assess long-term symptoms often associated with COVID-19 among those who had ever tested positive or always tested negative for COVID-19 between January 2020 and April 2021.

William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., said in an interview that this research “establishes more securely than before that you don’t have to be hospitalized with COVID in order to develop long COVID symptoms.”

That’s better known among infectious disease experts, he said, but added that “this survey really gives a firm database for that.”
 

Study results

The study’s results showed that, compared with respondents who had a negative test result, those who received a positive result reported a significantly higher prevalence of any long-term symptom (65.9% vs. 42.9%), fatigue (22.5% vs. 12.0%), change in sense of smell or taste (17.3% vs. 1.7%), shortness of breath (15.5% vs. 5.2%), cough (14.5% vs. 4.9%), and headache (13.8% vs. 9.9%).

More people who had a positive test result (76.2%) reported persistence for more than a month of at least one initially occurring symptom, compared with those whose test results were always negative (69.6%).

The numbers are further proof, Dr. Schaffner said, that COVID not only will be an acute stressor on the health care system but patients with long COVID will need help with managing care for the long term.

“We still don’t know what the COVID virus does that results in these long COVID symptoms,” he said. Vanderbilt and many other institutions have developed “long COVID” centers as a testament to how important the problem is.

Long COVID symptoms are not well understood and most studies have looked at the effects from patients who had been hospitalized with COVID-19.

In this survey, respondents self-reported whether they had ever had a positive SARS-CoV-2 test result (698), always received a negative test result (2,437), or never were tested for SARS-CoV-2 (2,750).

Compared with those who always tested negative, a larger proportion of those who tested positive (28.7% vs. 15.7%) reported believing that receiving a COVID-19 vaccine made their long-term symptoms better. No difference was found in reported beliefs that a vaccine made long-term symptoms worse.

Dr. Schaffner said he found that survey result interesting, but said that is not backed up by current data and would need further study.

“I would treat that with great caution,” he said. “I’m not dismissing it, but you can’t take that at face value. All of us who get sick and those of us who care for people who are sick – if there’s an intervention, we all hope for the best. We’re being optimistic. It’s when you do a randomized, double-blind, placebo-controlled study that you can find out whether your instincts or hopes were correct.”

The authors said that findings can inform public health preparedness, help guide care for people with post-COVID conditions, and help make the case for vaccines.

The study authors and Dr. Schaffner disclosed no relevant financial relationships.

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

Unlike in adults, seizures, including status epilepticus (SE), may be the first and main manifestation of COVID-19 in children, new research suggests.

Seizures may occur even in children with no history of epilepsy and in the absence of fever or severe COVID-19 illness, necessitating a “high index” of suspicion for the virus to make an early diagnosis and allow for appropriate infection control measures, say the researchers.

“We hope to increase physicians’ awareness of noninfluenza-like presentations of COVID in children. In areas with a high prevalence of COVID, we suggest that children with seizures be tested for COVID,” Tal Gilboa, MD, director of the child neurology unit and codirector of epilepsy, Hadassah Medical Center, Jerusalem, told this news organization.

The study was published online August 27 in the journal Seizure.
 

Presenting symptom

Among 175 children diagnosed with acute SARS-CoV-2 infection in the emergency department over 10 months in 2020, 11 (6%) presented with seizures. Studies in adults with COVID-19 have reported seizures in 0% to 2% of cases, the investigators note.

The 11 children with seizures (seven boys) ranged in age from 6 months to 17 years (median age, 11.5 years). All of them had seizures as the presenting sign of infection and none had severe COVID-19 requiring ventilatory or hemodynamic support. Six of the 11 children presented with fever.

Seven of the children had a prior history of neurological disorder: Five had epilepsy, one had a single unprovoked seizure 3 years before admission, and one had an intellectual disability. Three of the children had uncontrolled seizures despite appropriate treatment with antiseizure medication.

Nine of the 11 children presented with generalized tonic-clonic seizures. One child with a prior history of uncontrolled epilepsy with multiple seizure types had a focal tonic seizure. The youngest patient, a 5-month-old infant, presented with bilateral asymmetrical tonic-clonic seizure.

Of note, say the investigators, five of the 11 children presented with convulsive SE; none had a history of prior SE, and one had no history of seizures.

Although young age, especially under 12 months, is a known risk factor for SE, four of the five patients with SE were between 5 and 17 years old. All five children with SE responded to treatment with antiseizure medications.

All 11 children made a full recovery while in hospital, although further follow-up is essential to determine long-term outcomes, the researchers report.

“Children with no prior history of epilepsy and those with well-controlled epilepsy who present with breakthrough seizures, regardless of their body temperature, should be considered as potentially infected by SARS-CoV-2,” said Dr. Gilboa.

“It is possible, however unlikely, that a child, especially with prior epilepsy, may have an unprovoked seizure while being asymptomatically infected by SARS-CoV-2; in any case, infection control measures should be taken,” Dr. Gilboa added.
 

Need for replication

Weighing in on the study, Carl E. Stafstrom, MD, PhD, professor of neurology and pediatrics, Johns Hopkins University, Baltimore, said it’s important to note that “about half of the children had had epilepsy already, and for whatever reason, had a seizure, which required an ED visit, and then they found COVID.”

“Nevertheless, this article is interesting and surprising in what they found because nobody else has found nearly as frequent a seizure presentation,” said Dr. Stafstrom, director of the John M. Freeman Pediatric Epilepsy Center, Johns Hopkins Medicine.

“We would want to see some replication from other institutions and other populations,” he added.

The study had no specific funding. Dr. Gilboa and Dr. Stafstrom have reported no relevant financial relationships.

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

Unlike in adults, seizures, including status epilepticus (SE), may be the first and main manifestation of COVID-19 in children, new research suggests.

Seizures may occur even in children with no history of epilepsy and in the absence of fever or severe COVID-19 illness, necessitating a “high index” of suspicion for the virus to make an early diagnosis and allow for appropriate infection control measures, say the researchers.

“We hope to increase physicians’ awareness of noninfluenza-like presentations of COVID in children. In areas with a high prevalence of COVID, we suggest that children with seizures be tested for COVID,” Tal Gilboa, MD, director of the child neurology unit and codirector of epilepsy, Hadassah Medical Center, Jerusalem, told this news organization.

The study was published online August 27 in the journal Seizure.
 

Presenting symptom

Among 175 children diagnosed with acute SARS-CoV-2 infection in the emergency department over 10 months in 2020, 11 (6%) presented with seizures. Studies in adults with COVID-19 have reported seizures in 0% to 2% of cases, the investigators note.

The 11 children with seizures (seven boys) ranged in age from 6 months to 17 years (median age, 11.5 years). All of them had seizures as the presenting sign of infection and none had severe COVID-19 requiring ventilatory or hemodynamic support. Six of the 11 children presented with fever.

Seven of the children had a prior history of neurological disorder: Five had epilepsy, one had a single unprovoked seizure 3 years before admission, and one had an intellectual disability. Three of the children had uncontrolled seizures despite appropriate treatment with antiseizure medication.

Nine of the 11 children presented with generalized tonic-clonic seizures. One child with a prior history of uncontrolled epilepsy with multiple seizure types had a focal tonic seizure. The youngest patient, a 5-month-old infant, presented with bilateral asymmetrical tonic-clonic seizure.

Of note, say the investigators, five of the 11 children presented with convulsive SE; none had a history of prior SE, and one had no history of seizures.

Although young age, especially under 12 months, is a known risk factor for SE, four of the five patients with SE were between 5 and 17 years old. All five children with SE responded to treatment with antiseizure medications.

All 11 children made a full recovery while in hospital, although further follow-up is essential to determine long-term outcomes, the researchers report.

“Children with no prior history of epilepsy and those with well-controlled epilepsy who present with breakthrough seizures, regardless of their body temperature, should be considered as potentially infected by SARS-CoV-2,” said Dr. Gilboa.

“It is possible, however unlikely, that a child, especially with prior epilepsy, may have an unprovoked seizure while being asymptomatically infected by SARS-CoV-2; in any case, infection control measures should be taken,” Dr. Gilboa added.
 

Need for replication

Weighing in on the study, Carl E. Stafstrom, MD, PhD, professor of neurology and pediatrics, Johns Hopkins University, Baltimore, said it’s important to note that “about half of the children had had epilepsy already, and for whatever reason, had a seizure, which required an ED visit, and then they found COVID.”

“Nevertheless, this article is interesting and surprising in what they found because nobody else has found nearly as frequent a seizure presentation,” said Dr. Stafstrom, director of the John M. Freeman Pediatric Epilepsy Center, Johns Hopkins Medicine.

“We would want to see some replication from other institutions and other populations,” he added.

The study had no specific funding. Dr. Gilboa and Dr. Stafstrom have reported no relevant financial relationships.

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

Unlike in adults, seizures, including status epilepticus (SE), may be the first and main manifestation of COVID-19 in children, new research suggests.

Seizures may occur even in children with no history of epilepsy and in the absence of fever or severe COVID-19 illness, necessitating a “high index” of suspicion for the virus to make an early diagnosis and allow for appropriate infection control measures, say the researchers.

“We hope to increase physicians’ awareness of noninfluenza-like presentations of COVID in children. In areas with a high prevalence of COVID, we suggest that children with seizures be tested for COVID,” Tal Gilboa, MD, director of the child neurology unit and codirector of epilepsy, Hadassah Medical Center, Jerusalem, told this news organization.

The study was published online August 27 in the journal Seizure.
 

Presenting symptom

Among 175 children diagnosed with acute SARS-CoV-2 infection in the emergency department over 10 months in 2020, 11 (6%) presented with seizures. Studies in adults with COVID-19 have reported seizures in 0% to 2% of cases, the investigators note.

The 11 children with seizures (seven boys) ranged in age from 6 months to 17 years (median age, 11.5 years). All of them had seizures as the presenting sign of infection and none had severe COVID-19 requiring ventilatory or hemodynamic support. Six of the 11 children presented with fever.

Seven of the children had a prior history of neurological disorder: Five had epilepsy, one had a single unprovoked seizure 3 years before admission, and one had an intellectual disability. Three of the children had uncontrolled seizures despite appropriate treatment with antiseizure medication.

Nine of the 11 children presented with generalized tonic-clonic seizures. One child with a prior history of uncontrolled epilepsy with multiple seizure types had a focal tonic seizure. The youngest patient, a 5-month-old infant, presented with bilateral asymmetrical tonic-clonic seizure.

Of note, say the investigators, five of the 11 children presented with convulsive SE; none had a history of prior SE, and one had no history of seizures.

Although young age, especially under 12 months, is a known risk factor for SE, four of the five patients with SE were between 5 and 17 years old. All five children with SE responded to treatment with antiseizure medications.

All 11 children made a full recovery while in hospital, although further follow-up is essential to determine long-term outcomes, the researchers report.

“Children with no prior history of epilepsy and those with well-controlled epilepsy who present with breakthrough seizures, regardless of their body temperature, should be considered as potentially infected by SARS-CoV-2,” said Dr. Gilboa.

“It is possible, however unlikely, that a child, especially with prior epilepsy, may have an unprovoked seizure while being asymptomatically infected by SARS-CoV-2; in any case, infection control measures should be taken,” Dr. Gilboa added.
 

Need for replication

Weighing in on the study, Carl E. Stafstrom, MD, PhD, professor of neurology and pediatrics, Johns Hopkins University, Baltimore, said it’s important to note that “about half of the children had had epilepsy already, and for whatever reason, had a seizure, which required an ED visit, and then they found COVID.”

“Nevertheless, this article is interesting and surprising in what they found because nobody else has found nearly as frequent a seizure presentation,” said Dr. Stafstrom, director of the John M. Freeman Pediatric Epilepsy Center, Johns Hopkins Medicine.

“We would want to see some replication from other institutions and other populations,” he added.

The study had no specific funding. Dr. Gilboa and Dr. Stafstrom have reported no relevant financial relationships.

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

Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.

The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.

Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.

“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”

Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.

In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.

The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.

“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.

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

Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.

The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.

Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.

“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”

Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.

In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.

The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.

“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.

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

Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.

The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.

Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.

“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”

Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.

In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.

The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.

“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.

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

Here’s some encouraging news for once regarding SARS-CoV-2 infections: A study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV₁) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute in Stockholm.

“We found no effect of COVID-19 on spirometric lung function in generally healthy adults,” she said in an oral abstract presented at the European Respiratory Society 2021 International Congress.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

“The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults,” commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London.

“We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function,” she said. Dr. Simonds was not involved in either study.
 

Young adult study

Dr. Mogenson and colleagues assessed data on 853 participants in the BAMSE Project, a prospective birth cohort study that included 4,089 children born in Stockholm from 1994 to 1996. Of the participants, 147 had asthma. They have been regularly followed with questionnaires on respiratory symptoms and medications. In addition, at 8 and 16 years’ follow-up, spirometry measures and fractional exhaled nitric oxide (FeNO) levels were assessed, allergic sensitization tests were administered, and blood eosinophil levels were measured.

In 2020 and 2021, during the pandemic, the participants underwent spirometry testing and were assessed for antibodies against SARS-CoV-2, and they self-reported use of inhaled corticosteroids.

The investigators defined asthma as any physician diagnosis and asthma symptoms and/or asthma medication use within the previous year. Participants were determined to be COVID-19 seropositive if they had IgG antibodies to the SARS-CoV-2 spike greater than 25.09 AU/mL, IgM antibodies greater than 14.42 AU/mL, or IgA antibodies greater than 2.61 AU/mL, as measured with enzyme-linked immunosorbent assay.

Participants who had been vaccinated against COVID-19 were excluded.
 

No significant decreases

A total of 243 participants, including 38 with asthma, were seropositive for SARS-CoV-2 antibodies. The mean change in lung function from before the pandemic to the study end date during the pandemic were not significantly different between seropositive participants and seronegative participants or IgM-positive participants and seronegative participants.

Similarly, there were no significant differences in lung function between seropositive and seronegative participants in an analysis that was adjusted for sex, body mass index, smoking status, or prepandemic lung function.

Although there was a trend toward slightly lower function among seropositive participants with asthma in comparison with seronegative patients with asthma, it was not statistically significant, Dr. Mogenson said.

There were also no significant decreases in lung function from the prepandemic measure to the present in any of the inflammatory parameters, including blood eosinophil levels, FeNO, allergic sensitization, or inhaled corticosteroid use.
 

Potential misclassification

In the question-and-answer period that followed the presentation, session comoderator Sam Bayat, MD, PhD, from the University of Grenoble (France), who was not involved in the study, noted that “some subjects can have positive serology without any symptoms, while others can have symptomatic disease and a couple of months later they have negative serology.”

He asked Dr. Mogenson whether they had included in their study participants with symptomatic COVID-19 and whether that would change the findings.

“We did not have access to RNA testing, so we only had serology, and of course some participants could be wrongly classified to have disease – probably around 15%,” she acknowledged.

She noted that there were no significant changes in lung function among patients who reported having respiratory symptoms.

The study was funded by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, Formas, the European Research Council, and Region Stockholm. Dr. Mogenson, Dr. Simonds, and Dr. Bayat disclosed no relevant financial relationships.

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

Here’s some encouraging news for once regarding SARS-CoV-2 infections: A study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV₁) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute in Stockholm.

“We found no effect of COVID-19 on spirometric lung function in generally healthy adults,” she said in an oral abstract presented at the European Respiratory Society 2021 International Congress.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

“The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults,” commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London.

“We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function,” she said. Dr. Simonds was not involved in either study.
 

Young adult study

Dr. Mogenson and colleagues assessed data on 853 participants in the BAMSE Project, a prospective birth cohort study that included 4,089 children born in Stockholm from 1994 to 1996. Of the participants, 147 had asthma. They have been regularly followed with questionnaires on respiratory symptoms and medications. In addition, at 8 and 16 years’ follow-up, spirometry measures and fractional exhaled nitric oxide (FeNO) levels were assessed, allergic sensitization tests were administered, and blood eosinophil levels were measured.

In 2020 and 2021, during the pandemic, the participants underwent spirometry testing and were assessed for antibodies against SARS-CoV-2, and they self-reported use of inhaled corticosteroids.

The investigators defined asthma as any physician diagnosis and asthma symptoms and/or asthma medication use within the previous year. Participants were determined to be COVID-19 seropositive if they had IgG antibodies to the SARS-CoV-2 spike greater than 25.09 AU/mL, IgM antibodies greater than 14.42 AU/mL, or IgA antibodies greater than 2.61 AU/mL, as measured with enzyme-linked immunosorbent assay.

Participants who had been vaccinated against COVID-19 were excluded.
 

No significant decreases

A total of 243 participants, including 38 with asthma, were seropositive for SARS-CoV-2 antibodies. The mean change in lung function from before the pandemic to the study end date during the pandemic were not significantly different between seropositive participants and seronegative participants or IgM-positive participants and seronegative participants.

Similarly, there were no significant differences in lung function between seropositive and seronegative participants in an analysis that was adjusted for sex, body mass index, smoking status, or prepandemic lung function.

Although there was a trend toward slightly lower function among seropositive participants with asthma in comparison with seronegative patients with asthma, it was not statistically significant, Dr. Mogenson said.

There were also no significant decreases in lung function from the prepandemic measure to the present in any of the inflammatory parameters, including blood eosinophil levels, FeNO, allergic sensitization, or inhaled corticosteroid use.
 

Potential misclassification

In the question-and-answer period that followed the presentation, session comoderator Sam Bayat, MD, PhD, from the University of Grenoble (France), who was not involved in the study, noted that “some subjects can have positive serology without any symptoms, while others can have symptomatic disease and a couple of months later they have negative serology.”

He asked Dr. Mogenson whether they had included in their study participants with symptomatic COVID-19 and whether that would change the findings.

“We did not have access to RNA testing, so we only had serology, and of course some participants could be wrongly classified to have disease – probably around 15%,” she acknowledged.

She noted that there were no significant changes in lung function among patients who reported having respiratory symptoms.

The study was funded by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, Formas, the European Research Council, and Region Stockholm. Dr. Mogenson, Dr. Simonds, and Dr. Bayat disclosed no relevant financial relationships.

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

Here’s some encouraging news for once regarding SARS-CoV-2 infections: A study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV₁) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute in Stockholm.

“We found no effect of COVID-19 on spirometric lung function in generally healthy adults,” she said in an oral abstract presented at the European Respiratory Society 2021 International Congress.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

“The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults,” commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London.

“We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function,” she said. Dr. Simonds was not involved in either study.
 

Young adult study

Dr. Mogenson and colleagues assessed data on 853 participants in the BAMSE Project, a prospective birth cohort study that included 4,089 children born in Stockholm from 1994 to 1996. Of the participants, 147 had asthma. They have been regularly followed with questionnaires on respiratory symptoms and medications. In addition, at 8 and 16 years’ follow-up, spirometry measures and fractional exhaled nitric oxide (FeNO) levels were assessed, allergic sensitization tests were administered, and blood eosinophil levels were measured.

In 2020 and 2021, during the pandemic, the participants underwent spirometry testing and were assessed for antibodies against SARS-CoV-2, and they self-reported use of inhaled corticosteroids.

The investigators defined asthma as any physician diagnosis and asthma symptoms and/or asthma medication use within the previous year. Participants were determined to be COVID-19 seropositive if they had IgG antibodies to the SARS-CoV-2 spike greater than 25.09 AU/mL, IgM antibodies greater than 14.42 AU/mL, or IgA antibodies greater than 2.61 AU/mL, as measured with enzyme-linked immunosorbent assay.

Participants who had been vaccinated against COVID-19 were excluded.
 

No significant decreases

A total of 243 participants, including 38 with asthma, were seropositive for SARS-CoV-2 antibodies. The mean change in lung function from before the pandemic to the study end date during the pandemic were not significantly different between seropositive participants and seronegative participants or IgM-positive participants and seronegative participants.

Similarly, there were no significant differences in lung function between seropositive and seronegative participants in an analysis that was adjusted for sex, body mass index, smoking status, or prepandemic lung function.

Although there was a trend toward slightly lower function among seropositive participants with asthma in comparison with seronegative patients with asthma, it was not statistically significant, Dr. Mogenson said.

There were also no significant decreases in lung function from the prepandemic measure to the present in any of the inflammatory parameters, including blood eosinophil levels, FeNO, allergic sensitization, or inhaled corticosteroid use.
 

Potential misclassification

In the question-and-answer period that followed the presentation, session comoderator Sam Bayat, MD, PhD, from the University of Grenoble (France), who was not involved in the study, noted that “some subjects can have positive serology without any symptoms, while others can have symptomatic disease and a couple of months later they have negative serology.”

He asked Dr. Mogenson whether they had included in their study participants with symptomatic COVID-19 and whether that would change the findings.

“We did not have access to RNA testing, so we only had serology, and of course some participants could be wrongly classified to have disease – probably around 15%,” she acknowledged.

She noted that there were no significant changes in lung function among patients who reported having respiratory symptoms.

The study was funded by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, Formas, the European Research Council, and Region Stockholm. Dr. Mogenson, Dr. Simonds, and Dr. Bayat disclosed no relevant financial relationships.

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