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Multisystem inflammatory syndrome in children (MIS-C) is a postinfectious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related complication that has disproportionately affected racial/ethnic minority children. We conducted a pilot study to investigate risk factors for MIS-C aiming to understand MIS-C disparities.This case-control study included MIS-C cases and SARS-CoV-2-positive outpatient controls less than 18 years old frequency-matched 4:1 to cases by age group and site. Patients hospitalized with MIS-C were admitted between March 16 and October 2, 2020, across 17 pediatric hospitals. We evaluated race, ethnicity, social vulnerability index (SVI), insurance status, weight-for-age and underlying medical conditions as risk factors using mixed effects multivariable logistic regression.We compared 241 MIS-C cases with 817 outpatient SARS-CoV-2-positive at-risk controls. Cases and controls had similar sex, age and U.S. census region distribution. MIS-C patients were more frequently previously healthy, non-Hispanic Black, residing in higher SVI areas, and in the 95th percentile or higher for weight-for-age. In the multivariable analysis, the likelihood of MIS-C was higher among non-Hispanic Black children [adjusted odds ratio (aOR): 2.07; 95% CI: 1.23-3.48]. Additionally, SVI in the 2nd and 3rd tertiles (aOR: 1.88; 95% CI: 1.18-2.97 and aOR: 2.03; 95% CI: 1.19-3.47, respectively) were independent factors along with being previously healthy (aOR: 1.64; 95% CI: 1.18-2.28).In this study, non-Hispanic Black children were more likely to develop MIS-C after adjustment for sociodemographic factors, underlying medical conditions, and weight-for-age. Investigation of the potential contribution of immunologic, environmental, and other factors is warranted.

BACKGROUND: Estimates of rotavirus vaccine effectiveness (VE) in the United States appear higher in years with more rotavirus activity. We hypothesized rotavirus VE is constant over time but appears to vary as a function of temporal variation in local rotavirus cases and/or misclassified diagnoses. METHODS: We analyzed 6 years of data from eight US surveillance sites on 8- to 59-month olds with acute gastroenteritis symptoms. Children’s stool samples were tested via enzyme immunoassay (EIA); rotavirus-positive results were confirmed with molecular testing at the US Centers for Disease Control and Prevention. We defined rotavirus gastroenteritis cases by either positive on-site EIA results alone or positive EIA with Centers for Disease Control and Prevention confirmation. For each case definition, we estimated VE against any rotavirus gastroenteritis, moderate-to-severe disease, and hospitalization using two mixed-effect regression models: the first including year plus a year–vaccination interaction, and the second including the annual percent of rotavirus-positive tests plus a percent positive–vaccination interaction. We used multiple overimputation to bias-adjust for misclassification of cases defined by positive EIA alone. RESULTS: Estimates of annual rotavirus VE against all outcomes fluctuated temporally, particularly when we defined cases by on-site EIA alone and used a year–vaccination interaction. Use of confirmatory testing to define cases reduced, but did not eliminate, fluctuations. Temporal fluctuations in VE estimates further attenuated when we used a percent positive–vaccination interaction. Fluctuations persisted until bias-adjustment for diagnostic misclassification. CONCLUSIONS: Both controlling for time-varying rotavirus activity and bias-adjusting for diagnostic misclassification are critical for estimating the most valid annual rotavirus VE.

Immunization information systems (IISs) are confidential, population-based systems that contain immunization data for children, and, in some cases, adults, within a geographic area. There are generally two models for participation in an IIS, termed voluntary exclusion or "opt-out" and voluntary inclusion or "opt-in." Using the Texas opt-in consent system and statewide IIS (ImmTrac), we describe the costs associated with obtaining opt-in consent in hospitals as part of the birth registration process and in provider offices for children without prior consent. We also estimate the costs associated with a hypothetical opt-out system. Between October 2006 and August 2007, project staff conducted on-site time studies for patients in 8 birthing hospitals (n = 281), 16 provider offices (n = 131), and ImmTrac state offices in Austin, Texas (n = 100). Total costs per child and costs per year were estimated using a time-and-motion study in which the time associated with discussing ImmTrac and obtaining ImmTrac consent was measured. The annual costs associated with obtaining consent for Texas' opt-in IIS are estimated at $1 389 804.61. The average per child cost associated with ImmTrac consent completed at birth is $2.00, whereas the per child cost for consent completed in provider offices is $2.64. The annual costs of operating an alternative, opt-out system are estimated at $110 714.03, or $0.29 per child. This cost analysis demonstrated that the proposed opt-out costs were substantially less than the actual opt-in model currently utilized. Changing to an opt-out system could redirect limited healthcare funding to more critical areas such as vaccine purchasing and administration.

Antigenemia is common among children with rotavirus disease. Because obtaining stool specimens is cumbersome, we evaluated whether detection of antigenemia in sera obtained during routine clinical practice could augment rotavirus surveillance to assess the effect of vaccination.: We determined the sensitivity, specificity, and positive and negative predictive values of serum/plasma rotavirus antigen detection using fecal antigen positivity as the gold standard. Fecal specimens obtained by active surveillance and residual serum/plasma specimens obtained during routine clinical testing from children 15 days to 23 months of age presenting with acute gastroenteritis (AGE) to a children's hospital in Houston were tested for rotavirus using a commercially available enzyme immunoassay. Using case-control methods, we compared vaccine effectiveness (VE) using cases identified through serum/plasma testing versus stool testing.: Of the 205 AGE patients with fecal specimens, 71 (35%) had a serum/plasma sample available. Among these 71 children, antigenemia was detected in 22 of 29 with rotavirus-positive fecal specimens (sensitivity = 75%; 95% confidence interval [CI] = 60%-91%) versus 2 of 42 children with rotavirus-negative fecal specimens (specificity = 95%; 95% CI = 89%-100%). The positive and negative predictive values of rotavirus antigenemia were 92% (95% CI = 81%-100%) and 85% (95% CI = 75%-95%), respectively. Thirty-four of 195 children with AGE without fecal specimens had serum/plasma available; 10 (29%) had rotavirus antigenemia. Three-dose VE using cases identified through serum/plasma testing was similar (VE = 84%; 95% CI = 25%-96%) to that using cases identified though fecal testing (VE = 85%; 95% CI = 55%-95%).: Detection of antigenemia in routinely collected serum/plasma could augment identification of rotavirus disease for postlicensure evaluation of impact and effectiveness of rotavirus vaccination.

Fecal specimens from children presenting to Texas Children's Hospital with acute gastroenteritis were tested for the presence of rotavirus. Children were grouped according to vaccination status, and pentavalent rotavirus vaccine effectiveness was calculated. Pentavalent rotavirus vaccine effectiveness against severe rotavirus gastroenteritis was sustained during the first 2 years of the vaccination program. Overall 3-dose effectiveness was 83% to 86%; it was 92% to 93% among children 6 to 11 months of age and 78% to 84% among children ≥12 months of age.