User login
In Case You Missed It: COVID
Half of patients in hospital for COVID-19 get acute kidney injury
in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.
The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.
Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
COVID-19 giving nephrologists an opportunity to improve AKI care
“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.
“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.
He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:
- Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
- Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
- Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
- Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.
The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
In-hospital diuretic treatment links with AKI
One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m2.
During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.
Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).
The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.
For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
Second report links ventilation, vasopressors with worse AKI
A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.
Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.
In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.
Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.
Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.
The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.
Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
COVID-19 giving nephrologists an opportunity to improve AKI care
“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.
“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.
He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:
- Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
- Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
- Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
- Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.
The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
In-hospital diuretic treatment links with AKI
One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m2.
During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.
Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).
The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.
For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
Second report links ventilation, vasopressors with worse AKI
A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.
Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.
In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.
Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.
Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.
The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.
Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
COVID-19 giving nephrologists an opportunity to improve AKI care
“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.
“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.
He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:
- Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
- Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
- Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
- Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.
The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
In-hospital diuretic treatment links with AKI
One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m2.
During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.
Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).
The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.
For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
Second report links ventilation, vasopressors with worse AKI
A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.
Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.
In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.
Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.
Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Trend reversed: New cases of COVID-19 decline in children
New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.
The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.
Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.
Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.
New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.
The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.
Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.
Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.
New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.
The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.
Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.
Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.
New guidelines advise expanded use of high-flow nasal oxygen for patients with ARDS
Hospitalized patients with acute respiratory failure can benefit from high-flow nasal oxygen in certain settings, according to a new clinical guideline from the American College of Physicians.
High-flow nasal oxygen (HFNO) has demonstrated advantages including improved oxygenation and ventilation, wrote Arianne K. Baldomero, MD, of Minneapolis Veterans Affairs Health Care System and the University of Minnesota, Minneapolis, and colleagues. “However, the comparative benefits and harms of HFNO in clinical outcomes, including mortality, intubation, hospital length of stay, patient comfort, clearance of airway secretions, and reduced work of breathing are not well known.”
In the guideline, published in Annals of Internal Medicine, the authors recommend the use of high-flow nasal oxygen in hospitalized patients for initial or postextubation management of acute respiratory failure. The target population includes those patients treated in hospital wards, EDs, intermediate/step-down units, and ICUs.
Use of HFNO therapy as a form of noninvasive respiratory support for hospitalized patients has increased in recent years. The treatment involves delivering warm, humidified oxygen via nasal cannula at a flow level higher than the patient’s inspiratory flow.
Potential benefits of HFNO include greater patient comfort, improved compliance, and psychological benefits, according to the authors. HFNO also can be used as respiratory support in critically ill patients for a number of indications including respiratory failure or support post extubation; however, treatment of patients with COVID-19 and related conditions were not considered in the guideline.
The guideline was based on evidence comparing HFNO with conventional oxygen therapy (COT) and noninvasive ventilation (NIV). The authors reviewed 29 randomized, controlled trials that showed clinically meaningful outcomes in HFNO patients, as well as similar rates of, or reductions in, mortality, intubations, and hospital-acquired pneumonia, and increased reports of patient comfort. Data also supported the safety of HFNO with few, if any, contraindications other than problems with fitting the nasal cannula.
Across several trials comparing HFNO and NIV for initial management of acute respiratory failure, HFNO reduced all-cause mortality, intubation, and hospital-acquired pneumonia, although the authors categorized the results as “low-certainty evidence.” HFNO was not more effective than NIV for postextubation management. Based trials comparing HFNO and COT for postextubation management, the authors concluded that HFNO may reduce rates of reintubation and improve patient comfort, also with low-certainty evidence.
The research was limited by a lack of studies comparing HFNO with NIV or COT for acute respiratory failure in patients who were post lung transplantation, or for those with pulmonary embolism, pulmonary arterial hypertension, or asthma, the authors said. Other limitations included the variation in study design, study populations, and treatment protocols across the included studies. Additional research is needed to better identify the patients most likely to benefit from HFNO, according to type of acute respiratory failure.
Despite these limitations, the results support the guideline recommendation for HFNO in cases of acute respiratory failure and postextubation management. However, “broad applicability, including required clinician and health system experience and resource use, remains unknown,” the authors concluded.
Research catches up with practice
The guidelines are important at this time because “the medical literature over the past 3-4 years is catching up to what hospitalists, pulmonologists, and critical care specialists have been doing clinically over the past 6-8 years with perceived better results, Jacqueline W. Fincher, MD, MACP, President of the American College of Physicians, said in an interview.
“HFNO has been used to a varying degree over the last 6-8 years by physicians with much-perceived improved benefit in patients who are hypoxemic on usual noninvasive therapy or conventional oxygen therapy with the impending need for intubation or post extubation,” Dr. Fincher said. “During the COVID pandemic particularly with the attack on the respiratory system with COVID pneumonia and frequently associated ARDS [acute respiratory distress syndrome], the use of HFNO has been enormously helpful in trying to keep patients well oxygenated without having to intubate or reintubate them.
“We now have the medical literature that supports what has been seen clinically to make the recommendations and guidelines based on the scientific evidence,” Dr. Fincher added. “If we can avoid intubation associated with the patient being sedated, unable to eat, talk, or meaningfully participate in their care or get the patient off the ventilator sooner for the same reasons, then we have significantly improved the quality of their care, decreased their risk of infection, decreased their days in the ICU and the hospital, we will have succeeded in providing the best care possible. The availability of HFNO, with much greater comfort to the patient than being intubated, is a great tool in the toolbox of respiratory care.”
Dr. Fincher said she was not surprised by any of the recommendations. “We knew the use of HFNO helped but we were surprised by the evidence of the degree to which it is enormously helpful to patients.
“The good news is that HFNO is readily available at most hospitals, but it really requires an intensive care unit and a team of physicians, nurses, and respiratory therapists to be familiar with its use and work closely together to monitor the patient for significant changes in their respiratory status to titrate therapy,” she noted.
Looking ahead, some areas in need of more research that might impact updates to the guidelines include “What are some areas in need of more research that might impact future updates to these guidelines? Specifics on whether initiating HFNO earlier in the course of the patient’s hypoxemic illness is better or worse, as well as the use of HFNO outside of the ICU setting,” Dr. Fincher said. “The needed monitoring of the patient to know whether their respiratory status was deteriorating and how fast would be critical along with the specific indications for titration of the HFNO.”
The evidence review was commissioned and funded by the ACP. The data come from work supported by and conducted at the Minneapolis VA Health Care System. Lead author Dr. Baldomero was supported in part by the National Institutes of Health National Center for Advancing Translational Sciences.
Hospitalized patients with acute respiratory failure can benefit from high-flow nasal oxygen in certain settings, according to a new clinical guideline from the American College of Physicians.
High-flow nasal oxygen (HFNO) has demonstrated advantages including improved oxygenation and ventilation, wrote Arianne K. Baldomero, MD, of Minneapolis Veterans Affairs Health Care System and the University of Minnesota, Minneapolis, and colleagues. “However, the comparative benefits and harms of HFNO in clinical outcomes, including mortality, intubation, hospital length of stay, patient comfort, clearance of airway secretions, and reduced work of breathing are not well known.”
In the guideline, published in Annals of Internal Medicine, the authors recommend the use of high-flow nasal oxygen in hospitalized patients for initial or postextubation management of acute respiratory failure. The target population includes those patients treated in hospital wards, EDs, intermediate/step-down units, and ICUs.
Use of HFNO therapy as a form of noninvasive respiratory support for hospitalized patients has increased in recent years. The treatment involves delivering warm, humidified oxygen via nasal cannula at a flow level higher than the patient’s inspiratory flow.
Potential benefits of HFNO include greater patient comfort, improved compliance, and psychological benefits, according to the authors. HFNO also can be used as respiratory support in critically ill patients for a number of indications including respiratory failure or support post extubation; however, treatment of patients with COVID-19 and related conditions were not considered in the guideline.
The guideline was based on evidence comparing HFNO with conventional oxygen therapy (COT) and noninvasive ventilation (NIV). The authors reviewed 29 randomized, controlled trials that showed clinically meaningful outcomes in HFNO patients, as well as similar rates of, or reductions in, mortality, intubations, and hospital-acquired pneumonia, and increased reports of patient comfort. Data also supported the safety of HFNO with few, if any, contraindications other than problems with fitting the nasal cannula.
Across several trials comparing HFNO and NIV for initial management of acute respiratory failure, HFNO reduced all-cause mortality, intubation, and hospital-acquired pneumonia, although the authors categorized the results as “low-certainty evidence.” HFNO was not more effective than NIV for postextubation management. Based trials comparing HFNO and COT for postextubation management, the authors concluded that HFNO may reduce rates of reintubation and improve patient comfort, also with low-certainty evidence.
The research was limited by a lack of studies comparing HFNO with NIV or COT for acute respiratory failure in patients who were post lung transplantation, or for those with pulmonary embolism, pulmonary arterial hypertension, or asthma, the authors said. Other limitations included the variation in study design, study populations, and treatment protocols across the included studies. Additional research is needed to better identify the patients most likely to benefit from HFNO, according to type of acute respiratory failure.
Despite these limitations, the results support the guideline recommendation for HFNO in cases of acute respiratory failure and postextubation management. However, “broad applicability, including required clinician and health system experience and resource use, remains unknown,” the authors concluded.
Research catches up with practice
The guidelines are important at this time because “the medical literature over the past 3-4 years is catching up to what hospitalists, pulmonologists, and critical care specialists have been doing clinically over the past 6-8 years with perceived better results, Jacqueline W. Fincher, MD, MACP, President of the American College of Physicians, said in an interview.
“HFNO has been used to a varying degree over the last 6-8 years by physicians with much-perceived improved benefit in patients who are hypoxemic on usual noninvasive therapy or conventional oxygen therapy with the impending need for intubation or post extubation,” Dr. Fincher said. “During the COVID pandemic particularly with the attack on the respiratory system with COVID pneumonia and frequently associated ARDS [acute respiratory distress syndrome], the use of HFNO has been enormously helpful in trying to keep patients well oxygenated without having to intubate or reintubate them.
“We now have the medical literature that supports what has been seen clinically to make the recommendations and guidelines based on the scientific evidence,” Dr. Fincher added. “If we can avoid intubation associated with the patient being sedated, unable to eat, talk, or meaningfully participate in their care or get the patient off the ventilator sooner for the same reasons, then we have significantly improved the quality of their care, decreased their risk of infection, decreased their days in the ICU and the hospital, we will have succeeded in providing the best care possible. The availability of HFNO, with much greater comfort to the patient than being intubated, is a great tool in the toolbox of respiratory care.”
Dr. Fincher said she was not surprised by any of the recommendations. “We knew the use of HFNO helped but we were surprised by the evidence of the degree to which it is enormously helpful to patients.
“The good news is that HFNO is readily available at most hospitals, but it really requires an intensive care unit and a team of physicians, nurses, and respiratory therapists to be familiar with its use and work closely together to monitor the patient for significant changes in their respiratory status to titrate therapy,” she noted.
Looking ahead, some areas in need of more research that might impact updates to the guidelines include “What are some areas in need of more research that might impact future updates to these guidelines? Specifics on whether initiating HFNO earlier in the course of the patient’s hypoxemic illness is better or worse, as well as the use of HFNO outside of the ICU setting,” Dr. Fincher said. “The needed monitoring of the patient to know whether their respiratory status was deteriorating and how fast would be critical along with the specific indications for titration of the HFNO.”
The evidence review was commissioned and funded by the ACP. The data come from work supported by and conducted at the Minneapolis VA Health Care System. Lead author Dr. Baldomero was supported in part by the National Institutes of Health National Center for Advancing Translational Sciences.
Hospitalized patients with acute respiratory failure can benefit from high-flow nasal oxygen in certain settings, according to a new clinical guideline from the American College of Physicians.
High-flow nasal oxygen (HFNO) has demonstrated advantages including improved oxygenation and ventilation, wrote Arianne K. Baldomero, MD, of Minneapolis Veterans Affairs Health Care System and the University of Minnesota, Minneapolis, and colleagues. “However, the comparative benefits and harms of HFNO in clinical outcomes, including mortality, intubation, hospital length of stay, patient comfort, clearance of airway secretions, and reduced work of breathing are not well known.”
In the guideline, published in Annals of Internal Medicine, the authors recommend the use of high-flow nasal oxygen in hospitalized patients for initial or postextubation management of acute respiratory failure. The target population includes those patients treated in hospital wards, EDs, intermediate/step-down units, and ICUs.
Use of HFNO therapy as a form of noninvasive respiratory support for hospitalized patients has increased in recent years. The treatment involves delivering warm, humidified oxygen via nasal cannula at a flow level higher than the patient’s inspiratory flow.
Potential benefits of HFNO include greater patient comfort, improved compliance, and psychological benefits, according to the authors. HFNO also can be used as respiratory support in critically ill patients for a number of indications including respiratory failure or support post extubation; however, treatment of patients with COVID-19 and related conditions were not considered in the guideline.
The guideline was based on evidence comparing HFNO with conventional oxygen therapy (COT) and noninvasive ventilation (NIV). The authors reviewed 29 randomized, controlled trials that showed clinically meaningful outcomes in HFNO patients, as well as similar rates of, or reductions in, mortality, intubations, and hospital-acquired pneumonia, and increased reports of patient comfort. Data also supported the safety of HFNO with few, if any, contraindications other than problems with fitting the nasal cannula.
Across several trials comparing HFNO and NIV for initial management of acute respiratory failure, HFNO reduced all-cause mortality, intubation, and hospital-acquired pneumonia, although the authors categorized the results as “low-certainty evidence.” HFNO was not more effective than NIV for postextubation management. Based trials comparing HFNO and COT for postextubation management, the authors concluded that HFNO may reduce rates of reintubation and improve patient comfort, also with low-certainty evidence.
The research was limited by a lack of studies comparing HFNO with NIV or COT for acute respiratory failure in patients who were post lung transplantation, or for those with pulmonary embolism, pulmonary arterial hypertension, or asthma, the authors said. Other limitations included the variation in study design, study populations, and treatment protocols across the included studies. Additional research is needed to better identify the patients most likely to benefit from HFNO, according to type of acute respiratory failure.
Despite these limitations, the results support the guideline recommendation for HFNO in cases of acute respiratory failure and postextubation management. However, “broad applicability, including required clinician and health system experience and resource use, remains unknown,” the authors concluded.
Research catches up with practice
The guidelines are important at this time because “the medical literature over the past 3-4 years is catching up to what hospitalists, pulmonologists, and critical care specialists have been doing clinically over the past 6-8 years with perceived better results, Jacqueline W. Fincher, MD, MACP, President of the American College of Physicians, said in an interview.
“HFNO has been used to a varying degree over the last 6-8 years by physicians with much-perceived improved benefit in patients who are hypoxemic on usual noninvasive therapy or conventional oxygen therapy with the impending need for intubation or post extubation,” Dr. Fincher said. “During the COVID pandemic particularly with the attack on the respiratory system with COVID pneumonia and frequently associated ARDS [acute respiratory distress syndrome], the use of HFNO has been enormously helpful in trying to keep patients well oxygenated without having to intubate or reintubate them.
“We now have the medical literature that supports what has been seen clinically to make the recommendations and guidelines based on the scientific evidence,” Dr. Fincher added. “If we can avoid intubation associated with the patient being sedated, unable to eat, talk, or meaningfully participate in their care or get the patient off the ventilator sooner for the same reasons, then we have significantly improved the quality of their care, decreased their risk of infection, decreased their days in the ICU and the hospital, we will have succeeded in providing the best care possible. The availability of HFNO, with much greater comfort to the patient than being intubated, is a great tool in the toolbox of respiratory care.”
Dr. Fincher said she was not surprised by any of the recommendations. “We knew the use of HFNO helped but we were surprised by the evidence of the degree to which it is enormously helpful to patients.
“The good news is that HFNO is readily available at most hospitals, but it really requires an intensive care unit and a team of physicians, nurses, and respiratory therapists to be familiar with its use and work closely together to monitor the patient for significant changes in their respiratory status to titrate therapy,” she noted.
Looking ahead, some areas in need of more research that might impact updates to the guidelines include “What are some areas in need of more research that might impact future updates to these guidelines? Specifics on whether initiating HFNO earlier in the course of the patient’s hypoxemic illness is better or worse, as well as the use of HFNO outside of the ICU setting,” Dr. Fincher said. “The needed monitoring of the patient to know whether their respiratory status was deteriorating and how fast would be critical along with the specific indications for titration of the HFNO.”
The evidence review was commissioned and funded by the ACP. The data come from work supported by and conducted at the Minneapolis VA Health Care System. Lead author Dr. Baldomero was supported in part by the National Institutes of Health National Center for Advancing Translational Sciences.
FROM THE ANNALS OF INTERNAL MEDICINE
COVID-19 linked to novel epileptic seizures
, new research shows. In a retrospective study of more than 900 patients admitted to the hospital with COVID-19, those without a known history of epilepsy had three times greater odds of experiencing novel seizures than those with a known history of epilepsy.
In addition, among patients with new-onset seizures, hospital stays were about 15 days longer – and mortality rates were significantly higher.
“We’re finding that there are many neurological consequences that can happen with COVID-19 infections, and it’s important for clinicians to keep that in mind as they monitor people long term,” said study investigator Neeraj Singh, MD, neurologist and epileptologist with Northwell Health System, Great Neck, New York.
Dr. Singh noted that although seizures “might not be the most common thing we see in people with COVID-19, they seem to be new seizures and not just a seizure we knew would happen in someone with epilepsy.”
“So there’s definitely a need now for more prospective research and following people over time to fully understand all the different things that might be newly a problem for them in the long term,” he added.
Dr. Singh and Hardik Bhaskar, an undergraduate student at Hunter College, New York, presented the study findings at the American Academy of Neurology’s 2021 annual meeting.
Largest sample to date
“This study explores the relationship between the incidences of COVID-19 infections and [novel] epileptic seizures in the largest sample to date in a single New York–based hospital system,” the investigators noted. Novel seizures included both new-onset and breakthrough seizures.
Dr. Singh told meeting attendees that the “early epicenter” of the COVID pandemic was in New York and occurred from Feb. 29, 2020 to June 1, 2020. Patients with COVID-19 “had multiple neurological sequelae, including seizures, strokes, and encephalopathy,” he said.
However, the effects of COVID-19 on individuals with epilepsy “remain unclear,” Dr. Singh said.
For their study, the researchers assessed 917 patients in 13 New York City metropolitan hospitals. All participants had received a confirmed positive test result on PCR for COVID and had received an antiepileptic medication upon admission. The patients were admitted between Feb. 14 and June 14, 2020.
For the study, the patients were first divided into two groups: those with a history of epilepsy (n = 451), and those without such a history (n = 466).
The first group was further divided on the basis of those who presented with breakthrough seizures and those who presented without them. The second group was further divided on the basis of those who presented with new-onset seizures and those who presented without them.
Significant adverse outcomes
Results showed that 27% of the patients without a history of epilepsy experienced a novel/new-onset seizure and that 11% of the patients with a history of epilepsy experienced a novel/breakthrough seizure (odds ratio, 3.15; P < .0001).
In addition, participants with new-onset seizures had a longer stay in the hospital (mean, 26.9 days) than the subgroup with a history of epilepsy and no breakthrough seizures (10.9 days) and the subgroup with a history of epilepsy who did experience breakthrough seizures (12.8 days; P < .0001 for both comparisons).
In the group of patients with a history of epilepsy, there were no significant differences in lengths of stay between those with and those without breakthrough seizures (P = .68).
Although mortality rates did not differ significantly between the full group with a history of epilepsy versus the full group without epilepsy (23% vs. 25%; OR, 0.9), the mortality rate was significantly higher among patients who experienced novel seizures than among those who did not experience such seizures (29% vs. 23%; OR, 1.4; P = .045).
Mr. Bhaskar noted that there are “many hypotheses for the mechanism by which COVID-19 might cause seizures.” Those mechanisms include proinflammatory cytokine storms, which may increase the rate of apoptosis, neuronal necrosis, and glutamate concentrations and may disrupt the blood-brain barrier. Another hypothesis is that SARS-CoV-2 infection may lead to hypoxia and abnormal coagulation, resulting in stroke and a subsequent increase in the risk for seizures.
Interestingly, “the presence of antiepileptic medications in patients with epilepsy may confer a protective effect against breakthrough seizures,” Dr. Singh said. “However, some subclinical seizures may be misdiagnosed as encephalopathy when patients present with COVID-19 infections.”
He added that further research is needed into the mechanisms linking these infections and new-onset seizures and to “identify subclinical seizures in encephalopathic patients.”
Asked during the question-and-answer session whether the investigators had assessed differences by demographics, such as age or sex, Dr. Singh said, “We have not subdivided them that way yet,” but he said he would like to do so in the future. He also plans to look further into which specific medications were used by the participants.
The investigators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows. In a retrospective study of more than 900 patients admitted to the hospital with COVID-19, those without a known history of epilepsy had three times greater odds of experiencing novel seizures than those with a known history of epilepsy.
In addition, among patients with new-onset seizures, hospital stays were about 15 days longer – and mortality rates were significantly higher.
“We’re finding that there are many neurological consequences that can happen with COVID-19 infections, and it’s important for clinicians to keep that in mind as they monitor people long term,” said study investigator Neeraj Singh, MD, neurologist and epileptologist with Northwell Health System, Great Neck, New York.
Dr. Singh noted that although seizures “might not be the most common thing we see in people with COVID-19, they seem to be new seizures and not just a seizure we knew would happen in someone with epilepsy.”
“So there’s definitely a need now for more prospective research and following people over time to fully understand all the different things that might be newly a problem for them in the long term,” he added.
Dr. Singh and Hardik Bhaskar, an undergraduate student at Hunter College, New York, presented the study findings at the American Academy of Neurology’s 2021 annual meeting.
Largest sample to date
“This study explores the relationship between the incidences of COVID-19 infections and [novel] epileptic seizures in the largest sample to date in a single New York–based hospital system,” the investigators noted. Novel seizures included both new-onset and breakthrough seizures.
Dr. Singh told meeting attendees that the “early epicenter” of the COVID pandemic was in New York and occurred from Feb. 29, 2020 to June 1, 2020. Patients with COVID-19 “had multiple neurological sequelae, including seizures, strokes, and encephalopathy,” he said.
However, the effects of COVID-19 on individuals with epilepsy “remain unclear,” Dr. Singh said.
For their study, the researchers assessed 917 patients in 13 New York City metropolitan hospitals. All participants had received a confirmed positive test result on PCR for COVID and had received an antiepileptic medication upon admission. The patients were admitted between Feb. 14 and June 14, 2020.
For the study, the patients were first divided into two groups: those with a history of epilepsy (n = 451), and those without such a history (n = 466).
The first group was further divided on the basis of those who presented with breakthrough seizures and those who presented without them. The second group was further divided on the basis of those who presented with new-onset seizures and those who presented without them.
Significant adverse outcomes
Results showed that 27% of the patients without a history of epilepsy experienced a novel/new-onset seizure and that 11% of the patients with a history of epilepsy experienced a novel/breakthrough seizure (odds ratio, 3.15; P < .0001).
In addition, participants with new-onset seizures had a longer stay in the hospital (mean, 26.9 days) than the subgroup with a history of epilepsy and no breakthrough seizures (10.9 days) and the subgroup with a history of epilepsy who did experience breakthrough seizures (12.8 days; P < .0001 for both comparisons).
In the group of patients with a history of epilepsy, there were no significant differences in lengths of stay between those with and those without breakthrough seizures (P = .68).
Although mortality rates did not differ significantly between the full group with a history of epilepsy versus the full group without epilepsy (23% vs. 25%; OR, 0.9), the mortality rate was significantly higher among patients who experienced novel seizures than among those who did not experience such seizures (29% vs. 23%; OR, 1.4; P = .045).
Mr. Bhaskar noted that there are “many hypotheses for the mechanism by which COVID-19 might cause seizures.” Those mechanisms include proinflammatory cytokine storms, which may increase the rate of apoptosis, neuronal necrosis, and glutamate concentrations and may disrupt the blood-brain barrier. Another hypothesis is that SARS-CoV-2 infection may lead to hypoxia and abnormal coagulation, resulting in stroke and a subsequent increase in the risk for seizures.
Interestingly, “the presence of antiepileptic medications in patients with epilepsy may confer a protective effect against breakthrough seizures,” Dr. Singh said. “However, some subclinical seizures may be misdiagnosed as encephalopathy when patients present with COVID-19 infections.”
He added that further research is needed into the mechanisms linking these infections and new-onset seizures and to “identify subclinical seizures in encephalopathic patients.”
Asked during the question-and-answer session whether the investigators had assessed differences by demographics, such as age or sex, Dr. Singh said, “We have not subdivided them that way yet,” but he said he would like to do so in the future. He also plans to look further into which specific medications were used by the participants.
The investigators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows. In a retrospective study of more than 900 patients admitted to the hospital with COVID-19, those without a known history of epilepsy had three times greater odds of experiencing novel seizures than those with a known history of epilepsy.
In addition, among patients with new-onset seizures, hospital stays were about 15 days longer – and mortality rates were significantly higher.
“We’re finding that there are many neurological consequences that can happen with COVID-19 infections, and it’s important for clinicians to keep that in mind as they monitor people long term,” said study investigator Neeraj Singh, MD, neurologist and epileptologist with Northwell Health System, Great Neck, New York.
Dr. Singh noted that although seizures “might not be the most common thing we see in people with COVID-19, they seem to be new seizures and not just a seizure we knew would happen in someone with epilepsy.”
“So there’s definitely a need now for more prospective research and following people over time to fully understand all the different things that might be newly a problem for them in the long term,” he added.
Dr. Singh and Hardik Bhaskar, an undergraduate student at Hunter College, New York, presented the study findings at the American Academy of Neurology’s 2021 annual meeting.
Largest sample to date
“This study explores the relationship between the incidences of COVID-19 infections and [novel] epileptic seizures in the largest sample to date in a single New York–based hospital system,” the investigators noted. Novel seizures included both new-onset and breakthrough seizures.
Dr. Singh told meeting attendees that the “early epicenter” of the COVID pandemic was in New York and occurred from Feb. 29, 2020 to June 1, 2020. Patients with COVID-19 “had multiple neurological sequelae, including seizures, strokes, and encephalopathy,” he said.
However, the effects of COVID-19 on individuals with epilepsy “remain unclear,” Dr. Singh said.
For their study, the researchers assessed 917 patients in 13 New York City metropolitan hospitals. All participants had received a confirmed positive test result on PCR for COVID and had received an antiepileptic medication upon admission. The patients were admitted between Feb. 14 and June 14, 2020.
For the study, the patients were first divided into two groups: those with a history of epilepsy (n = 451), and those without such a history (n = 466).
The first group was further divided on the basis of those who presented with breakthrough seizures and those who presented without them. The second group was further divided on the basis of those who presented with new-onset seizures and those who presented without them.
Significant adverse outcomes
Results showed that 27% of the patients without a history of epilepsy experienced a novel/new-onset seizure and that 11% of the patients with a history of epilepsy experienced a novel/breakthrough seizure (odds ratio, 3.15; P < .0001).
In addition, participants with new-onset seizures had a longer stay in the hospital (mean, 26.9 days) than the subgroup with a history of epilepsy and no breakthrough seizures (10.9 days) and the subgroup with a history of epilepsy who did experience breakthrough seizures (12.8 days; P < .0001 for both comparisons).
In the group of patients with a history of epilepsy, there were no significant differences in lengths of stay between those with and those without breakthrough seizures (P = .68).
Although mortality rates did not differ significantly between the full group with a history of epilepsy versus the full group without epilepsy (23% vs. 25%; OR, 0.9), the mortality rate was significantly higher among patients who experienced novel seizures than among those who did not experience such seizures (29% vs. 23%; OR, 1.4; P = .045).
Mr. Bhaskar noted that there are “many hypotheses for the mechanism by which COVID-19 might cause seizures.” Those mechanisms include proinflammatory cytokine storms, which may increase the rate of apoptosis, neuronal necrosis, and glutamate concentrations and may disrupt the blood-brain barrier. Another hypothesis is that SARS-CoV-2 infection may lead to hypoxia and abnormal coagulation, resulting in stroke and a subsequent increase in the risk for seizures.
Interestingly, “the presence of antiepileptic medications in patients with epilepsy may confer a protective effect against breakthrough seizures,” Dr. Singh said. “However, some subclinical seizures may be misdiagnosed as encephalopathy when patients present with COVID-19 infections.”
He added that further research is needed into the mechanisms linking these infections and new-onset seizures and to “identify subclinical seizures in encephalopathic patients.”
Asked during the question-and-answer session whether the investigators had assessed differences by demographics, such as age or sex, Dr. Singh said, “We have not subdivided them that way yet,” but he said he would like to do so in the future. He also plans to look further into which specific medications were used by the participants.
The investigators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From AAN 2021
Feds lift pause of J&J COVID vaccine, add new warning
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Study: COVID-19 can kill months after infection
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Post–COVID-19 cardiac involvement in college athletes much rarer than thought
In a multicenter study conducted during September-December 2020, only 0.7% of 3,018 collegiate athletes who tested positive for SARS-CoV-2 infection were found to have definite, probable, or possible infection-related cardiac involvement.
None experienced an adverse cardiac event and only five (0.2%) required hospitalization for noncardiac complications of COVID-19.
“The take-home message is that cardiac involvement does not happen as much as we had initially feared. It’s in the range of 0.5% to 3%, depending on how you define cardiac involvement, which is not nothing, but it’s not the 30% or 50% that some early studies hinted at,” said Kimberly G. Harmon, MD, of the University of Washington, Seattle.
Dr. Harmon, along with Jeffrey A. Drezner, MD, also from UW, and Aaron L. Baggish, MD, of Massachusetts General Hospital, Boston, were co–primary investigators of the Outcomes Registry for Cardiac Conditions in Athletes (ORCCA) study. The group’s findings were published April 17 in Circulation.
Nearly 20,000 athletes tested
The researchers prospectively tested 19,378 athletes for SARS-CoV-2 infection from 42 U.S. colleges and universities during the study period. A total of 3,018 (16%; mean age, 20 years; 32% female) tested positive and underwent cardiac evaluation.
“We didn’t prescribe what the schools had to do in terms of cardiac evaluation, but most of these colleges are well resourced, and about 74% of athletes were evaluated using the triad testing strategy of 12-lead electrocardiography, cardiac troponin, and transthoracic echocardiography [TEE], with cardiac magnetic resonance [CMR ]when indicated,” explained Dr. Harmon. Only 198 athletes underwent primary screening with CMR.
Athletes were often tested multiple times for SARS-CoV-2 infection by participating institutions and were included in this study if they had any positive test and underwent postinfection cardiac screening.
The cohort includes athletes representing 26 distinct sporting disciplines, including American-style football (36%), basketball (9%), and cross country/track and field (8%). Most were asymptomatic or had only mild COVID-19 symptoms (33% and 29%, respectively).
‘Exercise appears to be protective’
Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG in 0.7% of athletes (21 of 2,999), cardiac troponin elevation in 0.9% (24/2,719), and abnormal TTE findings in 0.9% (24/2,556).
The odds of having cardiac involvement was 3.1 times higher in athletes with cardiopulmonary symptoms.
“One thing we’ve seen in the literature and in this cohort, is that exercise appears to be protective to some extent from COVID-19. We had a lot of cases, but in the whole cohort, only five athletes were hospitalized with COVID and those were for noncardiac reasons,” said Dr. Harmon.
During a median clinical surveillance of 113 days, there was one (0.03%) adverse cardiac event likely unrelated to SARS-CoV-2 infection.
The diagnostic yield for probable or definite cardiac involvement was 6.7 times higher for a CMR obtained for clinical reasons (10.1%) versus a primary screening CMR (1.5%).
“This is data we desperately needed. Small, single-center studies early in the pandemic had indicated a higher prevalence of cardiac involvement, which led us to be very conservative about return-to-play in the early days,” said Jeffrey Lander, MD, who was not involved in the study.
The study is complementary, he noted, to one published in March that looked at professional athletes post–COVID-19 and also found cardiac pathology in fewer than 1%. The mean age in that study was 25 years.
“They saw a similarly low rate of cardiac involvement in professional athletes, and together with this study, it gives us new information that is also reassuring,” added Dr. Lander, codirector of sports cardiology at Saint Barnabas Medical Center in Livingston, N.J., an RWJBarnabas Health facility, and team cardiologist for Seton Hall University in South Orange, N.J.
Limit CMR to symptomatic athletes
“I think this data can be extended beyond the college athlete. And it’s fair to say to high school athletes and young recreational athletes who have had asymptomatic or mild infection, you probably don’t need further workup if you’re feeling fine,” suggested Dr. Harmon.
“For those with moderate or severe illness, then the triple screen protocol is a good idea, particularly if they are having any symptoms,” she added.
Dr. Lander agrees that athletes should be screened by appropriate providers before returning to sports, but that CMR should not be used routinely for return-to-play screening.
“We’ve never taken a group of, say, 1,000 college athletes who just recovered from the flu and done cardiac MRIs on them, so it’s a bit like opening Pandora’s box when it’s used too liberally. It’s difficult to assess if the findings are secondary to COVID infection or from something entirely unrelated,” he noted.
ORCCA is a collaboration of the American Heart Association and the American Medical Society for Sports Medicine to track COVID-19 cases among National Collegiate Athletic Association (NCAA) athletes. The current study was supported by a grant from the American Medical Society for Sports Medicine.
In a multicenter study conducted during September-December 2020, only 0.7% of 3,018 collegiate athletes who tested positive for SARS-CoV-2 infection were found to have definite, probable, or possible infection-related cardiac involvement.
None experienced an adverse cardiac event and only five (0.2%) required hospitalization for noncardiac complications of COVID-19.
“The take-home message is that cardiac involvement does not happen as much as we had initially feared. It’s in the range of 0.5% to 3%, depending on how you define cardiac involvement, which is not nothing, but it’s not the 30% or 50% that some early studies hinted at,” said Kimberly G. Harmon, MD, of the University of Washington, Seattle.
Dr. Harmon, along with Jeffrey A. Drezner, MD, also from UW, and Aaron L. Baggish, MD, of Massachusetts General Hospital, Boston, were co–primary investigators of the Outcomes Registry for Cardiac Conditions in Athletes (ORCCA) study. The group’s findings were published April 17 in Circulation.
Nearly 20,000 athletes tested
The researchers prospectively tested 19,378 athletes for SARS-CoV-2 infection from 42 U.S. colleges and universities during the study period. A total of 3,018 (16%; mean age, 20 years; 32% female) tested positive and underwent cardiac evaluation.
“We didn’t prescribe what the schools had to do in terms of cardiac evaluation, but most of these colleges are well resourced, and about 74% of athletes were evaluated using the triad testing strategy of 12-lead electrocardiography, cardiac troponin, and transthoracic echocardiography [TEE], with cardiac magnetic resonance [CMR ]when indicated,” explained Dr. Harmon. Only 198 athletes underwent primary screening with CMR.
Athletes were often tested multiple times for SARS-CoV-2 infection by participating institutions and were included in this study if they had any positive test and underwent postinfection cardiac screening.
The cohort includes athletes representing 26 distinct sporting disciplines, including American-style football (36%), basketball (9%), and cross country/track and field (8%). Most were asymptomatic or had only mild COVID-19 symptoms (33% and 29%, respectively).
‘Exercise appears to be protective’
Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG in 0.7% of athletes (21 of 2,999), cardiac troponin elevation in 0.9% (24/2,719), and abnormal TTE findings in 0.9% (24/2,556).
The odds of having cardiac involvement was 3.1 times higher in athletes with cardiopulmonary symptoms.
“One thing we’ve seen in the literature and in this cohort, is that exercise appears to be protective to some extent from COVID-19. We had a lot of cases, but in the whole cohort, only five athletes were hospitalized with COVID and those were for noncardiac reasons,” said Dr. Harmon.
During a median clinical surveillance of 113 days, there was one (0.03%) adverse cardiac event likely unrelated to SARS-CoV-2 infection.
The diagnostic yield for probable or definite cardiac involvement was 6.7 times higher for a CMR obtained for clinical reasons (10.1%) versus a primary screening CMR (1.5%).
“This is data we desperately needed. Small, single-center studies early in the pandemic had indicated a higher prevalence of cardiac involvement, which led us to be very conservative about return-to-play in the early days,” said Jeffrey Lander, MD, who was not involved in the study.
The study is complementary, he noted, to one published in March that looked at professional athletes post–COVID-19 and also found cardiac pathology in fewer than 1%. The mean age in that study was 25 years.
“They saw a similarly low rate of cardiac involvement in professional athletes, and together with this study, it gives us new information that is also reassuring,” added Dr. Lander, codirector of sports cardiology at Saint Barnabas Medical Center in Livingston, N.J., an RWJBarnabas Health facility, and team cardiologist for Seton Hall University in South Orange, N.J.
Limit CMR to symptomatic athletes
“I think this data can be extended beyond the college athlete. And it’s fair to say to high school athletes and young recreational athletes who have had asymptomatic or mild infection, you probably don’t need further workup if you’re feeling fine,” suggested Dr. Harmon.
“For those with moderate or severe illness, then the triple screen protocol is a good idea, particularly if they are having any symptoms,” she added.
Dr. Lander agrees that athletes should be screened by appropriate providers before returning to sports, but that CMR should not be used routinely for return-to-play screening.
“We’ve never taken a group of, say, 1,000 college athletes who just recovered from the flu and done cardiac MRIs on them, so it’s a bit like opening Pandora’s box when it’s used too liberally. It’s difficult to assess if the findings are secondary to COVID infection or from something entirely unrelated,” he noted.
ORCCA is a collaboration of the American Heart Association and the American Medical Society for Sports Medicine to track COVID-19 cases among National Collegiate Athletic Association (NCAA) athletes. The current study was supported by a grant from the American Medical Society for Sports Medicine.
In a multicenter study conducted during September-December 2020, only 0.7% of 3,018 collegiate athletes who tested positive for SARS-CoV-2 infection were found to have definite, probable, or possible infection-related cardiac involvement.
None experienced an adverse cardiac event and only five (0.2%) required hospitalization for noncardiac complications of COVID-19.
“The take-home message is that cardiac involvement does not happen as much as we had initially feared. It’s in the range of 0.5% to 3%, depending on how you define cardiac involvement, which is not nothing, but it’s not the 30% or 50% that some early studies hinted at,” said Kimberly G. Harmon, MD, of the University of Washington, Seattle.
Dr. Harmon, along with Jeffrey A. Drezner, MD, also from UW, and Aaron L. Baggish, MD, of Massachusetts General Hospital, Boston, were co–primary investigators of the Outcomes Registry for Cardiac Conditions in Athletes (ORCCA) study. The group’s findings were published April 17 in Circulation.
Nearly 20,000 athletes tested
The researchers prospectively tested 19,378 athletes for SARS-CoV-2 infection from 42 U.S. colleges and universities during the study period. A total of 3,018 (16%; mean age, 20 years; 32% female) tested positive and underwent cardiac evaluation.
“We didn’t prescribe what the schools had to do in terms of cardiac evaluation, but most of these colleges are well resourced, and about 74% of athletes were evaluated using the triad testing strategy of 12-lead electrocardiography, cardiac troponin, and transthoracic echocardiography [TEE], with cardiac magnetic resonance [CMR ]when indicated,” explained Dr. Harmon. Only 198 athletes underwent primary screening with CMR.
Athletes were often tested multiple times for SARS-CoV-2 infection by participating institutions and were included in this study if they had any positive test and underwent postinfection cardiac screening.
The cohort includes athletes representing 26 distinct sporting disciplines, including American-style football (36%), basketball (9%), and cross country/track and field (8%). Most were asymptomatic or had only mild COVID-19 symptoms (33% and 29%, respectively).
‘Exercise appears to be protective’
Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG in 0.7% of athletes (21 of 2,999), cardiac troponin elevation in 0.9% (24/2,719), and abnormal TTE findings in 0.9% (24/2,556).
The odds of having cardiac involvement was 3.1 times higher in athletes with cardiopulmonary symptoms.
“One thing we’ve seen in the literature and in this cohort, is that exercise appears to be protective to some extent from COVID-19. We had a lot of cases, but in the whole cohort, only five athletes were hospitalized with COVID and those were for noncardiac reasons,” said Dr. Harmon.
During a median clinical surveillance of 113 days, there was one (0.03%) adverse cardiac event likely unrelated to SARS-CoV-2 infection.
The diagnostic yield for probable or definite cardiac involvement was 6.7 times higher for a CMR obtained for clinical reasons (10.1%) versus a primary screening CMR (1.5%).
“This is data we desperately needed. Small, single-center studies early in the pandemic had indicated a higher prevalence of cardiac involvement, which led us to be very conservative about return-to-play in the early days,” said Jeffrey Lander, MD, who was not involved in the study.
The study is complementary, he noted, to one published in March that looked at professional athletes post–COVID-19 and also found cardiac pathology in fewer than 1%. The mean age in that study was 25 years.
“They saw a similarly low rate of cardiac involvement in professional athletes, and together with this study, it gives us new information that is also reassuring,” added Dr. Lander, codirector of sports cardiology at Saint Barnabas Medical Center in Livingston, N.J., an RWJBarnabas Health facility, and team cardiologist for Seton Hall University in South Orange, N.J.
Limit CMR to symptomatic athletes
“I think this data can be extended beyond the college athlete. And it’s fair to say to high school athletes and young recreational athletes who have had asymptomatic or mild infection, you probably don’t need further workup if you’re feeling fine,” suggested Dr. Harmon.
“For those with moderate or severe illness, then the triple screen protocol is a good idea, particularly if they are having any symptoms,” she added.
Dr. Lander agrees that athletes should be screened by appropriate providers before returning to sports, but that CMR should not be used routinely for return-to-play screening.
“We’ve never taken a group of, say, 1,000 college athletes who just recovered from the flu and done cardiac MRIs on them, so it’s a bit like opening Pandora’s box when it’s used too liberally. It’s difficult to assess if the findings are secondary to COVID infection or from something entirely unrelated,” he noted.
ORCCA is a collaboration of the American Heart Association and the American Medical Society for Sports Medicine to track COVID-19 cases among National Collegiate Athletic Association (NCAA) athletes. The current study was supported by a grant from the American Medical Society for Sports Medicine.
FROM CIRCULATION
Can we get to ‘COVID zero’? Experts predict the next 8 months
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
Small clinics, practices key to COVID-19 vaccine success: State officials
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
COVID-19 infection conveys imperfect immunity in young adults
Do your patients think that getting COVID-19 is fully protective against subsequent reinfection? Tell it to the Marines.
A study of U.S. Marine recruits on their way to boot camp at Parris Island, S.C., showed that those who were seropositive at baseline, indicating prior exposure to SARS-CoV-2, remained at some risk for reinfection. They had about one-fifth the risk of subsequent infection, compared with seronegative recruits during basic training, but reinfections did occur.
The study, by Stuart C. Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues, was published in The Lancet Respiratory Medicine.
“Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection,” they wrote.
An infectious disease specialist who was not involved in the study said that the findings provide further evidence about the level of immunity acquired after an infection.
“It’s quite clear that reinfections do occur, they are of public health importance, and they’re something we need to be mindful of in terms of advising patients about whether a prior infection protects them from reinfection,” Mark Siedner, MD, MPH, a clinician and researcher in the division of infectious diseases at Massachusetts General Hospital, Boston, said in an interview.
The study results reinforce that “not all antibodies are the same,” said Sachin Gupta, MD, an attending physician in pulmonary and critical care medicine at Alameda Health System in Oakland, Calif. “We’re seeing still that 10% of folks who have antibodies can get infected again,” he said in an interview.
CHARM initiative
Dr. Sealfon and colleagues presented an analysis of data from the ironically named CHARM (COVID-19 Health Action Response for Marines) prospective study.
CHARM included U.S. Marine recruits, most of them male, aged 18-20 years, who were instructed to follow a 2-week unsupervised quarantine at home, after which they reported to a Marine-supervised facility for an additional 2-week quarantine.
At baseline, participants were tested for SARS-CoV-2 immunoglobulin G (IgG) seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein enzyme-linked immunosorbent assay (ELISA).
The recruits filled out questionnaires asking them to report any of 14 specific COVID-19–related symptoms or any other unspecified symptom, as well as demographic information, risk factors, and a brief medical history.
Investigators tested recruits for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay at weeks 0, 1, and 2 of quarantine, and any who had positive PCR results during quarantine were excluded.
Participants who had three negative swab PCR results during quarantine and a baseline serology test at the beginning of the supervised quarantine period – either seronegative or seropositive – then went on to enjoy their basic training at the Marine Corps Recruit Depot, Parris Island, S.C.
The participants were followed prospectively with PCR tests at weeks 2, 4, and 6 in both the seropositive and seronegative groups, and sera were obtained at the same time.
Holes in immunologic armor
Full data were available for a total of 189 participants who were seropositive and 2,247 who were seronegative at enrollment.
In all, 19 of 189 seropositive recruits (10%) had at least one PCR test positive for SARS-CoV-2 infection during the 6-week follow-up period. This translated into an incidence of 1.1 cases per person-year.
Of the 2,247 participants seronegative at baseline, 1,079 tested positive (6.2 cases per person-year; incidence rate ratio 0.18).
It appeared that antibodies provided some protection for seropositive recruits, as evidenced by a higher likelihood of infection among those with lower baseline full-length spike protein IgG titers than in those with higher baseline titers (hazard ratio 0.4, P < .001).
Among the seropositive participants who did acquire a second SARS-CoV-2 infection, viral loads in mid-turbinate nasal swabs were about 10-fold lower than in seronegative recruits who acquired infections during follow-up.
“This finding suggests that some reinfected individuals could have a similar capacity to transmit infection as those who are infected for the first time. The rate at which reinfection occurs after vaccines and natural immunity is important for estimating the proportion of the population that needs to be vaccinated to suppress the pandemic,” the investigators wrote.
Baseline neutralizing antibody titers were detected in 45 of the first 54 seropositive recruits who remained PCR negative throughout follow-up, but also in 6 of 19 seropositive participants who became infected during the 6 weeks of observation.
Lessons
Both Dr. Siedner and Dr. Gupta agreed with the authors that the risks for reinfection that were observed in young, physically fit people may differ for other populations, such as women (only 10% of seropositive recruits and 8% of seronegative recruits were female), older patients, or those who are immunocompromised.
Given that the adjusted odds ratio for reinfection in this study was nearly identical to that of a recent British study comparing infection rates between seropositive and seronegative health care workers, the risk of reinfection for other young adults and for the general population may be similar, Dr. Sealfon and colleagues wrote.
Adding to the challenge of reaching herd immunity is the observation that some patients who have recovered from COVID-19 are skeptical about the need for further protection.
“There are patients who feel like vaccination is of low benefit to them, and I think these are the same people who would be hesitant to get the vaccine anyway,” Dr. Gupta said.
Although no vaccine is perfect – the vaccine failure rate from the mRNA-based vaccines from Moderna and Pfizer/Biontech is about 5% – the protections they afford are unmistakable, Dr. Siedner said.
“I think it’s important to make the distinction that most postvaccination infections by and large have been very mild,” he said. “In people with normal immune systems, we have not seen an onslaught of postvaccination infections requiring hospitalization. Even if people do get infected after vaccination, the vaccines protect people from severe infection, and that’s what we want them to do.”
The investigators stated, “Young adults, of whom a high proportion are asymptomatically infected and become seropositive in the absence of known infection, can be an important source of transmission to more vulnerable populations. Evaluating the protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults is important for determining the need for vaccinating previously infected individuals in this age group.”
The study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency. Dr. Sealfon, Dr. Siedner, and Dr. Gupta have no conflicts of interest to report. Dr. Gupta is a member of the editorial advisory board for this publication.
Do your patients think that getting COVID-19 is fully protective against subsequent reinfection? Tell it to the Marines.
A study of U.S. Marine recruits on their way to boot camp at Parris Island, S.C., showed that those who were seropositive at baseline, indicating prior exposure to SARS-CoV-2, remained at some risk for reinfection. They had about one-fifth the risk of subsequent infection, compared with seronegative recruits during basic training, but reinfections did occur.
The study, by Stuart C. Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues, was published in The Lancet Respiratory Medicine.
“Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection,” they wrote.
An infectious disease specialist who was not involved in the study said that the findings provide further evidence about the level of immunity acquired after an infection.
“It’s quite clear that reinfections do occur, they are of public health importance, and they’re something we need to be mindful of in terms of advising patients about whether a prior infection protects them from reinfection,” Mark Siedner, MD, MPH, a clinician and researcher in the division of infectious diseases at Massachusetts General Hospital, Boston, said in an interview.
The study results reinforce that “not all antibodies are the same,” said Sachin Gupta, MD, an attending physician in pulmonary and critical care medicine at Alameda Health System in Oakland, Calif. “We’re seeing still that 10% of folks who have antibodies can get infected again,” he said in an interview.
CHARM initiative
Dr. Sealfon and colleagues presented an analysis of data from the ironically named CHARM (COVID-19 Health Action Response for Marines) prospective study.
CHARM included U.S. Marine recruits, most of them male, aged 18-20 years, who were instructed to follow a 2-week unsupervised quarantine at home, after which they reported to a Marine-supervised facility for an additional 2-week quarantine.
At baseline, participants were tested for SARS-CoV-2 immunoglobulin G (IgG) seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein enzyme-linked immunosorbent assay (ELISA).
The recruits filled out questionnaires asking them to report any of 14 specific COVID-19–related symptoms or any other unspecified symptom, as well as demographic information, risk factors, and a brief medical history.
Investigators tested recruits for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay at weeks 0, 1, and 2 of quarantine, and any who had positive PCR results during quarantine were excluded.
Participants who had three negative swab PCR results during quarantine and a baseline serology test at the beginning of the supervised quarantine period – either seronegative or seropositive – then went on to enjoy their basic training at the Marine Corps Recruit Depot, Parris Island, S.C.
The participants were followed prospectively with PCR tests at weeks 2, 4, and 6 in both the seropositive and seronegative groups, and sera were obtained at the same time.
Holes in immunologic armor
Full data were available for a total of 189 participants who were seropositive and 2,247 who were seronegative at enrollment.
In all, 19 of 189 seropositive recruits (10%) had at least one PCR test positive for SARS-CoV-2 infection during the 6-week follow-up period. This translated into an incidence of 1.1 cases per person-year.
Of the 2,247 participants seronegative at baseline, 1,079 tested positive (6.2 cases per person-year; incidence rate ratio 0.18).
It appeared that antibodies provided some protection for seropositive recruits, as evidenced by a higher likelihood of infection among those with lower baseline full-length spike protein IgG titers than in those with higher baseline titers (hazard ratio 0.4, P < .001).
Among the seropositive participants who did acquire a second SARS-CoV-2 infection, viral loads in mid-turbinate nasal swabs were about 10-fold lower than in seronegative recruits who acquired infections during follow-up.
“This finding suggests that some reinfected individuals could have a similar capacity to transmit infection as those who are infected for the first time. The rate at which reinfection occurs after vaccines and natural immunity is important for estimating the proportion of the population that needs to be vaccinated to suppress the pandemic,” the investigators wrote.
Baseline neutralizing antibody titers were detected in 45 of the first 54 seropositive recruits who remained PCR negative throughout follow-up, but also in 6 of 19 seropositive participants who became infected during the 6 weeks of observation.
Lessons
Both Dr. Siedner and Dr. Gupta agreed with the authors that the risks for reinfection that were observed in young, physically fit people may differ for other populations, such as women (only 10% of seropositive recruits and 8% of seronegative recruits were female), older patients, or those who are immunocompromised.
Given that the adjusted odds ratio for reinfection in this study was nearly identical to that of a recent British study comparing infection rates between seropositive and seronegative health care workers, the risk of reinfection for other young adults and for the general population may be similar, Dr. Sealfon and colleagues wrote.
Adding to the challenge of reaching herd immunity is the observation that some patients who have recovered from COVID-19 are skeptical about the need for further protection.
“There are patients who feel like vaccination is of low benefit to them, and I think these are the same people who would be hesitant to get the vaccine anyway,” Dr. Gupta said.
Although no vaccine is perfect – the vaccine failure rate from the mRNA-based vaccines from Moderna and Pfizer/Biontech is about 5% – the protections they afford are unmistakable, Dr. Siedner said.
“I think it’s important to make the distinction that most postvaccination infections by and large have been very mild,” he said. “In people with normal immune systems, we have not seen an onslaught of postvaccination infections requiring hospitalization. Even if people do get infected after vaccination, the vaccines protect people from severe infection, and that’s what we want them to do.”
The investigators stated, “Young adults, of whom a high proportion are asymptomatically infected and become seropositive in the absence of known infection, can be an important source of transmission to more vulnerable populations. Evaluating the protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults is important for determining the need for vaccinating previously infected individuals in this age group.”
The study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency. Dr. Sealfon, Dr. Siedner, and Dr. Gupta have no conflicts of interest to report. Dr. Gupta is a member of the editorial advisory board for this publication.
Do your patients think that getting COVID-19 is fully protective against subsequent reinfection? Tell it to the Marines.
A study of U.S. Marine recruits on their way to boot camp at Parris Island, S.C., showed that those who were seropositive at baseline, indicating prior exposure to SARS-CoV-2, remained at some risk for reinfection. They had about one-fifth the risk of subsequent infection, compared with seronegative recruits during basic training, but reinfections did occur.
The study, by Stuart C. Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues, was published in The Lancet Respiratory Medicine.
“Although antibodies induced by initial infection are largely protective, they do not guarantee effective SARS-CoV-2 neutralization activity or immunity against subsequent infection,” they wrote.
An infectious disease specialist who was not involved in the study said that the findings provide further evidence about the level of immunity acquired after an infection.
“It’s quite clear that reinfections do occur, they are of public health importance, and they’re something we need to be mindful of in terms of advising patients about whether a prior infection protects them from reinfection,” Mark Siedner, MD, MPH, a clinician and researcher in the division of infectious diseases at Massachusetts General Hospital, Boston, said in an interview.
The study results reinforce that “not all antibodies are the same,” said Sachin Gupta, MD, an attending physician in pulmonary and critical care medicine at Alameda Health System in Oakland, Calif. “We’re seeing still that 10% of folks who have antibodies can get infected again,” he said in an interview.
CHARM initiative
Dr. Sealfon and colleagues presented an analysis of data from the ironically named CHARM (COVID-19 Health Action Response for Marines) prospective study.
CHARM included U.S. Marine recruits, most of them male, aged 18-20 years, who were instructed to follow a 2-week unsupervised quarantine at home, after which they reported to a Marine-supervised facility for an additional 2-week quarantine.
At baseline, participants were tested for SARS-CoV-2 immunoglobulin G (IgG) seropositivity, defined as a dilution of 1:150 or more on receptor-binding domain and full-length spike protein enzyme-linked immunosorbent assay (ELISA).
The recruits filled out questionnaires asking them to report any of 14 specific COVID-19–related symptoms or any other unspecified symptom, as well as demographic information, risk factors, and a brief medical history.
Investigators tested recruits for SARS-CoV-2 infection by polymerase chain reaction (PCR) assay at weeks 0, 1, and 2 of quarantine, and any who had positive PCR results during quarantine were excluded.
Participants who had three negative swab PCR results during quarantine and a baseline serology test at the beginning of the supervised quarantine period – either seronegative or seropositive – then went on to enjoy their basic training at the Marine Corps Recruit Depot, Parris Island, S.C.
The participants were followed prospectively with PCR tests at weeks 2, 4, and 6 in both the seropositive and seronegative groups, and sera were obtained at the same time.
Holes in immunologic armor
Full data were available for a total of 189 participants who were seropositive and 2,247 who were seronegative at enrollment.
In all, 19 of 189 seropositive recruits (10%) had at least one PCR test positive for SARS-CoV-2 infection during the 6-week follow-up period. This translated into an incidence of 1.1 cases per person-year.
Of the 2,247 participants seronegative at baseline, 1,079 tested positive (6.2 cases per person-year; incidence rate ratio 0.18).
It appeared that antibodies provided some protection for seropositive recruits, as evidenced by a higher likelihood of infection among those with lower baseline full-length spike protein IgG titers than in those with higher baseline titers (hazard ratio 0.4, P < .001).
Among the seropositive participants who did acquire a second SARS-CoV-2 infection, viral loads in mid-turbinate nasal swabs were about 10-fold lower than in seronegative recruits who acquired infections during follow-up.
“This finding suggests that some reinfected individuals could have a similar capacity to transmit infection as those who are infected for the first time. The rate at which reinfection occurs after vaccines and natural immunity is important for estimating the proportion of the population that needs to be vaccinated to suppress the pandemic,” the investigators wrote.
Baseline neutralizing antibody titers were detected in 45 of the first 54 seropositive recruits who remained PCR negative throughout follow-up, but also in 6 of 19 seropositive participants who became infected during the 6 weeks of observation.
Lessons
Both Dr. Siedner and Dr. Gupta agreed with the authors that the risks for reinfection that were observed in young, physically fit people may differ for other populations, such as women (only 10% of seropositive recruits and 8% of seronegative recruits were female), older patients, or those who are immunocompromised.
Given that the adjusted odds ratio for reinfection in this study was nearly identical to that of a recent British study comparing infection rates between seropositive and seronegative health care workers, the risk of reinfection for other young adults and for the general population may be similar, Dr. Sealfon and colleagues wrote.
Adding to the challenge of reaching herd immunity is the observation that some patients who have recovered from COVID-19 are skeptical about the need for further protection.
“There are patients who feel like vaccination is of low benefit to them, and I think these are the same people who would be hesitant to get the vaccine anyway,” Dr. Gupta said.
Although no vaccine is perfect – the vaccine failure rate from the mRNA-based vaccines from Moderna and Pfizer/Biontech is about 5% – the protections they afford are unmistakable, Dr. Siedner said.
“I think it’s important to make the distinction that most postvaccination infections by and large have been very mild,” he said. “In people with normal immune systems, we have not seen an onslaught of postvaccination infections requiring hospitalization. Even if people do get infected after vaccination, the vaccines protect people from severe infection, and that’s what we want them to do.”
The investigators stated, “Young adults, of whom a high proportion are asymptomatically infected and become seropositive in the absence of known infection, can be an important source of transmission to more vulnerable populations. Evaluating the protection against subsequent SARS-CoV-2 infection conferred by seropositivity in young adults is important for determining the need for vaccinating previously infected individuals in this age group.”
The study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency. Dr. Sealfon, Dr. Siedner, and Dr. Gupta have no conflicts of interest to report. Dr. Gupta is a member of the editorial advisory board for this publication.
FROM THE LANCET RESPIRATORY MEDICINE