User login
COVID-19: Greater mortality among psych patients remains a mystery
Antipsychotics are not responsible for the increased COVID-related death rate among patients with serious mental illness (SMI), new research shows.
The significant increase in COVID-19 mortality that continues to be reported among those with schizophrenia and schizoaffective disorder “underscores the importance of protective interventions for this group, including priority vaccination,” study investigator Katlyn Nemani, MD, research assistant professor, department of psychiatry, New York University, told this news organization.
The study was published online September 22 in JAMA Psychiatry.
Threefold increase in death
Previous research has linked a diagnosis of a schizophrenia spectrum disorder, which includes schizophrenia and schizoaffective disorder, to an almost threefold increase in mortality among patients with COVID-19.
Some population-based research has also reported a link between antipsychotic medication use and increased risk for COVID-related mortality, but these studies did not take psychiatric diagnoses into account.
“This raised the question of whether the increased risk observed in this population is related to underlying psychiatric illness or its treatment,” said Dr. Nemani.
The retrospective cohort study included 464 adults (mean age, 53 years) who were diagnosed with COVID-19 between March 3, 2020, and Feb. 17, 2021, and who had previously been diagnosed with schizophrenia spectrum disorder or bipolar disorder. Of these, 42.2% were treated with an antipsychotic medication.
The primary endpoint was death within 60 days of COVID-19 diagnosis. Covariates included sociodemographic characteristics, such as patient-reported race and ethnicity, age, and insurance type, a psychiatric diagnosis, medical comorbidities, and smoking status.
Of the total, 41 patients (8.8%) died. The 60-day fatality rate was 13.7% among patients with a schizophrenia spectrum disorder (n = 182) and 5.7% among patients with bipolar disorder (n = 282).
Antipsychotic treatment was not significantly associated with mortality (odds ratio, 1.00; 95% confidence interval, 0.48-2.08; P = .99).
“This suggests that antipsychotic medication is unlikely to be responsible for the increased risk we’ve observed in this population, although this finding needs to be replicated,” said Dr. Nemani.
Surprise finding
A diagnosis of a schizophrenia spectrum disorder was associated with an almost threefold increased risk for mortality compared with bipolar disorder (OR, 2.88; 95% CI, 1.36-6.11; P = .006).
“This was a surprising finding,” said Dr. Nemani.
She noted that there is evidence suggesting the immune system may play a role in the pathogenesis of schizophrenia, and research has shown that pneumonia and infection are among the leading causes of premature mortality in this population.
As well, several potential risk factors disproportionately affect people with serious mental illness, including an increase in the prevalence of medical comorbidities such as cardiovascular disease and diabetes, socioeconomic disadvantages, and barriers to accessing timely care. Prior studies have also found that people with SMI are less likely to receive preventive care interventions, including vaccination, said Dr. Nemani.
However, these factors are unlikely to fully account for the increased risk found in the study, she said.
“Our study population was limited to people who had received treatment within the NYU Langone Health System. We took a comprehensive list of sociodemographic and medical risk factors into account, and our research was conducted prior to the availability of COVID-19 vaccines,” she said.
Further research is necessary to understand what underlies the increase in susceptibility to severe infection among patients with schizophrenia and to identify interventions that may mitigate risk, said Dr. Nemani.
“This includes evaluating systems-level factors, such as access to preventive interventions and treatment, as well as investigating underlying immune mechanisms that may contribute to severe and fatal infection,” she said.
The researchers could not validate psychiatric diagnoses or capture deaths not documented in the electronic health record. In addition, the limited sample size precluded analysis of the use of individual antipsychotic medications, which may differ in their associated effects.
“It’s possible individual antipsychotic medications may be associated with harmful or protective effects,” said Dr. Nemani.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antipsychotics are not responsible for the increased COVID-related death rate among patients with serious mental illness (SMI), new research shows.
The significant increase in COVID-19 mortality that continues to be reported among those with schizophrenia and schizoaffective disorder “underscores the importance of protective interventions for this group, including priority vaccination,” study investigator Katlyn Nemani, MD, research assistant professor, department of psychiatry, New York University, told this news organization.
The study was published online September 22 in JAMA Psychiatry.
Threefold increase in death
Previous research has linked a diagnosis of a schizophrenia spectrum disorder, which includes schizophrenia and schizoaffective disorder, to an almost threefold increase in mortality among patients with COVID-19.
Some population-based research has also reported a link between antipsychotic medication use and increased risk for COVID-related mortality, but these studies did not take psychiatric diagnoses into account.
“This raised the question of whether the increased risk observed in this population is related to underlying psychiatric illness or its treatment,” said Dr. Nemani.
The retrospective cohort study included 464 adults (mean age, 53 years) who were diagnosed with COVID-19 between March 3, 2020, and Feb. 17, 2021, and who had previously been diagnosed with schizophrenia spectrum disorder or bipolar disorder. Of these, 42.2% were treated with an antipsychotic medication.
The primary endpoint was death within 60 days of COVID-19 diagnosis. Covariates included sociodemographic characteristics, such as patient-reported race and ethnicity, age, and insurance type, a psychiatric diagnosis, medical comorbidities, and smoking status.
Of the total, 41 patients (8.8%) died. The 60-day fatality rate was 13.7% among patients with a schizophrenia spectrum disorder (n = 182) and 5.7% among patients with bipolar disorder (n = 282).
Antipsychotic treatment was not significantly associated with mortality (odds ratio, 1.00; 95% confidence interval, 0.48-2.08; P = .99).
“This suggests that antipsychotic medication is unlikely to be responsible for the increased risk we’ve observed in this population, although this finding needs to be replicated,” said Dr. Nemani.
Surprise finding
A diagnosis of a schizophrenia spectrum disorder was associated with an almost threefold increased risk for mortality compared with bipolar disorder (OR, 2.88; 95% CI, 1.36-6.11; P = .006).
“This was a surprising finding,” said Dr. Nemani.
She noted that there is evidence suggesting the immune system may play a role in the pathogenesis of schizophrenia, and research has shown that pneumonia and infection are among the leading causes of premature mortality in this population.
As well, several potential risk factors disproportionately affect people with serious mental illness, including an increase in the prevalence of medical comorbidities such as cardiovascular disease and diabetes, socioeconomic disadvantages, and barriers to accessing timely care. Prior studies have also found that people with SMI are less likely to receive preventive care interventions, including vaccination, said Dr. Nemani.
However, these factors are unlikely to fully account for the increased risk found in the study, she said.
“Our study population was limited to people who had received treatment within the NYU Langone Health System. We took a comprehensive list of sociodemographic and medical risk factors into account, and our research was conducted prior to the availability of COVID-19 vaccines,” she said.
Further research is necessary to understand what underlies the increase in susceptibility to severe infection among patients with schizophrenia and to identify interventions that may mitigate risk, said Dr. Nemani.
“This includes evaluating systems-level factors, such as access to preventive interventions and treatment, as well as investigating underlying immune mechanisms that may contribute to severe and fatal infection,” she said.
The researchers could not validate psychiatric diagnoses or capture deaths not documented in the electronic health record. In addition, the limited sample size precluded analysis of the use of individual antipsychotic medications, which may differ in their associated effects.
“It’s possible individual antipsychotic medications may be associated with harmful or protective effects,” said Dr. Nemani.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antipsychotics are not responsible for the increased COVID-related death rate among patients with serious mental illness (SMI), new research shows.
The significant increase in COVID-19 mortality that continues to be reported among those with schizophrenia and schizoaffective disorder “underscores the importance of protective interventions for this group, including priority vaccination,” study investigator Katlyn Nemani, MD, research assistant professor, department of psychiatry, New York University, told this news organization.
The study was published online September 22 in JAMA Psychiatry.
Threefold increase in death
Previous research has linked a diagnosis of a schizophrenia spectrum disorder, which includes schizophrenia and schizoaffective disorder, to an almost threefold increase in mortality among patients with COVID-19.
Some population-based research has also reported a link between antipsychotic medication use and increased risk for COVID-related mortality, but these studies did not take psychiatric diagnoses into account.
“This raised the question of whether the increased risk observed in this population is related to underlying psychiatric illness or its treatment,” said Dr. Nemani.
The retrospective cohort study included 464 adults (mean age, 53 years) who were diagnosed with COVID-19 between March 3, 2020, and Feb. 17, 2021, and who had previously been diagnosed with schizophrenia spectrum disorder or bipolar disorder. Of these, 42.2% were treated with an antipsychotic medication.
The primary endpoint was death within 60 days of COVID-19 diagnosis. Covariates included sociodemographic characteristics, such as patient-reported race and ethnicity, age, and insurance type, a psychiatric diagnosis, medical comorbidities, and smoking status.
Of the total, 41 patients (8.8%) died. The 60-day fatality rate was 13.7% among patients with a schizophrenia spectrum disorder (n = 182) and 5.7% among patients with bipolar disorder (n = 282).
Antipsychotic treatment was not significantly associated with mortality (odds ratio, 1.00; 95% confidence interval, 0.48-2.08; P = .99).
“This suggests that antipsychotic medication is unlikely to be responsible for the increased risk we’ve observed in this population, although this finding needs to be replicated,” said Dr. Nemani.
Surprise finding
A diagnosis of a schizophrenia spectrum disorder was associated with an almost threefold increased risk for mortality compared with bipolar disorder (OR, 2.88; 95% CI, 1.36-6.11; P = .006).
“This was a surprising finding,” said Dr. Nemani.
She noted that there is evidence suggesting the immune system may play a role in the pathogenesis of schizophrenia, and research has shown that pneumonia and infection are among the leading causes of premature mortality in this population.
As well, several potential risk factors disproportionately affect people with serious mental illness, including an increase in the prevalence of medical comorbidities such as cardiovascular disease and diabetes, socioeconomic disadvantages, and barriers to accessing timely care. Prior studies have also found that people with SMI are less likely to receive preventive care interventions, including vaccination, said Dr. Nemani.
However, these factors are unlikely to fully account for the increased risk found in the study, she said.
“Our study population was limited to people who had received treatment within the NYU Langone Health System. We took a comprehensive list of sociodemographic and medical risk factors into account, and our research was conducted prior to the availability of COVID-19 vaccines,” she said.
Further research is necessary to understand what underlies the increase in susceptibility to severe infection among patients with schizophrenia and to identify interventions that may mitigate risk, said Dr. Nemani.
“This includes evaluating systems-level factors, such as access to preventive interventions and treatment, as well as investigating underlying immune mechanisms that may contribute to severe and fatal infection,” she said.
The researchers could not validate psychiatric diagnoses or capture deaths not documented in the electronic health record. In addition, the limited sample size precluded analysis of the use of individual antipsychotic medications, which may differ in their associated effects.
“It’s possible individual antipsychotic medications may be associated with harmful or protective effects,” said Dr. Nemani.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID vaccination rates among pregnant people remain low
COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.
About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.
The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.
“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.
“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”
Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.
Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.
“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.
Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.
“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.
“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”
A version of this article first appeared on Medscape.com.
COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.
About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.
The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.
“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.
“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”
Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.
Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.
“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.
Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.
“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.
“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”
A version of this article first appeared on Medscape.com.
COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.
About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.
The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.
“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.
“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”
Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.
Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.
“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.
Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.
“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.
“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”
A version of this article first appeared on Medscape.com.
Age, C-reactive protein predict COVID-19 death in diabetes
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
COVID-19 hospitalization 80% more likely for smokers
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Children and COVID: New cases topped 200,000 after 3 weeks of declines
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Polyethylene glycol linked to rare allergic reactions seen with mRNA COVID-19 vaccines
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
These schools use weekly testing to keep kids in class – and COVID out
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Top questions answered about COVID-19 boosters for your patients
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
COVID-19 a rare trigger for Guillain-Barré syndrome
Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.
“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.
The study was published online in the journal Brain.
No uptick in pandemic cases
Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.
To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.
The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.
Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”
Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.
The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.
Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.
All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.
All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).
The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days.
More research needed
The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”
Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”
“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2.
“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.
The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.
A version of this article first appeared on Medscape.com.
Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.
“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.
The study was published online in the journal Brain.
No uptick in pandemic cases
Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.
To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.
The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.
Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”
Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.
The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.
Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.
All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.
All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).
The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days.
More research needed
The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”
Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”
“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2.
“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.
The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.
A version of this article first appeared on Medscape.com.
Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.
“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.
The study was published online in the journal Brain.
No uptick in pandemic cases
Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.
To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.
The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.
Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”
Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.
The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.
Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.
All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.
All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).
The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days.
More research needed
The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”
Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”
“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2.
“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.
The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.
A version of this article first appeared on Medscape.com.
CDC chief overrules panel, OKs boosters for health care workers
The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.
But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:
- Adults ages 65 and up and residents of long-term care facilities
- Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
- Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.
About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50 to 64.
In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.
This is the group Dr. Walensky added to the eligible list on her own.
Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville. Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.
“There was a real split in the committee,” he said.
The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.
“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”
She was not alone in feeling cautious.
“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.
“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”
The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
How much will the U.S. benefit from boosters?
Some felt squeamish about broadly recommending boosters at all.
“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.
Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”
Others agreed.
“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”
ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.
“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.
Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
Next steps
People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.
The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.
While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.
More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.
“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.
A version of this article first appeared on WebMD.com.
The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.
But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:
- Adults ages 65 and up and residents of long-term care facilities
- Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
- Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.
About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50 to 64.
In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.
This is the group Dr. Walensky added to the eligible list on her own.
Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville. Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.
“There was a real split in the committee,” he said.
The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.
“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”
She was not alone in feeling cautious.
“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.
“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”
The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
How much will the U.S. benefit from boosters?
Some felt squeamish about broadly recommending boosters at all.
“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.
Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”
Others agreed.
“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”
ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.
“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.
Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
Next steps
People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.
The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.
While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.
More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.
“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.
A version of this article first appeared on WebMD.com.
The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.
But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:
- Adults ages 65 and up and residents of long-term care facilities
- Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
- Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.
About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50 to 64.
In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.
This is the group Dr. Walensky added to the eligible list on her own.
Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville. Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.
“There was a real split in the committee,” he said.
The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.
“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”
She was not alone in feeling cautious.
“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.
“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”
The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
How much will the U.S. benefit from boosters?
Some felt squeamish about broadly recommending boosters at all.
“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.
Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”
Others agreed.
“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”
ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.
“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.
Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
Next steps
People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.
The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.
While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.
More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.
“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.
A version of this article first appeared on WebMD.com.