In COVID-19 patients, risk of bleeding rivals risk of thromboembolism

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There is no question that COVID-19 infection increases the risks of serious thromboembolic events, including pulmonary embolism (PE), but it also increases the risk of bleeding, complicating the benefit-to-risk calculations for anticoagulation, according to a review of data at the virtual Going Back to the Heart of Cardiology meeting.

“Bleeding is a significant cause of morbidity in patients with COVID-19, and this is an important concept to appreciate,” reported Rachel P. Rosovsky, MD, director of thrombosis research, Massachusetts General Hospital, Boston.

At least five guidelines, including those issued by the American College of Cardiology, International Society on Thrombosis and Haemostasis (ISTH), and the American College of Chest Physicians, have recently addressed anticoagulation in patients infected with COVID-19, but there are “substantive differences” between them, according to Dr. Rosovsky. The reason is that they are essentially no high quality trials to guide practice. Rather, the recommendations are based primarily on retrospective studies and expert opinion.

The single most common theme from the guidelines is that anticoagulation must be individualized to balance patient-specific risks of venous thromboembolism (VTE) and bleeding, said Dr. Rosovsky, whose group published a recent comparison of these guidelines (Flaczyk A et al. Crit Care 2020;24:559).

Although there is general consensus that all hospitalized patients with COVID-19 should receive anticoagulation unless there are contraindications, there are differences in the recommended intensity of the anticoagulation for different risk groups and there is even less is less consensus on the need to anticoagulate outpatients or patients after discharge, according to Dr. Rosovsky

In her own center, the standard is a prophylactic dose of low molecular weight heparin (LMWH) in an algorithm that calls for dose adjustments for some groups such as those with renal impairment or obesity. Alternative forms of anticoagulation are recommended for patients with a history of thrombocytopenia or are at high risk for hemorrhage. Full dose LMWH is recommended in patients already on an oral anticoagulant at time of hospitalization.

“The biggest question right now is when to consider increasing from a prophylactic dose to intermediate or full dose anticoagulation in high risk patients, especially those in the ICU patients,” Dr. Rosovsky said.

Current practices are diverse, according to a recently published survey led by Dr. Rosovsky (Rosovsky RP et al. Res Pract Thromb Haemost. 2020;4:969-83). According to the survey, which had responses from more than 500 physicians in 41 countries, 30% of centers escalate from a prophylactic dose of anticoagulation to an intermediate dose when patients move to the ICU. Although not all answered this question, 25% reported that they do not escalate at ICU transfer. For 15% of respondents, dose escalation is being offered to patients with a D-dimer exceeding six-times the upper limit of normal.

These practices have developed in the absence of prospective clinical trials, which are urgently needed, according to Dr. Rosovsky. The reason that trials specific to COVID-19 are particularly important is that this infection also engenders a high risk of major bleeding.

For example, in a multicenter retrospective study of 400 hospital-admitted COVID-19 patients the rates of major bleeding was 4.8% or exactly the same as the rate of radiographically confirmed VTE. At 7.6%, the rates of VTE and major bleeding were also exactly the same for ICU patients (Al-Samkari H et al. Blood 2020;136:489-500).

“An elevated D-dimer was a marker for both VTE and major bleeding,” reported Dr. Rosovsky, who was the senior author of this study. On the basis of odds ratio (OR), the risk of VTE was increased more than six-fold (OR, 6.79) and the risk of major bleeding by more than three-fold (OR, 3.56) when the D-dimer exceeded 2,500 ng/mL.

The risk of VTE from COVID-19 infection is well documented. For example, autopsy studies have shown widespread thrombosis, including PE, in patients who have died from COVID-19 infection, according to Dr. Rosovsky.

There is also evidence of benefit from anticoagulation. In an retrospective study from China undertaken early in the pandemic, there was no overall mortality benefit at 28 days among those who did receive LMWH when compared to those who did not, but there was a 20% absolute mortality benefit (52.4% vs. 32.8%; P = .017) in those with a D-dimer six-fold ULN (Tang N et al. J Thromb Haemost 2020;18:1094-9).

These types of data support the use of anticoagulation to manage VTE risk in at least some patients, but the reported rates of VTE across institutions and across inpatient and outpatient settings have varied “dramatically,” according to Dr. Rosovsky. The balance of VTE and major bleeding is delicate. In one retrospective study, the mortality advantage for therapeutic versus prophylactic dose of LMWH did not reach statistical significance, but the rate of major bleeding was nearly doubled (3.0% vs. 1.7%) (Nadkarni GN et al J Am Coll Cardiol 2020;76:1815-26).

Because of the many variables that might affect risk of VTE and risk of major bleeding in any individual patient, the benefit-to-risk calculation of anticoagulation is “complex,” according to Dr. Rosovsky. It is for this reason she urged clinicians to consider entering patients into clinical trials designed to generate evidence-based answers.

There is large and growing body of retrospective data that have helped characterize the risk of VTE and bleeding in patients with COVID-19, but “there is no substitute for a well-controlled clinical trial,” agreed Robert A. Harrington, MD, chairman of the department of medicine, Stanford (Calif.) University.

He and the comoderator of the session in which these data were presented agreed that anticoagulation must be administered within a narrow therapeutic window that will be best defined through controlled trial designs.

“There is a significant risk of doing harm,” said Fatima Rodriguez, MD, assistant professor of cardiology at Stanford University. She seconded the critical role of trial participation when possible and the need for clinical trials to better guide treatment decisions.

The meeting was sponsored by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

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There is no question that COVID-19 infection increases the risks of serious thromboembolic events, including pulmonary embolism (PE), but it also increases the risk of bleeding, complicating the benefit-to-risk calculations for anticoagulation, according to a review of data at the virtual Going Back to the Heart of Cardiology meeting.

“Bleeding is a significant cause of morbidity in patients with COVID-19, and this is an important concept to appreciate,” reported Rachel P. Rosovsky, MD, director of thrombosis research, Massachusetts General Hospital, Boston.

At least five guidelines, including those issued by the American College of Cardiology, International Society on Thrombosis and Haemostasis (ISTH), and the American College of Chest Physicians, have recently addressed anticoagulation in patients infected with COVID-19, but there are “substantive differences” between them, according to Dr. Rosovsky. The reason is that they are essentially no high quality trials to guide practice. Rather, the recommendations are based primarily on retrospective studies and expert opinion.

The single most common theme from the guidelines is that anticoagulation must be individualized to balance patient-specific risks of venous thromboembolism (VTE) and bleeding, said Dr. Rosovsky, whose group published a recent comparison of these guidelines (Flaczyk A et al. Crit Care 2020;24:559).

Although there is general consensus that all hospitalized patients with COVID-19 should receive anticoagulation unless there are contraindications, there are differences in the recommended intensity of the anticoagulation for different risk groups and there is even less is less consensus on the need to anticoagulate outpatients or patients after discharge, according to Dr. Rosovsky

In her own center, the standard is a prophylactic dose of low molecular weight heparin (LMWH) in an algorithm that calls for dose adjustments for some groups such as those with renal impairment or obesity. Alternative forms of anticoagulation are recommended for patients with a history of thrombocytopenia or are at high risk for hemorrhage. Full dose LMWH is recommended in patients already on an oral anticoagulant at time of hospitalization.

“The biggest question right now is when to consider increasing from a prophylactic dose to intermediate or full dose anticoagulation in high risk patients, especially those in the ICU patients,” Dr. Rosovsky said.

Current practices are diverse, according to a recently published survey led by Dr. Rosovsky (Rosovsky RP et al. Res Pract Thromb Haemost. 2020;4:969-83). According to the survey, which had responses from more than 500 physicians in 41 countries, 30% of centers escalate from a prophylactic dose of anticoagulation to an intermediate dose when patients move to the ICU. Although not all answered this question, 25% reported that they do not escalate at ICU transfer. For 15% of respondents, dose escalation is being offered to patients with a D-dimer exceeding six-times the upper limit of normal.

These practices have developed in the absence of prospective clinical trials, which are urgently needed, according to Dr. Rosovsky. The reason that trials specific to COVID-19 are particularly important is that this infection also engenders a high risk of major bleeding.

For example, in a multicenter retrospective study of 400 hospital-admitted COVID-19 patients the rates of major bleeding was 4.8% or exactly the same as the rate of radiographically confirmed VTE. At 7.6%, the rates of VTE and major bleeding were also exactly the same for ICU patients (Al-Samkari H et al. Blood 2020;136:489-500).

“An elevated D-dimer was a marker for both VTE and major bleeding,” reported Dr. Rosovsky, who was the senior author of this study. On the basis of odds ratio (OR), the risk of VTE was increased more than six-fold (OR, 6.79) and the risk of major bleeding by more than three-fold (OR, 3.56) when the D-dimer exceeded 2,500 ng/mL.

The risk of VTE from COVID-19 infection is well documented. For example, autopsy studies have shown widespread thrombosis, including PE, in patients who have died from COVID-19 infection, according to Dr. Rosovsky.

There is also evidence of benefit from anticoagulation. In an retrospective study from China undertaken early in the pandemic, there was no overall mortality benefit at 28 days among those who did receive LMWH when compared to those who did not, but there was a 20% absolute mortality benefit (52.4% vs. 32.8%; P = .017) in those with a D-dimer six-fold ULN (Tang N et al. J Thromb Haemost 2020;18:1094-9).

These types of data support the use of anticoagulation to manage VTE risk in at least some patients, but the reported rates of VTE across institutions and across inpatient and outpatient settings have varied “dramatically,” according to Dr. Rosovsky. The balance of VTE and major bleeding is delicate. In one retrospective study, the mortality advantage for therapeutic versus prophylactic dose of LMWH did not reach statistical significance, but the rate of major bleeding was nearly doubled (3.0% vs. 1.7%) (Nadkarni GN et al J Am Coll Cardiol 2020;76:1815-26).

Because of the many variables that might affect risk of VTE and risk of major bleeding in any individual patient, the benefit-to-risk calculation of anticoagulation is “complex,” according to Dr. Rosovsky. It is for this reason she urged clinicians to consider entering patients into clinical trials designed to generate evidence-based answers.

There is large and growing body of retrospective data that have helped characterize the risk of VTE and bleeding in patients with COVID-19, but “there is no substitute for a well-controlled clinical trial,” agreed Robert A. Harrington, MD, chairman of the department of medicine, Stanford (Calif.) University.

He and the comoderator of the session in which these data were presented agreed that anticoagulation must be administered within a narrow therapeutic window that will be best defined through controlled trial designs.

“There is a significant risk of doing harm,” said Fatima Rodriguez, MD, assistant professor of cardiology at Stanford University. She seconded the critical role of trial participation when possible and the need for clinical trials to better guide treatment decisions.

The meeting was sponsored by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

There is no question that COVID-19 infection increases the risks of serious thromboembolic events, including pulmonary embolism (PE), but it also increases the risk of bleeding, complicating the benefit-to-risk calculations for anticoagulation, according to a review of data at the virtual Going Back to the Heart of Cardiology meeting.

“Bleeding is a significant cause of morbidity in patients with COVID-19, and this is an important concept to appreciate,” reported Rachel P. Rosovsky, MD, director of thrombosis research, Massachusetts General Hospital, Boston.

At least five guidelines, including those issued by the American College of Cardiology, International Society on Thrombosis and Haemostasis (ISTH), and the American College of Chest Physicians, have recently addressed anticoagulation in patients infected with COVID-19, but there are “substantive differences” between them, according to Dr. Rosovsky. The reason is that they are essentially no high quality trials to guide practice. Rather, the recommendations are based primarily on retrospective studies and expert opinion.

The single most common theme from the guidelines is that anticoagulation must be individualized to balance patient-specific risks of venous thromboembolism (VTE) and bleeding, said Dr. Rosovsky, whose group published a recent comparison of these guidelines (Flaczyk A et al. Crit Care 2020;24:559).

Although there is general consensus that all hospitalized patients with COVID-19 should receive anticoagulation unless there are contraindications, there are differences in the recommended intensity of the anticoagulation for different risk groups and there is even less is less consensus on the need to anticoagulate outpatients or patients after discharge, according to Dr. Rosovsky

In her own center, the standard is a prophylactic dose of low molecular weight heparin (LMWH) in an algorithm that calls for dose adjustments for some groups such as those with renal impairment or obesity. Alternative forms of anticoagulation are recommended for patients with a history of thrombocytopenia or are at high risk for hemorrhage. Full dose LMWH is recommended in patients already on an oral anticoagulant at time of hospitalization.

“The biggest question right now is when to consider increasing from a prophylactic dose to intermediate or full dose anticoagulation in high risk patients, especially those in the ICU patients,” Dr. Rosovsky said.

Current practices are diverse, according to a recently published survey led by Dr. Rosovsky (Rosovsky RP et al. Res Pract Thromb Haemost. 2020;4:969-83). According to the survey, which had responses from more than 500 physicians in 41 countries, 30% of centers escalate from a prophylactic dose of anticoagulation to an intermediate dose when patients move to the ICU. Although not all answered this question, 25% reported that they do not escalate at ICU transfer. For 15% of respondents, dose escalation is being offered to patients with a D-dimer exceeding six-times the upper limit of normal.

These practices have developed in the absence of prospective clinical trials, which are urgently needed, according to Dr. Rosovsky. The reason that trials specific to COVID-19 are particularly important is that this infection also engenders a high risk of major bleeding.

For example, in a multicenter retrospective study of 400 hospital-admitted COVID-19 patients the rates of major bleeding was 4.8% or exactly the same as the rate of radiographically confirmed VTE. At 7.6%, the rates of VTE and major bleeding were also exactly the same for ICU patients (Al-Samkari H et al. Blood 2020;136:489-500).

“An elevated D-dimer was a marker for both VTE and major bleeding,” reported Dr. Rosovsky, who was the senior author of this study. On the basis of odds ratio (OR), the risk of VTE was increased more than six-fold (OR, 6.79) and the risk of major bleeding by more than three-fold (OR, 3.56) when the D-dimer exceeded 2,500 ng/mL.

The risk of VTE from COVID-19 infection is well documented. For example, autopsy studies have shown widespread thrombosis, including PE, in patients who have died from COVID-19 infection, according to Dr. Rosovsky.

There is also evidence of benefit from anticoagulation. In an retrospective study from China undertaken early in the pandemic, there was no overall mortality benefit at 28 days among those who did receive LMWH when compared to those who did not, but there was a 20% absolute mortality benefit (52.4% vs. 32.8%; P = .017) in those with a D-dimer six-fold ULN (Tang N et al. J Thromb Haemost 2020;18:1094-9).

These types of data support the use of anticoagulation to manage VTE risk in at least some patients, but the reported rates of VTE across institutions and across inpatient and outpatient settings have varied “dramatically,” according to Dr. Rosovsky. The balance of VTE and major bleeding is delicate. In one retrospective study, the mortality advantage for therapeutic versus prophylactic dose of LMWH did not reach statistical significance, but the rate of major bleeding was nearly doubled (3.0% vs. 1.7%) (Nadkarni GN et al J Am Coll Cardiol 2020;76:1815-26).

Because of the many variables that might affect risk of VTE and risk of major bleeding in any individual patient, the benefit-to-risk calculation of anticoagulation is “complex,” according to Dr. Rosovsky. It is for this reason she urged clinicians to consider entering patients into clinical trials designed to generate evidence-based answers.

There is large and growing body of retrospective data that have helped characterize the risk of VTE and bleeding in patients with COVID-19, but “there is no substitute for a well-controlled clinical trial,” agreed Robert A. Harrington, MD, chairman of the department of medicine, Stanford (Calif.) University.

He and the comoderator of the session in which these data were presented agreed that anticoagulation must be administered within a narrow therapeutic window that will be best defined through controlled trial designs.

“There is a significant risk of doing harm,” said Fatima Rodriguez, MD, assistant professor of cardiology at Stanford University. She seconded the critical role of trial participation when possible and the need for clinical trials to better guide treatment decisions.

The meeting was sponsored by MedscapeLive. MedscapeLive and this news organization are owned by the same parent company.

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COVID-19 and youth suicide: Do the numbers match the headlines?

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There’s little doubt that the COVID-19 pandemic has been hard on many children and adolescents just as it has been difficult for adults. The disruption of routines, reduced contact with friends, concern over getting ill, and financial turmoil suffered by many families is exacting a toll on our mental health, as has been documented by a number of recent surveys and studies.1,2

Dr. David C. Rettew

Quite understandably, concern about rising levels of anxiety and depression in youth prompts additional worries about suicide, the second leading cause of death in adolescents and young adults. In response, many organizations have rallied to provide additional resources to help prevent suicidal thinking and actions. Online mental health tips, support phone and text lines, and the availability of telemedicine have all been mobilized to help people cope and stay safe both physically and psychologically.

But what are the actual numbers when it comes to youth suicide during COVID-19? According to many headlines in the press, the statistics are grim and support many of distressing predictions that have been made. A December story in an Arizona newspaper, “With Teen Suicides on the Rise, Tucson Educators Struggle to Prioritize Mental Health,” described a 67% increase in teen suicides in 2020 compared with 2019 in one county.3 Another post from Psychology Today, “America is Facing a Teen Suicide Pandemic,” raised similar alarms.4 Concern over suicide has even been used politically to argue against restrictions that could reduce the spread of COVID-19 infections.

But despite this common perception shared by both health care professionals and the public, there actually is not evidence at this point that the COVID-19 pandemic has led to a broad spike in youth suicide deaths or attempts. A recent study published in the journal Pediatrics compared suicide screening results on youth presenting to emergency departments for any reason in 2020 to the same month in 2019.5 The authors found no consistent increases in reported suicidal ideation or suicide attempts with scattered elevations found in some months during 2020 compared with the previous year (including February 2020 before the pandemic really began) but not others. Internationally, newly analyzed data from 2020 with regard to suicide deaths have suggested “either no rise in suicide rates ... or a fall in the early months of the pandemic.” In my home and, admittedly small, state of Vermont, data from the Department of Health have shown 93 suicide deaths across all ages as of mid-November 2020 compared with a 5-year average of 96.

Why don’t the data match the headlines? There are a number of possibilities.

1. Suicide rates in youth were going up before the pandemic. As it takes time to verify and analyze data from large populations, many of the reports on suicide that have been published and released in 2020 summarize data from prior years. Without looking closely, a news organization can easily slap on a headline that implies that the data were obtained during the pandemic.

2. Fluctuations tend to occur from year to year. Thankfully, youth suicide remains rare (although not rare enough). With small numbers, regular variations from year to year can look huge in terms of percentages, especially if one doesn’t pull back and look at longer trends over time.

3. People are reaching out for mental health services. The public health message to access support and treatment for COVID 19–related mental health struggles appears to be having an effect, but this increased demand should not necessarily be viewed as a proxy for suicidal ideation and attempts.

While the understanding that we are not actually in the midst of a surge in COVID 19–related youth suicide is reassuring, it is important not to get complacent. Much of the data remains preliminary, and, even if these numbers hold up, there is no guarantee that things will continue this way, especially if the pandemic and it restrictions continue to drag on for many more months. And of course, whether or not the pandemic is making things significantly worse, youth suicide remains an enormous public health imperative with every one being a human tragedy.

It is also quite possible that more detailed analyses will eventually reveal a more complex association between youth suicide and COVID-19, with effects of the pandemic being realized regionally or more for some groups than others. Data from before the pandemic indicated, for example, that suicide rates are increasing more rapidly among African American youth compared with white children and adolescents.6 With the COVID-19 pandemic itself affecting disadvantaged communities more strongly, one could readily expect variable impacts in mental health related to race or socioeconomic status. A recent article voices these concerns for indigenous youth in Montana: a state with one of the highest per capita suicide rates in the country.7 The article notes, however, that the rate of suicide overall in Montana in 2020 is comparable to those of previous years.

Overall, pediatricians should not be needlessly panicked that the COVID-19 pandemic has sparked a surge in youth suicide. The data at this point simply don’t support that assertion despite many headlines to the contrary. At the same time, many children and adolescents are certainly struggling with the stresses the pandemic has created and continue to need our close monitoring and support.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine. Follow him on Twitter @PediPsych. His new book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood,” launches Feb. 1, 2021.

References

1. Copeland WE et al. Impact of COVID-19 pandemic on college student mental health and wellness. J Am Acad Child Adolesc Psychiatry. 2020;60(1):134-41. doi: 10.1016/j.jaac.2020.08.466.

2. Qiu J et al. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: Implications and policy recommendations. Gen Psychiatry. 2020;33:e100213. doi: 10.1136/gpsych-2020-100213.

3. Dhmara K. With teen suicides on the rise, Tucson educators struggle to prioritize mental health. Tuscon.com. Dec. 27, 2020.

4. Chafouleas, SM. America is facing a suicide epidemic: New data confirm the urgency of confronting it now. Psychology Today blog. Sept. 4, 2020.

5. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and after COVID-19. Pediatrics. 2020. doi: 10.1542/peds.2020-029280.

6. John A et al. Trends in suicide during the covid-19 pandemic. BMJ 2020;371:m4352. doi: 10.1136/bmj.m4352.

7. Reardon S. Health officials fear COVID-19 pandemic-related suicide spike among indigenous youth. Time Magazine. December 2020.

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There’s little doubt that the COVID-19 pandemic has been hard on many children and adolescents just as it has been difficult for adults. The disruption of routines, reduced contact with friends, concern over getting ill, and financial turmoil suffered by many families is exacting a toll on our mental health, as has been documented by a number of recent surveys and studies.1,2

Dr. David C. Rettew

Quite understandably, concern about rising levels of anxiety and depression in youth prompts additional worries about suicide, the second leading cause of death in adolescents and young adults. In response, many organizations have rallied to provide additional resources to help prevent suicidal thinking and actions. Online mental health tips, support phone and text lines, and the availability of telemedicine have all been mobilized to help people cope and stay safe both physically and psychologically.

But what are the actual numbers when it comes to youth suicide during COVID-19? According to many headlines in the press, the statistics are grim and support many of distressing predictions that have been made. A December story in an Arizona newspaper, “With Teen Suicides on the Rise, Tucson Educators Struggle to Prioritize Mental Health,” described a 67% increase in teen suicides in 2020 compared with 2019 in one county.3 Another post from Psychology Today, “America is Facing a Teen Suicide Pandemic,” raised similar alarms.4 Concern over suicide has even been used politically to argue against restrictions that could reduce the spread of COVID-19 infections.

But despite this common perception shared by both health care professionals and the public, there actually is not evidence at this point that the COVID-19 pandemic has led to a broad spike in youth suicide deaths or attempts. A recent study published in the journal Pediatrics compared suicide screening results on youth presenting to emergency departments for any reason in 2020 to the same month in 2019.5 The authors found no consistent increases in reported suicidal ideation or suicide attempts with scattered elevations found in some months during 2020 compared with the previous year (including February 2020 before the pandemic really began) but not others. Internationally, newly analyzed data from 2020 with regard to suicide deaths have suggested “either no rise in suicide rates ... or a fall in the early months of the pandemic.” In my home and, admittedly small, state of Vermont, data from the Department of Health have shown 93 suicide deaths across all ages as of mid-November 2020 compared with a 5-year average of 96.

Why don’t the data match the headlines? There are a number of possibilities.

1. Suicide rates in youth were going up before the pandemic. As it takes time to verify and analyze data from large populations, many of the reports on suicide that have been published and released in 2020 summarize data from prior years. Without looking closely, a news organization can easily slap on a headline that implies that the data were obtained during the pandemic.

2. Fluctuations tend to occur from year to year. Thankfully, youth suicide remains rare (although not rare enough). With small numbers, regular variations from year to year can look huge in terms of percentages, especially if one doesn’t pull back and look at longer trends over time.

3. People are reaching out for mental health services. The public health message to access support and treatment for COVID 19–related mental health struggles appears to be having an effect, but this increased demand should not necessarily be viewed as a proxy for suicidal ideation and attempts.

While the understanding that we are not actually in the midst of a surge in COVID 19–related youth suicide is reassuring, it is important not to get complacent. Much of the data remains preliminary, and, even if these numbers hold up, there is no guarantee that things will continue this way, especially if the pandemic and it restrictions continue to drag on for many more months. And of course, whether or not the pandemic is making things significantly worse, youth suicide remains an enormous public health imperative with every one being a human tragedy.

It is also quite possible that more detailed analyses will eventually reveal a more complex association between youth suicide and COVID-19, with effects of the pandemic being realized regionally or more for some groups than others. Data from before the pandemic indicated, for example, that suicide rates are increasing more rapidly among African American youth compared with white children and adolescents.6 With the COVID-19 pandemic itself affecting disadvantaged communities more strongly, one could readily expect variable impacts in mental health related to race or socioeconomic status. A recent article voices these concerns for indigenous youth in Montana: a state with one of the highest per capita suicide rates in the country.7 The article notes, however, that the rate of suicide overall in Montana in 2020 is comparable to those of previous years.

Overall, pediatricians should not be needlessly panicked that the COVID-19 pandemic has sparked a surge in youth suicide. The data at this point simply don’t support that assertion despite many headlines to the contrary. At the same time, many children and adolescents are certainly struggling with the stresses the pandemic has created and continue to need our close monitoring and support.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine. Follow him on Twitter @PediPsych. His new book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood,” launches Feb. 1, 2021.

References

1. Copeland WE et al. Impact of COVID-19 pandemic on college student mental health and wellness. J Am Acad Child Adolesc Psychiatry. 2020;60(1):134-41. doi: 10.1016/j.jaac.2020.08.466.

2. Qiu J et al. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: Implications and policy recommendations. Gen Psychiatry. 2020;33:e100213. doi: 10.1136/gpsych-2020-100213.

3. Dhmara K. With teen suicides on the rise, Tucson educators struggle to prioritize mental health. Tuscon.com. Dec. 27, 2020.

4. Chafouleas, SM. America is facing a suicide epidemic: New data confirm the urgency of confronting it now. Psychology Today blog. Sept. 4, 2020.

5. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and after COVID-19. Pediatrics. 2020. doi: 10.1542/peds.2020-029280.

6. John A et al. Trends in suicide during the covid-19 pandemic. BMJ 2020;371:m4352. doi: 10.1136/bmj.m4352.

7. Reardon S. Health officials fear COVID-19 pandemic-related suicide spike among indigenous youth. Time Magazine. December 2020.

There’s little doubt that the COVID-19 pandemic has been hard on many children and adolescents just as it has been difficult for adults. The disruption of routines, reduced contact with friends, concern over getting ill, and financial turmoil suffered by many families is exacting a toll on our mental health, as has been documented by a number of recent surveys and studies.1,2

Dr. David C. Rettew

Quite understandably, concern about rising levels of anxiety and depression in youth prompts additional worries about suicide, the second leading cause of death in adolescents and young adults. In response, many organizations have rallied to provide additional resources to help prevent suicidal thinking and actions. Online mental health tips, support phone and text lines, and the availability of telemedicine have all been mobilized to help people cope and stay safe both physically and psychologically.

But what are the actual numbers when it comes to youth suicide during COVID-19? According to many headlines in the press, the statistics are grim and support many of distressing predictions that have been made. A December story in an Arizona newspaper, “With Teen Suicides on the Rise, Tucson Educators Struggle to Prioritize Mental Health,” described a 67% increase in teen suicides in 2020 compared with 2019 in one county.3 Another post from Psychology Today, “America is Facing a Teen Suicide Pandemic,” raised similar alarms.4 Concern over suicide has even been used politically to argue against restrictions that could reduce the spread of COVID-19 infections.

But despite this common perception shared by both health care professionals and the public, there actually is not evidence at this point that the COVID-19 pandemic has led to a broad spike in youth suicide deaths or attempts. A recent study published in the journal Pediatrics compared suicide screening results on youth presenting to emergency departments for any reason in 2020 to the same month in 2019.5 The authors found no consistent increases in reported suicidal ideation or suicide attempts with scattered elevations found in some months during 2020 compared with the previous year (including February 2020 before the pandemic really began) but not others. Internationally, newly analyzed data from 2020 with regard to suicide deaths have suggested “either no rise in suicide rates ... or a fall in the early months of the pandemic.” In my home and, admittedly small, state of Vermont, data from the Department of Health have shown 93 suicide deaths across all ages as of mid-November 2020 compared with a 5-year average of 96.

Why don’t the data match the headlines? There are a number of possibilities.

1. Suicide rates in youth were going up before the pandemic. As it takes time to verify and analyze data from large populations, many of the reports on suicide that have been published and released in 2020 summarize data from prior years. Without looking closely, a news organization can easily slap on a headline that implies that the data were obtained during the pandemic.

2. Fluctuations tend to occur from year to year. Thankfully, youth suicide remains rare (although not rare enough). With small numbers, regular variations from year to year can look huge in terms of percentages, especially if one doesn’t pull back and look at longer trends over time.

3. People are reaching out for mental health services. The public health message to access support and treatment for COVID 19–related mental health struggles appears to be having an effect, but this increased demand should not necessarily be viewed as a proxy for suicidal ideation and attempts.

While the understanding that we are not actually in the midst of a surge in COVID 19–related youth suicide is reassuring, it is important not to get complacent. Much of the data remains preliminary, and, even if these numbers hold up, there is no guarantee that things will continue this way, especially if the pandemic and it restrictions continue to drag on for many more months. And of course, whether or not the pandemic is making things significantly worse, youth suicide remains an enormous public health imperative with every one being a human tragedy.

It is also quite possible that more detailed analyses will eventually reveal a more complex association between youth suicide and COVID-19, with effects of the pandemic being realized regionally or more for some groups than others. Data from before the pandemic indicated, for example, that suicide rates are increasing more rapidly among African American youth compared with white children and adolescents.6 With the COVID-19 pandemic itself affecting disadvantaged communities more strongly, one could readily expect variable impacts in mental health related to race or socioeconomic status. A recent article voices these concerns for indigenous youth in Montana: a state with one of the highest per capita suicide rates in the country.7 The article notes, however, that the rate of suicide overall in Montana in 2020 is comparable to those of previous years.

Overall, pediatricians should not be needlessly panicked that the COVID-19 pandemic has sparked a surge in youth suicide. The data at this point simply don’t support that assertion despite many headlines to the contrary. At the same time, many children and adolescents are certainly struggling with the stresses the pandemic has created and continue to need our close monitoring and support.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine. Follow him on Twitter @PediPsych. His new book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood,” launches Feb. 1, 2021.

References

1. Copeland WE et al. Impact of COVID-19 pandemic on college student mental health and wellness. J Am Acad Child Adolesc Psychiatry. 2020;60(1):134-41. doi: 10.1016/j.jaac.2020.08.466.

2. Qiu J et al. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: Implications and policy recommendations. Gen Psychiatry. 2020;33:e100213. doi: 10.1136/gpsych-2020-100213.

3. Dhmara K. With teen suicides on the rise, Tucson educators struggle to prioritize mental health. Tuscon.com. Dec. 27, 2020.

4. Chafouleas, SM. America is facing a suicide epidemic: New data confirm the urgency of confronting it now. Psychology Today blog. Sept. 4, 2020.

5. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and after COVID-19. Pediatrics. 2020. doi: 10.1542/peds.2020-029280.

6. John A et al. Trends in suicide during the covid-19 pandemic. BMJ 2020;371:m4352. doi: 10.1136/bmj.m4352.

7. Reardon S. Health officials fear COVID-19 pandemic-related suicide spike among indigenous youth. Time Magazine. December 2020.

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Cloth masks provide inferior protection vs. medical masks, suggests evidence review

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Cloth masks should not be considered equivalent to medical masks for the prevention of COVID-19 in clinical settings, according to an evidence review published Jan. 11 in Annals of Family Medicine.

Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.

And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.

“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.

The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
 

Filtration and fit

“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.

One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.

Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.

Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.


Generally consistent guidance

Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.

“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”

Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.

In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.

“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”

In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
 

 

 

Not considered PPE

According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”

Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.

“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.

When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.

In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
 

Limited data for comparisons

A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.

In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.

The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.

SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.

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Cloth masks should not be considered equivalent to medical masks for the prevention of COVID-19 in clinical settings, according to an evidence review published Jan. 11 in Annals of Family Medicine.

Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.

And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.

“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.

The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
 

Filtration and fit

“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.

One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.

Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.

Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.


Generally consistent guidance

Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.

“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”

Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.

In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.

“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”

In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
 

 

 

Not considered PPE

According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”

Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.

“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.

When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.

In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
 

Limited data for comparisons

A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.

In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.

The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.

SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.

Cloth masks should not be considered equivalent to medical masks for the prevention of COVID-19 in clinical settings, according to an evidence review published Jan. 11 in Annals of Family Medicine.

Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.

And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.

“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.

The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
 

Filtration and fit

“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.

One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.

Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.

Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.


Generally consistent guidance

Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.

“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”

Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.

In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.

“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”

In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
 

 

 

Not considered PPE

According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”

Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.

“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.

When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.

In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
 

Limited data for comparisons

A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.

In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.

The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.

SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.

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Feds authorize $3 billion to boost vaccine rollout

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The CDC will send $3 billion to the states to boost a lagging national COVID-19 vaccination program.

The Department of Health and Human Services announced the new funding as only 30% of the more than 22 million doses of vaccine distributed in the U.S. has been injected into Americans’ arms.

Along with the $3 billion, HHS said another $19 billion is headed to states and jurisdictions to boost COVID-19 testing programs. The amount each state will receive will be determined by population.

The news comes days after President-elect Joe Biden said he planned to release all available doses of vaccine after he takes office on Jan. 20. The Trump administration has been holding back millions of doses to ensure supply of vaccine to provide the necessary second dose for those who received the first shot.

“This funding is another timely investment that will strengthen our nation’s efforts to stop the COVID-19 pandemic in America,” CDC Director Robert Redfield, MD, said in a statement. “Particularly now, it is crucial that states and communities have the resources they need to conduct testing, and to distribute and administer safe, high-quality COVID-19 vaccines safely and equitably.”

Federal officials and public health experts, however, expressed concerns this weekend about Biden’s plan.

Outgoing Trump administration officials and others said they worry that doing so will leave providers without enough second doses for people getting the two-shot vaccines.

If Biden releases all available doses and the vaccine-making process has an issue, they said, that could pose a supply risk.

“We have product that is going through QC right now – quality control – for sterility, identity check that we have tens and tens of millions of product. We always will. But batches fail. Sterility fails ... and then you don’t have a product for that second dose,” Alex Azar, secretary of health and human services, told the American Hospital Association on Jan. 8, according to CNN.

“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.

One of the main roadblocks in the vaccine rollout has been administering the doses that have already been distributed. The U.S. has shipped 22.1 million doses, and 6.6 million first shots have been given, according to the latest CDC data updated Jan. 8. Mr. Azar and other federal health officials have encouraged states to use their current supply and expand vaccine access to more priority groups.

“We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting,” a spokesman for the U.S. Department of Health and Human Services told CNN. “We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”

Releasing more vaccines for first doses could create ethical concerns as well, since people getting vaccines expect to get a second dose in the proper amount of time, according to The Week. Biden’s transition team said on Jan. 8 that he won’t delay the second dose but, instead, plans to ramp up production to stay on track.

To do this well, the federal government should create a coordinated vaccine strategy that sets expectations for an around-the-clock operation and help state and local vaccination programs meet their goals, Leana Wen, MD, a professor at George Washington University, wrote in an editorial for The Washington Post.

“The Biden team’s urgency around vaccinations is commendable,” she added in a Twitter post on Jan. 11. “I’d like to see a guarantee that every 1st dose given will be followed with a timely 2nd dose. Otherwise, there are ethical concerns that could add to vaccine hesitancy.”

Biden has pledged that 100 million doses will be administered in his first 100 days in office. He has grown frustrated as concerns grow that his administration could fall short of the promise, according to Politico. His coronavirus response team has noted several challenges, including what they say is a lack of long-term planning by the Trump administration and an initial refusal to share key information.

“We’re uncovering new information each day, and we’re unearthing – of course – more work to be done,” Vivek Murthy, MD, Biden’s nominee for surgeon general, told Politico.

The team has uncovered staffing shortages, technology problems, and issues with health care insurance coverage. The incoming Biden team has developed several initiatives, such as mobile vaccination units and new federal sites to give shots. It could take weeks to get the vaccine rollout on track, the news outlet reported.

“Will this be challenging? Absolutely,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and Biden’s incoming chief medical adviser on the coronavirus, told Politico. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”

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

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The CDC will send $3 billion to the states to boost a lagging national COVID-19 vaccination program.

The Department of Health and Human Services announced the new funding as only 30% of the more than 22 million doses of vaccine distributed in the U.S. has been injected into Americans’ arms.

Along with the $3 billion, HHS said another $19 billion is headed to states and jurisdictions to boost COVID-19 testing programs. The amount each state will receive will be determined by population.

The news comes days after President-elect Joe Biden said he planned to release all available doses of vaccine after he takes office on Jan. 20. The Trump administration has been holding back millions of doses to ensure supply of vaccine to provide the necessary second dose for those who received the first shot.

“This funding is another timely investment that will strengthen our nation’s efforts to stop the COVID-19 pandemic in America,” CDC Director Robert Redfield, MD, said in a statement. “Particularly now, it is crucial that states and communities have the resources they need to conduct testing, and to distribute and administer safe, high-quality COVID-19 vaccines safely and equitably.”

Federal officials and public health experts, however, expressed concerns this weekend about Biden’s plan.

Outgoing Trump administration officials and others said they worry that doing so will leave providers without enough second doses for people getting the two-shot vaccines.

If Biden releases all available doses and the vaccine-making process has an issue, they said, that could pose a supply risk.

“We have product that is going through QC right now – quality control – for sterility, identity check that we have tens and tens of millions of product. We always will. But batches fail. Sterility fails ... and then you don’t have a product for that second dose,” Alex Azar, secretary of health and human services, told the American Hospital Association on Jan. 8, according to CNN.

“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.

One of the main roadblocks in the vaccine rollout has been administering the doses that have already been distributed. The U.S. has shipped 22.1 million doses, and 6.6 million first shots have been given, according to the latest CDC data updated Jan. 8. Mr. Azar and other federal health officials have encouraged states to use their current supply and expand vaccine access to more priority groups.

“We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting,” a spokesman for the U.S. Department of Health and Human Services told CNN. “We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”

Releasing more vaccines for first doses could create ethical concerns as well, since people getting vaccines expect to get a second dose in the proper amount of time, according to The Week. Biden’s transition team said on Jan. 8 that he won’t delay the second dose but, instead, plans to ramp up production to stay on track.

To do this well, the federal government should create a coordinated vaccine strategy that sets expectations for an around-the-clock operation and help state and local vaccination programs meet their goals, Leana Wen, MD, a professor at George Washington University, wrote in an editorial for The Washington Post.

“The Biden team’s urgency around vaccinations is commendable,” she added in a Twitter post on Jan. 11. “I’d like to see a guarantee that every 1st dose given will be followed with a timely 2nd dose. Otherwise, there are ethical concerns that could add to vaccine hesitancy.”

Biden has pledged that 100 million doses will be administered in his first 100 days in office. He has grown frustrated as concerns grow that his administration could fall short of the promise, according to Politico. His coronavirus response team has noted several challenges, including what they say is a lack of long-term planning by the Trump administration and an initial refusal to share key information.

“We’re uncovering new information each day, and we’re unearthing – of course – more work to be done,” Vivek Murthy, MD, Biden’s nominee for surgeon general, told Politico.

The team has uncovered staffing shortages, technology problems, and issues with health care insurance coverage. The incoming Biden team has developed several initiatives, such as mobile vaccination units and new federal sites to give shots. It could take weeks to get the vaccine rollout on track, the news outlet reported.

“Will this be challenging? Absolutely,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and Biden’s incoming chief medical adviser on the coronavirus, told Politico. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”

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

The CDC will send $3 billion to the states to boost a lagging national COVID-19 vaccination program.

The Department of Health and Human Services announced the new funding as only 30% of the more than 22 million doses of vaccine distributed in the U.S. has been injected into Americans’ arms.

Along with the $3 billion, HHS said another $19 billion is headed to states and jurisdictions to boost COVID-19 testing programs. The amount each state will receive will be determined by population.

The news comes days after President-elect Joe Biden said he planned to release all available doses of vaccine after he takes office on Jan. 20. The Trump administration has been holding back millions of doses to ensure supply of vaccine to provide the necessary second dose for those who received the first shot.

“This funding is another timely investment that will strengthen our nation’s efforts to stop the COVID-19 pandemic in America,” CDC Director Robert Redfield, MD, said in a statement. “Particularly now, it is crucial that states and communities have the resources they need to conduct testing, and to distribute and administer safe, high-quality COVID-19 vaccines safely and equitably.”

Federal officials and public health experts, however, expressed concerns this weekend about Biden’s plan.

Outgoing Trump administration officials and others said they worry that doing so will leave providers without enough second doses for people getting the two-shot vaccines.

If Biden releases all available doses and the vaccine-making process has an issue, they said, that could pose a supply risk.

“We have product that is going through QC right now – quality control – for sterility, identity check that we have tens and tens of millions of product. We always will. But batches fail. Sterility fails ... and then you don’t have a product for that second dose,” Alex Azar, secretary of health and human services, told the American Hospital Association on Jan. 8, according to CNN.

“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.

One of the main roadblocks in the vaccine rollout has been administering the doses that have already been distributed. The U.S. has shipped 22.1 million doses, and 6.6 million first shots have been given, according to the latest CDC data updated Jan. 8. Mr. Azar and other federal health officials have encouraged states to use their current supply and expand vaccine access to more priority groups.

“We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting,” a spokesman for the U.S. Department of Health and Human Services told CNN. “We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”

Releasing more vaccines for first doses could create ethical concerns as well, since people getting vaccines expect to get a second dose in the proper amount of time, according to The Week. Biden’s transition team said on Jan. 8 that he won’t delay the second dose but, instead, plans to ramp up production to stay on track.

To do this well, the federal government should create a coordinated vaccine strategy that sets expectations for an around-the-clock operation and help state and local vaccination programs meet their goals, Leana Wen, MD, a professor at George Washington University, wrote in an editorial for The Washington Post.

“The Biden team’s urgency around vaccinations is commendable,” she added in a Twitter post on Jan. 11. “I’d like to see a guarantee that every 1st dose given will be followed with a timely 2nd dose. Otherwise, there are ethical concerns that could add to vaccine hesitancy.”

Biden has pledged that 100 million doses will be administered in his first 100 days in office. He has grown frustrated as concerns grow that his administration could fall short of the promise, according to Politico. His coronavirus response team has noted several challenges, including what they say is a lack of long-term planning by the Trump administration and an initial refusal to share key information.

“We’re uncovering new information each day, and we’re unearthing – of course – more work to be done,” Vivek Murthy, MD, Biden’s nominee for surgeon general, told Politico.

The team has uncovered staffing shortages, technology problems, and issues with health care insurance coverage. The incoming Biden team has developed several initiatives, such as mobile vaccination units and new federal sites to give shots. It could take weeks to get the vaccine rollout on track, the news outlet reported.

“Will this be challenging? Absolutely,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and Biden’s incoming chief medical adviser on the coronavirus, told Politico. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”

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

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The psychiatrist and the vaccine

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When the long-awaited news of a Food and Drug Administration–approved vaccine came on Dec. 11, 2020, my first thought was that I would wait. I can manage a few more months of Zooming for work, my household is down to two people, I’m not at high risk of dying from COVID, and my husband is not going to be vaccinated any time soon, so a change in my status wouldn’t “free” me. I would rather have “my” vaccine go to a 70-year-old ICU janitor or a bus driver.

South_agency/Getty Images

The weeks have gone by. I expected there would be kinks, but it has now been a month – one in which COVID rates have soared, and hospitalizations and deaths have risen to unmanageable numbers in some places. Still, vaccines remain in freezers – people are dying while vials of prevention sit unused. I began to think that, when my “turn” came, the better thing was to be vaccinated. We need to have a large segment of the population vaccinated to squelch this virus, and it’s become much less clear to me that, if I yield my turn, it will go into the arm of a bus driver. The process has not been fair, and there are moments of media outrage when one group gets vaccinated before another, so perhaps we have reached point where the goal should not be to get the vaccine into the exact right person in the exact right order, but to get the vaccine into arms according to the protocol that has already been set. Anyone who does not end up in a hospital bed is doing the system a favor.

Mahmood Jahromi, MD, a psychiatrist in private practice in Towson, Md., described the process of vaccination as being similar to a bottleneck traffic jam. “Yes, one must be courteous to the car trying to but in, but no, don’t jam the glue because you are excessively kind. Let the traffic police do their job. When your name is called, go ahead and take it. The system needs to know people are accepting the vaccine, not by begging the authorities to be called ahead of others, but with respect for what is already designed.”

On Friday, Jan. 8, I received information on how to get vaccinated – it seems my “turn” has arrived. An email from the board of physicians informed me that I am in the “1A” category and included a link to sign up for a vaccine in Baltimore – vaccinations would be given until Jan. 29, Mondays to Thursdays from 10 a.m. to 4 p.m. and Fridays from 10 a.m. to 1 p.m. There are no weekend or evening hours, and one might think there would be enough urgency to call for this. The Maryland Psychiatric Society sent out a notice that Sheppard Pratt would be offering vaccines to all behavioral health providers in the state of Maryland during a 2-day clinic. I heard from others that health care workers can now get vaccinated at the Cow Palace (how great is that?) at the Maryland State Fairgrounds and another link was sent for those in Howard County, between Baltimore and Washington.

As I discussed this with colleagues, a couple of issues came up – the most common was one of not wanting to get the vaccine yet because there are others who need it more. Others voiced concern about a vaccine where the long-term effects remain unknown: Is this vaccine safe, might it spur autoimmune problems in the months or years to come? Is it safe for women who plan to become pregnant? Some have insisted it is safe. They say “follow the science” and have dismissed the skepticism. To my read, it makes perfect sense to be wary, but COVID spreads silently and it kills.

Dr. Dinah Miller

With a vaccine where so many are reluctant to get it, including many health care workers, Sue Kim, MD, a psychiatrist in private practice in Lutherville, Md., noted that she has concerns about the safety of the vaccine. “Getting it now is both altruistic and selfish, but letting others go first is also altruistic and selfish. In the meantime, if I get sick, I was too smart for my own good. How do you weigh this ethically?”

My personal feelings have been influenced by a few things. An article in the New York Times highlighted how New York City vaccinated 5 million people for smallpox in just 2 weeks in 1947. I am frustrated knowing that, a month after approval of the first vaccine, only 7 million people have received it in the entire United States. In that time period, millions have contracted COVID and thousands have died. Closer to home, a 45-year-old psychiatrist in Maryland died of COVID, and I have heard more stories about younger people with long-haul neurologic and vascular symptoms. The risk of COVID is feeling higher than it did, and the fact that the first vaccine was authorized after the election somehow makes me feel that it might be safer. Had it been approved right before, I would have worried – perhaps wrongly – that the authorization was a political maneuver, not one based on science.

As we think about what is best for ourselves, our families, our patients, and society as a whole, I believe that those who want the vaccine but don’t feel they should take their place in line before others who are higher risk must ask if it makes sense to wait. Each state is different. While Houston Methodist Hospital is reportedly giving its health care workers a $500 bonus to get the vaccine, Gov. Andrew Cuomo of New York announced that hospitals would be fined $100,000 if they don’t use all of their vaccines within 7 days of receipt and $1 million if they vaccinate anyone out of order. Gov. Cuomo later broadened who could be vaccinated to prevent wasting the vaccine, but there remains an element of being damned if you do and damned if you don’t.



Paul Nestadt, MD, a psychiatrist at Johns Hopkins University, Baltimore, noted that one distribution site initially had to waste unused vaccine when people did not come for their appointments. A waiting list was created for people who could come right away if called to prevent this waste. “To me, this only highlighted that the tier system, while a good idea, does not need to be written in stone. The goal needs to be getting shots in arms, building herd immunity. If there are two arms in front of you, shoot the health care worker or those who are vulnerable. But if there is a healthy arm in reach, it should get any shot made available.”

I registered to be vaccinated. Maryland is still vaccinating only health care workers and people in long-term care facilities – senior citizens and essential workers are not yet eligible. In Baltimore, vaccinations are available Mondays to Thursdays from 10 a.m. to 4 p.m. and on Fridays from 10 a.m. to 1 p.m. There are no options for early morning or weekend times, but there are slots still available for the coming week. As of this writing, there are 6,100 Marylanders dead, and more than 1,800 COVID patients in hospital beds, and our governor, Larry Hogan, has commercials to “Mask On Maryland” and “Wear the Damn Mask.” I’ll offer some changes: “Wake Up, World” and “Offer the Damn Shot.”

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore. Dr. Miller has no disclosures.

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When the long-awaited news of a Food and Drug Administration–approved vaccine came on Dec. 11, 2020, my first thought was that I would wait. I can manage a few more months of Zooming for work, my household is down to two people, I’m not at high risk of dying from COVID, and my husband is not going to be vaccinated any time soon, so a change in my status wouldn’t “free” me. I would rather have “my” vaccine go to a 70-year-old ICU janitor or a bus driver.

South_agency/Getty Images

The weeks have gone by. I expected there would be kinks, but it has now been a month – one in which COVID rates have soared, and hospitalizations and deaths have risen to unmanageable numbers in some places. Still, vaccines remain in freezers – people are dying while vials of prevention sit unused. I began to think that, when my “turn” came, the better thing was to be vaccinated. We need to have a large segment of the population vaccinated to squelch this virus, and it’s become much less clear to me that, if I yield my turn, it will go into the arm of a bus driver. The process has not been fair, and there are moments of media outrage when one group gets vaccinated before another, so perhaps we have reached point where the goal should not be to get the vaccine into the exact right person in the exact right order, but to get the vaccine into arms according to the protocol that has already been set. Anyone who does not end up in a hospital bed is doing the system a favor.

Mahmood Jahromi, MD, a psychiatrist in private practice in Towson, Md., described the process of vaccination as being similar to a bottleneck traffic jam. “Yes, one must be courteous to the car trying to but in, but no, don’t jam the glue because you are excessively kind. Let the traffic police do their job. When your name is called, go ahead and take it. The system needs to know people are accepting the vaccine, not by begging the authorities to be called ahead of others, but with respect for what is already designed.”

On Friday, Jan. 8, I received information on how to get vaccinated – it seems my “turn” has arrived. An email from the board of physicians informed me that I am in the “1A” category and included a link to sign up for a vaccine in Baltimore – vaccinations would be given until Jan. 29, Mondays to Thursdays from 10 a.m. to 4 p.m. and Fridays from 10 a.m. to 1 p.m. There are no weekend or evening hours, and one might think there would be enough urgency to call for this. The Maryland Psychiatric Society sent out a notice that Sheppard Pratt would be offering vaccines to all behavioral health providers in the state of Maryland during a 2-day clinic. I heard from others that health care workers can now get vaccinated at the Cow Palace (how great is that?) at the Maryland State Fairgrounds and another link was sent for those in Howard County, between Baltimore and Washington.

As I discussed this with colleagues, a couple of issues came up – the most common was one of not wanting to get the vaccine yet because there are others who need it more. Others voiced concern about a vaccine where the long-term effects remain unknown: Is this vaccine safe, might it spur autoimmune problems in the months or years to come? Is it safe for women who plan to become pregnant? Some have insisted it is safe. They say “follow the science” and have dismissed the skepticism. To my read, it makes perfect sense to be wary, but COVID spreads silently and it kills.

Dr. Dinah Miller

With a vaccine where so many are reluctant to get it, including many health care workers, Sue Kim, MD, a psychiatrist in private practice in Lutherville, Md., noted that she has concerns about the safety of the vaccine. “Getting it now is both altruistic and selfish, but letting others go first is also altruistic and selfish. In the meantime, if I get sick, I was too smart for my own good. How do you weigh this ethically?”

My personal feelings have been influenced by a few things. An article in the New York Times highlighted how New York City vaccinated 5 million people for smallpox in just 2 weeks in 1947. I am frustrated knowing that, a month after approval of the first vaccine, only 7 million people have received it in the entire United States. In that time period, millions have contracted COVID and thousands have died. Closer to home, a 45-year-old psychiatrist in Maryland died of COVID, and I have heard more stories about younger people with long-haul neurologic and vascular symptoms. The risk of COVID is feeling higher than it did, and the fact that the first vaccine was authorized after the election somehow makes me feel that it might be safer. Had it been approved right before, I would have worried – perhaps wrongly – that the authorization was a political maneuver, not one based on science.

As we think about what is best for ourselves, our families, our patients, and society as a whole, I believe that those who want the vaccine but don’t feel they should take their place in line before others who are higher risk must ask if it makes sense to wait. Each state is different. While Houston Methodist Hospital is reportedly giving its health care workers a $500 bonus to get the vaccine, Gov. Andrew Cuomo of New York announced that hospitals would be fined $100,000 if they don’t use all of their vaccines within 7 days of receipt and $1 million if they vaccinate anyone out of order. Gov. Cuomo later broadened who could be vaccinated to prevent wasting the vaccine, but there remains an element of being damned if you do and damned if you don’t.



Paul Nestadt, MD, a psychiatrist at Johns Hopkins University, Baltimore, noted that one distribution site initially had to waste unused vaccine when people did not come for their appointments. A waiting list was created for people who could come right away if called to prevent this waste. “To me, this only highlighted that the tier system, while a good idea, does not need to be written in stone. The goal needs to be getting shots in arms, building herd immunity. If there are two arms in front of you, shoot the health care worker or those who are vulnerable. But if there is a healthy arm in reach, it should get any shot made available.”

I registered to be vaccinated. Maryland is still vaccinating only health care workers and people in long-term care facilities – senior citizens and essential workers are not yet eligible. In Baltimore, vaccinations are available Mondays to Thursdays from 10 a.m. to 4 p.m. and on Fridays from 10 a.m. to 1 p.m. There are no options for early morning or weekend times, but there are slots still available for the coming week. As of this writing, there are 6,100 Marylanders dead, and more than 1,800 COVID patients in hospital beds, and our governor, Larry Hogan, has commercials to “Mask On Maryland” and “Wear the Damn Mask.” I’ll offer some changes: “Wake Up, World” and “Offer the Damn Shot.”

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore. Dr. Miller has no disclosures.

When the long-awaited news of a Food and Drug Administration–approved vaccine came on Dec. 11, 2020, my first thought was that I would wait. I can manage a few more months of Zooming for work, my household is down to two people, I’m not at high risk of dying from COVID, and my husband is not going to be vaccinated any time soon, so a change in my status wouldn’t “free” me. I would rather have “my” vaccine go to a 70-year-old ICU janitor or a bus driver.

South_agency/Getty Images

The weeks have gone by. I expected there would be kinks, but it has now been a month – one in which COVID rates have soared, and hospitalizations and deaths have risen to unmanageable numbers in some places. Still, vaccines remain in freezers – people are dying while vials of prevention sit unused. I began to think that, when my “turn” came, the better thing was to be vaccinated. We need to have a large segment of the population vaccinated to squelch this virus, and it’s become much less clear to me that, if I yield my turn, it will go into the arm of a bus driver. The process has not been fair, and there are moments of media outrage when one group gets vaccinated before another, so perhaps we have reached point where the goal should not be to get the vaccine into the exact right person in the exact right order, but to get the vaccine into arms according to the protocol that has already been set. Anyone who does not end up in a hospital bed is doing the system a favor.

Mahmood Jahromi, MD, a psychiatrist in private practice in Towson, Md., described the process of vaccination as being similar to a bottleneck traffic jam. “Yes, one must be courteous to the car trying to but in, but no, don’t jam the glue because you are excessively kind. Let the traffic police do their job. When your name is called, go ahead and take it. The system needs to know people are accepting the vaccine, not by begging the authorities to be called ahead of others, but with respect for what is already designed.”

On Friday, Jan. 8, I received information on how to get vaccinated – it seems my “turn” has arrived. An email from the board of physicians informed me that I am in the “1A” category and included a link to sign up for a vaccine in Baltimore – vaccinations would be given until Jan. 29, Mondays to Thursdays from 10 a.m. to 4 p.m. and Fridays from 10 a.m. to 1 p.m. There are no weekend or evening hours, and one might think there would be enough urgency to call for this. The Maryland Psychiatric Society sent out a notice that Sheppard Pratt would be offering vaccines to all behavioral health providers in the state of Maryland during a 2-day clinic. I heard from others that health care workers can now get vaccinated at the Cow Palace (how great is that?) at the Maryland State Fairgrounds and another link was sent for those in Howard County, between Baltimore and Washington.

As I discussed this with colleagues, a couple of issues came up – the most common was one of not wanting to get the vaccine yet because there are others who need it more. Others voiced concern about a vaccine where the long-term effects remain unknown: Is this vaccine safe, might it spur autoimmune problems in the months or years to come? Is it safe for women who plan to become pregnant? Some have insisted it is safe. They say “follow the science” and have dismissed the skepticism. To my read, it makes perfect sense to be wary, but COVID spreads silently and it kills.

Dr. Dinah Miller

With a vaccine where so many are reluctant to get it, including many health care workers, Sue Kim, MD, a psychiatrist in private practice in Lutherville, Md., noted that she has concerns about the safety of the vaccine. “Getting it now is both altruistic and selfish, but letting others go first is also altruistic and selfish. In the meantime, if I get sick, I was too smart for my own good. How do you weigh this ethically?”

My personal feelings have been influenced by a few things. An article in the New York Times highlighted how New York City vaccinated 5 million people for smallpox in just 2 weeks in 1947. I am frustrated knowing that, a month after approval of the first vaccine, only 7 million people have received it in the entire United States. In that time period, millions have contracted COVID and thousands have died. Closer to home, a 45-year-old psychiatrist in Maryland died of COVID, and I have heard more stories about younger people with long-haul neurologic and vascular symptoms. The risk of COVID is feeling higher than it did, and the fact that the first vaccine was authorized after the election somehow makes me feel that it might be safer. Had it been approved right before, I would have worried – perhaps wrongly – that the authorization was a political maneuver, not one based on science.

As we think about what is best for ourselves, our families, our patients, and society as a whole, I believe that those who want the vaccine but don’t feel they should take their place in line before others who are higher risk must ask if it makes sense to wait. Each state is different. While Houston Methodist Hospital is reportedly giving its health care workers a $500 bonus to get the vaccine, Gov. Andrew Cuomo of New York announced that hospitals would be fined $100,000 if they don’t use all of their vaccines within 7 days of receipt and $1 million if they vaccinate anyone out of order. Gov. Cuomo later broadened who could be vaccinated to prevent wasting the vaccine, but there remains an element of being damned if you do and damned if you don’t.



Paul Nestadt, MD, a psychiatrist at Johns Hopkins University, Baltimore, noted that one distribution site initially had to waste unused vaccine when people did not come for their appointments. A waiting list was created for people who could come right away if called to prevent this waste. “To me, this only highlighted that the tier system, while a good idea, does not need to be written in stone. The goal needs to be getting shots in arms, building herd immunity. If there are two arms in front of you, shoot the health care worker or those who are vulnerable. But if there is a healthy arm in reach, it should get any shot made available.”

I registered to be vaccinated. Maryland is still vaccinating only health care workers and people in long-term care facilities – senior citizens and essential workers are not yet eligible. In Baltimore, vaccinations are available Mondays to Thursdays from 10 a.m. to 4 p.m. and on Fridays from 10 a.m. to 1 p.m. There are no options for early morning or weekend times, but there are slots still available for the coming week. As of this writing, there are 6,100 Marylanders dead, and more than 1,800 COVID patients in hospital beds, and our governor, Larry Hogan, has commercials to “Mask On Maryland” and “Wear the Damn Mask.” I’ll offer some changes: “Wake Up, World” and “Offer the Damn Shot.”

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore. Dr. Miller has no disclosures.

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VA Ramps up Vaccinations as COVID-19 Cases Continue to Rise

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Facilities nationwide seeing surges in new cases and hospitalizations as rates in veterans and VA employees mirror national trends.

 

COVID-19 in the VA

Updated January 12, 2020

More than 181,000 veterans have contracted the COVID-19 virus and 7,385 have died, according to data released by the US Department of Veterans Affairs (VA) on January 12, 2020. The number of cases and deaths have increased sharply since November 2020. The VA also reports that it has administered at least 1 dose of the 2 approved vaccines to 33,875 veterans and 174,724 employees as of January 6.

Currently, the VA reports nearly 19,000 active cases of COVID-19, including 1,270 among VA employees. One hundred five VA employees have died from COVID-19.

Although facilities across the country are facing increased pressure as the number of cases rise, those in Southern California and Texas are reporting significant infection rates. Thirteen facilities have at least 300 active cases, including facilities in Loma Linda (418), Long Beach (381), Greater Los Angeles (361), and San Diego (274), all in California. In Texas, San Antonio (394), Dallas (370), Temple (338), and Houston (328) have all seen large numbers of active cases. Facilities in Columbia, South Carolina (420); Phoenix (407); Atlanta, Georgia (359); Cleveland, Ohio (352); and Orlando, (341) and Gainesville, Florida (340) also have reported significant numbers of cases.

While early on in the pandemic facilities in New York and New Jersey had reported the largest number of deaths, now nearly every facility has reported at least 1 death. Fourteen facilities have reported at least 100 deaths and 53 have reported between 50 and 99 deaths. The 7,385 VA COVID-19 deaths represent 2.0% of the 375,300 deaths reported in the US by Johns Hopkins University. VA has reported 0.8% of the total number of COVID-19 cases.

The VA also reports the demographic breakdown of its COVID-19 cases. Among the active cases, 56.9% are White, 18.3% Black, 9.4% Hispanic, and 1.4% Native American, Alaska Native, or Pacific Islander.

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Facilities nationwide seeing surges in new cases and hospitalizations as rates in veterans and VA employees mirror national trends.
Facilities nationwide seeing surges in new cases and hospitalizations as rates in veterans and VA employees mirror national trends.

 

COVID-19 in the VA

Updated January 12, 2020

More than 181,000 veterans have contracted the COVID-19 virus and 7,385 have died, according to data released by the US Department of Veterans Affairs (VA) on January 12, 2020. The number of cases and deaths have increased sharply since November 2020. The VA also reports that it has administered at least 1 dose of the 2 approved vaccines to 33,875 veterans and 174,724 employees as of January 6.

Currently, the VA reports nearly 19,000 active cases of COVID-19, including 1,270 among VA employees. One hundred five VA employees have died from COVID-19.

Although facilities across the country are facing increased pressure as the number of cases rise, those in Southern California and Texas are reporting significant infection rates. Thirteen facilities have at least 300 active cases, including facilities in Loma Linda (418), Long Beach (381), Greater Los Angeles (361), and San Diego (274), all in California. In Texas, San Antonio (394), Dallas (370), Temple (338), and Houston (328) have all seen large numbers of active cases. Facilities in Columbia, South Carolina (420); Phoenix (407); Atlanta, Georgia (359); Cleveland, Ohio (352); and Orlando, (341) and Gainesville, Florida (340) also have reported significant numbers of cases.

While early on in the pandemic facilities in New York and New Jersey had reported the largest number of deaths, now nearly every facility has reported at least 1 death. Fourteen facilities have reported at least 100 deaths and 53 have reported between 50 and 99 deaths. The 7,385 VA COVID-19 deaths represent 2.0% of the 375,300 deaths reported in the US by Johns Hopkins University. VA has reported 0.8% of the total number of COVID-19 cases.

The VA also reports the demographic breakdown of its COVID-19 cases. Among the active cases, 56.9% are White, 18.3% Black, 9.4% Hispanic, and 1.4% Native American, Alaska Native, or Pacific Islander.

 

COVID-19 in the VA

Updated January 12, 2020

More than 181,000 veterans have contracted the COVID-19 virus and 7,385 have died, according to data released by the US Department of Veterans Affairs (VA) on January 12, 2020. The number of cases and deaths have increased sharply since November 2020. The VA also reports that it has administered at least 1 dose of the 2 approved vaccines to 33,875 veterans and 174,724 employees as of January 6.

Currently, the VA reports nearly 19,000 active cases of COVID-19, including 1,270 among VA employees. One hundred five VA employees have died from COVID-19.

Although facilities across the country are facing increased pressure as the number of cases rise, those in Southern California and Texas are reporting significant infection rates. Thirteen facilities have at least 300 active cases, including facilities in Loma Linda (418), Long Beach (381), Greater Los Angeles (361), and San Diego (274), all in California. In Texas, San Antonio (394), Dallas (370), Temple (338), and Houston (328) have all seen large numbers of active cases. Facilities in Columbia, South Carolina (420); Phoenix (407); Atlanta, Georgia (359); Cleveland, Ohio (352); and Orlando, (341) and Gainesville, Florida (340) also have reported significant numbers of cases.

While early on in the pandemic facilities in New York and New Jersey had reported the largest number of deaths, now nearly every facility has reported at least 1 death. Fourteen facilities have reported at least 100 deaths and 53 have reported between 50 and 99 deaths. The 7,385 VA COVID-19 deaths represent 2.0% of the 375,300 deaths reported in the US by Johns Hopkins University. VA has reported 0.8% of the total number of COVID-19 cases.

The VA also reports the demographic breakdown of its COVID-19 cases. Among the active cases, 56.9% are White, 18.3% Black, 9.4% Hispanic, and 1.4% Native American, Alaska Native, or Pacific Islander.

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Over half of COVID-19 transmission may occur via asymptomatic people

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As COVID-19 cases surge and vaccinations lag, health authorities continue to seek additional ways to mitigate the spread of the novel coronavirus.

Now, a modeling study estimates that more than half of transmissions come from pre-, never-, and asymptomatic individuals, indicating that symptom-based screening will have little effect on spread.

Courtesy NIAID


The Centers for Disease Control and Prevention study, published online Jan. 7 in JAMA Network Open, concludes that for optimal control, protective measures such as masking and social distancing should be supplemented with strategic testing of potentially exposed but asymptomatic individuals .

“In the absence of effective and widespread use of therapeutics or vaccines that can shorten or eliminate infectivity, successful control of SARS-CoV-2 cannot rely solely on identifying and isolating symptomatic cases; even if implemented effectively, this strategy would be insufficient,” CDC biologist Michael J. Johansson, PhD, and colleagues warn. “Multiple measures that effectively address transmission risk in the absence of symptoms are imperative to control SARS-CoV-2.”

According to the authors, the effectiveness of some current transmission prevention efforts has been disputed and subject to mixed messaging. Therefore, they decided to model the proportion of COVID-19 infections that are likely the result of individuals who show no symptoms and may be unknowingly infecting others.

“Unfortunately, there continues to be some skepticism about the value of community-wide mitigation efforts for preventing transmission such as masking, distancing, and hand hygiene, particularly for people without symptoms,” corresponding author Jay C. Butler, MD, said in an interview. “So we wanted to have a base assumption about how much transmission occurs from asymptomatic people to underscore the importance of mitigation measures and of creating immunity through vaccine delivery.”

Such a yardstick is especially germane in the context of the new, more transmissible variant. “It really puts [things] in a bigger box and underscores, boldfaces, and italicizes the need to change people’s behaviors and the importance of mitigation,” Dr. Butler said. It also highlights the advisability of targeted strategic testing in congregate settings, schools, and universities, which is already underway.
 

The analysis

Based on data from several COVID-19 studies from last year, the CDC’s analytical model assumes at baseline that infectiousness peaks at the median point of symptom onset, and that 30% of infected individuals never develop symptoms but are nevertheless 75% as infectious as those who develop overt symptoms.

The investigators then model multiple scenarios of transmission based pre- and never-symptomatic individuals, assuming different incubation and infectious periods, and varying numbers of days from point of infection to symptom onset.

When combined, the models predicts that 59% of all transmission would come from asymptomatic transmission – 35% from presymptomatic individuals and 24% from never-symptomatic individuals.

The findings complement those of an earlier CDC analysis, according to the authors.

The overall proportion of transmission from presymptomatic and never-symptomatic individuals is key to identifying mitigation measures that may be able to control SARS-CoV-2, the authors stated.

For example, they explain, if the infection reproduction number (R) in a particular setting is 2.0, a reduction in transmission of at least 50% is needed in order to reduce R to below 1.0. “Given that in some settings R is likely much greater than 2 and more than half of transmissions may come from individuals who are asymptomatic at the time of transmission, effective control must mitigate transmission risk from people without symptoms,” they wrote.

The authors acknowledge that the study applies a simplistic model to a complex and evolving phenomenon, and that the exact proportions of presymptomatic and never-symptomatic transmission and the incubation periods are not known. They also note symptoms and transmissions appear to vary across different population groups, with older individuals more likely than younger persons to experience symptoms, according to previous studies.

 

 

“Assume that everyone is potentially infected”

Other experts agree that expanded testing of asymptomatic individuals is important. “Screening for fever and isolation of symptomatic individuals is a common-sense approach to help prevent spread, but these measures are by no means adequate since it’s been clearly documented that individuals who are either asymptomatic or presymptomatic can still spread the virus,” said Brett Williams, MD, an infectious disease specialist and assistant professor of medicine at Rush University in Chicago. 

“As we saw with the White House Rose Garden superspreader outbreak, testing does not reliably exclude infection either because the tested individual has not yet become positive or the test is falsely negative,” Dr. Williams, who was not involved in the CDC study, said in an interview. He further noted that when prevalence is as high as it currently is in the United States, the rate of false negatives will be high because a large proportion of those screened will be unknowingly infected.

At his center, all visitors and staff are screened with a temperature probe on entry, and since the earliest days of the pandemic, universal masking has been required. “Nationally there have been many instances of hospital break room outbreaks because of staff eating lunch together, and these outbreaks also demonstrate the incompleteness of symptomatic isolation,” Dr. Williams said.

For his part, virologist Frank Esper, MD, a pediatric infectious disease specialist at the Cleveland Clinic, said that while it’s been understood for some time that many infected people will not exhibit symptoms, “the question that remains is just how infectious are they?”

Dr. Esper’s takeaway from the modeling study is not so much that we need more screening of possibly exposed but asymptomatic people, but rather testing symptomatic people and tracing their contacts is not enough.

“We need to continue to assume that everyone is potentially infected whether they know it or not. And even though we have ramped up our testing to a much greater capacity than in the first wave, we need to continue to wear masks and socially distance because just identifying people who are sick and isolating or quarantining them is not going to be enough to contain the pandemic.”

And although assumption-based modeling is helpful, it cannot tell us “how many asymptomatic people are actually infected,” said Dr. Esper, who was not involved in the CDC study.

Dr. Esper also pointed out that the study estimates are based on data from early Chinese studies, but the virus has since changed. The new, more transmissible strain in the United States and elsewhere may involve not only more infections but also a longer presymptomatic stage. “So the CDC study may actually undershoot asymptomatic infections,” he said. 

He also agreed with the authors that when it comes to infection, not all humans are equal. “Older people tend to be more symptomatic and become symptomatic more quickly so the asymptomatic rate is not the same across board from young people age 20 to older people.”

The bottom line, said David. A. Hirschwerk, MD, an infectious disease specialist at Northwell Health in Manhasset, N.Y., is that these data support the maintenance of protective measures we’ve been taking over the past months. “They support the concept that asymptomatic people are a significant source of transmission and that we need to adhere to mask wearing and social distancing, particularly indoors,” Dr. Hirschwerk, who was not involved in the analysis, said in an interview. “More testing would be better but it has to be fast and it has to be efficient, and there are a lot of challenges to overcome.”

The study was done as part of the CDC’s coronavirus disease 2019 response and was supported solely by federal base and response funding. The authors and commentators have disclosed no relevant financial relationships.

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

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As COVID-19 cases surge and vaccinations lag, health authorities continue to seek additional ways to mitigate the spread of the novel coronavirus.

Now, a modeling study estimates that more than half of transmissions come from pre-, never-, and asymptomatic individuals, indicating that symptom-based screening will have little effect on spread.

Courtesy NIAID


The Centers for Disease Control and Prevention study, published online Jan. 7 in JAMA Network Open, concludes that for optimal control, protective measures such as masking and social distancing should be supplemented with strategic testing of potentially exposed but asymptomatic individuals .

“In the absence of effective and widespread use of therapeutics or vaccines that can shorten or eliminate infectivity, successful control of SARS-CoV-2 cannot rely solely on identifying and isolating symptomatic cases; even if implemented effectively, this strategy would be insufficient,” CDC biologist Michael J. Johansson, PhD, and colleagues warn. “Multiple measures that effectively address transmission risk in the absence of symptoms are imperative to control SARS-CoV-2.”

According to the authors, the effectiveness of some current transmission prevention efforts has been disputed and subject to mixed messaging. Therefore, they decided to model the proportion of COVID-19 infections that are likely the result of individuals who show no symptoms and may be unknowingly infecting others.

“Unfortunately, there continues to be some skepticism about the value of community-wide mitigation efforts for preventing transmission such as masking, distancing, and hand hygiene, particularly for people without symptoms,” corresponding author Jay C. Butler, MD, said in an interview. “So we wanted to have a base assumption about how much transmission occurs from asymptomatic people to underscore the importance of mitigation measures and of creating immunity through vaccine delivery.”

Such a yardstick is especially germane in the context of the new, more transmissible variant. “It really puts [things] in a bigger box and underscores, boldfaces, and italicizes the need to change people’s behaviors and the importance of mitigation,” Dr. Butler said. It also highlights the advisability of targeted strategic testing in congregate settings, schools, and universities, which is already underway.
 

The analysis

Based on data from several COVID-19 studies from last year, the CDC’s analytical model assumes at baseline that infectiousness peaks at the median point of symptom onset, and that 30% of infected individuals never develop symptoms but are nevertheless 75% as infectious as those who develop overt symptoms.

The investigators then model multiple scenarios of transmission based pre- and never-symptomatic individuals, assuming different incubation and infectious periods, and varying numbers of days from point of infection to symptom onset.

When combined, the models predicts that 59% of all transmission would come from asymptomatic transmission – 35% from presymptomatic individuals and 24% from never-symptomatic individuals.

The findings complement those of an earlier CDC analysis, according to the authors.

The overall proportion of transmission from presymptomatic and never-symptomatic individuals is key to identifying mitigation measures that may be able to control SARS-CoV-2, the authors stated.

For example, they explain, if the infection reproduction number (R) in a particular setting is 2.0, a reduction in transmission of at least 50% is needed in order to reduce R to below 1.0. “Given that in some settings R is likely much greater than 2 and more than half of transmissions may come from individuals who are asymptomatic at the time of transmission, effective control must mitigate transmission risk from people without symptoms,” they wrote.

The authors acknowledge that the study applies a simplistic model to a complex and evolving phenomenon, and that the exact proportions of presymptomatic and never-symptomatic transmission and the incubation periods are not known. They also note symptoms and transmissions appear to vary across different population groups, with older individuals more likely than younger persons to experience symptoms, according to previous studies.

 

 

“Assume that everyone is potentially infected”

Other experts agree that expanded testing of asymptomatic individuals is important. “Screening for fever and isolation of symptomatic individuals is a common-sense approach to help prevent spread, but these measures are by no means adequate since it’s been clearly documented that individuals who are either asymptomatic or presymptomatic can still spread the virus,” said Brett Williams, MD, an infectious disease specialist and assistant professor of medicine at Rush University in Chicago. 

“As we saw with the White House Rose Garden superspreader outbreak, testing does not reliably exclude infection either because the tested individual has not yet become positive or the test is falsely negative,” Dr. Williams, who was not involved in the CDC study, said in an interview. He further noted that when prevalence is as high as it currently is in the United States, the rate of false negatives will be high because a large proportion of those screened will be unknowingly infected.

At his center, all visitors and staff are screened with a temperature probe on entry, and since the earliest days of the pandemic, universal masking has been required. “Nationally there have been many instances of hospital break room outbreaks because of staff eating lunch together, and these outbreaks also demonstrate the incompleteness of symptomatic isolation,” Dr. Williams said.

For his part, virologist Frank Esper, MD, a pediatric infectious disease specialist at the Cleveland Clinic, said that while it’s been understood for some time that many infected people will not exhibit symptoms, “the question that remains is just how infectious are they?”

Dr. Esper’s takeaway from the modeling study is not so much that we need more screening of possibly exposed but asymptomatic people, but rather testing symptomatic people and tracing their contacts is not enough.

“We need to continue to assume that everyone is potentially infected whether they know it or not. And even though we have ramped up our testing to a much greater capacity than in the first wave, we need to continue to wear masks and socially distance because just identifying people who are sick and isolating or quarantining them is not going to be enough to contain the pandemic.”

And although assumption-based modeling is helpful, it cannot tell us “how many asymptomatic people are actually infected,” said Dr. Esper, who was not involved in the CDC study.

Dr. Esper also pointed out that the study estimates are based on data from early Chinese studies, but the virus has since changed. The new, more transmissible strain in the United States and elsewhere may involve not only more infections but also a longer presymptomatic stage. “So the CDC study may actually undershoot asymptomatic infections,” he said. 

He also agreed with the authors that when it comes to infection, not all humans are equal. “Older people tend to be more symptomatic and become symptomatic more quickly so the asymptomatic rate is not the same across board from young people age 20 to older people.”

The bottom line, said David. A. Hirschwerk, MD, an infectious disease specialist at Northwell Health in Manhasset, N.Y., is that these data support the maintenance of protective measures we’ve been taking over the past months. “They support the concept that asymptomatic people are a significant source of transmission and that we need to adhere to mask wearing and social distancing, particularly indoors,” Dr. Hirschwerk, who was not involved in the analysis, said in an interview. “More testing would be better but it has to be fast and it has to be efficient, and there are a lot of challenges to overcome.”

The study was done as part of the CDC’s coronavirus disease 2019 response and was supported solely by federal base and response funding. The authors and commentators have disclosed no relevant financial relationships.

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

As COVID-19 cases surge and vaccinations lag, health authorities continue to seek additional ways to mitigate the spread of the novel coronavirus.

Now, a modeling study estimates that more than half of transmissions come from pre-, never-, and asymptomatic individuals, indicating that symptom-based screening will have little effect on spread.

Courtesy NIAID


The Centers for Disease Control and Prevention study, published online Jan. 7 in JAMA Network Open, concludes that for optimal control, protective measures such as masking and social distancing should be supplemented with strategic testing of potentially exposed but asymptomatic individuals .

“In the absence of effective and widespread use of therapeutics or vaccines that can shorten or eliminate infectivity, successful control of SARS-CoV-2 cannot rely solely on identifying and isolating symptomatic cases; even if implemented effectively, this strategy would be insufficient,” CDC biologist Michael J. Johansson, PhD, and colleagues warn. “Multiple measures that effectively address transmission risk in the absence of symptoms are imperative to control SARS-CoV-2.”

According to the authors, the effectiveness of some current transmission prevention efforts has been disputed and subject to mixed messaging. Therefore, they decided to model the proportion of COVID-19 infections that are likely the result of individuals who show no symptoms and may be unknowingly infecting others.

“Unfortunately, there continues to be some skepticism about the value of community-wide mitigation efforts for preventing transmission such as masking, distancing, and hand hygiene, particularly for people without symptoms,” corresponding author Jay C. Butler, MD, said in an interview. “So we wanted to have a base assumption about how much transmission occurs from asymptomatic people to underscore the importance of mitigation measures and of creating immunity through vaccine delivery.”

Such a yardstick is especially germane in the context of the new, more transmissible variant. “It really puts [things] in a bigger box and underscores, boldfaces, and italicizes the need to change people’s behaviors and the importance of mitigation,” Dr. Butler said. It also highlights the advisability of targeted strategic testing in congregate settings, schools, and universities, which is already underway.
 

The analysis

Based on data from several COVID-19 studies from last year, the CDC’s analytical model assumes at baseline that infectiousness peaks at the median point of symptom onset, and that 30% of infected individuals never develop symptoms but are nevertheless 75% as infectious as those who develop overt symptoms.

The investigators then model multiple scenarios of transmission based pre- and never-symptomatic individuals, assuming different incubation and infectious periods, and varying numbers of days from point of infection to symptom onset.

When combined, the models predicts that 59% of all transmission would come from asymptomatic transmission – 35% from presymptomatic individuals and 24% from never-symptomatic individuals.

The findings complement those of an earlier CDC analysis, according to the authors.

The overall proportion of transmission from presymptomatic and never-symptomatic individuals is key to identifying mitigation measures that may be able to control SARS-CoV-2, the authors stated.

For example, they explain, if the infection reproduction number (R) in a particular setting is 2.0, a reduction in transmission of at least 50% is needed in order to reduce R to below 1.0. “Given that in some settings R is likely much greater than 2 and more than half of transmissions may come from individuals who are asymptomatic at the time of transmission, effective control must mitigate transmission risk from people without symptoms,” they wrote.

The authors acknowledge that the study applies a simplistic model to a complex and evolving phenomenon, and that the exact proportions of presymptomatic and never-symptomatic transmission and the incubation periods are not known. They also note symptoms and transmissions appear to vary across different population groups, with older individuals more likely than younger persons to experience symptoms, according to previous studies.

 

 

“Assume that everyone is potentially infected”

Other experts agree that expanded testing of asymptomatic individuals is important. “Screening for fever and isolation of symptomatic individuals is a common-sense approach to help prevent spread, but these measures are by no means adequate since it’s been clearly documented that individuals who are either asymptomatic or presymptomatic can still spread the virus,” said Brett Williams, MD, an infectious disease specialist and assistant professor of medicine at Rush University in Chicago. 

“As we saw with the White House Rose Garden superspreader outbreak, testing does not reliably exclude infection either because the tested individual has not yet become positive or the test is falsely negative,” Dr. Williams, who was not involved in the CDC study, said in an interview. He further noted that when prevalence is as high as it currently is in the United States, the rate of false negatives will be high because a large proportion of those screened will be unknowingly infected.

At his center, all visitors and staff are screened with a temperature probe on entry, and since the earliest days of the pandemic, universal masking has been required. “Nationally there have been many instances of hospital break room outbreaks because of staff eating lunch together, and these outbreaks also demonstrate the incompleteness of symptomatic isolation,” Dr. Williams said.

For his part, virologist Frank Esper, MD, a pediatric infectious disease specialist at the Cleveland Clinic, said that while it’s been understood for some time that many infected people will not exhibit symptoms, “the question that remains is just how infectious are they?”

Dr. Esper’s takeaway from the modeling study is not so much that we need more screening of possibly exposed but asymptomatic people, but rather testing symptomatic people and tracing their contacts is not enough.

“We need to continue to assume that everyone is potentially infected whether they know it or not. And even though we have ramped up our testing to a much greater capacity than in the first wave, we need to continue to wear masks and socially distance because just identifying people who are sick and isolating or quarantining them is not going to be enough to contain the pandemic.”

And although assumption-based modeling is helpful, it cannot tell us “how many asymptomatic people are actually infected,” said Dr. Esper, who was not involved in the CDC study.

Dr. Esper also pointed out that the study estimates are based on data from early Chinese studies, but the virus has since changed. The new, more transmissible strain in the United States and elsewhere may involve not only more infections but also a longer presymptomatic stage. “So the CDC study may actually undershoot asymptomatic infections,” he said. 

He also agreed with the authors that when it comes to infection, not all humans are equal. “Older people tend to be more symptomatic and become symptomatic more quickly so the asymptomatic rate is not the same across board from young people age 20 to older people.”

The bottom line, said David. A. Hirschwerk, MD, an infectious disease specialist at Northwell Health in Manhasset, N.Y., is that these data support the maintenance of protective measures we’ve been taking over the past months. “They support the concept that asymptomatic people are a significant source of transmission and that we need to adhere to mask wearing and social distancing, particularly indoors,” Dr. Hirschwerk, who was not involved in the analysis, said in an interview. “More testing would be better but it has to be fast and it has to be efficient, and there are a lot of challenges to overcome.”

The study was done as part of the CDC’s coronavirus disease 2019 response and was supported solely by federal base and response funding. The authors and commentators have disclosed no relevant financial relationships.

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

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Trust in a Vial

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On December 11, 2020, the US Food and Drug Administration (FDA) delivered the holiday gift America was waiting for—approval of the first COVID-19 vaccine. Following the recommendation of its expert advisory panel, the FDA issued its opening emergency use authorization (EUA) for the Pfizer and BioNTech product to be distributed and administered across the country.1 A week after that historic announcement, the FDA issued an EUA to Moderna for a second COVID-19 vaccine.2

An EUA is a misunderstood concept that, like the development of the vaccine itself, appears almost like a magical federal deliverance to a nation at a time when almost every other public health effort has floundered. An EUA is a regulatory process to enable a public health emergency response with medical countermeasures including not only vaccines, but also medications. Earlier in 2020, hydroxychloroquine and remdesivir each received EUAs for treating patients with COVID-19.3 The EUA for hydroxychloroquine was later revoked when more data raised concerns for its efficacy.4 EUAs do not mean the drugs are experimental or that everyone receiving them is participating in a research trial; however, for the sake of safety and science, data continue to be collected and analyzed. Issuance of an EUA indicates that after rigorous examination and an independent advisory board review of data submitted by the manufacturer, the FDA has determined the product and situation meet key criteria: (1) There is a public health emergency that threatens health and life and requires expedited procedures; (2) there are no extant approved products able to treat or prevent the disease; and (3) the known and potential benefits of the product outweigh the known and potential risks.5

The public and even the professional press have celebrated the arrival of this technologic triumph over a virus that had vanquished staggering numbers of lives and livelihoods. Much of the media coverage aptly chose the word “hope” to capture the significance of this unprecedented accomplishment for which so many millions yearned. A Google search for “hope” on the morning of December 20, yielded 339,000,000 results. For example, a headline especially salient for Federal Practitioner readers from the New York Times read, “‘A Shot of Hope’ What the Vaccine is like for Frontline Doctors and Nurses.”6

I want to briefly argue why even though I believe hope in and for the vaccine is desperately needed if we are to survive this long, dark winter, trust in the vaccine can actually usher in the warmth of economic recovery and the light of saved lives. Trust is crucial in 3 main areas if the awe-inspiring hope of the vaccine the EUAs codify is to be fulfilled. The venerable moral and civic virtue of trust has been trivialized and commercialized mostly mentioned in advertising for insurance or real estate companies. Medical virtue-ethicists Edmund Pellegrino and David Thomasma describe trust as the binding force that keeps civilization intact. “Trust is ineradicable in human relationships. Without we could not live in society or attain even the rudiments of a fulfilling life, they explain. “Without trust we could not anticipate the future, and we would therefore be paralyzed into inaction. Yet to trust and entrust is to become vulnerable and dependent on the good will and motivations of those we trust. Trust, ineradicable as it is, is also always problematic.”7

The first area where that trust is the hardest to secure is in the federal government, the actions and messages of which have seemed so inconstant, unjust, and deceptive to many. For enough citizens to roll up their sleeves, they must believe the outgoing and the incoming administrations and legislators can make rational plans translated into sound public health policy that place the good of humanity above other interests and then mobilize the resources of the country to deliver that good with consistency, fairness, and transparency.

The second area is trust in medical science. Long before COVID-19, American attitudes toward vaccines reflected reasonable fears and ridiculous conspiracy theories—both of which are serious obstacles to the breadth of immunization required to achieve herd immunity. Ordinary people must believe that the health care professionals and scientists at the Centers for Disease Control and Prevention and the FDA will never compromise safety for political expediency. Recent polls have shown an increase in the percentage of the population willing to consider vaccination. A December Gallop poll found that 63% of Americans were willing to be vaccinated for COVID-19.8 To raise those numbers high enough to approach herd immunity will require Americans to believe that the scientists who discover the vaccines and the companies that develop them have placed people above profit and ranked the safety of society above individual scientific renown.

Groups that have been the historic objects of exploitation in research and contemporary disparities in health care understandably have more distrust of science and medicine. While public health officials insist that they have developed a system of vaccine distribution that is equitable and prioritizes the sick and old and those who care for them before the rich and powerful, we should not be surprised that our communication of this assurance is viewed with skepticism. As a recent Medscape article advised, public health officials may need to rely on, “trusted messengers” to help some communities to “overcome vaccine hesitancy.”9

Third we must trust in our fellow citizens to maintain the public health measures of social distancing and mask wearing even after there is widespread vaccination. If we are to reap the benefits of a safe and effective vaccine, we must be a community of immunity, not just isolated inoculated individuals. We as health care practitioners must do all we can to educate the public that the adverse reactions to the vaccine so prominently featured in the media are expected with any new and complex biological product and do not signal risk that outweighs the deadliness of the virus.10

Fourth, and finally, we must trust in ourselves as health care professionals and administrators. We in the DoD, VA, and PHS have the knowledge and skills to endure the onslaught of pain and suffering we will all experience in one way or another in these next long months. We must believe that our courage and compassion can turn a vaccine into vaccinations sufficient to relieve the COVID-19 siege of our hospitals and intensive care units. When that day comes, hope will have been a plan we could trust. 

References

1. US Food and Drug Administration. FDA take key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine [press release]. Published December 11, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

2. US Food and Drug Administration. FDA takes additional action in fight against COVID-19 by Issuing emergency use authorization for second COVID-19 vaccine [press release]. Published December 18, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

3. US Food and Drug Administration. FDA approves first treatment for COVID-19 [press release]. Published October 22, 2020. Accessed December 20, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

4. US Food and Drug Administration. Coronavirus (COVID-19) update: FDA revokes emergency use authorization for chloroquine and hydroxychloroquine [press release]. Published June 15, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and

5. US Food and Drug Administration. Emergency use authorization for vaccines explained. Updated November 20, 2020. Accessed December 22, 2020. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

6. Healy J, Tompkins L, Burch ADS. ‘A shot of hope’: what the vaccine is like for frontline doctors and nurses. New York Times. Updated December 17, 2020. Accessed December 22, 2020. https://www.nytimes.com/2020/12/14/us/coronavirus-vaccine-doctors-nurses.html

7. Pellegrino E, Thomasma DC. The Virtues in Medical Practice . New York: Oxford University Press; 1993:65.

8. Brenan M. Willingness to get Covid-19 vaccine ticks up to 63% in the U.S. Published December 8, 2020. Accessed December 22, 2020. https://news.gallup.com/poll/327425/willingness-covid-vaccine-ticks.aspx

9. Eldred SM. Trusted messengers may help disenfranchised communities overcome vaccine hesitancy. Published December 17, 2020. Accessed December 22, 2020. https://www.medscape.com/viewarticle/942847

10. Chiu A. ‘Absolutely normal’: Covid vaccine side effects are not reason to avoid the shots, doctors say. Washington Post. Published December 3, 2020. Accessed December 22, 2020. https://www.washingtonpost.com/lifestyle/wellness/vaccine-side-effects-covid/2020/12/02/55bebac0-342c-11eb-8d38-6aea1adb3839_story.html

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On December 11, 2020, the US Food and Drug Administration (FDA) delivered the holiday gift America was waiting for—approval of the first COVID-19 vaccine. Following the recommendation of its expert advisory panel, the FDA issued its opening emergency use authorization (EUA) for the Pfizer and BioNTech product to be distributed and administered across the country.1 A week after that historic announcement, the FDA issued an EUA to Moderna for a second COVID-19 vaccine.2

An EUA is a misunderstood concept that, like the development of the vaccine itself, appears almost like a magical federal deliverance to a nation at a time when almost every other public health effort has floundered. An EUA is a regulatory process to enable a public health emergency response with medical countermeasures including not only vaccines, but also medications. Earlier in 2020, hydroxychloroquine and remdesivir each received EUAs for treating patients with COVID-19.3 The EUA for hydroxychloroquine was later revoked when more data raised concerns for its efficacy.4 EUAs do not mean the drugs are experimental or that everyone receiving them is participating in a research trial; however, for the sake of safety and science, data continue to be collected and analyzed. Issuance of an EUA indicates that after rigorous examination and an independent advisory board review of data submitted by the manufacturer, the FDA has determined the product and situation meet key criteria: (1) There is a public health emergency that threatens health and life and requires expedited procedures; (2) there are no extant approved products able to treat or prevent the disease; and (3) the known and potential benefits of the product outweigh the known and potential risks.5

The public and even the professional press have celebrated the arrival of this technologic triumph over a virus that had vanquished staggering numbers of lives and livelihoods. Much of the media coverage aptly chose the word “hope” to capture the significance of this unprecedented accomplishment for which so many millions yearned. A Google search for “hope” on the morning of December 20, yielded 339,000,000 results. For example, a headline especially salient for Federal Practitioner readers from the New York Times read, “‘A Shot of Hope’ What the Vaccine is like for Frontline Doctors and Nurses.”6

I want to briefly argue why even though I believe hope in and for the vaccine is desperately needed if we are to survive this long, dark winter, trust in the vaccine can actually usher in the warmth of economic recovery and the light of saved lives. Trust is crucial in 3 main areas if the awe-inspiring hope of the vaccine the EUAs codify is to be fulfilled. The venerable moral and civic virtue of trust has been trivialized and commercialized mostly mentioned in advertising for insurance or real estate companies. Medical virtue-ethicists Edmund Pellegrino and David Thomasma describe trust as the binding force that keeps civilization intact. “Trust is ineradicable in human relationships. Without we could not live in society or attain even the rudiments of a fulfilling life, they explain. “Without trust we could not anticipate the future, and we would therefore be paralyzed into inaction. Yet to trust and entrust is to become vulnerable and dependent on the good will and motivations of those we trust. Trust, ineradicable as it is, is also always problematic.”7

The first area where that trust is the hardest to secure is in the federal government, the actions and messages of which have seemed so inconstant, unjust, and deceptive to many. For enough citizens to roll up their sleeves, they must believe the outgoing and the incoming administrations and legislators can make rational plans translated into sound public health policy that place the good of humanity above other interests and then mobilize the resources of the country to deliver that good with consistency, fairness, and transparency.

The second area is trust in medical science. Long before COVID-19, American attitudes toward vaccines reflected reasonable fears and ridiculous conspiracy theories—both of which are serious obstacles to the breadth of immunization required to achieve herd immunity. Ordinary people must believe that the health care professionals and scientists at the Centers for Disease Control and Prevention and the FDA will never compromise safety for political expediency. Recent polls have shown an increase in the percentage of the population willing to consider vaccination. A December Gallop poll found that 63% of Americans were willing to be vaccinated for COVID-19.8 To raise those numbers high enough to approach herd immunity will require Americans to believe that the scientists who discover the vaccines and the companies that develop them have placed people above profit and ranked the safety of society above individual scientific renown.

Groups that have been the historic objects of exploitation in research and contemporary disparities in health care understandably have more distrust of science and medicine. While public health officials insist that they have developed a system of vaccine distribution that is equitable and prioritizes the sick and old and those who care for them before the rich and powerful, we should not be surprised that our communication of this assurance is viewed with skepticism. As a recent Medscape article advised, public health officials may need to rely on, “trusted messengers” to help some communities to “overcome vaccine hesitancy.”9

Third we must trust in our fellow citizens to maintain the public health measures of social distancing and mask wearing even after there is widespread vaccination. If we are to reap the benefits of a safe and effective vaccine, we must be a community of immunity, not just isolated inoculated individuals. We as health care practitioners must do all we can to educate the public that the adverse reactions to the vaccine so prominently featured in the media are expected with any new and complex biological product and do not signal risk that outweighs the deadliness of the virus.10

Fourth, and finally, we must trust in ourselves as health care professionals and administrators. We in the DoD, VA, and PHS have the knowledge and skills to endure the onslaught of pain and suffering we will all experience in one way or another in these next long months. We must believe that our courage and compassion can turn a vaccine into vaccinations sufficient to relieve the COVID-19 siege of our hospitals and intensive care units. When that day comes, hope will have been a plan we could trust. 

On December 11, 2020, the US Food and Drug Administration (FDA) delivered the holiday gift America was waiting for—approval of the first COVID-19 vaccine. Following the recommendation of its expert advisory panel, the FDA issued its opening emergency use authorization (EUA) for the Pfizer and BioNTech product to be distributed and administered across the country.1 A week after that historic announcement, the FDA issued an EUA to Moderna for a second COVID-19 vaccine.2

An EUA is a misunderstood concept that, like the development of the vaccine itself, appears almost like a magical federal deliverance to a nation at a time when almost every other public health effort has floundered. An EUA is a regulatory process to enable a public health emergency response with medical countermeasures including not only vaccines, but also medications. Earlier in 2020, hydroxychloroquine and remdesivir each received EUAs for treating patients with COVID-19.3 The EUA for hydroxychloroquine was later revoked when more data raised concerns for its efficacy.4 EUAs do not mean the drugs are experimental or that everyone receiving them is participating in a research trial; however, for the sake of safety and science, data continue to be collected and analyzed. Issuance of an EUA indicates that after rigorous examination and an independent advisory board review of data submitted by the manufacturer, the FDA has determined the product and situation meet key criteria: (1) There is a public health emergency that threatens health and life and requires expedited procedures; (2) there are no extant approved products able to treat or prevent the disease; and (3) the known and potential benefits of the product outweigh the known and potential risks.5

The public and even the professional press have celebrated the arrival of this technologic triumph over a virus that had vanquished staggering numbers of lives and livelihoods. Much of the media coverage aptly chose the word “hope” to capture the significance of this unprecedented accomplishment for which so many millions yearned. A Google search for “hope” on the morning of December 20, yielded 339,000,000 results. For example, a headline especially salient for Federal Practitioner readers from the New York Times read, “‘A Shot of Hope’ What the Vaccine is like for Frontline Doctors and Nurses.”6

I want to briefly argue why even though I believe hope in and for the vaccine is desperately needed if we are to survive this long, dark winter, trust in the vaccine can actually usher in the warmth of economic recovery and the light of saved lives. Trust is crucial in 3 main areas if the awe-inspiring hope of the vaccine the EUAs codify is to be fulfilled. The venerable moral and civic virtue of trust has been trivialized and commercialized mostly mentioned in advertising for insurance or real estate companies. Medical virtue-ethicists Edmund Pellegrino and David Thomasma describe trust as the binding force that keeps civilization intact. “Trust is ineradicable in human relationships. Without we could not live in society or attain even the rudiments of a fulfilling life, they explain. “Without trust we could not anticipate the future, and we would therefore be paralyzed into inaction. Yet to trust and entrust is to become vulnerable and dependent on the good will and motivations of those we trust. Trust, ineradicable as it is, is also always problematic.”7

The first area where that trust is the hardest to secure is in the federal government, the actions and messages of which have seemed so inconstant, unjust, and deceptive to many. For enough citizens to roll up their sleeves, they must believe the outgoing and the incoming administrations and legislators can make rational plans translated into sound public health policy that place the good of humanity above other interests and then mobilize the resources of the country to deliver that good with consistency, fairness, and transparency.

The second area is trust in medical science. Long before COVID-19, American attitudes toward vaccines reflected reasonable fears and ridiculous conspiracy theories—both of which are serious obstacles to the breadth of immunization required to achieve herd immunity. Ordinary people must believe that the health care professionals and scientists at the Centers for Disease Control and Prevention and the FDA will never compromise safety for political expediency. Recent polls have shown an increase in the percentage of the population willing to consider vaccination. A December Gallop poll found that 63% of Americans were willing to be vaccinated for COVID-19.8 To raise those numbers high enough to approach herd immunity will require Americans to believe that the scientists who discover the vaccines and the companies that develop them have placed people above profit and ranked the safety of society above individual scientific renown.

Groups that have been the historic objects of exploitation in research and contemporary disparities in health care understandably have more distrust of science and medicine. While public health officials insist that they have developed a system of vaccine distribution that is equitable and prioritizes the sick and old and those who care for them before the rich and powerful, we should not be surprised that our communication of this assurance is viewed with skepticism. As a recent Medscape article advised, public health officials may need to rely on, “trusted messengers” to help some communities to “overcome vaccine hesitancy.”9

Third we must trust in our fellow citizens to maintain the public health measures of social distancing and mask wearing even after there is widespread vaccination. If we are to reap the benefits of a safe and effective vaccine, we must be a community of immunity, not just isolated inoculated individuals. We as health care practitioners must do all we can to educate the public that the adverse reactions to the vaccine so prominently featured in the media are expected with any new and complex biological product and do not signal risk that outweighs the deadliness of the virus.10

Fourth, and finally, we must trust in ourselves as health care professionals and administrators. We in the DoD, VA, and PHS have the knowledge and skills to endure the onslaught of pain and suffering we will all experience in one way or another in these next long months. We must believe that our courage and compassion can turn a vaccine into vaccinations sufficient to relieve the COVID-19 siege of our hospitals and intensive care units. When that day comes, hope will have been a plan we could trust. 

References

1. US Food and Drug Administration. FDA take key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine [press release]. Published December 11, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

2. US Food and Drug Administration. FDA takes additional action in fight against COVID-19 by Issuing emergency use authorization for second COVID-19 vaccine [press release]. Published December 18, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

3. US Food and Drug Administration. FDA approves first treatment for COVID-19 [press release]. Published October 22, 2020. Accessed December 20, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

4. US Food and Drug Administration. Coronavirus (COVID-19) update: FDA revokes emergency use authorization for chloroquine and hydroxychloroquine [press release]. Published June 15, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and

5. US Food and Drug Administration. Emergency use authorization for vaccines explained. Updated November 20, 2020. Accessed December 22, 2020. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

6. Healy J, Tompkins L, Burch ADS. ‘A shot of hope’: what the vaccine is like for frontline doctors and nurses. New York Times. Updated December 17, 2020. Accessed December 22, 2020. https://www.nytimes.com/2020/12/14/us/coronavirus-vaccine-doctors-nurses.html

7. Pellegrino E, Thomasma DC. The Virtues in Medical Practice . New York: Oxford University Press; 1993:65.

8. Brenan M. Willingness to get Covid-19 vaccine ticks up to 63% in the U.S. Published December 8, 2020. Accessed December 22, 2020. https://news.gallup.com/poll/327425/willingness-covid-vaccine-ticks.aspx

9. Eldred SM. Trusted messengers may help disenfranchised communities overcome vaccine hesitancy. Published December 17, 2020. Accessed December 22, 2020. https://www.medscape.com/viewarticle/942847

10. Chiu A. ‘Absolutely normal’: Covid vaccine side effects are not reason to avoid the shots, doctors say. Washington Post. Published December 3, 2020. Accessed December 22, 2020. https://www.washingtonpost.com/lifestyle/wellness/vaccine-side-effects-covid/2020/12/02/55bebac0-342c-11eb-8d38-6aea1adb3839_story.html

References

1. US Food and Drug Administration. FDA take key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine [press release]. Published December 11, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

2. US Food and Drug Administration. FDA takes additional action in fight against COVID-19 by Issuing emergency use authorization for second COVID-19 vaccine [press release]. Published December 18, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

3. US Food and Drug Administration. FDA approves first treatment for COVID-19 [press release]. Published October 22, 2020. Accessed December 20, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

4. US Food and Drug Administration. Coronavirus (COVID-19) update: FDA revokes emergency use authorization for chloroquine and hydroxychloroquine [press release]. Published June 15, 2020. Accessed December 22, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and

5. US Food and Drug Administration. Emergency use authorization for vaccines explained. Updated November 20, 2020. Accessed December 22, 2020. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

6. Healy J, Tompkins L, Burch ADS. ‘A shot of hope’: what the vaccine is like for frontline doctors and nurses. New York Times. Updated December 17, 2020. Accessed December 22, 2020. https://www.nytimes.com/2020/12/14/us/coronavirus-vaccine-doctors-nurses.html

7. Pellegrino E, Thomasma DC. The Virtues in Medical Practice . New York: Oxford University Press; 1993:65.

8. Brenan M. Willingness to get Covid-19 vaccine ticks up to 63% in the U.S. Published December 8, 2020. Accessed December 22, 2020. https://news.gallup.com/poll/327425/willingness-covid-vaccine-ticks.aspx

9. Eldred SM. Trusted messengers may help disenfranchised communities overcome vaccine hesitancy. Published December 17, 2020. Accessed December 22, 2020. https://www.medscape.com/viewarticle/942847

10. Chiu A. ‘Absolutely normal’: Covid vaccine side effects are not reason to avoid the shots, doctors say. Washington Post. Published December 3, 2020. Accessed December 22, 2020. https://www.washingtonpost.com/lifestyle/wellness/vaccine-side-effects-covid/2020/12/02/55bebac0-342c-11eb-8d38-6aea1adb3839_story.html

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Anaphylaxis cases after COVID-19 vaccine rising but still rare: CDC

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Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.

There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.

The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.

Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.

There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.

Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.

“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”

Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.

“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
 

MMWR details

The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).

The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.

Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.

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

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Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.

There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.

The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.

Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.

There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.

Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.

“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”

Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.

“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
 

MMWR details

The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).

The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.

Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.

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

Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.

There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.

The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.

Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.

There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.

Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.

“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”

Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.

“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
 

MMWR details

The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).

The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.

Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.

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

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Study confirms key COVID-19 risk factors in children

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Children and adolescents who receive positive COVID-19 test results are not only more likely to have been in close contact with someone with a confirmed case of the virus but also are less likely to have reported consistent mask use among students and staff inside the school they attended, reported Charlotte V. Hobbs, MD, and colleagues at the University of Mississippi, Jackson.

FluxFactory/E+


In partnership with the Centers for Disease Control and Prevention’s COVID-19 Response Team, Dr. Hobbs and colleagues conducted a case-control study of 397 children and adolescents under 18 years of age to assess school, community, and close contact exposures associated with pediatric COVID-19. Patients tested for COVID-19 at outpatient health centers or emergency departments affiliated with the University of Mississippi Medical Center between Sept. 1 and Nov. 5, 2020, were included in the study.
 

Nearly two-thirds reported that exposure came from family members

Of the total study participants observed, 82 (21%) were under 4 years of age; 214 (54%) were female; 217 (55%) were non-Hispanic black, and 145 (37%) were non-Hispanic white. More than half (53%) sought testing because of COVID-19 symptoms. Of those who tested positive, 66% reported having come into close contact with a COVID-19 case, and 64% reported that those contacts were family members, compared with 15% of contacts who were schoolmates and 27% who were child care classmates.

All participants completed in-person school or child care attendance less than 14 days before testing positive for the virus, including 62% of patients testing positive and 68% of those testing negative. The authors noted that school attendance itself was not found to be associated with any positive test results. In fact, parents in 64% of positive cases and 76% of negative cases reported mask wearing among children and staff inside places of learning.

Of those study participants testing positive who did come into close contact with someone with COVID-19, the contacts were more likely to be family members than school or child care classmates. Specifically, they were more likely, in the 2-week period preceding testing, to have attended gatherings with individuals outside their immediate households, including social events and activities with other children. Parents of students testing positive were also less likely to report consistent indoor mask use among their children older than 2 years and school staff members.

School attendance was not found to increase likelihood of testing positive

Attending in-person school or child care during the 2 weeks before the SARS-CoV-2 test was not associated with greater likelihood of testing positive, the study authors noted, adding that the majority of study respondents reported universal mask use inside school and child care facilities, consistent with Mississippi State Department of Health recommended guidelines.

Dr. Hobbs and colleagues reported at least four limitations of the study. They noted that the study participants may not be representative of youth in other geographic regions of the country. They considered the possibility of unmeasured confounding of participant behaviors that may not have been factored into the study. No attempt was made to verify parent claims of mask use at schools and child care programs. Lastly, they acknowledged that “case or control status might be subject to misclassification because of imperfect sensitivity or specificity of PCR-based testing.

As of Dec. 14, 2020, the CDC reported that 10.2% of all COVID-19 cases in the United States were in children and adolescents under the age of 18.

“Continued efforts to prevent transmission at schools and child care programs are important, as are assessments of various types of activities and exposures to identify risk factors for COVID-19 as children engage in classroom and social interactions.” Promoting behaviors to reduce exposures to the virus among youth in the household, the community, schools, and child care programs is important to preventing outbreaks of the virus at schools, the authors cautioned.

In a separate interview with this news organization, Karalyn Kinsella, MD, general pediatrician in a small group private practice in Cheshire, Conn., said, “What this report tells me is that COVID cases are more common when mask use is inconsistent in schools and at home and in schools that don’t properly adhere to CDC guidelines. Overall, so long as social distancing guidelines are followed, schools are pretty safe places for kids during this pandemic.”

This finding is important, since many families are keeping their children out of school over fears of contracting the virus, she added. Some of the consequences these children are suffering include a lack of social connection and structure, which in some cases is leading to worsening anxiety and depression, and for those with disabilities, such as those who receive physical therapy, occupational therapy, speech or have IEPs, they’re not getting the full benefit of the services that they would otherwise receive in person, she observed.

“I don’t think families really understand the risks of getting together with family or friends “in their bubble” or the risk of continuing sports participation. This is where the majority of COVID cases are coming from,” she said, adding that it is important to discuss this risk with them at appointments. So, when families ask us what we think of in-person learning, I think we should feel fairly confident that the benefit may outweigh the risk.”

Dr. Hobbs and colleagues, and Dr. Kinsella, had no conflicts of interest to report.

SOURCE: MMWR Morb Mortal Wkly Rep. 2020;69:1925-9. doi: 10.15585/mmwr.mm6950e3.

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Children and adolescents who receive positive COVID-19 test results are not only more likely to have been in close contact with someone with a confirmed case of the virus but also are less likely to have reported consistent mask use among students and staff inside the school they attended, reported Charlotte V. Hobbs, MD, and colleagues at the University of Mississippi, Jackson.

FluxFactory/E+


In partnership with the Centers for Disease Control and Prevention’s COVID-19 Response Team, Dr. Hobbs and colleagues conducted a case-control study of 397 children and adolescents under 18 years of age to assess school, community, and close contact exposures associated with pediatric COVID-19. Patients tested for COVID-19 at outpatient health centers or emergency departments affiliated with the University of Mississippi Medical Center between Sept. 1 and Nov. 5, 2020, were included in the study.
 

Nearly two-thirds reported that exposure came from family members

Of the total study participants observed, 82 (21%) were under 4 years of age; 214 (54%) were female; 217 (55%) were non-Hispanic black, and 145 (37%) were non-Hispanic white. More than half (53%) sought testing because of COVID-19 symptoms. Of those who tested positive, 66% reported having come into close contact with a COVID-19 case, and 64% reported that those contacts were family members, compared with 15% of contacts who were schoolmates and 27% who were child care classmates.

All participants completed in-person school or child care attendance less than 14 days before testing positive for the virus, including 62% of patients testing positive and 68% of those testing negative. The authors noted that school attendance itself was not found to be associated with any positive test results. In fact, parents in 64% of positive cases and 76% of negative cases reported mask wearing among children and staff inside places of learning.

Of those study participants testing positive who did come into close contact with someone with COVID-19, the contacts were more likely to be family members than school or child care classmates. Specifically, they were more likely, in the 2-week period preceding testing, to have attended gatherings with individuals outside their immediate households, including social events and activities with other children. Parents of students testing positive were also less likely to report consistent indoor mask use among their children older than 2 years and school staff members.

School attendance was not found to increase likelihood of testing positive

Attending in-person school or child care during the 2 weeks before the SARS-CoV-2 test was not associated with greater likelihood of testing positive, the study authors noted, adding that the majority of study respondents reported universal mask use inside school and child care facilities, consistent with Mississippi State Department of Health recommended guidelines.

Dr. Hobbs and colleagues reported at least four limitations of the study. They noted that the study participants may not be representative of youth in other geographic regions of the country. They considered the possibility of unmeasured confounding of participant behaviors that may not have been factored into the study. No attempt was made to verify parent claims of mask use at schools and child care programs. Lastly, they acknowledged that “case or control status might be subject to misclassification because of imperfect sensitivity or specificity of PCR-based testing.

As of Dec. 14, 2020, the CDC reported that 10.2% of all COVID-19 cases in the United States were in children and adolescents under the age of 18.

“Continued efforts to prevent transmission at schools and child care programs are important, as are assessments of various types of activities and exposures to identify risk factors for COVID-19 as children engage in classroom and social interactions.” Promoting behaviors to reduce exposures to the virus among youth in the household, the community, schools, and child care programs is important to preventing outbreaks of the virus at schools, the authors cautioned.

In a separate interview with this news organization, Karalyn Kinsella, MD, general pediatrician in a small group private practice in Cheshire, Conn., said, “What this report tells me is that COVID cases are more common when mask use is inconsistent in schools and at home and in schools that don’t properly adhere to CDC guidelines. Overall, so long as social distancing guidelines are followed, schools are pretty safe places for kids during this pandemic.”

This finding is important, since many families are keeping their children out of school over fears of contracting the virus, she added. Some of the consequences these children are suffering include a lack of social connection and structure, which in some cases is leading to worsening anxiety and depression, and for those with disabilities, such as those who receive physical therapy, occupational therapy, speech or have IEPs, they’re not getting the full benefit of the services that they would otherwise receive in person, she observed.

“I don’t think families really understand the risks of getting together with family or friends “in their bubble” or the risk of continuing sports participation. This is where the majority of COVID cases are coming from,” she said, adding that it is important to discuss this risk with them at appointments. So, when families ask us what we think of in-person learning, I think we should feel fairly confident that the benefit may outweigh the risk.”

Dr. Hobbs and colleagues, and Dr. Kinsella, had no conflicts of interest to report.

SOURCE: MMWR Morb Mortal Wkly Rep. 2020;69:1925-9. doi: 10.15585/mmwr.mm6950e3.

Children and adolescents who receive positive COVID-19 test results are not only more likely to have been in close contact with someone with a confirmed case of the virus but also are less likely to have reported consistent mask use among students and staff inside the school they attended, reported Charlotte V. Hobbs, MD, and colleagues at the University of Mississippi, Jackson.

FluxFactory/E+


In partnership with the Centers for Disease Control and Prevention’s COVID-19 Response Team, Dr. Hobbs and colleagues conducted a case-control study of 397 children and adolescents under 18 years of age to assess school, community, and close contact exposures associated with pediatric COVID-19. Patients tested for COVID-19 at outpatient health centers or emergency departments affiliated with the University of Mississippi Medical Center between Sept. 1 and Nov. 5, 2020, were included in the study.
 

Nearly two-thirds reported that exposure came from family members

Of the total study participants observed, 82 (21%) were under 4 years of age; 214 (54%) were female; 217 (55%) were non-Hispanic black, and 145 (37%) were non-Hispanic white. More than half (53%) sought testing because of COVID-19 symptoms. Of those who tested positive, 66% reported having come into close contact with a COVID-19 case, and 64% reported that those contacts were family members, compared with 15% of contacts who were schoolmates and 27% who were child care classmates.

All participants completed in-person school or child care attendance less than 14 days before testing positive for the virus, including 62% of patients testing positive and 68% of those testing negative. The authors noted that school attendance itself was not found to be associated with any positive test results. In fact, parents in 64% of positive cases and 76% of negative cases reported mask wearing among children and staff inside places of learning.

Of those study participants testing positive who did come into close contact with someone with COVID-19, the contacts were more likely to be family members than school or child care classmates. Specifically, they were more likely, in the 2-week period preceding testing, to have attended gatherings with individuals outside their immediate households, including social events and activities with other children. Parents of students testing positive were also less likely to report consistent indoor mask use among their children older than 2 years and school staff members.

School attendance was not found to increase likelihood of testing positive

Attending in-person school or child care during the 2 weeks before the SARS-CoV-2 test was not associated with greater likelihood of testing positive, the study authors noted, adding that the majority of study respondents reported universal mask use inside school and child care facilities, consistent with Mississippi State Department of Health recommended guidelines.

Dr. Hobbs and colleagues reported at least four limitations of the study. They noted that the study participants may not be representative of youth in other geographic regions of the country. They considered the possibility of unmeasured confounding of participant behaviors that may not have been factored into the study. No attempt was made to verify parent claims of mask use at schools and child care programs. Lastly, they acknowledged that “case or control status might be subject to misclassification because of imperfect sensitivity or specificity of PCR-based testing.

As of Dec. 14, 2020, the CDC reported that 10.2% of all COVID-19 cases in the United States were in children and adolescents under the age of 18.

“Continued efforts to prevent transmission at schools and child care programs are important, as are assessments of various types of activities and exposures to identify risk factors for COVID-19 as children engage in classroom and social interactions.” Promoting behaviors to reduce exposures to the virus among youth in the household, the community, schools, and child care programs is important to preventing outbreaks of the virus at schools, the authors cautioned.

In a separate interview with this news organization, Karalyn Kinsella, MD, general pediatrician in a small group private practice in Cheshire, Conn., said, “What this report tells me is that COVID cases are more common when mask use is inconsistent in schools and at home and in schools that don’t properly adhere to CDC guidelines. Overall, so long as social distancing guidelines are followed, schools are pretty safe places for kids during this pandemic.”

This finding is important, since many families are keeping their children out of school over fears of contracting the virus, she added. Some of the consequences these children are suffering include a lack of social connection and structure, which in some cases is leading to worsening anxiety and depression, and for those with disabilities, such as those who receive physical therapy, occupational therapy, speech or have IEPs, they’re not getting the full benefit of the services that they would otherwise receive in person, she observed.

“I don’t think families really understand the risks of getting together with family or friends “in their bubble” or the risk of continuing sports participation. This is where the majority of COVID cases are coming from,” she said, adding that it is important to discuss this risk with them at appointments. So, when families ask us what we think of in-person learning, I think we should feel fairly confident that the benefit may outweigh the risk.”

Dr. Hobbs and colleagues, and Dr. Kinsella, had no conflicts of interest to report.

SOURCE: MMWR Morb Mortal Wkly Rep. 2020;69:1925-9. doi: 10.15585/mmwr.mm6950e3.

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