scholarly journals Myocarditis After mRNA-1273 Vaccination: A Population-Based Analysis of 151 Million Vaccine Recipients Worldwide

2021 ◽  
Author(s):  
Walter Straus ◽  
Veronica Urdaneta ◽  
Daina B. Esposito ◽  
James A. Mansi ◽  
Cesar Sanz Rodriguez ◽  
...  
Keyword(s):  
Safety Data ◽  
Reference Population ◽  
Population Based ◽  
Reporting Rate ◽  
Case Definition ◽  
Adult Males ◽  
Safety Database ◽  
Vaccination Rates ◽  
Safety Event ◽  
Rate Ratios

Background: Growing evidence indicates a causal relationship between SARS–CoV–2 infection and myocarditis. Post–authorization safety data have also identified myocarditis as a rare safety event following mRNA COVID–19 vaccination, most notably among younger adult males and after dose 2. To further evaluate the potential risk after vaccination, we queried the Moderna global safety database to assess the occurrence of myocarditis/myopericarditis among mRNA–1273 vaccine recipients worldwide since first international Emergency Use Authorization issuance. Methods: Reports of myocarditis/myopericarditis entered into the Moderna global safety database from December 18, 2020 to September 30, 2021 were reviewed and classified based on the Brighton Collaboration case definition. The cumulative observed occurrence of myocarditis/myopericarditis was assessed by calculating the reported rate after any known dose of mRNA–1273 according to age and sex. This reporting rate was compared to a population–based incidence rate (US military) to calculate observed–to–expected rate ratios (RR). Results: Through September 30, 2021, a total of 1,439 cases of myocarditis/myopericarditis among approximately 151.1 million mRNA–1273 vaccine recipients were reported to the Moderna global safety database. The overall reporting rate among all vaccine recipients was 0.95 cases per 100,000 vaccine recipients, which was lower than the expected rate from the reference population (2.12 cases per 100,000 vaccine recipients; RR [95% CI]: 0.45 [0.42–0.48]). When stratified by sex and age, observed rates were highest for males aged ≤39 years, particularly those aged 18–24 years (7.40 cases per 100,000 vaccine recipients), which was higher than expected (RR [95% CI]: 3.49 [2.88–4.22]). For males and females aged <18 years, the rate ratio for myocarditis was 1.05 (95% CI, 0.52–2.13) and 0.21 (95% CI, 0.04–0.94), respectively. When considering only cases occurring within 7 days after vaccination, the observed rate was highest for males aged 18–24 years after dose 2 (4.9 cases per 100,000 doses administered). Conclusion: Myocarditis/myopericarditis accounted for 0.4% of adverse events reported to the Moderna global safety database after mRNA–1273 vaccination; rates were higher than expected in males aged 18–24 years, with most occurring by 7 days after dose 2, but were not higher than expected for the overall population of vaccine recipients and were lower than that observed in individuals infected with SARS–CoV–2.

scholarly journals Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine ◽  
2021 ◽  
Author(s):  
Tiphanie P. Vogel ◽  
Karina A. Top ◽  
Christos Karatzios ◽  
David C. Hilmers ◽  
Lorena I. Tapia ◽  
...  
Keyword(s):  
Data Collection ◽  
Safety Data ◽  
Case Definition ◽  
Inflammatory Syndrome

scholarly journals Estimating the asymptomatic proportion of SARS-CoV-2 infection in the general population: Analysis of nationwide serosurvey data in the Netherlands

2021 ◽  
Author(s):  
Scott A. McDonald ◽  
Fuminari Miura ◽  
Eric R. A. Vos ◽  
Michiel van Boven ◽  
Hester E. de Melker ◽  
...  
Keyword(s):  
The Netherlands ◽  
Population Analysis ◽  
Large Population ◽  
Population Based ◽  
Attributable Risk ◽  
Case Definition ◽  
Aggregated Data ◽  
Age Dependent ◽  
Additive Regression ◽  
June July

Abstract Background The proportion of SARS-CoV-2 positive persons who are asymptomatic—and whether this proportion is age-dependent—are still open research questions. Because an unknown proportion of reported symptoms among SARS-CoV-2 positives will be attributable to another infection or affliction, the observed, or 'crude' proportion without symptoms may underestimate the proportion of persons without symptoms that are caused by SARS-CoV-2 infection. Methods Based on two rounds of a large population-based serological study comprising test results on seropositivity and self-reported symptom history conducted in April/May and June/July 2020 in the Netherlands (n = 7517), we estimated the proportion of reported symptoms among those persons infected with SARS-CoV-2 that is attributable to this infection, where the set of relevant symptoms fulfills the ECDC case definition of COVID-19, using inferential methods for the attributable risk (AR). Generalised additive regression modelling was used to estimate the age-dependent relative risk (RR) of reported symptoms, and the AR and asymptomatic proportion (AP) were calculated from the fitted RR. Results Using age-aggregated data, the 'crude' AP was 37% but the model-estimated AP was 65% (95% CI 63–68%). The estimated AP varied with age, from 74% (95% CI 65–90%) for < 20 years, to 61% (95% CI 57–65%) for the 50–59 years age-group. Conclusion Whereas the 'crude' AP represents a lower bound for the proportion of persons infected with SARS-CoV-2 without COVID-19 symptoms, the AP as estimated via an attributable risk approach represents an upper bound. Age-specific AP estimates can inform the implementation of public health actions such as targetted virological testing and therefore enhance containment strategies.

scholarly journals Public health impact of delaying second dose of BNT162b2 or mRNA-1273 covid-19 vaccine: simulation agent based modeling study

BMJ ◽  
2021 ◽  
pp. n1087
Author(s):  
Santiago Romero-Brufau ◽  
Ayush Chopra ◽  
Alex J Ryu ◽  
Esma Gel ◽  
Ramesh Raskar ◽  
...  
Keyword(s):  
Hospital Admissions ◽  
Vaccination Strategy ◽  
Population Based ◽  
Agent Based Modeling ◽  
Sensitivity Analyses ◽  
Agent Based ◽  
Cumulative Mortality ◽  
Vaccination Rates ◽  
Dose Strategy ◽  
Modeling Study

AbstractObjectiveTo estimate population health outcomes with delayed second dose versus standard schedule of SARS-CoV-2 mRNA vaccination.DesignSimulation agent based modeling study.SettingSimulated population based on real world US county.ParticipantsThe simulation included 100 000 agents, with a representative distribution of demographics and occupations. Networks of contacts were established to simulate potentially infectious interactions though occupation, household, and random interactions.InterventionsSimulation of standard covid-19 vaccination versus delayed second dose vaccination prioritizing the first dose. The simulation runs were replicated 10 times. Sensitivity analyses included first dose vaccine efficacy of 50%, 60%, 70%, 80%, and 90% after day 12 post-vaccination; vaccination rate of 0.1%, 0.3%, and 1% of population per day; assuming the vaccine prevents only symptoms but not asymptomatic spread (that is, non-sterilizing vaccine); and an alternative vaccination strategy that implements delayed second dose for people under 65 years of age, but not until all those above this age have been vaccinated.Main outcome measuresCumulative covid-19 mortality, cumulative SARS-CoV-2 infections, and cumulative hospital admissions due to covid-19 over 180 days.ResultsOver all simulation replications, the median cumulative mortality per 100 000 for standard dosing versus delayed second dose was 226 v 179, 233 v 207, and 235 v 236 for 90%, 80%, and 70% first dose efficacy, respectively. The delayed second dose strategy was optimal for vaccine efficacies at or above 80% and vaccination rates at or below 0.3% of the population per day, under both sterilizing and non-sterilizing vaccine assumptions, resulting in absolute cumulative mortality reductions between 26 and 47 per 100 000. The delayed second dose strategy for people under 65 performed consistently well under all vaccination rates tested.ConclusionsA delayed second dose vaccination strategy, at least for people aged under 65, could result in reduced cumulative mortality under certain conditions.

The Role of the Physical and Traffic Environment in Child Pedestrian Injuries

PEDIATRICS ◽  
1996 ◽  
Vol 98 (6) ◽  
pp. 1096-1103
Author(s):  
Phyllis F. Agran ◽  
Diane G. Winn ◽  
Craig L. Anderson ◽  
Cecile Tran ◽  
Celeste P. Del Valle
Keyword(s):  
Injury Risk ◽  
Population Based ◽  
Traffic Volume ◽  
Vehicular Traffic ◽  
Single Family ◽  
Pedestrian Injury ◽  
Vehicular Speed ◽  
Pedestrian Injuries ◽  
And Gender ◽  
Rate Ratios

Objective. To identify environmental risk factors on residential streets for pediatric pedestrian injuries. Method. The sample consisted of 39 Latino children 0 to 14 years of age injured as pedestrians on a street in the same block as their home and 62 randomly selected neighborhood control subjects matched to the case by city, age or year of birth, ethnicity, and gender. The cases were identified from a population-based hospital and coroner's office surveillance system established in north-central Orange County, CA. Neighborhood assessments were performed from 3:45 PM to 5 PM, a fairly active time for young pedestrians. The cases were compared with the controls using conditional logistic regressions; in this study design, the odds ratios were interpreted as estimates of the incidence rate ratios. Results. Children living in a multifamily residence had an incidence of injury greater than that of children living in single-family residence on a single lot (odds ratio [OR] 3.1, 95% confidence interval [CI] 1.3-7.6). The ORs in the highest category were several times those in the lowest category for both parked vehicles (OR 9.6, 95% CI 2.6-36) and total number of pedestrians observed (OR 4.7, 95% CI 1.4-16). Vehicle parking, total pedestrians, vehicular traffic volume, and speed were examined in a multivariate model. The association of vehicles parked on the street with pedestrian injury risk remained significant. Unlike the crude results, progressively greater vehicular speed was associated with a marked increase in risk. Progressively higher vehicular traffic volume was associated with a progressively lower adjusted OR. Conclusion. The results of this analysis would indicate that residential streets with a high proportion of multifamily residences, over 50% of the curb occupied with parked vehicles, and a large number of pedestrians observed in unenclosed areas should receive high priority for intervention programs to reduce pediatric pedestrian injuries. The analysis suggests that on these streets, measures to reduce the amount of street parking (thus increasing visibility) and reductions in vehicular speed should be considered to decrease pedestrian injuries.

Symptom patterns in childhood arterial ischemic stroke: Analysis of a population-based study in Germany

2018 ◽  
Vol 230 (06) ◽  
pp. 319-325
Author(s):  
Lucia Gerstl ◽  
Raphael Weinberger ◽  
Rüdiger von Kries ◽  
Florian Heinen ◽  
Andreas Sebastian Schroeder ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Clinical Symptoms ◽  
Population Based ◽  
Case Definition ◽  
Childhood Stroke ◽  
Older Children ◽  
Arterial Ischemic Stroke ◽  
Focal Neurological Deficit ◽  
Symptom Patterns ◽  
Specific Symptoms

Hintergrund Die zeitliche Verzögerung zwischen Symptombeginn und Diagnose ist eine Herausforderung in der Behandlung von Kindern mit arteriell ischämischem Schlaganfall. Frühere Studien zur klinischen Präsentation beschäftigten sich v. a. mit kumulativen Symptomen. Zielsetzung Ziel dieser Studie ist es, mögliche Symptommuster aufzuzeigen. Methoden In einer aktiven Beobachtungsstudie zwischen 01/2015 und 12/2016 (ESPED-Studie) wurden Kinder mit Erstdiagnose eines arteriell ischämischen Schlaganfalls eingeschlossen. Isoliert auftretende Erstsymptome wurden verschiedenen Symptomkombinationen gegenübergestellt. Zudem wurde untersucht, inwieweit ein als „akut“ oder „progredient“ klassifiziertes Auftreten der Symptome Rückschlüsse auf die zugrundeliegende Ätiologie erlaubt. Ergebnisse Es wurden 99 Kinder in die Studie eingeschlossen. Unabhängig vom Alter traten überwiegend fokale Symptome auf (86%). Krampfanfälle als Initialsymptom wurden insbesondere bei Säuglingen beschrieben (67%), wohin-gegen diffuse, unspezifische Symptome vor allem bei Vorschulkindern (38%) und älteren Kindern (59%) auftraten. Isoliert traten fokale Symptome bei 37 Kindern auf, 48 Kinder zeigten zusätzlich unspezifische Symptome, darunter auch 9 Kinder mit Krampfanfällen. Isolierte unspezifische Symptome zeigten sich lediglich bei 7 Kindern, 2 Kinder wurden nur mit Krampfanfällen symptomatisch. Die Akuität des Symptombeginns wurde bei 53/78 als „akut“ und bei “25/78 Fällen als „progredient“ klassifiziert, lieferte jedoch keinen Hinweis auf die zugrundeliegende Ätiologie. Schlussfolgerung Jedes neue fokal neurologische Defizit sollte unabhängig vom Auftreten (isoliert oder kombiniert, akut oder progredient) an einen kindlichen Schlaganfall denken lassen. Background Time delay between onset of clinical symptoms and diagnosis is a challenge in childhood arterial ischemic stroke. Most previous studies reported cumulative symptoms. Objective We attempted to identify typical symptom patterns and assessed their emergence in childhood stroke. Methods Prospective active surveillance in ESPED, a hospital based Pediatric Surveillance Unit for rare diseases in Germany, between January 2015 and December 2016. Case definition: first diagnosis of a radiologically confirmed arterial ischemic stroke. Symptom patterns were identified as occurring in isolation or in combination. We distinguished acute vs. progressive onset. We ascertained risk factors to identify the possible etiology. Results 99 children with childhood arterial ischemic stroke were reported. Focal symptoms were the predominant presenting feature (86%), independent of age. Seizures were more often seen in infants < 1 year (67%), whereas diffuse symptoms were more present in pre-school children (38%) and older children (59%). 37 children had focal features alone and 48 additional non-specific features, including 9 with seizures. Isolated non-specific features accounted for 7 cases, and 2 children had (focal) seizures as the only symptom. In 77% of all cases at least one risk factor was identified. The emergence of symptoms was acute in 53/78 cases and progressive in 25/78 cases. The pattern of emergence was unrelated to the underlying etiology. Conclusions Any new focal neurological deficit in isolation, or associated with seizures or further non-specific symptoms should alert to childhood stroke.

Estimating the incidence of first-episode psychosis using population-based health administrative data to inform early psychosis intervention services

2018 ◽  
Vol 49 (12) ◽  
pp. 2091-2099 ◽  
Author(s):  
Kelly K. Anderson ◽  
Ross Norman ◽  
Arlene G. MacDougall ◽  
Jordan Edwards ◽  
Lena Palaniyappan ◽  
...  
Keyword(s):  
Psychotic Disorder ◽  
Administrative Data ◽  
Catchment Area ◽  
Population Based ◽  
First Episode Psychosis ◽  
Case Definition ◽  
First Episode ◽  
Affective Psychosis ◽  
Health Administrative Data ◽  
Episode Psychosis

AbstractBackgroundDiscrepancies between population-based estimates of the incidence of psychotic disorder and the treated incidence reported by early psychosis intervention (EPI) programs suggest additional cases may be receiving services elsewhere in the health system. Our objective was to estimate the incidence of non-affective psychotic disorder in the catchment area of an EPI program, and compare this to EPI-treated incidence estimates.MethodsWe constructed a retrospective cohort (1997–2015) of incident cases of non-affective psychosis aged 16–50 years in an EPI program catchment using population-based linked health administrative data. Cases were identified by either one hospitalization or two outpatient physician billings within a 12-month period with a diagnosis of non-affective psychosis. We estimated the cumulative incidence and EPI-treated incidence of non-affective psychosis using denominator data from the census. We also estimated the incidence of first-episode psychosis (people who would meet the case definition for an EPI program) using a novel approach.ResultsOur case definition identified 3245 cases of incident non-affective psychosis over the 17-year period. We estimate that the incidence of first-episode non-affective psychosis in the program catchment area is 33.3 per 100 000 per year (95% CI 31.4–35.1), which is more than twice as high as the EPI-treated incidence of 18.8 per 100 000 per year (95% CI 17.4–20.3).ConclusionsCase ascertainment strategies limited to specialized psychiatric services may substantially underestimate the incidence of non-affective psychotic disorders, relative to population-based estimates. Accurate information on the epidemiology of first-episode psychosis will enable us to more effectively resource EPI services and evaluate their coverage.

scholarly journals Direct and Electronic Health Record Access to the Clinical Decision Support for Immunizations in the Minnesota Immunization Information System

2016 ◽  
Vol 8s2 ◽  
pp. BII.S40208
Author(s):  
Sripriya Rajamani ◽  
Aaron Bieringer ◽  
Stephanie Wallerius ◽  
Daniel Jensen ◽  
Tamara Winden ◽  
...  
Keyword(s):  
Decision Support ◽  
Clinical Decision Support ◽  
Health Care Providers ◽  
Clinical Decision ◽  
Population Based ◽  
Direct Access ◽  
Care Providers ◽  
Study Objective ◽  
Vaccination Rates ◽  
Electronic Health

Immunization information systems (IIS) are population-based and confidential computerized systems maintained by public health agencies containing individual data on immunizations from participating health care providers. IIS hold comprehensive vaccination histories given across providers and over time. An important aspect to IIS is the clinical decision support for immunizations (CDSi), consisting of vaccine forecasting algorithms to determine needed immunizations. The study objective was to analyze the CDSi presentation by IIS in Minnesota (Minnesota Immunization Information Connection [MIIC]) through direct access by IIS interface and by access through electronic health records (EHRs) to outline similarities and differences. The immunization data presented were similar across the three systems examined, but with varying ability to integrate data across MIIC and EHR, which impacts immunization data reconciliation. Study findings will lead to better understanding of immunization data display, clinical decision support, and user functionalities with the ultimate goal of promoting IIS CDSi to improve vaccination rates.

scholarly journals Validation of a Case Definition for Pediatric Brain Injury Using Administrative Data

2017 ◽  
Vol 44 (2) ◽  
pp. 161-169 ◽  
Author(s):  
Jane McChesney-Corbeil ◽  
Karen Barlow ◽  
Hude Quan ◽  
Guanmin Chen ◽  
Samuel Wiebe ◽  
...  
Keyword(s):  
Brain Injury ◽  
Administrative Data ◽  
Predictive Value ◽  
External Validation ◽  
Secondary Data ◽  
Population Based ◽  
Case Definition ◽  
Case Definitions ◽  
Icd 10 ◽  
Pediatric Tbi

AbstractBackground: Health administrative data are a common population-based data source for traumatic brain injury (TBI) surveillance and research; however, before using these data for surveillance, it is important to develop a validated case definition. The objective of this study was to identify the optimal International Classification of Disease , edition 10 (ICD-10), case definition to ascertain children with TBI in emergency room (ER) or hospital administrative data. We tested multiple case definitions. Methods: Children who visited the ER were identified from the Regional Emergency Department Information System at Alberta Children’s Hospital. Secondary data were collected for children with trauma, musculoskeletal, or central nervous system complaints who visited the ER between October 5, 2005, and June 6, 2007. TBI status was determined based on chart review. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each case definition. Results: Of 6639 patients, 1343 had a TBI. The best case definition was, “1 hospital or 1 ER encounter coded with an ICD-10 code for TBI in 1 year” (sensitivity 69.8% [95% confidence interval (CI), 67.3-72.2], specificity 96.7% [95% CI, 96.2-97.2], PPV 84.2% [95% CI 82.0-86.3], NPV 92.7% [95% CI, 92.0-93.3]). The nonspecific code S09.9 identified >80% of TBI cases in our study. Conclusions: The optimal ICD-10–based case definition for pediatric TBI in this study is valid and should be considered for future pediatric TBI surveillance studies. However, external validation is recommended before use in other jurisdictions, particularly because it is plausible that a larger proportion of patients in our cohort had milder injuries.

scholarly journals Seroprevalence of anti-SARS-CoV-2 antibodies six months into the vaccination campaign in Geneva, Switzerland

2021 ◽  
Author(s):  
Silvia Stringhini ◽  
María-Eugenia Zaballa ◽  
Nick Pullen ◽  
Javier Perez-Saez ◽  
Carlos de Mestral ◽  
...  
Keyword(s):  
Vaccination Campaign ◽  
Age Groups ◽  
Credible Interval ◽  
Population Based ◽  
Vaccine Hesitancy ◽  
Socioeconomically Disadvantaged ◽  
Cross Sectional ◽  
Vaccination Rates ◽  
Health Measures ◽  
Random Samples

Background: Up-to-date seroprevalence estimates are critical to describe the SARS-CoV-2 immune landscape in the population and guide public health measures. We aimed to estimate the seroprevalence of anti-SARS-CoV-2 antibodies 15 months into the COVID-19 pandemic and six months into the vaccination campaign. Methods: We conducted a population-based cross-sectional serosurvey between June 1 and July 7, 2021, recruiting participants from age- and sex-stratified random samples of the general population. We tested participants for anti-SARS-CoV-2 antibodies targeting the spike (S) or nucleocapsid (N) proteins (Roche Elecsys immunoassays). We estimated the anti-SARS-CoV-2 antibodies seroprevalence following vaccination and/or infection (anti-S antibodies), or infection only (anti-N antibodies). Results: We included 3355 individuals, of which 1814 (54.1%) were women, 697 (20.8%) were aged <18 years and 449 (13.4%) were aged ≥65 years, 2161 (64.4%) tested positive for anti-S antibodies, and 906 (27.0%) tested positive for anti-N antibodies. The total seroprevalence of anti-SARS-CoV-2 antibodies was 66.1% (95% credible interval, 64.1-68.0). Considering the presence of anti-N antibodies, we estimated that 29.9% (28.0-31.9) of the population developed antibodies after infection; the rest having developed antibodies only via vaccination. Seroprevalence estimates were similar across sexes, but differed markedly across age groups, being lowest among children aged 0-5 years (20.8% [15.5-26.7]) and highest among older adults aged ≥75 years (93.1% [89.6-96.0]). Seroprevalence of antibodies developed via infection and/or vaccination was higher among participants with a higher educational level. Conclusions: Most adults have developed anti-SARS-CoV-2 antibodies, while most teenagers and children remain vulnerable to infection. As the SARS-CoV-2 Delta variant spreads and vaccination rates stagnate, efforts are needed to address vaccine hesitancy, particularly among younger individuals and socioeconomically disadvantaged groups, and to minimize spread among children.

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