The Hospitalist

The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children^1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.³ We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.

STUDY 1

Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.

Background

Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
 

Study overview and results

The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV₁. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
 

Limitations

Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV₁, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
 

Important findings and implications

While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
 

STUDY 2

Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.

Background

Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
 

Study overview and results

The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.⁴ They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
 

Limitations

These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
 

Important findings and implications

This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.

STUDY 3

Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.

Background

Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
 

Study overview and results

The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
 

Limitations

Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
 

Important findings and implications

Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
 

STUDY 4

Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.

Background

Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
 

Study overview and results

The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
 

Limitations

The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
 

Important findings and implications

Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
 

STUDY 5

McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.

Background

Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.

Study overview and results

In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
 

Limitations

This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
 

Important findings and implications

An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
 

Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.

References

1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.

2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.

3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.

4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.

The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children^1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.³ We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.

STUDY 1

Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.

Background

Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
 

Study overview and results

The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV₁. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
 

Limitations

Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV₁, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
 

Important findings and implications

While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
 

STUDY 2

Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.

Background

Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
 

Study overview and results

The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.⁴ They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
 

Limitations

These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
 

Important findings and implications

This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.

STUDY 3

Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.

Background

Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
 

Study overview and results

The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
 

Limitations

Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
 

Important findings and implications

Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
 

STUDY 4

Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.

Background

Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
 

Study overview and results

The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
 

Limitations

The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
 

Important findings and implications

Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
 

STUDY 5

McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.

Background

Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.

Study overview and results

In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
 

Limitations

This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
 

Important findings and implications

An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
 

Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.

References

1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.

2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.

3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.

4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.

The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children^1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.³ We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.

STUDY 1

Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.

Background

Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
 

Study overview and results

The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV₁. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
 

Limitations

Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV₁, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
 

Important findings and implications

While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
 

STUDY 2

Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.

Background

Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
 

Study overview and results

The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.⁴ They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
 

Limitations

These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
 

Important findings and implications

This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.

STUDY 3

Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.

Background

Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
 

Study overview and results

The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
 

Limitations

Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
 

Important findings and implications

Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
 

STUDY 4

Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.

Background

Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
 

Study overview and results

The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
 

Limitations

The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
 

Important findings and implications

Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
 

STUDY 5

McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.

Background

Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.

Study overview and results

In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
 

Limitations

This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
 

Important findings and implications

An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
 

Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.

References

1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.

2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.

3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.

4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.

Researchers have detected a highly contagious coronavirus variant in the United Kingdom, leading Prime Minister Boris Johnson to shut down parts of the country and triggering other nations to impose travel and shipping restrictions on England.

Mr. Johnson held a crisis meeting with ministers Monday after Saturday’s shutdown announcement. The prime minister said in a nationally televised address that this coronavirus variant may be “up to 70% more transmissible than the old variant” and was probably responsible for an increase in cases in southeastern England.

“There is still much we don’t know. While we are fairly certain the variant is transmitted more quickly, there is no evidence to suggest that it is more lethal or causes more severe illness. Equally there is no evidence to suggest the vaccine will be any less effective against the new variant,” he said.

Public Health England says it is working to learn as much about the variant as possible. “We know that mortality is a lagging indicator, and we will need to continually monitor this over the coming weeks,” the agency says.

That scientific uncertainty about the variant’s threat shook European nations that were rushing to ship goods to England in advance of a Dec. 31 Brexit deadline. Under Brexit, which is short for “British exit,” the United Kingdom will leave the European Union on Jan. 31, 2020. Until then, the two sides will come up with new trade and security relationships.

European Union members Austria, Belgium, Bulgaria, France, Germany, Ireland, Italy, and the Netherlands announced travel restrictions hours after Johnson’s speech.

Those restrictions created food uncertainty across the U.K., which imports about a quarter of its food from the EU, according to The New York Times. Long lines of trucks heading to ports in the U.K. came to a standstill on major roads such as the M20 near Kent and the Port of Dover.

Outside Europe, Canada, India, Iran, Israel, Hong Kong, Saudi Arabia, and Turkey banned all incoming flights from the U.K. And more bans could come.
 

The U.S. reaction

The United States has not imposed any new limits on travel with the United Kingdom, although New York Gov. Andrew Cuomo (D) has requested all passengers bound for John F. Kennedy International Airport from the U.K. be tested before boarding and a new travel ban be placed for Europe. He says the federal government must take action now to avoid a crisis situation like the one New York experienced in March and April.

“The United States has a number of flights coming in from the U.K. each day, and we have done absolutely nothing,” Mr. Cuomo said in a statement on the governor’s webpage. “To me, this is reprehensible because this is what happened in the spring. How many times in life do you have to make the same mistake before you learn?”

Leading U.S. health officials have downplayed the dangers of the virus.

“We don’t know that it’s more dangerous, and very importantly, we have not seen a single mutation yet that would make it evade the vaccine,” U.S. Assistant Secretary of Health and Human Services Adm. Brett Giroir, MD, said Sunday on ABC’s This Week with George Stephanopoulos. “I can’t say that won’t happen in the future, but right now it looks like the vaccine will cover everything that we see.”

Dr. Giroir said the HHS and other U.S. government agencies will monitor the variant.

“Viruses mutate,” he said. “We’ve seen almost 4,000 different mutations among this virus. There is no indication that the mutation right now that they’re talking about is overcoming England.”
 

Where did the variant come from?

Public Health England says the coronavirus variant had existed in the U.K. since September and circulated at very low levels until mid-November.

“The increase in cases linked to the new variant first came to light in late November when PHE was investigating why infection rates in Kent were not falling despite national restrictions. We then discovered a cluster linked to this variant spreading rapidly into London and Essex,” the agency said.

Public Health England says there’s no evidence the new variant is resistant to the Pfizer-BioNTech vaccine, which is now being given across the country to high-priority groups such as health care workers.

An article in The BMJ, a British medical journal, says the variant was first detected by Covid-19 Genomics UK, a consortium that tests the random genetic sequencing of positive COVID-19 samples around the U.K. The variant cases were mostly in the southeast of England.

A University of Birmingham professor said in a Dec. 15 briefing that the variant accounts for 20% of viruses sequenced in Norfolk, 10% in Essex, and 3% in Suffolk. “There are no data to suggest it had been imported from abroad, so it is likely to have evolved in the U.K.,” he said.

The variant is named VUI-202012/01, for the first “variant under investigation” in December 2020, BMJ says. It’s defined by a set of 17 mutations, with the most significant mutation in the spike protein the virus uses to bind to the human ACE2 receptor.

“Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people,” the article says.

The European Centre for Disease Prevention and Control says the variant emerged during the time of year when people usually socialize more.

“There is no indication at this point of increased infection severity associated with the new variant,” the agency said. “A few cases with the new variant have to date been reported by Denmark and the Netherlands and, according to media reports, in Belgium.”

Mr. Johnson announced tighter restrictions on England’s hardest-hit areas, such as the southeast and east of England, where new coronavirus cases have continued to rise. And he said people must cut back on their Christmas socializing.

“In England, those living in tier 4 areas should not mix with anyone outside their own household at Christmas, though support bubbles will remain in place for those at particular risk of loneliness or isolation,” he said.

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

Researchers have detected a highly contagious coronavirus variant in the United Kingdom, leading Prime Minister Boris Johnson to shut down parts of the country and triggering other nations to impose travel and shipping restrictions on England.

Mr. Johnson held a crisis meeting with ministers Monday after Saturday’s shutdown announcement. The prime minister said in a nationally televised address that this coronavirus variant may be “up to 70% more transmissible than the old variant” and was probably responsible for an increase in cases in southeastern England.

“There is still much we don’t know. While we are fairly certain the variant is transmitted more quickly, there is no evidence to suggest that it is more lethal or causes more severe illness. Equally there is no evidence to suggest the vaccine will be any less effective against the new variant,” he said.

Public Health England says it is working to learn as much about the variant as possible. “We know that mortality is a lagging indicator, and we will need to continually monitor this over the coming weeks,” the agency says.

That scientific uncertainty about the variant’s threat shook European nations that were rushing to ship goods to England in advance of a Dec. 31 Brexit deadline. Under Brexit, which is short for “British exit,” the United Kingdom will leave the European Union on Jan. 31, 2020. Until then, the two sides will come up with new trade and security relationships.

European Union members Austria, Belgium, Bulgaria, France, Germany, Ireland, Italy, and the Netherlands announced travel restrictions hours after Johnson’s speech.

Those restrictions created food uncertainty across the U.K., which imports about a quarter of its food from the EU, according to The New York Times. Long lines of trucks heading to ports in the U.K. came to a standstill on major roads such as the M20 near Kent and the Port of Dover.

Outside Europe, Canada, India, Iran, Israel, Hong Kong, Saudi Arabia, and Turkey banned all incoming flights from the U.K. And more bans could come.
 

The U.S. reaction

The United States has not imposed any new limits on travel with the United Kingdom, although New York Gov. Andrew Cuomo (D) has requested all passengers bound for John F. Kennedy International Airport from the U.K. be tested before boarding and a new travel ban be placed for Europe. He says the federal government must take action now to avoid a crisis situation like the one New York experienced in March and April.

“The United States has a number of flights coming in from the U.K. each day, and we have done absolutely nothing,” Mr. Cuomo said in a statement on the governor’s webpage. “To me, this is reprehensible because this is what happened in the spring. How many times in life do you have to make the same mistake before you learn?”

Leading U.S. health officials have downplayed the dangers of the virus.

“We don’t know that it’s more dangerous, and very importantly, we have not seen a single mutation yet that would make it evade the vaccine,” U.S. Assistant Secretary of Health and Human Services Adm. Brett Giroir, MD, said Sunday on ABC’s This Week with George Stephanopoulos. “I can’t say that won’t happen in the future, but right now it looks like the vaccine will cover everything that we see.”

Dr. Giroir said the HHS and other U.S. government agencies will monitor the variant.

“Viruses mutate,” he said. “We’ve seen almost 4,000 different mutations among this virus. There is no indication that the mutation right now that they’re talking about is overcoming England.”
 

Where did the variant come from?

Public Health England says the coronavirus variant had existed in the U.K. since September and circulated at very low levels until mid-November.

“The increase in cases linked to the new variant first came to light in late November when PHE was investigating why infection rates in Kent were not falling despite national restrictions. We then discovered a cluster linked to this variant spreading rapidly into London and Essex,” the agency said.

Public Health England says there’s no evidence the new variant is resistant to the Pfizer-BioNTech vaccine, which is now being given across the country to high-priority groups such as health care workers.

An article in The BMJ, a British medical journal, says the variant was first detected by Covid-19 Genomics UK, a consortium that tests the random genetic sequencing of positive COVID-19 samples around the U.K. The variant cases were mostly in the southeast of England.

A University of Birmingham professor said in a Dec. 15 briefing that the variant accounts for 20% of viruses sequenced in Norfolk, 10% in Essex, and 3% in Suffolk. “There are no data to suggest it had been imported from abroad, so it is likely to have evolved in the U.K.,” he said.

The variant is named VUI-202012/01, for the first “variant under investigation” in December 2020, BMJ says. It’s defined by a set of 17 mutations, with the most significant mutation in the spike protein the virus uses to bind to the human ACE2 receptor.

“Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people,” the article says.

The European Centre for Disease Prevention and Control says the variant emerged during the time of year when people usually socialize more.

“There is no indication at this point of increased infection severity associated with the new variant,” the agency said. “A few cases with the new variant have to date been reported by Denmark and the Netherlands and, according to media reports, in Belgium.”

Mr. Johnson announced tighter restrictions on England’s hardest-hit areas, such as the southeast and east of England, where new coronavirus cases have continued to rise. And he said people must cut back on their Christmas socializing.

“In England, those living in tier 4 areas should not mix with anyone outside their own household at Christmas, though support bubbles will remain in place for those at particular risk of loneliness or isolation,” he said.

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

Researchers have detected a highly contagious coronavirus variant in the United Kingdom, leading Prime Minister Boris Johnson to shut down parts of the country and triggering other nations to impose travel and shipping restrictions on England.

Mr. Johnson held a crisis meeting with ministers Monday after Saturday’s shutdown announcement. The prime minister said in a nationally televised address that this coronavirus variant may be “up to 70% more transmissible than the old variant” and was probably responsible for an increase in cases in southeastern England.

“There is still much we don’t know. While we are fairly certain the variant is transmitted more quickly, there is no evidence to suggest that it is more lethal or causes more severe illness. Equally there is no evidence to suggest the vaccine will be any less effective against the new variant,” he said.

Public Health England says it is working to learn as much about the variant as possible. “We know that mortality is a lagging indicator, and we will need to continually monitor this over the coming weeks,” the agency says.

That scientific uncertainty about the variant’s threat shook European nations that were rushing to ship goods to England in advance of a Dec. 31 Brexit deadline. Under Brexit, which is short for “British exit,” the United Kingdom will leave the European Union on Jan. 31, 2020. Until then, the two sides will come up with new trade and security relationships.

European Union members Austria, Belgium, Bulgaria, France, Germany, Ireland, Italy, and the Netherlands announced travel restrictions hours after Johnson’s speech.

Those restrictions created food uncertainty across the U.K., which imports about a quarter of its food from the EU, according to The New York Times. Long lines of trucks heading to ports in the U.K. came to a standstill on major roads such as the M20 near Kent and the Port of Dover.

Outside Europe, Canada, India, Iran, Israel, Hong Kong, Saudi Arabia, and Turkey banned all incoming flights from the U.K. And more bans could come.
 

The U.S. reaction

The United States has not imposed any new limits on travel with the United Kingdom, although New York Gov. Andrew Cuomo (D) has requested all passengers bound for John F. Kennedy International Airport from the U.K. be tested before boarding and a new travel ban be placed for Europe. He says the federal government must take action now to avoid a crisis situation like the one New York experienced in March and April.

“The United States has a number of flights coming in from the U.K. each day, and we have done absolutely nothing,” Mr. Cuomo said in a statement on the governor’s webpage. “To me, this is reprehensible because this is what happened in the spring. How many times in life do you have to make the same mistake before you learn?”

Leading U.S. health officials have downplayed the dangers of the virus.

“We don’t know that it’s more dangerous, and very importantly, we have not seen a single mutation yet that would make it evade the vaccine,” U.S. Assistant Secretary of Health and Human Services Adm. Brett Giroir, MD, said Sunday on ABC’s This Week with George Stephanopoulos. “I can’t say that won’t happen in the future, but right now it looks like the vaccine will cover everything that we see.”

Dr. Giroir said the HHS and other U.S. government agencies will monitor the variant.

“Viruses mutate,” he said. “We’ve seen almost 4,000 different mutations among this virus. There is no indication that the mutation right now that they’re talking about is overcoming England.”
 

Where did the variant come from?

Public Health England says the coronavirus variant had existed in the U.K. since September and circulated at very low levels until mid-November.

“The increase in cases linked to the new variant first came to light in late November when PHE was investigating why infection rates in Kent were not falling despite national restrictions. We then discovered a cluster linked to this variant spreading rapidly into London and Essex,” the agency said.

Public Health England says there’s no evidence the new variant is resistant to the Pfizer-BioNTech vaccine, which is now being given across the country to high-priority groups such as health care workers.

An article in The BMJ, a British medical journal, says the variant was first detected by Covid-19 Genomics UK, a consortium that tests the random genetic sequencing of positive COVID-19 samples around the U.K. The variant cases were mostly in the southeast of England.

A University of Birmingham professor said in a Dec. 15 briefing that the variant accounts for 20% of viruses sequenced in Norfolk, 10% in Essex, and 3% in Suffolk. “There are no data to suggest it had been imported from abroad, so it is likely to have evolved in the U.K.,” he said.

The variant is named VUI-202012/01, for the first “variant under investigation” in December 2020, BMJ says. It’s defined by a set of 17 mutations, with the most significant mutation in the spike protein the virus uses to bind to the human ACE2 receptor.

“Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people,” the article says.

The European Centre for Disease Prevention and Control says the variant emerged during the time of year when people usually socialize more.

“There is no indication at this point of increased infection severity associated with the new variant,” the agency said. “A few cases with the new variant have to date been reported by Denmark and the Netherlands and, according to media reports, in Belgium.”

Mr. Johnson announced tighter restrictions on England’s hardest-hit areas, such as the southeast and east of England, where new coronavirus cases have continued to rise. And he said people must cut back on their Christmas socializing.

“In England, those living in tier 4 areas should not mix with anyone outside their own household at Christmas, though support bubbles will remain in place for those at particular risk of loneliness or isolation,” he said.

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

The new SARS-CoV-2 virus variant is spreading so rapidly that U.K. Prime Minister Boris Johnson announced a new Tier 4 for London, and parts of the South East and East of England that are currently in Tier 3.

Mr. Johnson told a Downing Street briefing: “The new variant could increase the R by 0.4 or more, and although there’s considerable uncertainty, it may be up to 70% more transmissible than the old variant, the original version of the disease.”

England’s Tier 4 is the equivalent of the old national lockdown restrictions and began Dec. 20.

It prevents Christmas relaxation for gatherings in Tier 4, aside from support bubbles.

Non-essential shops, gyms, and hairdressers will also close. People shouldn’t enter or leave Tier 4.

In the rest of England, special Christmas measures are reduced to 1 day down from the previous 5.
 

Canceling Christmas

Mr. Johnson had previously said it would be “inhuman” to cancel Christmas.

“When the science changes, we must change our response,” Mr. Johnson said. “When the virus changes its method of attack, we must change our method of defence. And as your Prime Minister I sincerely believe there is no alternative open to me.”

He added: “We’re sacrificing the chance to see our loved ones this Christmas so we have a better chance of protecting their lives so that we can see them at future Christmases.”

He denied he’d been slow to react to rising cases and evidence around the virus variant.
 

Rest of the UK

The PM’s announcement for England followed calls with the cabinet, and with the leaders of Scotland, Wales, and Northern Ireland.

Wales has brought forward its planned national lockdown to start at midnight with rules eased on Christmas Day. First Minister Mark Drakeford said: “The situation is incredibly serious. I cannot overstate this.” 

Seventeen new variant cases have already been identified in Scotland. First Minister Nicola Sturgeon said: “We do now face a very serious situation. It is, in fact, probably the most serious and potentially dangerous juncture we have faced since the start of the COVID pandemic in February, and March.”

Although she said the situation in Scotland is not as severe as other parts of the UK, preventative measures were needed.

Restrictions will now only be lifted on Christmas day itself, and there’s a ban on non-essential travel to and from the rest of the UK. 

Level 4 measures will be applied to all of mainland Scotland for 3 weeks from Boxing Day.

Ms. Sturgeon said making the announcement about Christmas made her want to cry. 

New variant

The variant was identified through Public Health England genomic surveillance. Chief Medical Adviser Professor Chris Whitty issued a statement saying: “As a result of the rapid spread of the new variant, preliminary modelling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly.

“We have alerted the World Health Organisation and are continuing to analyse the available data to improve our understanding.

“There is no current evidence to suggest the new strain causes a higher mortality rate or that it affects vaccines and treatments although urgent work is underway to confirm this.”

He told the news briefing: “In the South East, 43% of the virus is now this new variant, in Eastern England it’s 59%, and in London 62%.”

Rates of hospitalisation were higher where the new variant was more prevalent.
 

‘Cause for concern’

Chief Scientific Adviser Sir Patrick Vallance said: “The new variant contains 23 different changes, many of them associated with changes in the protein that the virus makes. This is an unusually large number of variants. It’s also got variants in areas of the virus that are known to be associated with how the virus binds to cells and enters cells. So there are some changes, which cause concern in terms of how the virus looks.”

He added: “This virus transmits and spreads fast.”

The variant may have originated in the UK, Sir Patrick said: “There’s a large outbreak in the UK, it may have started here, we don’t know for sure.”

Earlier, SAGE member, and Director of the Wellcome Trust, Sir Jeremy Farrar tweeted: “The new strain of COVID-19 is worrying & real cause for concern & extra caution. Research is ongoing to understand more, but acting urgently now is critical. There is no part of the UK & globally that should not be concerned. As in many countries, the situation is fragile.”

Dr. Samantha Batt-Rawden, president of Doctors’ Association UK and a senior intensive care registrar in the South East of England commented: “We realise how disappointing the new restrictions will be for many today, especially those in Tier 4 areas. However, doctors across the UK, but especially those in the South East are telling us that the surge in cases is already putting hospitals and critical care units under enormous strain.”  

 

Vaccines

Mr. Johnson said 350,000 people across the UK have now had the first dose of the Pfizer/BioNTech vaccine.

On Dec. 18, the US FDA granted emergency use of Moderna’s messenger RNA COVID-19 vaccine, the country’s second after the Pfizer/BioNTech product.

The Moderna vaccine, and the Oxford/AstraZeneca jab, are still being assessed by the UK’s MHRA.
 

Daily data

In Dec. 19’s daily data another 27,052 UK positive tests were reported and 534 deaths.

The total number of deaths within 28 days of a positive test now stands at 67,075.

There are 18,771 COVID-19 patients in hospital and 1,364 ventilator beds are in use.
 

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

The new SARS-CoV-2 virus variant is spreading so rapidly that U.K. Prime Minister Boris Johnson announced a new Tier 4 for London, and parts of the South East and East of England that are currently in Tier 3.

Mr. Johnson told a Downing Street briefing: “The new variant could increase the R by 0.4 or more, and although there’s considerable uncertainty, it may be up to 70% more transmissible than the old variant, the original version of the disease.”

England’s Tier 4 is the equivalent of the old national lockdown restrictions and began Dec. 20.

It prevents Christmas relaxation for gatherings in Tier 4, aside from support bubbles.

Non-essential shops, gyms, and hairdressers will also close. People shouldn’t enter or leave Tier 4.

In the rest of England, special Christmas measures are reduced to 1 day down from the previous 5.
 

Canceling Christmas

Mr. Johnson had previously said it would be “inhuman” to cancel Christmas.

“When the science changes, we must change our response,” Mr. Johnson said. “When the virus changes its method of attack, we must change our method of defence. And as your Prime Minister I sincerely believe there is no alternative open to me.”

He added: “We’re sacrificing the chance to see our loved ones this Christmas so we have a better chance of protecting their lives so that we can see them at future Christmases.”

He denied he’d been slow to react to rising cases and evidence around the virus variant.
 

Rest of the UK

The PM’s announcement for England followed calls with the cabinet, and with the leaders of Scotland, Wales, and Northern Ireland.

Wales has brought forward its planned national lockdown to start at midnight with rules eased on Christmas Day. First Minister Mark Drakeford said: “The situation is incredibly serious. I cannot overstate this.” 

Seventeen new variant cases have already been identified in Scotland. First Minister Nicola Sturgeon said: “We do now face a very serious situation. It is, in fact, probably the most serious and potentially dangerous juncture we have faced since the start of the COVID pandemic in February, and March.”

Although she said the situation in Scotland is not as severe as other parts of the UK, preventative measures were needed.

Restrictions will now only be lifted on Christmas day itself, and there’s a ban on non-essential travel to and from the rest of the UK. 

Level 4 measures will be applied to all of mainland Scotland for 3 weeks from Boxing Day.

Ms. Sturgeon said making the announcement about Christmas made her want to cry. 

New variant

The variant was identified through Public Health England genomic surveillance. Chief Medical Adviser Professor Chris Whitty issued a statement saying: “As a result of the rapid spread of the new variant, preliminary modelling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly.

“We have alerted the World Health Organisation and are continuing to analyse the available data to improve our understanding.

“There is no current evidence to suggest the new strain causes a higher mortality rate or that it affects vaccines and treatments although urgent work is underway to confirm this.”

He told the news briefing: “In the South East, 43% of the virus is now this new variant, in Eastern England it’s 59%, and in London 62%.”

Rates of hospitalisation were higher where the new variant was more prevalent.
 

‘Cause for concern’

Chief Scientific Adviser Sir Patrick Vallance said: “The new variant contains 23 different changes, many of them associated with changes in the protein that the virus makes. This is an unusually large number of variants. It’s also got variants in areas of the virus that are known to be associated with how the virus binds to cells and enters cells. So there are some changes, which cause concern in terms of how the virus looks.”

He added: “This virus transmits and spreads fast.”

The variant may have originated in the UK, Sir Patrick said: “There’s a large outbreak in the UK, it may have started here, we don’t know for sure.”

Earlier, SAGE member, and Director of the Wellcome Trust, Sir Jeremy Farrar tweeted: “The new strain of COVID-19 is worrying & real cause for concern & extra caution. Research is ongoing to understand more, but acting urgently now is critical. There is no part of the UK & globally that should not be concerned. As in many countries, the situation is fragile.”

Dr. Samantha Batt-Rawden, president of Doctors’ Association UK and a senior intensive care registrar in the South East of England commented: “We realise how disappointing the new restrictions will be for many today, especially those in Tier 4 areas. However, doctors across the UK, but especially those in the South East are telling us that the surge in cases is already putting hospitals and critical care units under enormous strain.”  

 

Vaccines

Mr. Johnson said 350,000 people across the UK have now had the first dose of the Pfizer/BioNTech vaccine.

On Dec. 18, the US FDA granted emergency use of Moderna’s messenger RNA COVID-19 vaccine, the country’s second after the Pfizer/BioNTech product.

The Moderna vaccine, and the Oxford/AstraZeneca jab, are still being assessed by the UK’s MHRA.
 

Daily data

In Dec. 19’s daily data another 27,052 UK positive tests were reported and 534 deaths.

The total number of deaths within 28 days of a positive test now stands at 67,075.

There are 18,771 COVID-19 patients in hospital and 1,364 ventilator beds are in use.
 

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

The new SARS-CoV-2 virus variant is spreading so rapidly that U.K. Prime Minister Boris Johnson announced a new Tier 4 for London, and parts of the South East and East of England that are currently in Tier 3.

Mr. Johnson told a Downing Street briefing: “The new variant could increase the R by 0.4 or more, and although there’s considerable uncertainty, it may be up to 70% more transmissible than the old variant, the original version of the disease.”

England’s Tier 4 is the equivalent of the old national lockdown restrictions and began Dec. 20.

It prevents Christmas relaxation for gatherings in Tier 4, aside from support bubbles.

Non-essential shops, gyms, and hairdressers will also close. People shouldn’t enter or leave Tier 4.

In the rest of England, special Christmas measures are reduced to 1 day down from the previous 5.
 

Canceling Christmas

Mr. Johnson had previously said it would be “inhuman” to cancel Christmas.

“When the science changes, we must change our response,” Mr. Johnson said. “When the virus changes its method of attack, we must change our method of defence. And as your Prime Minister I sincerely believe there is no alternative open to me.”

He added: “We’re sacrificing the chance to see our loved ones this Christmas so we have a better chance of protecting their lives so that we can see them at future Christmases.”

He denied he’d been slow to react to rising cases and evidence around the virus variant.
 

Rest of the UK

The PM’s announcement for England followed calls with the cabinet, and with the leaders of Scotland, Wales, and Northern Ireland.

Wales has brought forward its planned national lockdown to start at midnight with rules eased on Christmas Day. First Minister Mark Drakeford said: “The situation is incredibly serious. I cannot overstate this.” 

Seventeen new variant cases have already been identified in Scotland. First Minister Nicola Sturgeon said: “We do now face a very serious situation. It is, in fact, probably the most serious and potentially dangerous juncture we have faced since the start of the COVID pandemic in February, and March.”

Although she said the situation in Scotland is not as severe as other parts of the UK, preventative measures were needed.

Restrictions will now only be lifted on Christmas day itself, and there’s a ban on non-essential travel to and from the rest of the UK. 

Level 4 measures will be applied to all of mainland Scotland for 3 weeks from Boxing Day.

Ms. Sturgeon said making the announcement about Christmas made her want to cry. 

New variant

The variant was identified through Public Health England genomic surveillance. Chief Medical Adviser Professor Chris Whitty issued a statement saying: “As a result of the rapid spread of the new variant, preliminary modelling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly.

“We have alerted the World Health Organisation and are continuing to analyse the available data to improve our understanding.

“There is no current evidence to suggest the new strain causes a higher mortality rate or that it affects vaccines and treatments although urgent work is underway to confirm this.”

He told the news briefing: “In the South East, 43% of the virus is now this new variant, in Eastern England it’s 59%, and in London 62%.”

Rates of hospitalisation were higher where the new variant was more prevalent.
 

‘Cause for concern’

Chief Scientific Adviser Sir Patrick Vallance said: “The new variant contains 23 different changes, many of them associated with changes in the protein that the virus makes. This is an unusually large number of variants. It’s also got variants in areas of the virus that are known to be associated with how the virus binds to cells and enters cells. So there are some changes, which cause concern in terms of how the virus looks.”

He added: “This virus transmits and spreads fast.”

The variant may have originated in the UK, Sir Patrick said: “There’s a large outbreak in the UK, it may have started here, we don’t know for sure.”

Earlier, SAGE member, and Director of the Wellcome Trust, Sir Jeremy Farrar tweeted: “The new strain of COVID-19 is worrying & real cause for concern & extra caution. Research is ongoing to understand more, but acting urgently now is critical. There is no part of the UK & globally that should not be concerned. As in many countries, the situation is fragile.”

Dr. Samantha Batt-Rawden, president of Doctors’ Association UK and a senior intensive care registrar in the South East of England commented: “We realise how disappointing the new restrictions will be for many today, especially those in Tier 4 areas. However, doctors across the UK, but especially those in the South East are telling us that the surge in cases is already putting hospitals and critical care units under enormous strain.”  

 

Vaccines

Mr. Johnson said 350,000 people across the UK have now had the first dose of the Pfizer/BioNTech vaccine.

On Dec. 18, the US FDA granted emergency use of Moderna’s messenger RNA COVID-19 vaccine, the country’s second after the Pfizer/BioNTech product.

The Moderna vaccine, and the Oxford/AstraZeneca jab, are still being assessed by the UK’s MHRA.
 

Daily data

In Dec. 19’s daily data another 27,052 UK positive tests were reported and 534 deaths.

The total number of deaths within 28 days of a positive test now stands at 67,075.

There are 18,771 COVID-19 patients in hospital and 1,364 ventilator beds are in use.
 

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

An influential federal advisory panel on Dec. 20 voted to recommend that the elderly and certain essential workers be the next group of Americans to get access to limited doses of COVID-19 vaccine.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted 13-1 for the recommendation. This builds on ACIP’s initial recommendation about which groups should be in the first wave of vaccinations, described as Phase 1a.

ACIP earlier recommended that Phase 1a include U.S. health care workers, a group of about 21 million people, and residents of long-term care facilities, a group of about 3 million.

On Dec. 20, ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults aged 75 years and older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC.

Phase 1c then would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million.

The Food and Drug Administration recently granted emergency use authorizations for two COVID-19 vaccines, one developed by Pfizer-BioNTech and another from Moderna. Other companies, including Johnson & Johnson, have advanced their potential rival COVID-19 vaccines into late-stages of testing. To date, about 2.83 million doses of Pfizer’s COVID-19 vaccine have been distributed and 556,208 doses have been administered, according to the CDC.

But there will likely still be a period of months when competition for limited doses of COVID-19 vaccine will trigger difficult decisions. Current estimates indicate there will be enough supply to provide COVID-19 vaccines for 20 million people in December, 30 million people in January, and 50 million people in February, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.

State governments and health systems will take ACIP’s recommendations into account as they roll out the initial supplies of COVID-19 vaccines.

There’s clearly wide latitude in these decisions. Recently, for example, many members of Congress tweeted photos of themselves getting COVID-19 vaccines, despite not falling into ACIP’s description of the Phase 1 group.
 

Difficult choices

All ACIP members described the Dec. 20 vote as a difficult decision. It forced them to choose among segments of the U.S. population that could benefit from early access to the limited supply of COVID-19 vaccines.

“For every group we add, it means we subtract a group. For every group we subtract, it means they don’t get the vaccine” for some months, said ACIP member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn. “It’s incredibly humbling and heartbreaking.”

ACIP member Henry Bernstein, DO, who cast the lone dissenting vote, said he agreed with most of the panel’s recommendation. He said he fully supported the inclusion of adults aged 75 years and older and essential frontline workers in the second wave, Phase 1b. But he voted no because the data on COVID-19 morbidity and mortality for adults aged 65-74 years is similar enough to the older group to warrant their inclusion in the first wave.

“Therefore, inclusion of the 65- to 74-year-old group in Phase 1b made more sense to me,” said Dr. Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

As defined by the CDC, frontline essential workers included in phase 1b will be those commonly called “first responders,” such as firefighters and police officers. Also in this group are teachers, support staff, daycare providers, and those employed in grocery and agriculture industries. Others in this group would include U.S. Postal Service employees and transit workers.

ACIP panelists noted the difficulties that will emerge as government officials and leaders of health care organizations move to apply their guidance to real-world decisions about distributing a limited supply of COVID-19 vaccine. There’s a potential to worsen existing disparities in access to health care, as people with more income may find it easier to obtain proof that they qualify as having a high-risk condition, said José Romero, MD, the chair of ACIP.

Many people “don’t have access to medical care and can’t come up with a doctor’s note that says, ‘I have diabetes,’ ” he said.

ACIP panelists also noted in their deliberations that people may technically qualify for a priority group but have little risk, such as someone with a chronic medical condition who works from home.

And the risk for COVID-19 remains serious even for those who will ultimately fall into the phase 2 for vaccination. Young adults have suffered serious complications following COVID-19, such as stroke, that may alter their lives dramatically, ACIP member Dr. Talbot said, adding that she is reminded of this in her work.

“We need to be very cautious about saying, ‘Young adults will be fine,’ ” she said. “I spent the past week on back-up clinical call and have read these charts and have cried every day.”

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines. The other panel members have reported no relevant financial relationships.
 

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

An influential federal advisory panel on Dec. 20 voted to recommend that the elderly and certain essential workers be the next group of Americans to get access to limited doses of COVID-19 vaccine.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted 13-1 for the recommendation. This builds on ACIP’s initial recommendation about which groups should be in the first wave of vaccinations, described as Phase 1a.

ACIP earlier recommended that Phase 1a include U.S. health care workers, a group of about 21 million people, and residents of long-term care facilities, a group of about 3 million.

On Dec. 20, ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults aged 75 years and older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC.

Phase 1c then would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million.

The Food and Drug Administration recently granted emergency use authorizations for two COVID-19 vaccines, one developed by Pfizer-BioNTech and another from Moderna. Other companies, including Johnson & Johnson, have advanced their potential rival COVID-19 vaccines into late-stages of testing. To date, about 2.83 million doses of Pfizer’s COVID-19 vaccine have been distributed and 556,208 doses have been administered, according to the CDC.

But there will likely still be a period of months when competition for limited doses of COVID-19 vaccine will trigger difficult decisions. Current estimates indicate there will be enough supply to provide COVID-19 vaccines for 20 million people in December, 30 million people in January, and 50 million people in February, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.

State governments and health systems will take ACIP’s recommendations into account as they roll out the initial supplies of COVID-19 vaccines.

There’s clearly wide latitude in these decisions. Recently, for example, many members of Congress tweeted photos of themselves getting COVID-19 vaccines, despite not falling into ACIP’s description of the Phase 1 group.
 

Difficult choices

All ACIP members described the Dec. 20 vote as a difficult decision. It forced them to choose among segments of the U.S. population that could benefit from early access to the limited supply of COVID-19 vaccines.

“For every group we add, it means we subtract a group. For every group we subtract, it means they don’t get the vaccine” for some months, said ACIP member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn. “It’s incredibly humbling and heartbreaking.”

ACIP member Henry Bernstein, DO, who cast the lone dissenting vote, said he agreed with most of the panel’s recommendation. He said he fully supported the inclusion of adults aged 75 years and older and essential frontline workers in the second wave, Phase 1b. But he voted no because the data on COVID-19 morbidity and mortality for adults aged 65-74 years is similar enough to the older group to warrant their inclusion in the first wave.

“Therefore, inclusion of the 65- to 74-year-old group in Phase 1b made more sense to me,” said Dr. Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

As defined by the CDC, frontline essential workers included in phase 1b will be those commonly called “first responders,” such as firefighters and police officers. Also in this group are teachers, support staff, daycare providers, and those employed in grocery and agriculture industries. Others in this group would include U.S. Postal Service employees and transit workers.

ACIP panelists noted the difficulties that will emerge as government officials and leaders of health care organizations move to apply their guidance to real-world decisions about distributing a limited supply of COVID-19 vaccine. There’s a potential to worsen existing disparities in access to health care, as people with more income may find it easier to obtain proof that they qualify as having a high-risk condition, said José Romero, MD, the chair of ACIP.

Many people “don’t have access to medical care and can’t come up with a doctor’s note that says, ‘I have diabetes,’ ” he said.

ACIP panelists also noted in their deliberations that people may technically qualify for a priority group but have little risk, such as someone with a chronic medical condition who works from home.

And the risk for COVID-19 remains serious even for those who will ultimately fall into the phase 2 for vaccination. Young adults have suffered serious complications following COVID-19, such as stroke, that may alter their lives dramatically, ACIP member Dr. Talbot said, adding that she is reminded of this in her work.

“We need to be very cautious about saying, ‘Young adults will be fine,’ ” she said. “I spent the past week on back-up clinical call and have read these charts and have cried every day.”

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines. The other panel members have reported no relevant financial relationships.
 

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

An influential federal advisory panel on Dec. 20 voted to recommend that the elderly and certain essential workers be the next group of Americans to get access to limited doses of COVID-19 vaccine.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted 13-1 for the recommendation. This builds on ACIP’s initial recommendation about which groups should be in the first wave of vaccinations, described as Phase 1a.

ACIP earlier recommended that Phase 1a include U.S. health care workers, a group of about 21 million people, and residents of long-term care facilities, a group of about 3 million.

On Dec. 20, ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults aged 75 years and older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC.

Phase 1c then would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million.

The Food and Drug Administration recently granted emergency use authorizations for two COVID-19 vaccines, one developed by Pfizer-BioNTech and another from Moderna. Other companies, including Johnson & Johnson, have advanced their potential rival COVID-19 vaccines into late-stages of testing. To date, about 2.83 million doses of Pfizer’s COVID-19 vaccine have been distributed and 556,208 doses have been administered, according to the CDC.

But there will likely still be a period of months when competition for limited doses of COVID-19 vaccine will trigger difficult decisions. Current estimates indicate there will be enough supply to provide COVID-19 vaccines for 20 million people in December, 30 million people in January, and 50 million people in February, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.

State governments and health systems will take ACIP’s recommendations into account as they roll out the initial supplies of COVID-19 vaccines.

There’s clearly wide latitude in these decisions. Recently, for example, many members of Congress tweeted photos of themselves getting COVID-19 vaccines, despite not falling into ACIP’s description of the Phase 1 group.
 

Difficult choices

All ACIP members described the Dec. 20 vote as a difficult decision. It forced them to choose among segments of the U.S. population that could benefit from early access to the limited supply of COVID-19 vaccines.

“For every group we add, it means we subtract a group. For every group we subtract, it means they don’t get the vaccine” for some months, said ACIP member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn. “It’s incredibly humbling and heartbreaking.”

ACIP member Henry Bernstein, DO, who cast the lone dissenting vote, said he agreed with most of the panel’s recommendation. He said he fully supported the inclusion of adults aged 75 years and older and essential frontline workers in the second wave, Phase 1b. But he voted no because the data on COVID-19 morbidity and mortality for adults aged 65-74 years is similar enough to the older group to warrant their inclusion in the first wave.

“Therefore, inclusion of the 65- to 74-year-old group in Phase 1b made more sense to me,” said Dr. Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

As defined by the CDC, frontline essential workers included in phase 1b will be those commonly called “first responders,” such as firefighters and police officers. Also in this group are teachers, support staff, daycare providers, and those employed in grocery and agriculture industries. Others in this group would include U.S. Postal Service employees and transit workers.

ACIP panelists noted the difficulties that will emerge as government officials and leaders of health care organizations move to apply their guidance to real-world decisions about distributing a limited supply of COVID-19 vaccine. There’s a potential to worsen existing disparities in access to health care, as people with more income may find it easier to obtain proof that they qualify as having a high-risk condition, said José Romero, MD, the chair of ACIP.

Many people “don’t have access to medical care and can’t come up with a doctor’s note that says, ‘I have diabetes,’ ” he said.

ACIP panelists also noted in their deliberations that people may technically qualify for a priority group but have little risk, such as someone with a chronic medical condition who works from home.

And the risk for COVID-19 remains serious even for those who will ultimately fall into the phase 2 for vaccination. Young adults have suffered serious complications following COVID-19, such as stroke, that may alter their lives dramatically, ACIP member Dr. Talbot said, adding that she is reminded of this in her work.

“We need to be very cautious about saying, ‘Young adults will be fine,’ ” she said. “I spent the past week on back-up clinical call and have read these charts and have cried every day.”

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines. The other panel members have reported no relevant financial relationships.
 

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

About twice as many patients were admitted to hospitals in France for COVID-19 during a 2-month period than were admitted for seasonal influenza during a 3-month period the previous year, according to a study published online in The Lancet Respiratory Medicine.

In-hospital mortality was nearly three times higher for COVID-19 than for seasonal influenza, researchers found. In addition, patients with COVID-19 were more likely to require invasive mechanical ventilation (9.7% vs. 4%) and had longer average ICU stays (15 days vs. 8 days).

“SARS-CoV-2 appears to have a higher potential for respiratory pathogenicity, leading to more respiratory complications in patients with fewer comorbidities, and it is associated with a higher risk of mortality, particularly in adolescents, although any conclusions for this age group must be treated with caution considering the small number of deaths,” wrote Lionel Piroth, MD, PhD, of the infectious diseases department, Dijon (France) University Hospital, and colleagues.

The study “is the largest to date to compare the two diseases and confirms that COVID-19 is far more serious than the flu,” study author Catherine Quantin, MD, PhD, said in a news release. “The finding that the COVID-19 death rate was three times higher than for seasonal influenza is particularly striking when reminded that the 2018/2019 flu season had been the worst in the past five years in France in terms of number of deaths,” continued Dr. Quantin, who jointly led the research. She is affiliated with the University Hospital of Dijon and Inserm.

The investigators analyzed data from a national database and compared 89,530 COVID-19 hospital admissions between March 1 and April 30, 2020, with 45,819 seasonal flu hospital admissions between Dec. 1, 2018, and Feb. 28, 2019.

The death rate was 16.9% among patients hospitalized with COVID-19, compared with 5.8% among patients hospitalized with influenza.

Fewer patients younger 18 years were hospitalized with COVID-19 than with seasonal influenza (1.4% vs. 19.5%; 1,227 vs. 8,942), but a larger proportion of those younger than 5 years required intensive care for COVID-19 (2.9% vs. 0.9%). The fatality rates in children younger than 5 years were similar for both groups (0.5% vs. 0.2%).

Among patients aged 11-17 years, 5 of 548 (1.1%) patients with COVID-19 died, compared with 1 of 804 (0.1%) patients with flu.

Testing practices for influenza likely varied across hospitals, whereas testing for COVID-19 may have been more standardized. This could be a limitation of the study, the researchers noted. In addition, flu seasons vary year to year, and influenza cases may depend on vaccination coverage and residual population immunity.

“The large sample size is an important strength of the study and it is assumed that the indication for hospital admission in the two periods was the same and thus does not bias the results,” Eskild Petersen, MD, DMsc, wrote in a comment accompanying the study. “The results ... clearly show that COVID-19 is more serious than seasonal influenza.”

Furthermore, this study and prior research show that “COVID-19 is not an innocent infection in children and adolescents,” said Dr. Petersen, who is affiliated with the University of Aarhus in Denmark and the European Society for Clinical Microbiology and Infectious Diseases Emerging Infections Task Force.

The study was funded by the French National Research Agency. Two authors have various financial ties to several pharmaceutical companies, details of which are available in the journal article. Dr. Petersen has disclosed no relevant financial relationships.

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

About twice as many patients were admitted to hospitals in France for COVID-19 during a 2-month period than were admitted for seasonal influenza during a 3-month period the previous year, according to a study published online in The Lancet Respiratory Medicine.

In-hospital mortality was nearly three times higher for COVID-19 than for seasonal influenza, researchers found. In addition, patients with COVID-19 were more likely to require invasive mechanical ventilation (9.7% vs. 4%) and had longer average ICU stays (15 days vs. 8 days).

“SARS-CoV-2 appears to have a higher potential for respiratory pathogenicity, leading to more respiratory complications in patients with fewer comorbidities, and it is associated with a higher risk of mortality, particularly in adolescents, although any conclusions for this age group must be treated with caution considering the small number of deaths,” wrote Lionel Piroth, MD, PhD, of the infectious diseases department, Dijon (France) University Hospital, and colleagues.

The study “is the largest to date to compare the two diseases and confirms that COVID-19 is far more serious than the flu,” study author Catherine Quantin, MD, PhD, said in a news release. “The finding that the COVID-19 death rate was three times higher than for seasonal influenza is particularly striking when reminded that the 2018/2019 flu season had been the worst in the past five years in France in terms of number of deaths,” continued Dr. Quantin, who jointly led the research. She is affiliated with the University Hospital of Dijon and Inserm.

The investigators analyzed data from a national database and compared 89,530 COVID-19 hospital admissions between March 1 and April 30, 2020, with 45,819 seasonal flu hospital admissions between Dec. 1, 2018, and Feb. 28, 2019.

The death rate was 16.9% among patients hospitalized with COVID-19, compared with 5.8% among patients hospitalized with influenza.

Fewer patients younger 18 years were hospitalized with COVID-19 than with seasonal influenza (1.4% vs. 19.5%; 1,227 vs. 8,942), but a larger proportion of those younger than 5 years required intensive care for COVID-19 (2.9% vs. 0.9%). The fatality rates in children younger than 5 years were similar for both groups (0.5% vs. 0.2%).

Among patients aged 11-17 years, 5 of 548 (1.1%) patients with COVID-19 died, compared with 1 of 804 (0.1%) patients with flu.

Testing practices for influenza likely varied across hospitals, whereas testing for COVID-19 may have been more standardized. This could be a limitation of the study, the researchers noted. In addition, flu seasons vary year to year, and influenza cases may depend on vaccination coverage and residual population immunity.

“The large sample size is an important strength of the study and it is assumed that the indication for hospital admission in the two periods was the same and thus does not bias the results,” Eskild Petersen, MD, DMsc, wrote in a comment accompanying the study. “The results ... clearly show that COVID-19 is more serious than seasonal influenza.”

Furthermore, this study and prior research show that “COVID-19 is not an innocent infection in children and adolescents,” said Dr. Petersen, who is affiliated with the University of Aarhus in Denmark and the European Society for Clinical Microbiology and Infectious Diseases Emerging Infections Task Force.

The study was funded by the French National Research Agency. Two authors have various financial ties to several pharmaceutical companies, details of which are available in the journal article. Dr. Petersen has disclosed no relevant financial relationships.

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

About twice as many patients were admitted to hospitals in France for COVID-19 during a 2-month period than were admitted for seasonal influenza during a 3-month period the previous year, according to a study published online in The Lancet Respiratory Medicine.

In-hospital mortality was nearly three times higher for COVID-19 than for seasonal influenza, researchers found. In addition, patients with COVID-19 were more likely to require invasive mechanical ventilation (9.7% vs. 4%) and had longer average ICU stays (15 days vs. 8 days).

“SARS-CoV-2 appears to have a higher potential for respiratory pathogenicity, leading to more respiratory complications in patients with fewer comorbidities, and it is associated with a higher risk of mortality, particularly in adolescents, although any conclusions for this age group must be treated with caution considering the small number of deaths,” wrote Lionel Piroth, MD, PhD, of the infectious diseases department, Dijon (France) University Hospital, and colleagues.

The study “is the largest to date to compare the two diseases and confirms that COVID-19 is far more serious than the flu,” study author Catherine Quantin, MD, PhD, said in a news release. “The finding that the COVID-19 death rate was three times higher than for seasonal influenza is particularly striking when reminded that the 2018/2019 flu season had been the worst in the past five years in France in terms of number of deaths,” continued Dr. Quantin, who jointly led the research. She is affiliated with the University Hospital of Dijon and Inserm.

The investigators analyzed data from a national database and compared 89,530 COVID-19 hospital admissions between March 1 and April 30, 2020, with 45,819 seasonal flu hospital admissions between Dec. 1, 2018, and Feb. 28, 2019.

The death rate was 16.9% among patients hospitalized with COVID-19, compared with 5.8% among patients hospitalized with influenza.

Fewer patients younger 18 years were hospitalized with COVID-19 than with seasonal influenza (1.4% vs. 19.5%; 1,227 vs. 8,942), but a larger proportion of those younger than 5 years required intensive care for COVID-19 (2.9% vs. 0.9%). The fatality rates in children younger than 5 years were similar for both groups (0.5% vs. 0.2%).

Among patients aged 11-17 years, 5 of 548 (1.1%) patients with COVID-19 died, compared with 1 of 804 (0.1%) patients with flu.

Testing practices for influenza likely varied across hospitals, whereas testing for COVID-19 may have been more standardized. This could be a limitation of the study, the researchers noted. In addition, flu seasons vary year to year, and influenza cases may depend on vaccination coverage and residual population immunity.

“The large sample size is an important strength of the study and it is assumed that the indication for hospital admission in the two periods was the same and thus does not bias the results,” Eskild Petersen, MD, DMsc, wrote in a comment accompanying the study. “The results ... clearly show that COVID-19 is more serious than seasonal influenza.”

Furthermore, this study and prior research show that “COVID-19 is not an innocent infection in children and adolescents,” said Dr. Petersen, who is affiliated with the University of Aarhus in Denmark and the European Society for Clinical Microbiology and Infectious Diseases Emerging Infections Task Force.

The study was funded by the French National Research Agency. Two authors have various financial ties to several pharmaceutical companies, details of which are available in the journal article. Dr. Petersen has disclosed no relevant financial relationships.

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

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

As expected, the US Food and Drug Administration granted Moderna an emergency use authorization (EUA) for its messenger RNA COVID-19 vaccine December 18. The vaccine becomes the second authorized for emergency use in the United States, and will likely increase the number of vaccine doses available in the coming days.

There is one final step — the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer/BioNTech mRNA vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

Scaling up distribution of the two vaccine products will come next. She notes that even under less emergent conditions, making sure people who need a vaccine receive it can be hard. “I hope the media attention around this will make more people aware that there are vaccines that might help them,” said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The EUA for the Moderna vaccine follows a review by the independent VRBPAC members on December 17, which voted 20-0 with one abstention to recommend the EUA. The vaccine is authorized for use in people 18 and older.


Emergency approval of a second COVID-19 vaccine “is great — we need all the tools we can to fight this pandemic,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at the University of Chicago, told Medscape Medical News. “The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated.

“It’s incumbent upon all us healthcare professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz continued. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase 3 clinical trials.”

“I know the critical role physicians play as vaccine influencers,” AMA President Susan Bailey, MD, said during a December 14 webinar for journalists reporting on COVID-19 vaccines. “We have to continue to do what physicians have always done: review the evidence and trust the science. Lives are at stake.” The webinar was cosponsored by the AMA and the Poynter Institute.

Ramping up healthcare provider immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for healthcare workers and staff, and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, Georgia, told Medscape Medical News.

“We had been hoping for a vaccine with a 70% or 80% efficacy, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both mRNA vaccines “did exceed expectations for sure — this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas.

Unanswered questions remain

Schrantz likewise said the high efficacy rate was important but not all that is needed. “[W]hat we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile, and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge in the long run is another question. Answers could come over time from the ongoing phase 3 trials, as well as from post-EUA surveillance among vaccine recipients.  

“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on December 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”

“The key is to be humble, keep your eyes open and know that once the vaccine is out there, there may be things we learn that we don’t know now. That is true for virtually any medical innovation,” Paul Offit, MD, director of The Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA VRBPAC, said during the AMA/Poynter Institute webinar.

During the same webinar, an attendee asked about prioritizing immunization for spouses and family members of healthcare workers. “My husband wants to know that too,” replied Patricia A. Stinchfield, APRN, CNP, pediatric nurse practitioner in infectious diseases at Children’s Minnesota, St. Paul.

“It is true we should be thinking about our healthcare workers’ family members. But at this point in time we just don’t have the supplies to address it that way,” said Stinchfield, who is also the president-elect of the National Foundation for Infectious Diseases.

Advantages beyond the numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more than one product is the potential to offer an option when a specific vaccine is contraindicated. “We could offer someone a different vaccine…similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle — the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Offit said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product does not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for an EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”

Future outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccines from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”

“My greatest hope is that a year from now we look back and realize we did something really amazing together,” Bailey said, “and we have a feeling of accomplishment and appreciation for all the hard work that has been done.”

Mehta shared the important message he shares when walking around the hospital: “While these vaccines are coming and they are very promising, we need to continue to remember the 3 Ws: wearing a mask, washing your hands, and watching your distance,” he said.

“With the combination of those 3Ws and those vaccines, we will hopefully come through this COVID pandemic.”

El Sahly receives funding through the NIH for her research, including her role as co-chair of the Moderna vaccine phase 3 clinical trial. Schrantz is a site investigator for the Moderna and Janssen vaccine trials. Mehta also receives funding through the NIH. None of these experts had any relevant financial disclosures.

This article first appeared on Medscape.com.

As expected, the US Food and Drug Administration granted Moderna an emergency use authorization (EUA) for its messenger RNA COVID-19 vaccine December 18. The vaccine becomes the second authorized for emergency use in the United States, and will likely increase the number of vaccine doses available in the coming days.

There is one final step — the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer/BioNTech mRNA vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

Scaling up distribution of the two vaccine products will come next. She notes that even under less emergent conditions, making sure people who need a vaccine receive it can be hard. “I hope the media attention around this will make more people aware that there are vaccines that might help them,” said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The EUA for the Moderna vaccine follows a review by the independent VRBPAC members on December 17, which voted 20-0 with one abstention to recommend the EUA. The vaccine is authorized for use in people 18 and older.


Emergency approval of a second COVID-19 vaccine “is great — we need all the tools we can to fight this pandemic,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at the University of Chicago, told Medscape Medical News. “The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated.

“It’s incumbent upon all us healthcare professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz continued. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase 3 clinical trials.”

“I know the critical role physicians play as vaccine influencers,” AMA President Susan Bailey, MD, said during a December 14 webinar for journalists reporting on COVID-19 vaccines. “We have to continue to do what physicians have always done: review the evidence and trust the science. Lives are at stake.” The webinar was cosponsored by the AMA and the Poynter Institute.

Ramping up healthcare provider immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for healthcare workers and staff, and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, Georgia, told Medscape Medical News.

“We had been hoping for a vaccine with a 70% or 80% efficacy, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both mRNA vaccines “did exceed expectations for sure — this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas.

Unanswered questions remain

Schrantz likewise said the high efficacy rate was important but not all that is needed. “[W]hat we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile, and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge in the long run is another question. Answers could come over time from the ongoing phase 3 trials, as well as from post-EUA surveillance among vaccine recipients.  

“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on December 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”

“The key is to be humble, keep your eyes open and know that once the vaccine is out there, there may be things we learn that we don’t know now. That is true for virtually any medical innovation,” Paul Offit, MD, director of The Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA VRBPAC, said during the AMA/Poynter Institute webinar.

During the same webinar, an attendee asked about prioritizing immunization for spouses and family members of healthcare workers. “My husband wants to know that too,” replied Patricia A. Stinchfield, APRN, CNP, pediatric nurse practitioner in infectious diseases at Children’s Minnesota, St. Paul.

“It is true we should be thinking about our healthcare workers’ family members. But at this point in time we just don’t have the supplies to address it that way,” said Stinchfield, who is also the president-elect of the National Foundation for Infectious Diseases.

Advantages beyond the numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more than one product is the potential to offer an option when a specific vaccine is contraindicated. “We could offer someone a different vaccine…similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle — the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Offit said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product does not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for an EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”

Future outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccines from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”

“My greatest hope is that a year from now we look back and realize we did something really amazing together,” Bailey said, “and we have a feeling of accomplishment and appreciation for all the hard work that has been done.”

Mehta shared the important message he shares when walking around the hospital: “While these vaccines are coming and they are very promising, we need to continue to remember the 3 Ws: wearing a mask, washing your hands, and watching your distance,” he said.

“With the combination of those 3Ws and those vaccines, we will hopefully come through this COVID pandemic.”

El Sahly receives funding through the NIH for her research, including her role as co-chair of the Moderna vaccine phase 3 clinical trial. Schrantz is a site investigator for the Moderna and Janssen vaccine trials. Mehta also receives funding through the NIH. None of these experts had any relevant financial disclosures.

This article first appeared on Medscape.com.

As expected, the US Food and Drug Administration granted Moderna an emergency use authorization (EUA) for its messenger RNA COVID-19 vaccine December 18. The vaccine becomes the second authorized for emergency use in the United States, and will likely increase the number of vaccine doses available in the coming days.

There is one final step — the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer/BioNTech mRNA vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

Scaling up distribution of the two vaccine products will come next. She notes that even under less emergent conditions, making sure people who need a vaccine receive it can be hard. “I hope the media attention around this will make more people aware that there are vaccines that might help them,” said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The EUA for the Moderna vaccine follows a review by the independent VRBPAC members on December 17, which voted 20-0 with one abstention to recommend the EUA. The vaccine is authorized for use in people 18 and older.


Emergency approval of a second COVID-19 vaccine “is great — we need all the tools we can to fight this pandemic,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at the University of Chicago, told Medscape Medical News. “The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated.

“It’s incumbent upon all us healthcare professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz continued. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase 3 clinical trials.”

“I know the critical role physicians play as vaccine influencers,” AMA President Susan Bailey, MD, said during a December 14 webinar for journalists reporting on COVID-19 vaccines. “We have to continue to do what physicians have always done: review the evidence and trust the science. Lives are at stake.” The webinar was cosponsored by the AMA and the Poynter Institute.

Ramping up healthcare provider immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for healthcare workers and staff, and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, Georgia, told Medscape Medical News.

“We had been hoping for a vaccine with a 70% or 80% efficacy, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both mRNA vaccines “did exceed expectations for sure — this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas.

Unanswered questions remain

Schrantz likewise said the high efficacy rate was important but not all that is needed. “[W]hat we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile, and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge in the long run is another question. Answers could come over time from the ongoing phase 3 trials, as well as from post-EUA surveillance among vaccine recipients.  

“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on December 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”

“The key is to be humble, keep your eyes open and know that once the vaccine is out there, there may be things we learn that we don’t know now. That is true for virtually any medical innovation,” Paul Offit, MD, director of The Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA VRBPAC, said during the AMA/Poynter Institute webinar.

During the same webinar, an attendee asked about prioritizing immunization for spouses and family members of healthcare workers. “My husband wants to know that too,” replied Patricia A. Stinchfield, APRN, CNP, pediatric nurse practitioner in infectious diseases at Children’s Minnesota, St. Paul.

“It is true we should be thinking about our healthcare workers’ family members. But at this point in time we just don’t have the supplies to address it that way,” said Stinchfield, who is also the president-elect of the National Foundation for Infectious Diseases.

Advantages beyond the numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more than one product is the potential to offer an option when a specific vaccine is contraindicated. “We could offer someone a different vaccine…similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle — the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Offit said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product does not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for an EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”

Future outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccines from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”

“My greatest hope is that a year from now we look back and realize we did something really amazing together,” Bailey said, “and we have a feeling of accomplishment and appreciation for all the hard work that has been done.”

Mehta shared the important message he shares when walking around the hospital: “While these vaccines are coming and they are very promising, we need to continue to remember the 3 Ws: wearing a mask, washing your hands, and watching your distance,” he said.

“With the combination of those 3Ws and those vaccines, we will hopefully come through this COVID pandemic.”

El Sahly receives funding through the NIH for her research, including her role as co-chair of the Moderna vaccine phase 3 clinical trial. Schrantz is a site investigator for the Moderna and Janssen vaccine trials. Mehta also receives funding through the NIH. None of these experts had any relevant financial disclosures.

This article first appeared on Medscape.com.

Like most health care workers at his hospital in Lafayette, Ind., Ramesh Adhikari, MD, FHM, occasionally gets an email noting that a patient he saw later tested positive for COVID-19. He’s reminded to self-monitor for symptoms. But 10 months into the pandemic, it has become increasingly unlikely for contact tracing investigations to result in clinicians quarantining.

The very act of working in the hospital, Dr. Adhikari said, means being likely to see COVID-19 every day, whether in a known patient or an asymptomatic person who tests positive later. If hospitalists had to quarantine after every interaction with a COVID-positive person, there wouldn’t be anyone left to do their jobs.

“It’s really hard to do [contact tracing] in health care workers thoroughly because of the way we work,” Dr. Adhikari said. “It’s impossible to do it absolutely.”

In a recently updated guidance, the Centers for Disease Control and Prevention extended more leeway in contact tracing when community rates of COVID-19 surge, even allowing that contact tracing “may not be possible” in certain situations. And by defining an exposure more narrowly – health care workers are only considered “exposed” if their contact was more than 15 minutes or lacking in some form of PPE – the guidelines suggest that hospitals can rely more on universal PPE and screening protocols, as Dr. Adhikari’s hospital does, and less on extensive contact tracing to curtail viral spread.

Accordingly, while contact tracing has gotten more lax, doctors say, universal precautions – including full PPE and screening of symptoms for patients and health care workers – have become more stringent.

It’s a shift from the beginning of the pandemic. At first, CDC recommended wearing masks only during aerosol-producing procedures. Exposures were frequently reported and health care workers sent home. With more evidence in favor of stricter PPE requirements, hospitals including the one where Shyam Odeti, MD, FHM, works in Johnson City, Tenn., have adopted a universal precaution strategy – requiring masks everywhere and a gown, face shield, gloves, and N95 to enter a COVID-positive patient’s room. Thus, most exposures fall into that low-risk category.

“If I get it and am asymptomatic, I don’t think my colleagues would be exposed by any means because of these stringent policies being enforced,” said Dr. Odeti, a hospitalist who often wears a surgical mask on top of his N95 all day. “And U.S. health care is not in a state that can afford to quarantine health care workers for 14 days.”
 

Can universal PPE precautions supplant contact tracing?

The extent of contact tracing varies by hospital. Larger university and community hospitals often have infection control and occupational health teams that can do their own contact tracing, while smaller institutions can’t always spare staff. And some state health departments get involved with contact tracing of health care workers while others do not.

“I would venture to say that most hospitals are doing something in terms of contact tracing,” said Pam Falk, MPH, CIC, a member of the Association for Professionals in Infection Control and Epidemiology’s COVID-19 task force and an infection control consultant. “It kind of depends on their bandwidth.”

But there’s no longer a norm. Outside of a pandemic, with ample staffing and far fewer instances that need to be investigated, standards for contact tracing are higher, Dr. Falk said: When a patient is found to have an airborne disease such as tuberculosis, measles, mumps, or chickenpox, a hospital’s infection prevention team should investigate, confirm the diagnosis and identify everyone who was exposed. The hospital’s occupational health team assists in deciding who will likely need prophylactic treatment and if employees should be furloughed. The thoroughness of such measures has always depended on a hospital’s bandwidth.

Because PPE seems to be able to contain COVID-19 better than some of the older diseases targeted by contact tracing, universal protections may be a reasonable alternative in current circumstances, doctors said – if PPE is available.

“At the end of the day, universal source control with surgical masks – and ideally eye protection for clinicians as well – should prevent most transmissions,” said Aaron Richterman, MD, from the division of infectious diseases at the Hospital of the University of Pennsylvania, Philadelphia, who coauthored a JAMA commentary on decreased transmission rates in hospitals.

Contact tracing is still useful, though, to identify weaknesses in universal protection measures, he said.

“I don’t think it’s worth abandoning. It’s like a tool in the toolbox. All are imperfect, and none work 100% of the time,” Dr. Richterman said, but using all of them can achieve a fairly high measure of safety. Of the tools, universal masking likely works the best, he contends, so it should be the top pick for hospitals without resources to use all of the tools.

A recent incident at Brigham and Women’s Hospital in Boston is a case study in how contact tracing can work together with universal protections to identify cracks in the system, said Dr. Richterman, who worked at the hospital earlier in the pandemic.

Mass General Brigham adopted a universal masking policy for staff and patients in March 2020. Then, when the system experienced an outbreak in September, the hospital did “a very detailed public evaluation that included contact tracing and universal testing,” Dr. Richterman said. Testing even included genetic analysis of the virus to confirm which cases were hospital acquired. In the end, the hospital identified weaknesses in infection control that could be rectified, such as clinicians eating too close together.

“The approach is not to point fingers, but to say: ‘What’s wrong with the system and how do we improve?’ ” Dr. Richterman said. “To ask, why did that maskless transmission happen? Is there not enough space to eat? Are people working too many hours? It’s useful for systems to understand where transmissions are happening.”

Amith Skandhan, MD, SFHM, a hospitalist in Dothan, Ala., is comfortable without much contact tracing as long as there is universal PPE use. His hospital informs clinicians of exposures, but “basically we’re trained to treat every patient as if they had COVID,” he said, so “I feel more secure in the hospital than in the community.” Masks have become so habitual they’re like part of your regular clothing, he said – you feel incomplete if you don’t have one.

While ad hoc approaches to contact tracing may be useful in the current stage of the pandemic, they are likely to be short-lived: Once a community’s positivity rate falls, the CDC’s guidance suggests how hospitals can return to full contact tracing.

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

Like most health care workers at his hospital in Lafayette, Ind., Ramesh Adhikari, MD, FHM, occasionally gets an email noting that a patient he saw later tested positive for COVID-19. He’s reminded to self-monitor for symptoms. But 10 months into the pandemic, it has become increasingly unlikely for contact tracing investigations to result in clinicians quarantining.

The very act of working in the hospital, Dr. Adhikari said, means being likely to see COVID-19 every day, whether in a known patient or an asymptomatic person who tests positive later. If hospitalists had to quarantine after every interaction with a COVID-positive person, there wouldn’t be anyone left to do their jobs.

“It’s really hard to do [contact tracing] in health care workers thoroughly because of the way we work,” Dr. Adhikari said. “It’s impossible to do it absolutely.”

In a recently updated guidance, the Centers for Disease Control and Prevention extended more leeway in contact tracing when community rates of COVID-19 surge, even allowing that contact tracing “may not be possible” in certain situations. And by defining an exposure more narrowly – health care workers are only considered “exposed” if their contact was more than 15 minutes or lacking in some form of PPE – the guidelines suggest that hospitals can rely more on universal PPE and screening protocols, as Dr. Adhikari’s hospital does, and less on extensive contact tracing to curtail viral spread.

Accordingly, while contact tracing has gotten more lax, doctors say, universal precautions – including full PPE and screening of symptoms for patients and health care workers – have become more stringent.

It’s a shift from the beginning of the pandemic. At first, CDC recommended wearing masks only during aerosol-producing procedures. Exposures were frequently reported and health care workers sent home. With more evidence in favor of stricter PPE requirements, hospitals including the one where Shyam Odeti, MD, FHM, works in Johnson City, Tenn., have adopted a universal precaution strategy – requiring masks everywhere and a gown, face shield, gloves, and N95 to enter a COVID-positive patient’s room. Thus, most exposures fall into that low-risk category.

“If I get it and am asymptomatic, I don’t think my colleagues would be exposed by any means because of these stringent policies being enforced,” said Dr. Odeti, a hospitalist who often wears a surgical mask on top of his N95 all day. “And U.S. health care is not in a state that can afford to quarantine health care workers for 14 days.”
 

Can universal PPE precautions supplant contact tracing?

The extent of contact tracing varies by hospital. Larger university and community hospitals often have infection control and occupational health teams that can do their own contact tracing, while smaller institutions can’t always spare staff. And some state health departments get involved with contact tracing of health care workers while others do not.

“I would venture to say that most hospitals are doing something in terms of contact tracing,” said Pam Falk, MPH, CIC, a member of the Association for Professionals in Infection Control and Epidemiology’s COVID-19 task force and an infection control consultant. “It kind of depends on their bandwidth.”

But there’s no longer a norm. Outside of a pandemic, with ample staffing and far fewer instances that need to be investigated, standards for contact tracing are higher, Dr. Falk said: When a patient is found to have an airborne disease such as tuberculosis, measles, mumps, or chickenpox, a hospital’s infection prevention team should investigate, confirm the diagnosis and identify everyone who was exposed. The hospital’s occupational health team assists in deciding who will likely need prophylactic treatment and if employees should be furloughed. The thoroughness of such measures has always depended on a hospital’s bandwidth.

Because PPE seems to be able to contain COVID-19 better than some of the older diseases targeted by contact tracing, universal protections may be a reasonable alternative in current circumstances, doctors said – if PPE is available.

“At the end of the day, universal source control with surgical masks – and ideally eye protection for clinicians as well – should prevent most transmissions,” said Aaron Richterman, MD, from the division of infectious diseases at the Hospital of the University of Pennsylvania, Philadelphia, who coauthored a JAMA commentary on decreased transmission rates in hospitals.

Contact tracing is still useful, though, to identify weaknesses in universal protection measures, he said.

“I don’t think it’s worth abandoning. It’s like a tool in the toolbox. All are imperfect, and none work 100% of the time,” Dr. Richterman said, but using all of them can achieve a fairly high measure of safety. Of the tools, universal masking likely works the best, he contends, so it should be the top pick for hospitals without resources to use all of the tools.

A recent incident at Brigham and Women’s Hospital in Boston is a case study in how contact tracing can work together with universal protections to identify cracks in the system, said Dr. Richterman, who worked at the hospital earlier in the pandemic.

Mass General Brigham adopted a universal masking policy for staff and patients in March 2020. Then, when the system experienced an outbreak in September, the hospital did “a very detailed public evaluation that included contact tracing and universal testing,” Dr. Richterman said. Testing even included genetic analysis of the virus to confirm which cases were hospital acquired. In the end, the hospital identified weaknesses in infection control that could be rectified, such as clinicians eating too close together.

“The approach is not to point fingers, but to say: ‘What’s wrong with the system and how do we improve?’ ” Dr. Richterman said. “To ask, why did that maskless transmission happen? Is there not enough space to eat? Are people working too many hours? It’s useful for systems to understand where transmissions are happening.”

Amith Skandhan, MD, SFHM, a hospitalist in Dothan, Ala., is comfortable without much contact tracing as long as there is universal PPE use. His hospital informs clinicians of exposures, but “basically we’re trained to treat every patient as if they had COVID,” he said, so “I feel more secure in the hospital than in the community.” Masks have become so habitual they’re like part of your regular clothing, he said – you feel incomplete if you don’t have one.

While ad hoc approaches to contact tracing may be useful in the current stage of the pandemic, they are likely to be short-lived: Once a community’s positivity rate falls, the CDC’s guidance suggests how hospitals can return to full contact tracing.

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

Like most health care workers at his hospital in Lafayette, Ind., Ramesh Adhikari, MD, FHM, occasionally gets an email noting that a patient he saw later tested positive for COVID-19. He’s reminded to self-monitor for symptoms. But 10 months into the pandemic, it has become increasingly unlikely for contact tracing investigations to result in clinicians quarantining.

The very act of working in the hospital, Dr. Adhikari said, means being likely to see COVID-19 every day, whether in a known patient or an asymptomatic person who tests positive later. If hospitalists had to quarantine after every interaction with a COVID-positive person, there wouldn’t be anyone left to do their jobs.

“It’s really hard to do [contact tracing] in health care workers thoroughly because of the way we work,” Dr. Adhikari said. “It’s impossible to do it absolutely.”

In a recently updated guidance, the Centers for Disease Control and Prevention extended more leeway in contact tracing when community rates of COVID-19 surge, even allowing that contact tracing “may not be possible” in certain situations. And by defining an exposure more narrowly – health care workers are only considered “exposed” if their contact was more than 15 minutes or lacking in some form of PPE – the guidelines suggest that hospitals can rely more on universal PPE and screening protocols, as Dr. Adhikari’s hospital does, and less on extensive contact tracing to curtail viral spread.

Accordingly, while contact tracing has gotten more lax, doctors say, universal precautions – including full PPE and screening of symptoms for patients and health care workers – have become more stringent.

It’s a shift from the beginning of the pandemic. At first, CDC recommended wearing masks only during aerosol-producing procedures. Exposures were frequently reported and health care workers sent home. With more evidence in favor of stricter PPE requirements, hospitals including the one where Shyam Odeti, MD, FHM, works in Johnson City, Tenn., have adopted a universal precaution strategy – requiring masks everywhere and a gown, face shield, gloves, and N95 to enter a COVID-positive patient’s room. Thus, most exposures fall into that low-risk category.

“If I get it and am asymptomatic, I don’t think my colleagues would be exposed by any means because of these stringent policies being enforced,” said Dr. Odeti, a hospitalist who often wears a surgical mask on top of his N95 all day. “And U.S. health care is not in a state that can afford to quarantine health care workers for 14 days.”
 

Can universal PPE precautions supplant contact tracing?

The extent of contact tracing varies by hospital. Larger university and community hospitals often have infection control and occupational health teams that can do their own contact tracing, while smaller institutions can’t always spare staff. And some state health departments get involved with contact tracing of health care workers while others do not.

“I would venture to say that most hospitals are doing something in terms of contact tracing,” said Pam Falk, MPH, CIC, a member of the Association for Professionals in Infection Control and Epidemiology’s COVID-19 task force and an infection control consultant. “It kind of depends on their bandwidth.”

But there’s no longer a norm. Outside of a pandemic, with ample staffing and far fewer instances that need to be investigated, standards for contact tracing are higher, Dr. Falk said: When a patient is found to have an airborne disease such as tuberculosis, measles, mumps, or chickenpox, a hospital’s infection prevention team should investigate, confirm the diagnosis and identify everyone who was exposed. The hospital’s occupational health team assists in deciding who will likely need prophylactic treatment and if employees should be furloughed. The thoroughness of such measures has always depended on a hospital’s bandwidth.

Because PPE seems to be able to contain COVID-19 better than some of the older diseases targeted by contact tracing, universal protections may be a reasonable alternative in current circumstances, doctors said – if PPE is available.

“At the end of the day, universal source control with surgical masks – and ideally eye protection for clinicians as well – should prevent most transmissions,” said Aaron Richterman, MD, from the division of infectious diseases at the Hospital of the University of Pennsylvania, Philadelphia, who coauthored a JAMA commentary on decreased transmission rates in hospitals.

Contact tracing is still useful, though, to identify weaknesses in universal protection measures, he said.

“I don’t think it’s worth abandoning. It’s like a tool in the toolbox. All are imperfect, and none work 100% of the time,” Dr. Richterman said, but using all of them can achieve a fairly high measure of safety. Of the tools, universal masking likely works the best, he contends, so it should be the top pick for hospitals without resources to use all of the tools.

A recent incident at Brigham and Women’s Hospital in Boston is a case study in how contact tracing can work together with universal protections to identify cracks in the system, said Dr. Richterman, who worked at the hospital earlier in the pandemic.

Mass General Brigham adopted a universal masking policy for staff and patients in March 2020. Then, when the system experienced an outbreak in September, the hospital did “a very detailed public evaluation that included contact tracing and universal testing,” Dr. Richterman said. Testing even included genetic analysis of the virus to confirm which cases were hospital acquired. In the end, the hospital identified weaknesses in infection control that could be rectified, such as clinicians eating too close together.

“The approach is not to point fingers, but to say: ‘What’s wrong with the system and how do we improve?’ ” Dr. Richterman said. “To ask, why did that maskless transmission happen? Is there not enough space to eat? Are people working too many hours? It’s useful for systems to understand where transmissions are happening.”

Amith Skandhan, MD, SFHM, a hospitalist in Dothan, Ala., is comfortable without much contact tracing as long as there is universal PPE use. His hospital informs clinicians of exposures, but “basically we’re trained to treat every patient as if they had COVID,” he said, so “I feel more secure in the hospital than in the community.” Masks have become so habitual they’re like part of your regular clothing, he said – you feel incomplete if you don’t have one.

While ad hoc approaches to contact tracing may be useful in the current stage of the pandemic, they are likely to be short-lived: Once a community’s positivity rate falls, the CDC’s guidance suggests how hospitals can return to full contact tracing.

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

Fellowship is a time of great growth for pediatric hospital medicine fellows as clinicians, educators, scholars, and as leaders. Leadership is a crucial skill for hospitalists that is cultivated throughout fellowship. As fellows, we step into the role of clinical team leader for the first time and it is our responsibility to create a clinical and educational environment that is safe, inviting and engaging.

For possibly the first time in our careers, pediatric hospital medicine fellows are expected to make final decisions, big and small. We are faced with high-pressure situations almost daily, whether it is a rapid response on a patient, tough diagnostic and therapeutic decisions, difficult conversations with families, or dealing with challenging team members.

Soon after starting fellowship I was faced with a such a situation. The patient was a 6-month-old infant with trisomy 21 who was admitted because of feeding difficulties. They were working on oral feeds but required nasogastric (NG) feeds to meet caloric needs. On my first day on service, the residents indicated that the medical team desired the patient to have a gastrostomy tube (G-tube) placed. I was hoping to send the patient home for a few weeks with the NG tube to see if they were making progress on their oral feeds before deciding on the need for a G-tube. However, the patient’s parents pulled me aside in the hallway and said they were considering a third possibility.

The parents felt strongly about a trial period of a few weeks without the NG tube to see if the patient was able to maintain adequate weight gain with just oral feeds. The bedside nurse reiterated that the family felt their concerns had not been considered up until this point. As the fellow and team leader, it was my job to navigate between my resident team, myself, and the family in order to make a final decision. Through a bedside meeting and shared decision making, we were able to compromise and negotiate a decision, allowing the patient to go home on just oral feeds with close follow-up with their pediatrician. Afterwards, I found myself searching for strategies to be a better leader in these situations.

I found a potential answer in a recent article from the Harvard Business Review titled “What Aircraft Crews Know About Managing High-Pressure Situations.”¹ The article discusses crew resource management (CRM), which was developed in the 1980s and is used in civil and military aviation worldwide. CRM is based on two principles to improve crisis management: The hierarchy on the flight deck must be flattened, and crew members must be actively integrated into the flight’s work flows and decision-making processes.

The authors of the article conducted two different studies to further understand CRM and its effects. The first study included observing 11 flight crews in emergency simulations. In the study, the flight crew had to react to an emergency, and then conduct a landing of the aircraft. What the authors found was that the captain’s style of communication had a major impact on crew performance in two major ways: Crews performed consistently better under times of pressure when the copilot was included in the decision-making process, and captains who asked open-ended questions (“How do you assess the situation”) came up with better solutions than captains who asked “yes or no” questions.

The authors conclude that “involving colleagues as equal decision partners by asking them questions…aids constructive, factual information exchange.” The second study consisted of conducting 61 interviews with flight crew members to better understand crisis management. In the interviews, the same theme occurred, that open-ended questions are vital in all decision-making processes and may be preventative against dangerous or imperfect outcomes. As fellows and team leaders we can learn from CRM and these studies. We need to flatten the hierarchy and ask open-ended questions.

To flatten the hierarchy, we should value the thoughts and opinions of all our team members. Now more than ever in this current COVID-19 pandemic with many hospitals instituting telehealth/telerounding for some or all team members, it is essential to utilize our entire “flight crew” (physicians, nurses, therapists, subspecialists, social worker, case managers, etc.) during routine decisions and high-stake decisions. We should make sure our flight crew, especially the bedside nurse is part of the decision-making process.² This means we need to ensure they are present and given a voice on clinical rounds. To flatten the hierarchy, we must take pride in eliciting other team member’s opinions. We must realize that we alone do not have all the answers, and other team members may have different frameworks in which they process a decision.

Finally, in medicine, our patients and families are included in our flight crew. They too must have a voice in the decision-making process. Previous studies have shown that patients and families desire to be included in the decision-making process, and opportunities exist to improve shared decision-making in pediatrics.^3-5 Lastly, we should commit to asking open-ended questions from our team and our patients. We should value their input and use their answers and frameworks to make the best decision for our patients.

I wasn’t aware at the time, but I was using some of the principles of CRM while navigating my high-pressure situation. A bedside meeting with all team members and the patient’s family helped to flatten the hierarchy by understanding and valuing each team member’s input. Asking open-ended questions of the different team members led to a more inviting and engaging clinical and learning environment. These strategies helped to lead our team into a clinical decision that wasn’t entirely clear at first but ended up being the best decision for the patient, as they are now thriving without ever requiring supplemental nutrition after discharge.

As physicians, we have learned a lot from the airline industry about wellness and the effect of fatigue on performance. It is clear now that we can also learn from them about clinical decision-making and leadership strategies. When adopted for health care, CRM principles have been shown to result in a culture of safety and long-term behavioral change.^6,7 If we can model ourselves after the airline industry by following the principles of CRM, then we will be better clinicians, educators, and leaders.

Dr. Palmer is a second-year pediatric hospital medicine fellow at Children’s Hospital Los Angeles and is working toward a masters in academic medicine at the University of Southern California, Los Angeles, with a focus on curriculum development and educational scholarship production.

References

1. Hagan J et al. What Aircraft Crews Know About Managing High-Pressure Situations. Harvard Business Review. 2019 Dec. https://hbr.org/2019/12/what-aircraft-crews-know-about-managing-high-pressure-situations

2. Erickson J. Bedside nurse involvement in end-of-life decision-making: A brief review of the literature. Dimens Crit Care Nurs. 2013;32(2):65-8.

3. Richards CA et al. Physicians perceptions of shared decision-making in neonatal and pediatric critical care. Am J Hosp Palliat Care. 2018;35(4):669-76.

4. Boland L et al. Barriers and facilitators of pediatric shared decision-making: A systematic review. Implement Sci. 2019 Jan 18. doi: 10.1186/s13012-018-0851-5.

5. Blankenburg R et al. Shared decision-making during inpatient rounds: Opportunities for improvement in patient engagement and communication. J Hosp Med. 2018;13(7):453-61.

6. Kemper PF et al. Crew resource management training in the intensive care unit. A multisite controlled before-after study. BMJ Qual Saf. 2016;25(8):577-87.

7. Sax HC et al. Can aviation-based team training elicit sustainable behavioral change? Arch Surg. 2009;144(12):1133-7.

Fellowship is a time of great growth for pediatric hospital medicine fellows as clinicians, educators, scholars, and as leaders. Leadership is a crucial skill for hospitalists that is cultivated throughout fellowship. As fellows, we step into the role of clinical team leader for the first time and it is our responsibility to create a clinical and educational environment that is safe, inviting and engaging.

For possibly the first time in our careers, pediatric hospital medicine fellows are expected to make final decisions, big and small. We are faced with high-pressure situations almost daily, whether it is a rapid response on a patient, tough diagnostic and therapeutic decisions, difficult conversations with families, or dealing with challenging team members.

Soon after starting fellowship I was faced with a such a situation. The patient was a 6-month-old infant with trisomy 21 who was admitted because of feeding difficulties. They were working on oral feeds but required nasogastric (NG) feeds to meet caloric needs. On my first day on service, the residents indicated that the medical team desired the patient to have a gastrostomy tube (G-tube) placed. I was hoping to send the patient home for a few weeks with the NG tube to see if they were making progress on their oral feeds before deciding on the need for a G-tube. However, the patient’s parents pulled me aside in the hallway and said they were considering a third possibility.

The parents felt strongly about a trial period of a few weeks without the NG tube to see if the patient was able to maintain adequate weight gain with just oral feeds. The bedside nurse reiterated that the family felt their concerns had not been considered up until this point. As the fellow and team leader, it was my job to navigate between my resident team, myself, and the family in order to make a final decision. Through a bedside meeting and shared decision making, we were able to compromise and negotiate a decision, allowing the patient to go home on just oral feeds with close follow-up with their pediatrician. Afterwards, I found myself searching for strategies to be a better leader in these situations.

I found a potential answer in a recent article from the Harvard Business Review titled “What Aircraft Crews Know About Managing High-Pressure Situations.”¹ The article discusses crew resource management (CRM), which was developed in the 1980s and is used in civil and military aviation worldwide. CRM is based on two principles to improve crisis management: The hierarchy on the flight deck must be flattened, and crew members must be actively integrated into the flight’s work flows and decision-making processes.

The authors of the article conducted two different studies to further understand CRM and its effects. The first study included observing 11 flight crews in emergency simulations. In the study, the flight crew had to react to an emergency, and then conduct a landing of the aircraft. What the authors found was that the captain’s style of communication had a major impact on crew performance in two major ways: Crews performed consistently better under times of pressure when the copilot was included in the decision-making process, and captains who asked open-ended questions (“How do you assess the situation”) came up with better solutions than captains who asked “yes or no” questions.

The authors conclude that “involving colleagues as equal decision partners by asking them questions…aids constructive, factual information exchange.” The second study consisted of conducting 61 interviews with flight crew members to better understand crisis management. In the interviews, the same theme occurred, that open-ended questions are vital in all decision-making processes and may be preventative against dangerous or imperfect outcomes. As fellows and team leaders we can learn from CRM and these studies. We need to flatten the hierarchy and ask open-ended questions.

To flatten the hierarchy, we should value the thoughts and opinions of all our team members. Now more than ever in this current COVID-19 pandemic with many hospitals instituting telehealth/telerounding for some or all team members, it is essential to utilize our entire “flight crew” (physicians, nurses, therapists, subspecialists, social worker, case managers, etc.) during routine decisions and high-stake decisions. We should make sure our flight crew, especially the bedside nurse is part of the decision-making process.² This means we need to ensure they are present and given a voice on clinical rounds. To flatten the hierarchy, we must take pride in eliciting other team member’s opinions. We must realize that we alone do not have all the answers, and other team members may have different frameworks in which they process a decision.

Finally, in medicine, our patients and families are included in our flight crew. They too must have a voice in the decision-making process. Previous studies have shown that patients and families desire to be included in the decision-making process, and opportunities exist to improve shared decision-making in pediatrics.^3-5 Lastly, we should commit to asking open-ended questions from our team and our patients. We should value their input and use their answers and frameworks to make the best decision for our patients.

I wasn’t aware at the time, but I was using some of the principles of CRM while navigating my high-pressure situation. A bedside meeting with all team members and the patient’s family helped to flatten the hierarchy by understanding and valuing each team member’s input. Asking open-ended questions of the different team members led to a more inviting and engaging clinical and learning environment. These strategies helped to lead our team into a clinical decision that wasn’t entirely clear at first but ended up being the best decision for the patient, as they are now thriving without ever requiring supplemental nutrition after discharge.

As physicians, we have learned a lot from the airline industry about wellness and the effect of fatigue on performance. It is clear now that we can also learn from them about clinical decision-making and leadership strategies. When adopted for health care, CRM principles have been shown to result in a culture of safety and long-term behavioral change.^6,7 If we can model ourselves after the airline industry by following the principles of CRM, then we will be better clinicians, educators, and leaders.

Dr. Palmer is a second-year pediatric hospital medicine fellow at Children’s Hospital Los Angeles and is working toward a masters in academic medicine at the University of Southern California, Los Angeles, with a focus on curriculum development and educational scholarship production.

References

1. Hagan J et al. What Aircraft Crews Know About Managing High-Pressure Situations. Harvard Business Review. 2019 Dec. https://hbr.org/2019/12/what-aircraft-crews-know-about-managing-high-pressure-situations

2. Erickson J. Bedside nurse involvement in end-of-life decision-making: A brief review of the literature. Dimens Crit Care Nurs. 2013;32(2):65-8.

3. Richards CA et al. Physicians perceptions of shared decision-making in neonatal and pediatric critical care. Am J Hosp Palliat Care. 2018;35(4):669-76.

4. Boland L et al. Barriers and facilitators of pediatric shared decision-making: A systematic review. Implement Sci. 2019 Jan 18. doi: 10.1186/s13012-018-0851-5.

5. Blankenburg R et al. Shared decision-making during inpatient rounds: Opportunities for improvement in patient engagement and communication. J Hosp Med. 2018;13(7):453-61.

6. Kemper PF et al. Crew resource management training in the intensive care unit. A multisite controlled before-after study. BMJ Qual Saf. 2016;25(8):577-87.

7. Sax HC et al. Can aviation-based team training elicit sustainable behavioral change? Arch Surg. 2009;144(12):1133-7.

Fellowship is a time of great growth for pediatric hospital medicine fellows as clinicians, educators, scholars, and as leaders. Leadership is a crucial skill for hospitalists that is cultivated throughout fellowship. As fellows, we step into the role of clinical team leader for the first time and it is our responsibility to create a clinical and educational environment that is safe, inviting and engaging.

For possibly the first time in our careers, pediatric hospital medicine fellows are expected to make final decisions, big and small. We are faced with high-pressure situations almost daily, whether it is a rapid response on a patient, tough diagnostic and therapeutic decisions, difficult conversations with families, or dealing with challenging team members.

Soon after starting fellowship I was faced with a such a situation. The patient was a 6-month-old infant with trisomy 21 who was admitted because of feeding difficulties. They were working on oral feeds but required nasogastric (NG) feeds to meet caloric needs. On my first day on service, the residents indicated that the medical team desired the patient to have a gastrostomy tube (G-tube) placed. I was hoping to send the patient home for a few weeks with the NG tube to see if they were making progress on their oral feeds before deciding on the need for a G-tube. However, the patient’s parents pulled me aside in the hallway and said they were considering a third possibility.

The parents felt strongly about a trial period of a few weeks without the NG tube to see if the patient was able to maintain adequate weight gain with just oral feeds. The bedside nurse reiterated that the family felt their concerns had not been considered up until this point. As the fellow and team leader, it was my job to navigate between my resident team, myself, and the family in order to make a final decision. Through a bedside meeting and shared decision making, we were able to compromise and negotiate a decision, allowing the patient to go home on just oral feeds with close follow-up with their pediatrician. Afterwards, I found myself searching for strategies to be a better leader in these situations.

I found a potential answer in a recent article from the Harvard Business Review titled “What Aircraft Crews Know About Managing High-Pressure Situations.”¹ The article discusses crew resource management (CRM), which was developed in the 1980s and is used in civil and military aviation worldwide. CRM is based on two principles to improve crisis management: The hierarchy on the flight deck must be flattened, and crew members must be actively integrated into the flight’s work flows and decision-making processes.

The authors of the article conducted two different studies to further understand CRM and its effects. The first study included observing 11 flight crews in emergency simulations. In the study, the flight crew had to react to an emergency, and then conduct a landing of the aircraft. What the authors found was that the captain’s style of communication had a major impact on crew performance in two major ways: Crews performed consistently better under times of pressure when the copilot was included in the decision-making process, and captains who asked open-ended questions (“How do you assess the situation”) came up with better solutions than captains who asked “yes or no” questions.

The authors conclude that “involving colleagues as equal decision partners by asking them questions…aids constructive, factual information exchange.” The second study consisted of conducting 61 interviews with flight crew members to better understand crisis management. In the interviews, the same theme occurred, that open-ended questions are vital in all decision-making processes and may be preventative against dangerous or imperfect outcomes. As fellows and team leaders we can learn from CRM and these studies. We need to flatten the hierarchy and ask open-ended questions.

To flatten the hierarchy, we should value the thoughts and opinions of all our team members. Now more than ever in this current COVID-19 pandemic with many hospitals instituting telehealth/telerounding for some or all team members, it is essential to utilize our entire “flight crew” (physicians, nurses, therapists, subspecialists, social worker, case managers, etc.) during routine decisions and high-stake decisions. We should make sure our flight crew, especially the bedside nurse is part of the decision-making process.² This means we need to ensure they are present and given a voice on clinical rounds. To flatten the hierarchy, we must take pride in eliciting other team member’s opinions. We must realize that we alone do not have all the answers, and other team members may have different frameworks in which they process a decision.

Finally, in medicine, our patients and families are included in our flight crew. They too must have a voice in the decision-making process. Previous studies have shown that patients and families desire to be included in the decision-making process, and opportunities exist to improve shared decision-making in pediatrics.^3-5 Lastly, we should commit to asking open-ended questions from our team and our patients. We should value their input and use their answers and frameworks to make the best decision for our patients.

I wasn’t aware at the time, but I was using some of the principles of CRM while navigating my high-pressure situation. A bedside meeting with all team members and the patient’s family helped to flatten the hierarchy by understanding and valuing each team member’s input. Asking open-ended questions of the different team members led to a more inviting and engaging clinical and learning environment. These strategies helped to lead our team into a clinical decision that wasn’t entirely clear at first but ended up being the best decision for the patient, as they are now thriving without ever requiring supplemental nutrition after discharge.

As physicians, we have learned a lot from the airline industry about wellness and the effect of fatigue on performance. It is clear now that we can also learn from them about clinical decision-making and leadership strategies. When adopted for health care, CRM principles have been shown to result in a culture of safety and long-term behavioral change.^6,7 If we can model ourselves after the airline industry by following the principles of CRM, then we will be better clinicians, educators, and leaders.

Dr. Palmer is a second-year pediatric hospital medicine fellow at Children’s Hospital Los Angeles and is working toward a masters in academic medicine at the University of Southern California, Los Angeles, with a focus on curriculum development and educational scholarship production.

References

1. Hagan J et al. What Aircraft Crews Know About Managing High-Pressure Situations. Harvard Business Review. 2019 Dec. https://hbr.org/2019/12/what-aircraft-crews-know-about-managing-high-pressure-situations

2. Erickson J. Bedside nurse involvement in end-of-life decision-making: A brief review of the literature. Dimens Crit Care Nurs. 2013;32(2):65-8.

3. Richards CA et al. Physicians perceptions of shared decision-making in neonatal and pediatric critical care. Am J Hosp Palliat Care. 2018;35(4):669-76.

4. Boland L et al. Barriers and facilitators of pediatric shared decision-making: A systematic review. Implement Sci. 2019 Jan 18. doi: 10.1186/s13012-018-0851-5.

5. Blankenburg R et al. Shared decision-making during inpatient rounds: Opportunities for improvement in patient engagement and communication. J Hosp Med. 2018;13(7):453-61.

6. Kemper PF et al. Crew resource management training in the intensive care unit. A multisite controlled before-after study. BMJ Qual Saf. 2016;25(8):577-87.

7. Sax HC et al. Can aviation-based team training elicit sustainable behavioral change? Arch Surg. 2009;144(12):1133-7.

The 16 million–plus people in the United States, and 72 million worldwide, who have been infected with COVID-19 – and survived – are likely asking themselves the same questions: Am I immune now? Is it over or do I have to brace myself for the possibility of a reinfection? Moreover, could the second time potentially be worse than the first?

I was diagnosed with COVID in March of this year. After spending 10 days in the hospital, and one night in the ICU, it took another 2 months for the air-hunger, headaches, and fatigue to completely resolve. Compared with many other unfortunate victims, I did all right – and I am very grateful for the care I received.

Now, as the surge in cases takes new life, I will be on the front lines taking care of patients. Having had an eventful personal encounter with the virus, I now have a unique vantage point and remain fully committed to paying my fortunate circumstances forward. Although I can’t help but have the same question faced by millions of others: Am I safe now?

It is no surprise that studies have shown health care workers comprising 6% of COVID hospital admissions, with one-third of these admissions being nurses. Recently, we heard that over 900 health care workers at Mayo Clinic had acquired the infection in the first 2 weeks of the ongoing second COVID surge. Are these frontline workers protected? Can they return to work with no fear of a rerun? Or, for that matter, anyone who has been afflicted by COVID – are they now forever immune?

There are no clear answers here. But to understand this a little, let’s quickly revisit some basic principles of immunity.
 

Innate and adaptive immunity

Simply put, there are two forms of immunity: innate and adaptive. Innate immunity encompasses our body’s natural protective mechanisms that come into play almost immediately. This enables recognition of the virus and activates an immediate antiviral defense and attempt at removal of the infective agent. This, however, does not always do the job. Accordingly, a couple weeks after the initial exposure to the pathogen, adaptive immunity is invoked. Circulating white blood cells within our body recognize the virus and set off an immune response, involving the activation of T and B cells that actively attack the infective agent. It is this T- and B-cell–mediated immunity that should protect one against a second infection with the same agent.

What about herd immunity?

Herd immunity is defined as essentially yielding to the virus and letting it spread naturally in order to develop community-wide immunity. By consequence of a large proportion of the population becoming immune after exposure to the disease, person-to-person spread can potentially be mitigated. This does not confer immunity to the virus at the individual level; rather, it reduces the risk of vulnerable people coming in contact with the pathogen.

Unfortunately, depending on herd immunity as a way to deal with COVID-19 has not worked well, even in well-contained countries like Sweden, where a disproportionate number of their most vulnerable populations have died. It is self-evident that containment strategies with vaccination may be our best way forward to achieve herd immunity. Not surrendering to the virus.
 

Am I safe from reinfection?

In all honesty, we’re not entirely sure. But it is important to recognize a few points when considering your relative safety.

• The immune system is far from perfect. Not everyone has a robust immune response. And in those who do, the immune response can wane over time, potentially allowing for reinfection. While rare, there have already been some clearly documented reinfections, four that have been confirmed and published; two patients (in Nevada and Ecuador) actually fared worse the second time around.
• The virus can mutate and escape detection by the immune system. One could still be susceptible to reinfection from a different strain. (At least, this remains the case with the influenza virus.) There is some evidence that SARS-CoV-2 does not mutate rapidly, and hence this may not be a problem. But we don’t know for certain, at least as of yet.
• Even a vigorous immune response can be overwhelmed by the virus. It is unclear whether the relative length of time and the amount of virus exposure could undermine a previously primed immune system.

A prior infection and a consequent healthy immunity may help you combat a reinfection but it does not prevent you from harboring or carrying the virus. You may be asymptomatic, but you can still be a carrier and spread the infection. I am a strong advocate for limiting your exposure to others no matter your previous exposure status, in order to limit the spread of the virus.
 

So, what should I do?

I guess the answer is that you can’t be too careful. Not everyone has had their antibody levels tested, and even if positive, it is unclear how well that affords protection. It is best to presume that you are vulnerable for a reinfection and that you can still carry and spread the virus. This may be the safest approach until we actually achieve herd immunity through vaccination.

Even then, for a period of time, there will remain a sense of uncertainty. So, containment strategies inclusive of distancing and masking will and should remain a way of life at least until mid-2021, when we will be in a better position to reassess the landscape.

The surge is back. As I repay my debt and get back to the front line, I will continue to mask up and practice distancing. I am taking no chances of getting reinfected or being an asymptomatic carrier.

I had COVID, I also have antibodies, and I will be taking the vaccine. I implore you all to do the same.

Jag Singh is a physician, scientist, and professor at Harvard. He is passionate about social issues, leadership, digital health, and medical innovations. You can follow him on Twitter @JagSinghMD.

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

The 16 million–plus people in the United States, and 72 million worldwide, who have been infected with COVID-19 – and survived – are likely asking themselves the same questions: Am I immune now? Is it over or do I have to brace myself for the possibility of a reinfection? Moreover, could the second time potentially be worse than the first?

I was diagnosed with COVID in March of this year. After spending 10 days in the hospital, and one night in the ICU, it took another 2 months for the air-hunger, headaches, and fatigue to completely resolve. Compared with many other unfortunate victims, I did all right – and I am very grateful for the care I received.

Now, as the surge in cases takes new life, I will be on the front lines taking care of patients. Having had an eventful personal encounter with the virus, I now have a unique vantage point and remain fully committed to paying my fortunate circumstances forward. Although I can’t help but have the same question faced by millions of others: Am I safe now?

It is no surprise that studies have shown health care workers comprising 6% of COVID hospital admissions, with one-third of these admissions being nurses. Recently, we heard that over 900 health care workers at Mayo Clinic had acquired the infection in the first 2 weeks of the ongoing second COVID surge. Are these frontline workers protected? Can they return to work with no fear of a rerun? Or, for that matter, anyone who has been afflicted by COVID – are they now forever immune?

There are no clear answers here. But to understand this a little, let’s quickly revisit some basic principles of immunity.
 

Innate and adaptive immunity

Simply put, there are two forms of immunity: innate and adaptive. Innate immunity encompasses our body’s natural protective mechanisms that come into play almost immediately. This enables recognition of the virus and activates an immediate antiviral defense and attempt at removal of the infective agent. This, however, does not always do the job. Accordingly, a couple weeks after the initial exposure to the pathogen, adaptive immunity is invoked. Circulating white blood cells within our body recognize the virus and set off an immune response, involving the activation of T and B cells that actively attack the infective agent. It is this T- and B-cell–mediated immunity that should protect one against a second infection with the same agent.

What about herd immunity?

Herd immunity is defined as essentially yielding to the virus and letting it spread naturally in order to develop community-wide immunity. By consequence of a large proportion of the population becoming immune after exposure to the disease, person-to-person spread can potentially be mitigated. This does not confer immunity to the virus at the individual level; rather, it reduces the risk of vulnerable people coming in contact with the pathogen.

Unfortunately, depending on herd immunity as a way to deal with COVID-19 has not worked well, even in well-contained countries like Sweden, where a disproportionate number of their most vulnerable populations have died. It is self-evident that containment strategies with vaccination may be our best way forward to achieve herd immunity. Not surrendering to the virus.
 

Am I safe from reinfection?

In all honesty, we’re not entirely sure. But it is important to recognize a few points when considering your relative safety.

• The immune system is far from perfect. Not everyone has a robust immune response. And in those who do, the immune response can wane over time, potentially allowing for reinfection. While rare, there have already been some clearly documented reinfections, four that have been confirmed and published; two patients (in Nevada and Ecuador) actually fared worse the second time around.
• The virus can mutate and escape detection by the immune system. One could still be susceptible to reinfection from a different strain. (At least, this remains the case with the influenza virus.) There is some evidence that SARS-CoV-2 does not mutate rapidly, and hence this may not be a problem. But we don’t know for certain, at least as of yet.
• Even a vigorous immune response can be overwhelmed by the virus. It is unclear whether the relative length of time and the amount of virus exposure could undermine a previously primed immune system.

A prior infection and a consequent healthy immunity may help you combat a reinfection but it does not prevent you from harboring or carrying the virus. You may be asymptomatic, but you can still be a carrier and spread the infection. I am a strong advocate for limiting your exposure to others no matter your previous exposure status, in order to limit the spread of the virus.
 

So, what should I do?

I guess the answer is that you can’t be too careful. Not everyone has had their antibody levels tested, and even if positive, it is unclear how well that affords protection. It is best to presume that you are vulnerable for a reinfection and that you can still carry and spread the virus. This may be the safest approach until we actually achieve herd immunity through vaccination.

Even then, for a period of time, there will remain a sense of uncertainty. So, containment strategies inclusive of distancing and masking will and should remain a way of life at least until mid-2021, when we will be in a better position to reassess the landscape.

The surge is back. As I repay my debt and get back to the front line, I will continue to mask up and practice distancing. I am taking no chances of getting reinfected or being an asymptomatic carrier.

I had COVID, I also have antibodies, and I will be taking the vaccine. I implore you all to do the same.

Jag Singh is a physician, scientist, and professor at Harvard. He is passionate about social issues, leadership, digital health, and medical innovations. You can follow him on Twitter @JagSinghMD.

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

The 16 million–plus people in the United States, and 72 million worldwide, who have been infected with COVID-19 – and survived – are likely asking themselves the same questions: Am I immune now? Is it over or do I have to brace myself for the possibility of a reinfection? Moreover, could the second time potentially be worse than the first?

I was diagnosed with COVID in March of this year. After spending 10 days in the hospital, and one night in the ICU, it took another 2 months for the air-hunger, headaches, and fatigue to completely resolve. Compared with many other unfortunate victims, I did all right – and I am very grateful for the care I received.

Now, as the surge in cases takes new life, I will be on the front lines taking care of patients. Having had an eventful personal encounter with the virus, I now have a unique vantage point and remain fully committed to paying my fortunate circumstances forward. Although I can’t help but have the same question faced by millions of others: Am I safe now?

It is no surprise that studies have shown health care workers comprising 6% of COVID hospital admissions, with one-third of these admissions being nurses. Recently, we heard that over 900 health care workers at Mayo Clinic had acquired the infection in the first 2 weeks of the ongoing second COVID surge. Are these frontline workers protected? Can they return to work with no fear of a rerun? Or, for that matter, anyone who has been afflicted by COVID – are they now forever immune?

There are no clear answers here. But to understand this a little, let’s quickly revisit some basic principles of immunity.
 

Innate and adaptive immunity

Simply put, there are two forms of immunity: innate and adaptive. Innate immunity encompasses our body’s natural protective mechanisms that come into play almost immediately. This enables recognition of the virus and activates an immediate antiviral defense and attempt at removal of the infective agent. This, however, does not always do the job. Accordingly, a couple weeks after the initial exposure to the pathogen, adaptive immunity is invoked. Circulating white blood cells within our body recognize the virus and set off an immune response, involving the activation of T and B cells that actively attack the infective agent. It is this T- and B-cell–mediated immunity that should protect one against a second infection with the same agent.

What about herd immunity?

Herd immunity is defined as essentially yielding to the virus and letting it spread naturally in order to develop community-wide immunity. By consequence of a large proportion of the population becoming immune after exposure to the disease, person-to-person spread can potentially be mitigated. This does not confer immunity to the virus at the individual level; rather, it reduces the risk of vulnerable people coming in contact with the pathogen.

Unfortunately, depending on herd immunity as a way to deal with COVID-19 has not worked well, even in well-contained countries like Sweden, where a disproportionate number of their most vulnerable populations have died. It is self-evident that containment strategies with vaccination may be our best way forward to achieve herd immunity. Not surrendering to the virus.
 

Am I safe from reinfection?

In all honesty, we’re not entirely sure. But it is important to recognize a few points when considering your relative safety.

• The immune system is far from perfect. Not everyone has a robust immune response. And in those who do, the immune response can wane over time, potentially allowing for reinfection. While rare, there have already been some clearly documented reinfections, four that have been confirmed and published; two patients (in Nevada and Ecuador) actually fared worse the second time around.
• The virus can mutate and escape detection by the immune system. One could still be susceptible to reinfection from a different strain. (At least, this remains the case with the influenza virus.) There is some evidence that SARS-CoV-2 does not mutate rapidly, and hence this may not be a problem. But we don’t know for certain, at least as of yet.
• Even a vigorous immune response can be overwhelmed by the virus. It is unclear whether the relative length of time and the amount of virus exposure could undermine a previously primed immune system.

A prior infection and a consequent healthy immunity may help you combat a reinfection but it does not prevent you from harboring or carrying the virus. You may be asymptomatic, but you can still be a carrier and spread the infection. I am a strong advocate for limiting your exposure to others no matter your previous exposure status, in order to limit the spread of the virus.
 

So, what should I do?

I guess the answer is that you can’t be too careful. Not everyone has had their antibody levels tested, and even if positive, it is unclear how well that affords protection. It is best to presume that you are vulnerable for a reinfection and that you can still carry and spread the virus. This may be the safest approach until we actually achieve herd immunity through vaccination.

Even then, for a period of time, there will remain a sense of uncertainty. So, containment strategies inclusive of distancing and masking will and should remain a way of life at least until mid-2021, when we will be in a better position to reassess the landscape.

The surge is back. As I repay my debt and get back to the front line, I will continue to mask up and practice distancing. I am taking no chances of getting reinfected or being an asymptomatic carrier.

I had COVID, I also have antibodies, and I will be taking the vaccine. I implore you all to do the same.

Jag Singh is a physician, scientist, and professor at Harvard. He is passionate about social issues, leadership, digital health, and medical innovations. You can follow him on Twitter @JagSinghMD.

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