Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
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Query Trace: Gertz RE [original query] |
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Durability of original monovalent mRNA vaccine effectiveness against COVID-19 Omicron-associated hospitalization in children and adolescents - United States, 2021-2023
Zambrano LD , Newhams MM , Simeone RM , Payne AB , Wu M , Orzel-Lockwood AO , Halasa NB , Calixte JM , Pannaraj PS , Mongkolrattanothai K , Boom JA , Sahni LC , Kamidani S , Chiotos K , Cameron MA , Maddux AB , Irby K , Schuster JE , Mack EH , Biggs A , Coates BM , Michelson KN , Bline KE , Nofziger RA , Crandall H , Hobbs CV , Gertz SJ , Heidemann SM , Bradford TT , Walker TC , Schwartz SP , Staat MA , Bhumbra SS , Hume JR , Kong M , Stockwell MS , Connors TJ , Cullimore ML , Flori HR , Levy ER , Cvijanovich NZ , Zinter MS , Maamari M , Bowens C , Zerr DM , Guzman-Cottrill JA , Gonzalez I , Campbell AP , Randolph AG . MMWR Morb Mortal Wkly Rep 2024 73 (15) 330-338 Pediatric COVID-19 vaccination is effective in preventing COVID-19-related hospitalization, but duration of protection of the original monovalent vaccine during SARS-CoV-2 Omicron predominance merits evaluation, particularly given low coverage with updated COVID-19 vaccines. During December 19, 2021-October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19-related hospitalization and critical illness among U.S. children and adolescents aged 5-18 years, using a case-control design. Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness. Most case-patients (persons with a positive SARS-CoV-2 test result) were unvaccinated, despite the high frequency of reported underlying conditions associated with severe COVID-19. VE of the original monovalent vaccine against COVID-19-related hospitalizations was 52% (95% CI = 33%-66%) when the most recent dose was administered <120 days before hospitalization and 19% (95% CI = 2%-32%) if the interval was 120-364 days. VE of the original monovalent vaccine against COVID-19-related hospitalization was 31% (95% CI = 18%-43%) if the last dose was received any time within the previous year. VE against critical COVID-19-related illness, defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death, was 57% (95% CI = 21%-76%) when the most recent dose was received <120 days before hospitalization, 25% (95% CI = -9% to 49%) if it was received 120-364 days before hospitalization, and 38% (95% CI = 15%-55%) if the last dose was received any time within the previous year. VE was similar after excluding children and adolescents with documented immunocompromising conditions. Because of the low frequency of children who received updated COVID-19 vaccines and waning effectiveness of original monovalent doses, these data support CDC recommendations that all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19. |
Pre-existing immunocompromising conditions and outcomes of acute COVID-19 patients admitted for pediatric intensive care
Rowan CM , LaBere B , Young CC , Zambrano LD , Newhams MM , Kucukak S , McNamara ER , Mack EH , Fitzgerald JC , Irby K , Maddux AB , Schuster JE , Kong M , Dapul H , Schwartz SP , Bembea MM , Loftis LL , Kolmar AR , Babbitt CJ , Nofziger RA , Hall MW , Gertz SJ , Cvijanovich NZ , Zinter MS , Halasa NB , Bradford TT , McLaughlin GE , Singh AR , Hobbs CV , Wellnitz K , Staat MA , Coates BM , Crandall HR , Maamari M , Havlin KM , Schwarz AJ , Carroll CL , Levy ER , Moffitt KL , Campbell AP , Randolph AG , Chou J . Clin Infect Dis 2024 BACKGROUND: We aimed to determine if pre-existing immunocompromising conditions (ICCs) were associated with the presentation or outcome of patients with acute coronavirus disease 2019 (COVID-19) admitted for pediatric intensive care. METHODS: 55 hospitals in 30 U.S. states reported cases through the Overcoming COVID-19 public health surveillance registry. Patients <21 years admitted March 12, 2020-December 30, 2021 to the pediatric intensive care unit (PICU) or high acuity unit for acute COVID-19 were included. RESULTS: Of 1,274 patients, 105 (8.2%) had an ICC including 33 (31.4%) hematologic malignancies, 24 (22.9%) primary immunodeficiencies and disorders of hematopoietic cells, 19 (18.1%) nonmalignant organ failure with solid organ transplantation, 16 (15.2%) solid tumors and 13 (12.4%) autoimmune disorders. Patients with ICCs were older, had more underlying renal conditions, and had lower white blood cell and platelet counts than those without ICCs, but had similar clinical disease severity upon admission. In-hospital mortality from COVID-19 was higher (11.4% vs. 4.6%, p = 0.005) and hospitalization was longer (p = 0.01) in patients with ICCs. New major morbidities upon discharge were not different between those with and without ICC (10.5% vs 13.9%, p = 0.40). In patients with ICC, bacterial co-infection was more common in those with life-threatening COVID-19. CONCLUSIONS: In this national case series of patients <21 years of age with acute COVID-19 admitted for intensive care, existence of a prior ICCs were associated with worse clinical outcomes. Reassuringly, most patients with ICCs hospitalized in the PICU for severe acute COVID-19 survived and were discharged home without new severe morbidities. |
Demographic and travel characteristics and self-reported predeparture SARS-CoV-2 testing behavior in air passengers entering the United States from foreign destinations from July to September 2021
Panasci A , Gearhart S , Shaum A , Simental AJ , Mitchell C , Mitcham D , Williams G , Shake N , Brown C , Gertz AM . Immun Inflamm Dis 2023 11 (12) e1019 INTRODUCTION: From January 2021 to June 2022, the United States Centers for Disease Control and Prevention required predeparture SARS-CoV-2 testing for all air passengers arriving into the United States from a foreign country. METHODS: Using data collected during a surveillance project, we described predeparture testing behavior among a convenience sample of international air passengers entering the United States from July to September 2021 at six US ports of entry. We analyzed pairwise relationships between self-reported test type, test timing, demographic and travel characteristics, and COVID-19 vaccination status using chi-square and Fisher's exact tests. RESULTS: Participants were more likely to get a NAAT versus antigen test if they identified as non-Hispanic Asian or Pacific Islander (68.2%, n = 173), non-Hispanic Black (62.6%, n = 147), or if they preferred not to report race and ethnicity (60.8%, n = 209) when compared to those who identified as non-Hispanic White (47.1%, n = 1086, all p < 0.05). Those who identified as Hispanic or Latino (n = 671) were less likely to get a NAAT than the non-Hispanic White group (39.5% vs. 47.1%, p < 0.05). Participants arriving in the US from the Americas were less likely to get a NAAT (38.5%, n = 871) compared to those arriving from Europe (45.5%, n = 1165, p < 0.05). Participants who reported receiving their predeparture test 2 days or 3 or more days before departure were more likely to report receiving a NAAT (52.2%, n = 879, and 60.2%, n = 410, respectively) than those who reported testing within 1 day (41.4%, n = 1040, all p < 0.001) of departure. DISCUSSION: Test type was significantly associated with race and ethnicity, departure region, and test timing. Differences likely reflected regional disparities in the availability of tests at the time of the activity. Discrepancies in predeparture test timing and type worldwide may have consequences for the effectiveness and equity of travel requirements in future pandemics. |
Characteristics and clinical outcomes of vaccine-eligible US children under-5 years hospitalized for acute COVID-19 in a national network
Zambrano LD , Newhams MM , Simeone RM , Fleming-Dutra KE , Halasa N , Wu M , Orzel-Lockwood AO , Kamidani S , Pannaraj PS , Chiotos K , Cameron MA , Maddux AB , Schuster JE , Crandall H , Kong M , Nofziger RA , Staat MA , Bhumbra SS , Irby K , Boom JA , Sahni LC , Hume JR , Gertz SJ , Maamari M , Bowens C , Levy ER , Bradford TT , Walker TC , Schwartz SP , Mack EH , Guzman-Cottrill JA , Hobbs CV , Zinter MS , Cvijanovich NZ , Bline KE , Hymes SR , Campbell AP , Randolph AG . Pediatr Infect Dis J 2023 BACKGROUND AND OBJECTIVES: In June 2022, the mRNA COVID-19 vaccination was recommended for young children. We examined clinical characteristics and factors associated with vaccination status among vaccine-eligible young children hospitalized for acute COVID-19. METHODS: We enrolled inpatients aged 8 months to <5 years with acute community-acquired COVID-19 across 28 US pediatric hospitals from September 20, 2022 to May 31, 2023. We assessed demographic and clinical factors, including the highest level of respiratory support, and vaccination status defined as unvaccinated, incomplete, or complete primary series [at least 2 (Moderna) or 3 (Pfizer-BioNTech) mRNA vaccine doses ≥14 days before hospitalization]. RESULTS: Among 597 children, 174 (29.1%) patients were admitted to the intensive care unit and 75 (12.6%) had a life-threatening illness, including 51 (8.5%) requiring invasive mechanical ventilation. Children with underlying respiratory and neurologic/neuromuscular conditions more frequently received higher respiratory support. Only 4.5% of children hospitalized for COVID-19 (n = 27) had completed their primary COVID-19 vaccination series and 7.0% (n = 42) of children initiated but did not complete their primary series. Among 528 unvaccinated children, nearly half (n = 251) were previously healthy, 3 of them required extracorporeal membrane oxygenation for acute COVID-19 and 1 died. CONCLUSIONS: Most young children hospitalized for acute COVID-19, including most children admitted to the intensive care unit and with life-threatening illness, had not initiated COVID-19 vaccination despite being eligible. Nearly half of these children had no underlying conditions. Of the small percentage of children who initiated a COVID-19 primary series, most had not completed it before hospitalization. |
Risk factors for health impairments in children after hospitalization for acute COVID-19 or MIS-C
Maddux AB , Young CC , Kucukak S , Zambrano LD , Newhams MM , Rollins CK , Halasa NB , Gertz SJ , Mack EH , Schwartz S , Kong M , Loftis LL , Irby K , Rowan CM , Tarquinio KM , Zinter MS , Crandall H , Cvijanovich NZ , Schuster JE , Fitzgerald JC , Staat MA , Hobbs CV , Nofziger RA , Shein S , Flori H , Cullimore ML , Chatani BM , Levy ER , Typpo KV , Hume JR , Campbell AP , Randolph AG . Front Pediatr 2023 11 1260372 OBJECTIVE: To identify risk factors for persistent impairments after pediatric hospitalization for acute coronavirus disease 2019 (COVID-19) or multisystem inflammatory syndrome in children (MIS-C) during the SARS-CoV-2 pandemic. METHODS: Across 25 U.S. Overcoming COVID-19 Network hospitals, we conducted a prospective cohort study of patients <21-years-old hospitalized for acute COVID-19 or MIS-C (May 2020 to March 2022) surveyed 2- to 4-months post-admission. Multivariable regression was used to calculate adjusted risk ratios (aRR) and 95% confidence intervals (CI). RESULTS: Of 232 children with acute COVID-19, 71 (30.6%) had persistent symptoms and 50 (21.6%) had activity impairments at follow-up; for MIS-C (n = 241), 56 (23.2%) had persistent symptoms and 58 (24.1%) had activity impairments. In adjusted analyses of patients with acute COVID-19, receipt of mechanical ventilation was associated with persistent symptoms [aRR 1.83 (95% CI: 1.07, 3.13)] whereas obesity [aRR 2.18 (95% CI: 1.05, 4.51)] and greater organ system involvement [aRR 1.35 (95% CI: 1.13, 1.61)] were associated with activity impairment. For patients with MIS-C, having a pre-existing respiratory condition was associated with persistent symptoms [aRR 3.04 (95% CI: 1.70, 5.41)] whereas obesity [aRR 1.86 (95% CI: 1.09, 3.15)] and greater organ system involvement [aRR 1.26 (1.00, 1.58)] were associated with activity impairments. DISCUSSION: Among patients hospitalized, nearly one in three hospitalized with acute COVID-19 and one in four hospitalized with MIS-C had persistent impairments for ≥2 months post-hospitalization. Persistent impairments were associated with more severe illness and underlying health conditions, identifying populations to target for follow-up. |
Effectiveness of maternal mRNA COVID-19 vaccination during pregnancy against COVID-19-associated hospitalizations in infants aged <6 months during SARS-cov-2 Omicron predominance - 20 states, March 9, 2022-May 31, 2023
Simeone RM , Zambrano LD , Halasa NB , Fleming-Dutra KE , Newhams MM , Wu MJ , Orzel-Lockwood AO , Kamidani S , Pannaraj PS , Irby K , Maddux AB , Hobbs CV , Cameron MA , Boom JA , Sahni LC , Kong M , Nofziger RA , Schuster JE , Crandall H , Hume JR , Staat MA , Mack EH , Bradford TT , Heidemann SM , Levy ER , Gertz SJ , Bhumbra SS , Walker TC , Bline KE , Michelson KN , Zinter MS , Flori HR , Campbell AP , Randolph AG . MMWR Morb Mortal Wkly Rep 2023 72 (39) 1057-1064 Infants aged <6 months are not eligible for COVID-19 vaccination. Vaccination during pregnancy has been associated with protection against infant COVID-19-related hospitalization. The Overcoming COVID-19 Network conducted a case-control study during March 9, 2022-May 31, 2023, to evaluate the effectiveness of maternal receipt of a COVID-19 vaccine dose (vaccine effectiveness [VE]) during pregnancy against COVID-19-related hospitalization in infants aged <6 months and a subset of infants aged <3 months. VE was calculated as (1 - adjusted odds ratio) x 100% among all infants aged <6 months and <3 months. Case-patients (infants hospitalized for COVID-19 outside of birth hospitalization and who had a positive SARS-CoV-2 test result) and control patients (infants hospitalized for COVID-19-like illness with a negative SARS-CoV-2 test result) were compared. Odds ratios were determined using multivariable logistic regression, comparing the odds of receipt of a maternal COVID-19 vaccine dose (completion of a 2-dose vaccination series or a third or higher dose) during pregnancy with maternal nonvaccination between case- and control patients. VE of maternal vaccination during pregnancy against COVID-19-related hospitalization was 35% (95% CI = 15%-51%) among infants aged <6 months and 54% (95% CI = 32%-68%) among infants aged <3 months. Intensive care unit admissions occurred in 23% of all case-patients, and invasive mechanical ventilation was more common among infants of unvaccinated (9%) compared with vaccinated mothers (1%) (p = 0.02). Maternal vaccination during pregnancy provides some protection against COVID-19-related hospitalizations among infants, particularly those aged <3 months. Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19. |
Infants admitted to US intensive care units for RSV infection during the 2022 seasonal peak
Halasa N , Zambrano LD , Amarin JZ , Stewart LS , Newhams MM , Levy ER , Shein SL , Carroll CL , Fitzgerald JC , Michaels MG , Bline K , Cullimore ML , Loftis L , Montgomery VL , Jeyapalan AS , Pannaraj PS , Schwarz AJ , Cvijanovich NZ , Zinter MS , Maddux AB , Bembea MM , Irby K , Zerr DM , Kuebler JD , Babbitt CJ , Gaspers MG , Nofziger RA , Kong M , Coates BM , Schuster JE , Gertz SJ , Mack EH , White BR , Harvey H , Hobbs CV , Dapul H , Butler AD , Bradford TT , Rowan CM , Wellnitz K , Staat MA , Aguiar CL , Hymes SR , Randolph AG , Campbell AP . JAMA Netw Open 2023 6 (8) e2328950 IMPORTANCE: Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) and infant hospitalization worldwide. OBJECTIVE: To evaluate the characteristics and outcomes of RSV-related critical illness in US infants during peak 2022 RSV transmission. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used a public health prospective surveillance registry in 39 pediatric hospitals across 27 US states. Participants were infants admitted for 24 or more hours between October 17 and December 16, 2022, to a unit providing intensive care due to laboratory-confirmed RSV infection. EXPOSURE: Respiratory syncytial virus. MAIN OUTCOMES AND MEASURES: Data were captured on demographics, clinical characteristics, signs and symptoms, laboratory values, severity measures, and clinical outcomes, including receipt of noninvasive respiratory support, invasive mechanical ventilation, vasopressors or extracorporeal membrane oxygenation, and death. Mixed-effects multivariable log-binomial regression models were used to assess associations between intubation status and demographic factors, gestational age, and underlying conditions, including hospital as a random effect to account for between-site heterogeneity. RESULTS: The first 15 to 20 consecutive eligible infants from each site were included for a target sample size of 600. Among the 600 infants, the median (IQR) age was 2.6 (1.4-6.0) months; 361 (60.2%) were male, 169 (28.9%) were born prematurely, and 487 (81.2%) had no underlying medical conditions. Primary reasons for admission included LRTI (594 infants [99.0%]) and apnea or bradycardia (77 infants [12.8%]). Overall, 143 infants (23.8%) received invasive mechanical ventilation (median [IQR], 6.0 [4.0-10.0] days). The highest level of respiratory support for nonintubated infants was high-flow nasal cannula (243 infants [40.5%]), followed by bilevel positive airway pressure (150 infants [25.0%]) and continuous positive airway pressure (52 infants [8.7%]). Infants younger than 3 months, those born prematurely (gestational age <37 weeks), or those publicly insured were at higher risk for intubation. Four infants (0.7%) received extracorporeal membrane oxygenation, and 2 died. The median (IQR) length of hospitalization for survivors was 5 (4-10) days. CONCLUSIONS AND RELEVANCE: In this cross-sectional study, most US infants who required intensive care for RSV LRTIs were young, healthy, and born at term. These findings highlight the need for RSV preventive interventions targeting all infants to reduce the burden of severe RSV illness. |
The modified clinical progression scale for pediatric patients: Evaluation as a severity metric and outcome measure in severe acute viral respiratory illness
Leland SB , Staffa SJ , Newhams MM , Khemani RG , Marshall JC , Young CC , Maddux AB , Hall MW , Weiss SL , Schwarz AJ , Coates BM , Sanders RC Jr , Kong M , Thomas NJ , Nofziger RA , Cullimore ML , Halasa NB , Loftis LL , Cvijanovich NZ , Schuster JE , Flori H , Gertz SJ , Hume JR , Olson SM , Patel MM , Zurakowski D , Randolph AG . Pediatr Crit Care Med 2023 24 (12) 998-1009 OBJECTIVES: To develop, evaluate, and explore the use of a pediatric ordinal score as a potential clinical trial outcome metric in children hospitalized with acute hypoxic respiratory failure caused by viral respiratory infections. DESIGN: We modified the World Health Organization Clinical Progression Scale for pediatric patients (CPS-Ped) and assigned CPS-Ped at admission, days 2-4, 7, and 14. We identified predictors of clinical improvement (day 14 CPS-Ped ≤ 2 or a three-point decrease) using competing risks regression and compared clinical improvement to hospital length of stay (LOS) and ventilator-free days. We estimated sample sizes (80% power) to detect a 15% clinical improvement. SETTING: North American pediatric hospitals. PATIENTS: Three cohorts of pediatric patients with acute hypoxic respiratory failure receiving intensive care: two influenza (pediatric intensive care influenza [PICFLU], n = 263, 31 sites; PICFLU vaccine effectiveness [PICFLU-VE], n = 143, 17 sites) and one COVID-19 (n = 237, 47 sites). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Invasive mechanical ventilation rates were 71.4%, 32.9%, and 37.1% for PICFLU, PICFLU-VE, and COVID-19 with less than 5% mortality for all three cohorts. Maximum CPS-Ped (0 = home at respiratory baseline to 8 = death) was positively associated with hospital LOS (p < 0.001, all cohorts). Across the three cohorts, many patients' CPS-Ped worsened after admission (39%, 18%, and 49%), with some patients progressing to invasive mechanical ventilation or death (19%, 11%, and 17%). Despite this, greater than 76% of patients across cohorts clinically improved by day 14. Estimated sample sizes per group using CPS-Ped to detect a percentage increase in clinical improvement were feasible (influenza 15%, n = 142; 10%, n = 225; COVID-19, 15% n = 208) compared with mortality (n > 21,000, all), and ventilator-free days (influenza 15%, n = 167). CONCLUSIONS: The CPS-Ped can be used to describe the time course of illness and threshold for clinical improvement in hospitalized children and adolescents with acute respiratory failure from viral infections. This outcome measure could feasibly be used in clinical trials to evaluate in-hospital recovery. |
A distinct cross-reactive autoimmune response in multisystem inflammatory syndrome in children (MIS-C) (preprint)
Bodansky A , Sabatino JJ , Vazquez SE , Chou J , Novak T , Moffitt KL , Miller HS , Kung AF , Rackaityte E , Zamecnik CR , Rajan JV , Kortbawi H , Mandel-Brehm C , Mitchell A , Wang CY , Saxena A , Zorn K , Yu DJL , Asaki J , Pluvinage JV , Wilson MR , Loftis LL , Hobbs CV , Tarquinio KM , Kong M , Fitzgerald JC , Espinal PS , Walker TC , Schwartz SP , Crandall H , Irby K , Staat MA , Rowan CM , Schuster JE , Halasa NB , Gertz SJ , Mack EH , Maddux AB , Cvijanovich NZ , Zinter MS , Zambrano LD , Campbell AP , Randolph AG , Anderson MS , DeRisi JL , Kelley H , Murdock M , Colston C , Typpo KV , Sanders RC , Yates M , Smith C , Port E , Mansour R , Shankman S , Baig N , Zorensky F , Chatani B , McLaughlin G , Jones K , Coates BM , Newhams MM , Kucukak S , McNamara ER , Moon HK , Kobayashi T , Melo J , Jackson SR , Rosales MKE , Young C , Chen SR , Da Costa Aguiar R , Gutierrez-Arcelus M , Elkins M , Williams D , Williams L , Cheng L , Zhang Y , Crethers D , Morley D , Steltz S , Zakar K , Armant MA , Ciuculescu F , Flori HR , Dahmer MK , Levy ER , Behl S , Drapeau NM , Kietzman A , Hill S , Cullimore ML , McCulloh RJ , Nofziger RA , Rohlfs CC , Burnett R , Bush J , Reed N , Ampofo KK , Patel MM . medRxiv 2023 30 Multisystem inflammatory syndrome in children (MIS-C) is a severe, post-infectious sequela of SARS-CoV-2 infection, yet the pathophysiological mechanism connecting the infection to the broad inflammatory syndrome remains unknown. Here we leveraged a large set of MIS-C patient samples (n=199) to identify a distinct set of host proteins that are differentially targeted by patient autoantibodies relative to matched controls. We identified an autoreactive epitope within SNX8, a protein expressed primarily in immune cells which regulates an antiviral pathway associated with MIS-C pathogenesis. In parallel, we also probed the SARS-CoV-2 proteome-wide MIS-C patient antibody response and found it to be differentially reactive to a distinct domain of the SARS-CoV-2 nucleocapsid (N) protein relative to controls. This viral N region and the mapped SNX8 epitope bear remarkable biochemical similarity. Furthermore, we find that many children with anti-SNX8 autoantibodies also have T-cells cross-reactive to both SNX8 and this distinct domain of the SARS-CoV-2 N protein. Together, these findings suggest that MIS-C patients develop a distinct immune response against the SARS-CoV-2 N protein that is associated with cross reactivity to the self-protein SNX8, demonstrating a link from the infection to the inflammatory syndrome. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC 4.0 International license. |
Neurological and psychological sequelae associated with multisystem inflammatory syndrome in children
Rollins CK , Calderon J , Wypij D , Taylor AM , Davalji Kanjiker TS , Rohde JS , Maiman M , Zambrano LD , Newhams MM , Rodriguez S , Hart N , Worhach J , Kucukak S , Poussaint TY , Son MBF , Friedman ML , Gertz SJ , Hobbs CV , Kong M , Maddux AB , McGuire JL , Licht PA , Staat MA , Yonker LM , Mazumdar M , Randolph AG , Campbell AP , Newburger JW . JAMA Netw Open 2023 6 (7) e2324369 IMPORTANCE: Acute neurological involvement occurs in some patients with multisystem inflammatory syndrome in children (MIS-C), but few data report neurological and psychological sequelae, and no investigations include direct assessments of cognitive function 6 to 12 months after discharge. OBJECTIVE: To characterize neurological, psychological, and quality of life sequelae after MIS-C. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional cohort study was conducted in the US and Canada. Participants included children with MIS-C diagnosed from November 2020 through November 2021, 6 to 12 months after hospital discharge, and their sibling or community controls, when available. Data analysis was performed from August 2022 to May 2023. EXPOSURE: Diagnosis of MIS-C. MAIN OUTCOMES AND MEASURES: A central study site remotely administered a onetime neurological examination and in-depth neuropsychological assessment including measures of cognition, behavior, quality of life, and daily function. Generalized estimating equations, accounting for matching, assessed for group differences. RESULTS: Sixty-four patients with MIS-C (mean [SD] age, 11.5 [3.9] years; 20 girls [31%]) and 44 control participants (mean [SD] age, 12.6 [3.7] years; 20 girls [45%]) were enrolled. The MIS-C group exhibited abnormalities on neurological examination more frequently than controls (15 of 61 children [25%] vs 3 of 43 children [7%]; odds ratio, 4.7; 95% CI, 1.3-16.7). Although the 2 groups performed similarly on most cognitive measures, the MIS-C group scored lower on the National Institutes of Health Cognition Toolbox List Sort Working Memory Test, a measure of executive functioning (mean [SD] scores, 96.1 [14.3] vs 103.1 [10.5]). Parents reported worse psychological outcomes in cases compared with controls, particularly higher scores for depression symptoms (mean [SD] scores, 52.6 [13.1] vs 47.8 [9.4]) and somatization (mean [SD] scores, 55.5 [15.5] vs 47.0 [7.6]). Self-reported (mean [SD] scores, 79.6 [13.1] vs 85.5 [12.3]) and parent-reported (mean [SD] scores, 80.3 [15.5] vs 88.6 [13.0]) quality of life scores were also lower in cases than controls. CONCLUSIONS AND RELEVANCE: In this cohort study, compared with contemporaneous sibling or community controls, patients with MIS-C had more abnormal neurologic examinations, worse working memory scores, more somatization and depression symptoms, and lower quality of life 6 to 12 months after hospital discharge. Although these findings need to be confirmed in larger studies, enhanced monitoring may be warranted for early identification and treatment of neurological and psychological symptoms. |
SARS-CoV-2 cases reported on international arriving and domestic flights: United States, January 2020-December 2021
Preston LE , Rey A , Dumas S , Rodriguez A , Gertz AM , Delea KC , Alvarado-Ramy F , Christensen DL , Brown C , Chen TH . Am J Public Health 2023 113 (8) e1-e5 Objectives. To describe trends in the number of air travelers categorized as infectious with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2; the virus that causes COVID-19) in the context of total US COVID-19 vaccinations administered, and overall case counts of SARS-CoV-2 in the United States. Methods. We searched the Quarantine Activity Reporting System (QARS) database for travelers with inbound international or domestic air travel, a positive SARS-CoV-2 lab result, and a surveillance categorization of SARS-CoV-2 infection reported during January 2020 to December 2021. Travelers were categorized as infectious during travel if they had arrival dates from 2 days before to 10 days after symptom onset or a positive viral test. Results. We identified 80 715 persons meeting our inclusion criteria; 67 445 persons (83.6%) had at least 1 symptom reported. Of 67 445 symptomatic passengers, 43 884 (65.1%) reported an initial symptom onset date after their flight arrival date. The number of infectious travelers mirrored the overall number of US SARS-CoV-2 cases. Conclusions. Most travelers in the study were asymptomatic during travel, and therefore unknowingly traveled while infectious. During periods of high community transmission, it is important for travelers to stay up to date with COVID-19 vaccinations and consider wearing a high-quality mask to decrease the risk of transmission. (Am J Public Health. Published online ahead of print June 15, 2023:e1-e5. https://doi.org/10.2105/AJPH.2023.307325). |
Effectiveness of Pfizer-BioNTech mRNA Vaccination Against COVID-19 Hospitalization Among Persons Aged 12-18 Years - United States, June-September 2021.
Olson SM , Newhams MM , Halasa NB , Price AM , Boom JA , Sahni LC , Irby K , Walker TC , Schwartz SP , Pannaraj PS , Maddux AB , Bradford TT , Nofziger RA , Boutselis BJ , Cullimore ML , Mack EH , Schuster JE , Gertz SJ , Cvijanovich NZ , Kong M , Cameron MA , Staat MA , Levy ER , Chatani BM , Chiotos K , Zambrano LD , Campbell AP , Patel MM , Randolph AG , Overcoming COVID-19 Investigators . MMWR Morb Mortal Wkly Rep 2021 70 (42) 1483-1488 Pfizer-BioNTech COVID-19 vaccine is authorized for use in children and adolescents aged 12-15 years and is licensed by the Food and Drug Administration (FDA) for persons aged ≥16 (1). A randomized placebo-controlled trial demonstrated an efficacy of 100% (95% confidence interval [CI] = 75.3%-100%) in preventing outpatient COVID-19 in persons aged 12-15 years (2); however, data among adolescents on vaccine effectiveness (VE) against COVID-19 in real-world settings are limited, especially among hospitalized patients. In early September 2021, U.S. pediatric COVID-19 hospitalizations reached the highest level during the pandemic (3,4). In a test-negative, case-control study at 19 pediatric hospitals in 16 states during June 1-September 30, 2021, the effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization was assessed among children and adolescents aged 12-18 years. Among 464 hospitalized persons aged 12-18 years (179 case-patients and 285 controls), the median age was 15 years, 72% had at least one underlying condition, including obesity, and 68% attended in-person school. Effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization was 93% (95% CI = 83%-97%), during the period when B.1.617.2 (Delta) was the predominant variant. This evaluation demonstrated that 2 doses of Pfizer-BioNTech vaccine are highly effective at preventing COVID-19 hospitalization among persons aged 12-18 years and reinforces the importance of vaccination to protect U.S. youths against severe COVID-19. |
Clinical course associated with aseptic meningitis induced by intravenous immunoglobulin for the treatment of multisystem inflammatory syndrome in children
Young CC , LaRovere KL , Newhams MM , Kucukak S , Gertz SJ , Maddux AB , Halasa NB , Crandall H , Kong M , Fitzgerald JC , Irby K , Randolph AG , Campbell AP , Son MBF . J Pediatr 2023 257 113372 Aseptic meningitis is a rare but potentially serious complication of intravenous immunoglobulin (IVIG) treatment. In this case series, meningitic symptoms following IVIG initiation in patients with multisystem inflammatory syndrome were rare (7/2,086 [0.3%]). However, they required the need for additional therapy and/or readmission. |
NFKB2 haploinsufficiency identified via screening for IFNα2 autoantibodies in children and adolescents hospitalized with SARS-CoV-2-related complications.
Bodansky A , Vazquez SE , Chou J , Novak T , Al-Musa A , Young C , Newhams M , Kucukak S , Zambrano LD , Mitchell A , Wang CY , Moffitt K , Halasa NB , Loftis LL , Schwartz SP , Walker TC , Mack EH , Fitzgerald JC , Gertz SJ , Rowan CM , Irby K , Sanders RC Jr , Kong M , Schuster JE , Staat MA , Zinter MS , Cvijanovich NZ , Tarquinio KM , Coates BM , Flori HR , Dahmer MK , Crandall H , Cullimore ML , Levy ER , Chatani B , Nofziger R , Geha RS , DeRisi J , Campbell AP , Anderson M , Randolph AG . J Allergy Clin Immunol 2023 151 (4) 926-930.e2 BACKGROUND: Autoantibodies against type I IFNs occur in approximately 10% of adults with life-threatening coronavirus disease 2019 (COVID-19). The frequency of anti-IFN autoantibodies in children with severe sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is unknown. OBJECTIVE: We quantified anti-type I IFN autoantibodies in a multicenter cohort of children with severe COVID-19, multisystem inflammatory syndrome in children (MIS-C), and mild SARS-CoV-2 infections. METHODS: Circulating anti-IFN-α2 antibodies were measured by a radioligand binding assay. Whole-exome sequencing, RNA sequencing, and functional studies of peripheral blood mononuclear cells were used to study any patients with levels of anti-IFN-α2 autoantibodies exceeding the assay's positive control. RESULTS: Among 168 patients with severe COVID-19, 199 with MIS-C, and 45 with mild SARS-CoV-2 infections, only 1 had high levels of anti-IFN-α2 antibodies. Anti-IFN-α2 autoantibodies were not detected in patients treated with intravenous immunoglobulin before sample collection. Whole-exome sequencing identified a missense variant in the ankyrin domain of NFKB2, encoding the p100 subunit of nuclear factor kappa-light-chain enhancer of activated B cells, aka NF-κB, essential for noncanonical NF-κB signaling. The patient's peripheral blood mononuclear cells exhibited impaired cleavage of p100 characteristic of NFKB2 haploinsufficiency, an inborn error of immunity with a high prevalence of autoimmunity. CONCLUSIONS: High levels of anti-IFN-α2 autoantibodies in children and adolescents with MIS-C, severe COVID-19, and mild SARS-CoV-2 infections are rare but can occur in patients with inborn errors of immunity. |
Association of asthma with treatments and outcomes in children with critical influenza
Maddux AB , Grunwell JR , Newhams MM , Chen SR , Olson SM , Halasa NB , Weiss SL , Coates BM , Schuster JE , Hall MW , Nofziger RA , Flori HR , Gertz SJ , Kong M , Sanders RCJr , Irby K , Hume JR , Cullimore ML , Shein SL , Thomas NJ , Miller K , Patel M , Fitzpatrick AM , Phipatanakul W , Randolph AG . J Allergy Clin Immunol Pract 2022 11 (3) 836-843 e3 BACKGROUND: Hospitalization for severe influenza infection in childhood may result in post-discharge sequelae. OBJECTIVE(S): To evaluate inpatient management and post-discharge sequelae in children with critical respiratory illness due to influenza with or without pre-existing asthma. METHODS: Prospective, observational multicenter study of children (8-months to 17-years-old) admitted to a pediatric intensive care or high-acuity unit (11/2019-4/2020) for influenza. Results were stratified by pre-existing asthma. Pre-hospital status, hospital treatments and outcomes were collected. Surveys at approximately 90 days post-discharge evaluated post-discharge health resource use, functional status, and respiratory symptoms. RESULTS: 165 children with influenza: 56 (33.9%) with and 109 (66.1%) without pre-existing asthma (41.1% and 39.4% fully vaccinated against influenza, respectively). Fifteen (26.7%) patients with and 34 (31.1%) without pre-existing asthma were intubated. More patients with versus without pre-existing asthma received pharmacologic asthma treatments during hospitalization (76.7% vs 28.4%). Of 136 (82.4%) patients with 90-day survey data (46 [33.8%] with and 90 [66.1%] without pre-existing asthma), a similar proportion had an Emergency Department/urgent care visit (4.3%, 6.6%) or hospital readmission (8.6%, 3.3%) for a respiratory condition. Patients with pre-existing asthma more frequently experienced asthma symptoms (78.2% vs 3.3%) and had respiratory specialist visits (52% vs 20%) post-discharge. Ten of 109 (11.1%) patients without pre-existing asthma reported being newly diagnosed with asthma. CONCLUSIONS: Respiratory health resource use and symptoms are important post-discharge outcomes after influenza critical illness in children with and without pre-existing asthma. Less than half of children were vaccinated for influenza, a tool that could mitigate critical illness and its sequelae. |
Changes in Distribution of Severe Neurologic Involvement in US Pediatric Inpatients With COVID-19 or Multisystem Inflammatory Syndrome in Children in 2021 vs 2020.
LaRovere KL , Poussaint TY , Young CC , Newhams MM , Kucukak S , Irby K , Kong M , Schwartz SP , Walker TC , Bembea MM , Wellnitz K , Havlin KM , Cvijanovich NZ , Hall MW , Fitzgerald JC , Schuster JE , Hobbs CV , Halasa NB , Singh AR , Mack EH , Bradford TT , Gertz SJ , Schwarz AJ , Typpo KV , Loftis LL , Giuliano JSJr , Horwitz SM , Biagas KV , Clouser KN , Rowan CM , Maddux AB , Soma VL , Babbitt CJ , Aguiar CL , Kolmar AR , Heidemann SM , Harvey H , Zambrano LD , Campbell AP , Randolph AG . JAMA Neurol 2022 80 (1) 91-98 IMPORTANCE: In 2020 during the COVID-19 pandemic, neurologic involvement was common in children and adolescents hospitalized in the United States for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related complications. OBJECTIVE: To provide an update on the spectrum of SARS-CoV-2-related neurologic involvement among children and adolescents in 2021. DESIGN, SETTING, AND PARTICIPANTS: Case series investigation of patients reported to public health surveillance hospitalized with SARS-CoV-2-related illness between December 15, 2020, and December 31, 2021, in 55 US hospitals in 31 states with follow-up at hospital discharge. A total of 2253 patients were enrolled during the investigation period. Patients suspected of having multisystem inflammatory syndrome in children (MIS-C) who did not meet criteria (n=85) were excluded. Patients (<21 years) with positive SARS-CoV-2 test results (reverse transcriptase-polymerase chain reaction and/or antibody) meeting criteria for MIS-C or acute COVID-19 were included in the analysis. EXPOSURE: SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES: Patients with neurologic involvement had acute neurologic signs, symptoms, or diseases on presentation or during hospitalization. Life-threatening neurologic involvement was adjudicated by experts based on clinical and/or neuroradiological features. Type and severity of neurologic involvement, laboratory and imaging data, vaccination status, and hospital discharge outcomes (death or survival with new neurologic deficits). RESULTS: Of 2168 patients included (58% male; median age, 10.3 years), 1435 (66%) met criteria for MIS-C, and 476 (22%) had documented neurologic involvement. Patients with neurologic involvement vs without were older (median age, 12 vs 10 years) and more frequently had underlying neurologic disorders (107 of 476 [22%] vs 240 of 1692 [14%]). Among those with neurologic involvement, 42 (9%) developed acute SARS-CoV-2-related life-threatening conditions, including central nervous system infection/demyelination (n=23; 15 with possible/confirmed encephalitis, 6 meningitis, 1 transverse myelitis, 1 nonhemorrhagic leukoencephalopathy), stroke (n=11), severe encephalopathy (n=5), acute fulminant cerebral edema (n=2), and Guillain-Barr syndrome (n=1). Ten of 42 (24%) survived with new neurologic deficits at discharge and 8 (19%) died. Among patients with life-threatening neurologic conditions, 15 of 16 vaccine-eligible patients (94%) were unvaccinated. CONCLUSIONS AND RELEVANCE: SARS-CoV-2-related neurologic involvement persisted in US children and adolescents hospitalized for COVID-19 or MIS-C in 2021 and was again mostly transient. Central nervous system infection/demyelination accounted for a higher proportion of life-threatening conditions, and most vaccine-eligible patients were unvaccinated. COVID-19 vaccination may prevent some SARS-CoV-2-related neurologic complications and merits further study. |
Factors associated with COVID-19 non-vaccination in adolescents hospitalized without COVID-19.
Sahni LC , Price AM , Olson SM , Newhams MM , Pannaraj PS , Maddux AB , Halasa NB , Bline KE , Cameron MA , Schwartz SP , Walker TC , Irby K , Chiotos K , Nofziger RA , Mack EH , Smallcomb L , Bradford TT , Kamidani S , Tarquinio KM , Cvijanovich NZ , Schuster JE , Bhumbra SS , Levy ER , Hobbs CV , Cullimore ML , Coates BM , Heidemann SM , Gertz SJ , Kong M , Flori HR , Staat MA , Zinter MS , Hume JR , Chatani BM , Gaspers MG , Maamari M , Randolph AG , Patel MM , Boom JA . J Pediatric Infect Dis Soc 2022 12 (1) 29-35 BACKGROUND: Pfizer-BioNTech COVID-19 vaccine received emergency use authorization for persons ≥16 years in December 2020 and for adolescents 12-15 years in May 2021. Despite the clear benefits and favorable safety profile, vaccine uptake in adolescents has been suboptimal. We sought to assess factors associated with COVID-19 non-vaccination in adolescents 12-18 years of age. METHODS: Between June 1, 2021 and April 29, 2022, we assessed factors associated with COVID-19 non-vaccination in hospitalized adolescents ages 12-18 years enrolled in the Overcoming COVID-19 vaccine effectiveness network. Demographic characteristics and clinical information were captured through parent interview and/or electronic medical record abstraction; COVID-19 vaccination was assessed through documented sources. We assessed associations between receipt of COVID-19 vaccine and demographic and clinical factors using univariate and multivariable logistic regression and estimated adjusted odds ratios (aOR) for each factor associated with non-vaccination. RESULTS: Among 1,665 hospitalized adolescents without COVID-19, 56% were unvaccinated. Unvaccinated adolescents were younger (median age 15.1 years vs. 15.4 years, p<0.01) and resided in areas with higher social vulnerability index (SVI) scores (median 0.6 vs 0.5, p<0.001) than vaccinated adolescents. Residence in the Midwest [aOR 2.60 (95% CI: 1.80, 3.79)] or South [aOR 2.49 (95% CI: 1.77, 3.54)] US census regions, rarely or never receiving influenza vaccine [aOR 5.31 (95% CI: 3.81, 7.47)], and rarely or never taking precautions against COVID-19 [aOR 3.17 (95% CI: 1.94, 5.31)] were associated with non-vaccination against COVID-19. CONCLUSIONS: Efforts to increase COVID-19 vaccination of adolescents should focus on persons with geographic, socioeconomic, and medical risk factors associated with non-vaccination. |
Tachyarrhythmias During Hospitalization for COVID-19 or Multisystem Inflammatory Syndrome in Children and Adolescents.
Dionne A , Friedman KG , Young CC , Newhams MM , Kucukak S , Jackson AM , Fitzgerald JC , Smallcomb LS , Heidemann S , McLaughlin GE , Irby K , Bradford TT , Horwitz SM , Loftis LL , Soma VL , Rowan CM , Kong M , Halasa NB , Tarquinio KM , Schwarz AJ , Hume JR , Gertz SJ , Clouser KN , Carroll CL , Wellnitz K , Cullimore ML , Doymaz S , Levy ER , Typpo KV , Lansell AN , Butler AD , Kuebler JD , Zambrano LD , Campbell AP , Patel MM , Randolph AG , Newburger JW . J Am Heart Assoc 2022 11 (20) e025915 Background Cardiac complications related to COVID-19 in children and adolescents include ventricular dysfunction, myocarditis, coronary artery aneurysm, and bradyarrhythmias, but tachyarrhythmias are less understood. The goal of this study was to evaluate the frequency, characteristics, and outcomes of children and adolescents experiencing tachyarrhythmias while hospitalized for acute severe COVID-19 or multisystem inflammatory syndrome in children. Methods and Results This study involved a case series of 63 patients with tachyarrhythmias reported in a public health surveillance registry of patients aged <21 years hospitalized from March 15, 2020, to December 31, 2021, at 63 US hospitals. Patients with tachyarrhythmias were compared with patients with severe COVID-19-related complications without tachyarrhythmias. Tachyarrhythmias were reported in 22 of 1257 patients (1.8%) with acute COVID-19 and 41 of 2343 (1.7%) patients with multisystem inflammatory syndrome in children. They included supraventricular tachycardia in 28 (44%), accelerated junctional rhythm in 9 (14%), and ventricular tachycardia in 38 (60%); >1 type was reported in 12 (19%). Registry patients with versus without tachyarrhythmia were older (median age, 15.4 [range, 10.4-17.4] versus 10.0 [range, 5.4-14.8] years) and had higher illness severity on hospital admission. Intervention for treatment of tachyarrhythmia was required in 37 (59%) patients and included antiarrhythmic medication (n=31, 49%), electrical cardioversion (n=11, 17%), cardiopulmonary resuscitation (n=8, 13%), and extracorporeal membrane oxygenation (n=9, 14%). Patients with tachyarrhythmias had longer hospital length of stay than those who did not, and 9 (14%) versus 77 (2%) died. Conclusions Tachyarrhythmias were a rare complication of acute severe COVID-19 and multisystem inflammatory syndrome in children and adolescents and were associated with worse clinical outcomes, highlighting the importance of close monitoring, aggressive treatment, and postdischarge care. |
BNT162b2 mRNA Vaccination Against COVID-19 is Associated with Decreased Likelihood of Multisystem Inflammatory Syndrome in U.S. Children Ages 5-18 Years.
Zambrano LD , Newhams MM , Olson SM , Halasa NB , Price AM , Orzel AO , Young CC , Boom JA , Sahni LC , Maddux AB , Bline KE , Kamidani S , Tarquinio KM , Chiotos K , Schuster JE , Cullimore ML , Heidemann SM , Hobbs CV , Nofziger RA , Pannaraj PS , Cameron MA , Walker TC , Schwartz SP , Michelson KN , Coates BM , Flori HR , Mack EH , Smallcomb L , Gertz SJ , Bhumbra SS , Bradford TT , Levy ER , Kong M , Irby K , Cvijanovich NZ , Zinter MS , Bowens C , Crandall H , Hume JR , Patel MM , Campbell AP , Randolph AG . Clin Infect Dis 2022 76 (3) e90-e100 BACKGROUND: Multisystem inflammatory syndrome in children (MIS-C), linked to antecedent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is associated with considerable morbidity. Prevention of SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19) by vaccination might also decrease MIS-C likelihood. METHODS: In a multicenter case-control public health investigation of children ages 5-18 years hospitalized from July 1, 2021 to April 7, 2022, we compared the odds of being fully vaccinated (two doses of BNT162b2 vaccine 28 days before hospital admission) between MIS-C case-patients and hospital-based controls who tested negative for SARS-CoV-2. These associations were examined by age group, timing of vaccination, and periods of Delta and Omicron variant predominance using multivariable logistic regression. RESULTS: We compared 304 MIS-C case-patients (280 [92%] unvaccinated) with 502 controls (346 [69%] unvaccinated). MIS-C was associated with decreased likelihood of vaccination (aOR, 0.16 95% CI, 0.10-0.26), including among children ages 5-11 years (aOR, 0.22 95% CI, 0.10-0.52), ages 12-18 years (aOR, 0.10 95% CI, 0.05-0.19), and during the Delta (aOR, 0.06 95% CI, 0.02-0.15) and Omicron (aOR, 0.22 95% CI, 0.11-0.42) variant-predominant periods. This association persisted beyond 120 days after the second dose (aOR, 0.08, 95% CI, 0.03-0.22) in 12-18 year-olds. Among all MIS-C case-patients, 187 (62%) required intensive care unit admission and 280 (92%) vaccine-eligible patients were unvaccinated. CONCLUSIONS: Vaccination with two doses of BNT162b2 is associated with reduced likelihood of MIS-C in children ages 5-18 years. Most vaccine eligible hospitalized patients with MIS-C were unvaccinated. |
Health Impairments in Children and Adolescents After Hospitalization for Acute COVID-19 or MIS-C.
Maddux AB , Berbert L , Young CC , Feldstein LR , Zambrano LD , Kucukak S , Newhams MM , Miller K , FitzGerald MM , He J , Halasa NB , Cvijanovich NZ , Loftis LL , Walker TC , Schwartz SP , Gertz SJ , Tarquinio KM , Fitzgerald JC , Kong M , Schuster JE , Mack EH , Hobbs CV , Rowan CM , Staat MA , Zinter MS , Irby K , Crandall H , Flori H , Cullimore ML , Nofziger RA , Shein SL , Gaspers MG , Hume JR , Levy ER , Chen SR , Patel MM , Tenforde MW , Weller E , Campbell AP , Randolph AG . Pediatrics 2022 150 (3) OBJECTIVE: To evaluate risk factors for post-discharge sequelae in children and adolescents after hospitalization for acute COVID-19 or multisystem inflammatory syndrome in children (MIS-C). METHODS: Multicenter prospective observational cohort study conducted in 25 US pediatric hospitals. Patients <21-years-old, hospitalized May 2020 to May 2021 for acute COVID-19 or MIS-C with follow-up 2-4 months after admission. We assessed readmissions, caregiver-reported persistent symptoms or activity impairment, and new morbidities identified by the Functional Status Scale. Multivariable regression was used to calculate adjusted risk ratios (aRR). RESULTS: Of 358 eligible patients, 2-4 month survey data were available for 119/155 (76.8%) with acute COVID-19 and 160/203 (78.8%) with MIS-C. Thirteen (11%) patients with acute COVID-19 and 12 (8%) with MIS-C had a readmission. Thirty-two (26.9%) patients with acute COVID-19 had persistent symptoms (22.7%) or activity impairment (14.3%) and 48 (30.0%) patients with MIS-C had persistent symptoms (20.0%) or activity impairment (21.3%). For patients with acute COVID-19, persistent symptoms (aRR, 1.29[95% CI, 1.04-1.59]) and activity impairment (aRR, 1.37[95% CI, 1.06-1.78]) were associated with more organs systems involved. Patients with MIS-C and pre-existing respiratory conditions more frequently had persistent symptoms (aRR, 3.09[95% CI, 1.55-6.14]) and those with obesity more frequently had activity impairment (aRR, 2.52[95% CI, 1.35-4.69]). New morbidities were infrequent (9% COVID-19 and 1% MIS-C). CONCLUSIONS: Over one in four children hospitalized with acute COVID-19 or MIS-C experienced persistent symptoms or activity impairment for at least 2 months. Patients with MIS-C and respiratory conditions or obesity are at higher risk of prolonged recovery. |
Life-Threatening Complications of Influenza versus COVID-19 in U.S. Children.
Halasa NB , Spieker AJ , Young CC , Olson SM , Newhams MM , Amarin JZ , Moffitt KL , Nakamura MM , Levy ER , Soma VL , Talj R , Weiss SL , Fitzgerald JC , Mack EH , Maddux AB , Schuster JE , Coates BM , Hall MW , Schwartz SP , Schwarz AJ , Kong M , Spinella PC , Loftis LL , McLaughlin GE , Hobbs CV , Rowan CM , Bembea MM , Nofziger RA , Babbitt CJ , Bowens C , Flori HR , Gertz SJ , Zinter MS , Giuliano JS , Hume JR , Cvijanovich NZ , Singh AR , Crandall HA , Thomas NJ , Cullimore ML , Patel MM , Randolph AG . Clin Infect Dis 2022 76 (3) e280-e290 BACKGROUND: Clinical differences between critical illness from influenza infection versus coronavirus disease 2019 (COVID-19) have not been well characterized in pediatric patients. METHODS: We compared U.S. children (8 months to 17 years) admitted to the intensive care or high acuity unit with influenza (17 hospitals, 12/19/2019-3/9/2020) or COVID-19 (52 hospitals, 3/15/2020-12/31/2020). We compared demographics, underlying conditions, clinical presentation, severity, and outcomes. Using mixed-effects models, we assessed the odds of death or requiring life-support for influenza versus COVID-19 after adjustment for age, sex, race and Hispanic origin, and underlying conditions including obesity. RESULTS: Children with influenza (n = 179) were younger than those with COVID-19 (n = 381; median 5.2 vs. 13.8 years), less likely to be non-Hispanic black (14.5% vs. 27.6%) or Hispanic (24.0% vs. 36.2%), and less likely to have ≥1 underlying condition (66.4% vs. 78.5%) or be obese (21.4% vs. 42.2%). They were similarly likely to require invasive mechanical ventilation (both 30.2%), vasopressor support (19.6% and 19.9%), or extracorporeal membrane oxygenation (2.2% and 2.9%). Four children with influenza (2.2%) and 11 children with COVID-19 (2.9%) died. The odds of death or requiring life-support in children with influenza vs. COVID-19 were similar (adjusted odds ratio, 1.30 [95% CI: 0.78-2.15; P = 0.32]). Median duration of hospital stay was shorter for influenza than COVID-19 (5 versus 7 days). CONCLUSIONS: Despite differences in demographics and clinical characteristics of children with influenza or COVID-19, the frequency of life-threatening complications was similar. Our findings highlight the importance of implementing prevention measures to reduce transmission and disease severity of influenza and COVID-19. |
Maternal Vaccination and Risk of Hospitalization for Covid-19 among Infants.
Halasa NB , Olson SM , Staat MA , Newhams MM , Price AM , Pannaraj PS , Boom JA , Sahni LC , Chiotos K , Cameron MA , Bline KE , Hobbs CV , Maddux AB , Coates BM , Michelson KN , Heidemann SM , Irby K , Nofziger RA , Mack EH , Smallcomb L , Schwartz SP , Walker TC , Gertz SJ , Schuster JE , Kamidani S , Tarquinio KM , Bhumbra SS , Maamari M , Hume JR , Crandall H , Levy ER , Zinter MS , Bradford TT , Flori HR , Cullimore ML , Kong M , Cvijanovich NZ , Gilboa SM , Polen KN , Campbell AP , Randolph AG , Patel MM . N Engl J Med 2022 387 (2) 109-119 BACKGROUND: Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants. METHODS: We used a case-control test-negative design to assess the effectiveness of maternal vaccination during pregnancy against hospitalization for Covid-19 among infants younger than 6 months of age. Between July 1, 2021, and March 8, 2022, we enrolled infants hospitalized for Covid-19 (case infants) and infants hospitalized without Covid-19 (control infants) at 30 hospitals in 22 states. We estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among case infants and control infants during circulation of the B.1.617.2 (delta) variant (July 1, 2021, to December 18, 2021) and the B.1.1.259 (omicron) variant (December 19, 2021, to March 8, 2022). RESULTS: A total of 537 case infants (181 of whom had been admitted to a hospital during the delta period and 356 during the omicron period; median age, 2 months) and 512 control infants were enrolled and included in the analyses; 16% of the case infants and 29% of the control infants had been born to mothers who had been fully vaccinated against Covid-19 during pregnancy. Among the case infants, 113 (21%) received intensive care (64 [12%] received mechanical ventilation or vasoactive infusions). Two case infants died from Covid-19; neither infant's mother had been vaccinated during pregnancy. The effectiveness of maternal vaccination against hospitalization for Covid-19 among infants was 52% (95% confidence interval [CI], 33 to 65) overall, 80% (95% CI, 60 to 90) during the delta period, and 38% (95% CI, 8 to 58) during the omicron period. Effectiveness was 69% (95% CI, 50 to 80) when maternal vaccination occurred after 20 weeks of pregnancy and 38% (95% CI, 3 to 60) during the first 20 weeks of pregnancy. CONCLUSIONS: Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age. (Funded by the Centers for Disease Control and Prevention.). |
Public health actions to control measles among Afghan evacuees during Operation Allies Welcome - United States, September-November 2021
Masters NB , Mathis AD , Leung J , Raines K , Clemmons NS , Miele K , Balajee SA , Lanzieri TM , Marin M , Christensen DL , Clarke KR , Cruz MA , Gallagher K , Gearhart S , Gertz AM , Grady-Erickson O , Habrun CA , Kim G , Kinzer MH , Miko S , Oberste MS , Petras JK , Pieracci EG , Pray IW , Rosenblum HG , Ross JM , Rothney EE , Segaloff HE , Shepersky LV , Skrobarcek KA , Stadelman AM , Sumner KM , Waltenburg MA , Weinberg M , Worrell MC , Bessette NE , Peake LR , Vogt MP , Robinson M , Westergaard RP , Griesser RH , Icenogle JP , Crooke SN , Bankamp B , Stanley SE , Friedrichs PA , Fletcher LD , Zapata IA , Wolfe HO , Gandhi PH , Charles JY , Brown CM , Cetron MS , Pesik N , Knight NW , Alvarado-Ramy F , Bell M , Talley LE , Rotz LD , Rota PA , Sugerman DE , Gastañaduy PA . MMWR Morb Mortal Wkly Rep 2022 71 (17) 592-596 On August 29, 2021, the United States government oversaw the emergent establishment of Operation Allies Welcome (OAW), led by the U.S. Department of Homeland Security (DHS) and implemented by the U.S. Department of Defense (DoD) and U.S. Department of State (DoS), to safely resettle U.S. citizens and Afghan nationals from Afghanistan to the United States. Evacuees were temporarily housed at several overseas locations in Europe and Asia* before being transported via military and charter flights through two U.S. international airports, and onward to eight U.S. military bases,(†) with hotel A used for isolation and quarantine of persons with or exposed to certain infectious diseases.(§) On August 30, CDC issued an Epi-X notice encouraging public health officials to maintain vigilance for measles among Afghan evacuees because of an ongoing measles outbreak in Afghanistan (25,988 clinical cases reported nationwide during January-November 2021) (1) and low routine measles vaccination coverage (66% and 43% for the first and second doses, respectively, in 2020) (2). |
Risk factors for death and illness in dogs imported into the United States, 2010-2018
Pieracci EG , Maskery B , Stauffer K , Gertz A , Brown C . Transbound Emerg Dis 2022 69 (5) e1749-e1757 CDC estimates 1 million dogs are imported into the United States annually. With the movement of large numbers of animals into the United States the risk of disease importation, especially emerging diseases, and animal welfare issues are of concern. Dogs that arrive to the United States ill or dead are investigated by public health authorities to ensure dogs are not infected with diseases of concern (such as rabies). We identified factors associated with illness and death in imported dogs and estimated the initial investigation cost to public health authorities. Dog importation data from the CDC's Quarantine Activity Reporting System were reviewed from 2010 to 2018. The date of entry, country of origin, port of entry, transportation method and breed were extracted to examine factors associated with illness and death in dogs during international travel. Costs for public health investigations were estimated from data collected by the Bureau of Labor Statistics and Office of Personal Management. Death or illness was more likely to occur in brachycephalic breeds (aOR = 3.88, 95%CI 2.74-5.51). Transportation of dogs via cargo (aOR = 2.41, 95%CI 1.57-3.70) or as checked baggage (aOR = 5.74, 95%CI 3.65-9.03) were also associated with death or illness. On average, 19 dog illnesses or deaths were reported annually from 2010 to 2018. The estimated annual cost to public health authorities to conduct initial public health assessments ranged from $2,071 to $104,648. Current regulations do not provide adequate resources or mechanisms to monitor the rates of morbidity and mortality of imported dogs. There are growing attempts to assess animal welfare and communicable disease importation risks. However, because the responsibility for dogs' health and wellbeing is overseen by multiple agencies it is challenging to coordinate implementation and enforcement measures. A joint federal agency approach to identify interventions that reduce dog morbidity and mortality during flights while continuing to protect US borders from public health and foreign animal disease threats could be beneficial. |
Use of At-Home COVID-19 Tests - United States, August 23, 2021-March 12, 2022.
Rader B , Gertz A , Iuliano AD , Gilmer M , Wronski L , Astley CM , Sewalk K , Varrelman TJ , Cohen J , Parikh R , Reese HE , Reed C , Brownstein JS . MMWR Morb Mortal Wkly Rep 2022 71 (13) 489-494 COVID-19 testing provides information regarding exposure and transmission risks, guides preventative measures (e.g., if and when to start and end isolation and quarantine), identifies opportunities for appropriate treatments, and helps assess disease prevalence (1). At-home rapid COVID-19 antigen tests (at-home tests) are a convenient and accessible alternative to laboratory-based diagnostic nucleic acid amplification tests (NAATs) for SARS-CoV-2, the virus that causes COVID-19 (2-4). With the emergence of the SARS-CoV-2 B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in 2021, demand for at-home tests increased(†) (5). At-home tests are commonly used for school- or employer-mandated testing and for confirmation of SARS-CoV-2 infection in a COVID-19-like illness or following exposure (6). Mandated COVID-19 reporting requirements omit at-home tests, and there are no standard processes for test takers or manufacturers to share results with appropriate health officials (2). Therefore, with increased COVID-19 at-home test use, laboratory-based reporting systems might increasingly underreport the actual incidence of infection. Data from a cross-sectional, nonprobability-based online survey (August 23, 2021-March 12, 2022) of U.S. adults aged ≥18 years were used to estimate self-reported at-home test use over time, and by demographic characteristics, geography, symptoms/syndromes, and reasons for testing. From the Delta-predominant period (August 23-December 11, 2021) to the Omicron-predominant period (December 19, 2021-March 12, 2022)(§) (7), at-home test use among respondents with self-reported COVID-19-like illness(¶) more than tripled from 5.7% to 20.1%. The two most commonly reported reasons for testing among persons who used an at-home test were COVID-19 exposure (39.4%) and COVID-19-like symptoms (28.9%). At-home test use differed by race (e.g., self-identified as White [5.9%] versus self-identified as Black [2.8%]), age (adults aged 30-39 years [6.4%] versus adults aged ≥75 years [3.6%]), household income (>$150,000 [9.5%] versus $50,000-$74,999 [4.7%]), education (postgraduate degree [8.4%] versus high school or less [3.5%]), and geography (New England division [9.6%] versus West South Central division [3.7%]). COVID-19 testing, including at-home tests, along with prevention measures, such as quarantine and isolation when warranted, wearing a well-fitted mask when recommended after a positive test or known exposure, and staying up to date with vaccination,** can help reduce the spread of COVID-19. Further, providing reliable and low-cost or free at-home test kits to underserved populations with otherwise limited access to COVID-19 testing could assist with continued prevention efforts. |
BNT162b2 Protection against the Omicron Variant in Children and Adolescents.
Price AM , Olson SM , Newhams MM , Halasa NB , Boom JA , Sahni LC , Pannaraj PS , Irby K , Bline KE , Maddux AB , Nofziger RA , Cameron MA , Walker TC , Schwartz SP , Mack EH , Smallcomb L , Schuster JE , Hobbs CV , Kamidani S , Tarquinio KM , Bradford TT , Levy ER , Chiotos K , Bhumbra SS , Cvijanovich NZ , Heidemann SM , Cullimore ML , Gertz SJ , Coates BM , Staat MA , Zinter MS , Kong M , Chatani BM , Hume JR , Typpo KV , Maamari M , Flori HR , Tenforde MW , Zambrano LD , Campbell AP , Patel MM , Randolph AG . N Engl J Med 2022 386 (20) 1899-1909 BACKGROUND: Spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.1.529 (omicron) variant, which led to increased U.S. hospitalizations for coronavirus disease 2019 (Covid-19), generated concern about immune evasion and the duration of protection from vaccines in children and adolescents. METHODS: Using a case-control, test-negative design, we assessed vaccine effectiveness against laboratory-confirmed Covid-19 leading to hospitalization and against critical Covid-19 (i.e., leading to receipt of life support or to death). From July 1, 2021, to February 17, 2022, we enrolled case patients with Covid-19 and controls without Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2 messenger RNA vaccine) at least 14 days before illness among case patients and controls, according to time since vaccination for patients 12 to 18 years of age and in periods coinciding with circulation of B.1.617.2 (delta) (July 1, 2021, to December 18, 2021) and omicron (December 19, 2021, to February 17, 2022) among patients 5 to 11 and 12 to 18 years of age. RESULTS: We enrolled 1185 case patients (1043 [88%] of whom were unvaccinated, 291 [25%] of whom received life support, and 14 of whom died) and 1627 controls. During the delta-predominant period, vaccine effectiveness against hospitalization for Covid-19 among adolescents 12 to 18 years of age was 93% (95% confidence interval [CI], 89 to 95) 2 to 22 weeks after vaccination and was 92% (95% CI, 80 to 97) at 23 to 44 weeks. Among adolescents 12 to 18 years of age (median interval since vaccination, 162 days) during the omicron-predominant period, vaccine effectiveness was 40% (95% CI, 9 to 60) against hospitalization for Covid-19, 79% (95% CI, 51 to 91) against critical Covid-19, and 20% (95% CI, -25 to 49) against noncritical Covid-19. During the omicron period, vaccine effectiveness against hospitalization among children 5 to 11 years of age was 68% (95% CI, 42 to 82; median interval since vaccination, 34 days). CONCLUSIONS: BNT162b2 vaccination reduced the risk of omicron-associated hospitalization by two thirds among children 5 to 11 years of age. Although two doses provided lower protection against omicron-associated hospitalization than against delta-associated hospitalization among adolescents 12 to 18 years of age, vaccination prevented critical illness caused by either variant. (Funded by the Centers for Disease Control and Prevention.). |
Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19-Associated Hospitalization in Infants Aged <6 Months - 17 States, July 2021-January 2022.
Halasa NB , Olson SM , Staat MA , Newhams MM , Price AM , Boom JA , Sahni LC , Cameron MA , Pannaraj PS , Bline KE , Bhumbra SS , Bradford TT , Chiotos K , Coates BM , Cullimore ML , Cvijanovich NZ , Flori HR , Gertz SJ , Heidemann SM , Hobbs CV , Hume JR , Irby K , Kamidani S , Kong M , Levy ER , Mack EH , Maddux AB , Michelson KN , Nofziger RA , Schuster JE , Schwartz SP , Smallcomb L , Tarquinio KM , Walker TC , Zinter MS , Gilboa SM , Polen KN , Campbell AP , Randolph AG , Patel MM . MMWR Morb Mortal Wkly Rep 2022 71 (7) 264-270 COVID-19 vaccination is recommended for persons who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future, to protect them from COVID-19.(§) Infants are at risk for life-threatening complications from COVID-19, including acute respiratory failure (1). Evidence from other vaccine-preventable diseases suggests that maternal immunization can provide protection to infants, especially during the high-risk first 6 months of life, through passive transplacental antibody transfer (2). Recent studies of COVID-19 vaccination during pregnancy suggest the possibility of transplacental transfer of SARS-CoV-2-specific antibodies that might provide protection to infants (3-5); however, no epidemiologic evidence currently exists for the protective benefits of maternal immunization during pregnancy against COVID-19 in infants. The Overcoming COVID-19 network conducted a test-negative, case-control study at 20 pediatric hospitals in 17 states during July 1, 2021-January 17, 2022, to assess effectiveness of maternal completion of a 2-dose primary mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization in infants. Among 379 hospitalized infants aged <6 months (176 with COVID-19 [case-infants] and 203 without COVID-19 [control-infants]), the median age was 2 months, 21% had at least one underlying medical condition, and 22% of case- and control-infants were born premature (<37 weeks gestation). Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months was 61% (95% CI = 31%-78%). Completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy might help prevent COVID-19 hospitalization among infants aged <6 months. |
Vaccine Effectiveness Against Life-Threatening Influenza Illness in US Children.
Olson SM , Newhams MM , Halasa NB , Feldstein LR , Novak T , Weiss SL , Coates BM , Schuster JE , Schwarz AJ , Maddux AB , Hall MW , Nofziger RA , Flori HR , Gertz SJ , Kong M , Sanders RC , Irby K , Hume JR , Cullimore ML , Shein SL , Thomas NJ , Stewart LS , Barnes JR , Patel MM , Randolph AG . Clin Infect Dis 2022 75 (2) 230-238 BACKGROUND: Predominance of 2 antigenically drifted influenza viruses during the 2019-2020 season offered an opportunity to assess vaccine effectiveness against life-threatening pediatric influenza disease from vaccine-mismatched viruses in the United States. METHODS: We enrolled children aged <18 years admitted to the intensive care unit with acute respiratory infection across 17 hospitals. Respiratory specimens were tested using reverse-transcription polymerase chain reaction for influenza viruses and sequenced. Using a test-negative design, we estimated vaccine effectiveness comparing odds of vaccination in test-positive case patients vs test-negative controls, stratifying by age, virus type, and severity. Life-threating influenza included death or invasive mechanical ventilation, vasopressors, cardiopulmonary resuscitation, dialysis, or extracorporeal membrane oxygenation. RESULTS: We enrolled 159 critically ill influenza case-patients (70% ≤8 years; 51% A/H1N1pdm09 and 25% B-Victoria viruses) and 132 controls (69% were aged ≤8 years). Among 56 sequenced A/H1N1pdm09 viruses, 29 (52%) were vaccine-mismatched (A/H1N1pdm09/5A+156K) and 23 (41%) were vaccine-matched (A/H1N1pdm09/5A+187A,189E). Among sequenced B-lineage viruses, majority (30 of 31) were vaccine-mismatched. Effectiveness against critical influenza was 63% (95% confidence interval [CI], 38% to 78%) and similar by age. Effectiveness was 75% (95% CI, 49% to 88%) against life-threatening influenza vs 57% (95% CI, 24% to 76%) against non-life-threating influenza. Effectiveness was 78% (95% CI, 41% to 92%) against matched A(H1N1)pdm09 viruses, 47% (95% CI, -21% to 77%) against mismatched A(H1N1)pdm09 viruses, and 75% (95% CI, 37% to 90%) against mismatched B-Victoria viruses. CONCLUSIONS: During a season when vaccine-mismatched influenza viruses predominated, vaccination was associated with a reduced risk of critical and life-threatening influenza illness in children. |
A Description of COVID-19-Directed Therapy in Children Admitted to US Intensive Care Units 2020.
Schuster JE , Halasa NB , Nakamura M , Levy ER , Fitzgerald JC , Young CC , Newhams MM , Bourgeois F , Staat MA , Hobbs CV , Dapul H , Feldstein LR , Jackson AM , Mack EH , Walker TC , Maddux AB , Spinella PC , Loftis LL , Kong M , Rowan CM , Bembea MM , McLaughlin GE , Hall MW , Babbitt CJ , Maamari M , Zinter MS , Cvijanovich NZ , Michelson KN , Gertz SJ , Carroll CL , Thomas NJ , Giuliano JS , Singh AR , Hymes SR , Schwarz AJ , McGuire JK , Nofziger RA , Flori HR , Clouser KN , Wellnitz K , Cullimore ML , Hume JR , Patel M , Randolph AG . J Pediatric Infect Dis Soc 2022 11 (5) 191-198 BACKGROUND: It is unclear how acute coronavirus disease 2019 (COVID-19)-directed therapies are used in children with life-threatening COVID-19 in US hospitals. We described characteristics of children hospitalized in the intensive care unit or step-down unit (ICU/SDU) who received COVID-19-directed therapies and the specific therapies administered. METHODS: Between March 15, 2020 and December 27, 2020, children <18 years of age in the ICU/SDU with acute COVID-19 at 48 pediatric hospitals in the United States were identified. Demographics, laboratory values, and clinical course were compared in children who did and did not receive COVID-19-directed therapies. Trends in COVID-19-directed therapies over time were evaluated. RESULTS: Of 424 children in the ICU/SDU, 235 (55%) received COVID-19-directed therapies. Children who received COVID-19-directed therapies were older than those who did not receive COVID-19-directed therapies (13.3 [5.6-16.2] vs 9.8 [0.65-15.9] years), more had underlying medical conditions (188 [80%] vs 104 [55%]; difference = 25% [95% CI: 16% to 34%]), more received respiratory support (206 [88%] vs 71 [38%]; difference = 50% [95% CI: 34% to 56%]), and more died (8 [3.4%] vs 0). Of the 235 children receiving COVID-19-directed therapies, 172 (73%) received systemic steroids and 150 (64%) received remdesivir, with rising remdesivir use over the study period (14% in March/April to 57% November/December). CONCLUSION: Despite the lack of pediatric data evaluating treatments for COVID-19 in critically ill children, more than half of children requiring intensive or high acuity care received COVID-19-directed therapies. |
Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021.
Zambrano LD , Newhams MM , Olson SM , Halasa NB , Price AM , Boom JA , Sahni LC , Kamidani S , Tarquinio KM , Maddux AB , Heidemann SM , Bhumbra SS , Bline KE , Nofziger RA , Hobbs CV , Bradford TT , Cvijanovich NZ , Irby K , Mack EH , Cullimore ML , Pannaraj PS , Kong M , Walker TC , Gertz SJ , Michelson KN , Cameron MA , Chiotos K , Maamari M , Schuster JE , Orzel AO , Patel MM , Campbell AP , Randolph AG . MMWR Morb Mortal Wkly Rep 2022 71 (2) 52-58 Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5),(§) and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design(¶) among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children. |
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