Kawasaki Disease After Vaccination Reports to the Vaccine Adverse Event Reporting System 1990-2007
ABSTRACT Kawasaki disease (KD) is a multisystemic vasculitis primarily affecting children<5 years. A review of RotaTeq (rotavirus vaccine live) clinical trial data revealed higher, though not statistically significantly, KD rates among RotaTeq vaccines than placebo recipients. In June 2007, the RotaTeq label was revised accordingly.
To describe and assess KD reported to Vaccine Adverse Event Reporting System (VAERS) for all US licensed vaccines.
We reviewed all KD reports received by VAERS from 1990 through mid-October 2007. Cases were characterized by age, gender, onset interval, and vaccine type. Proportional reporting ratio (PRR) was used to evaluate KD reporting for each vaccine compared with all others. Reporting rates were calculated using number of doses distributed as denominator.
Through October 14, 2007, 107 KD reports were received by VAERS: 26 were categorized as classic cases, 19 atypical, 52 possible, and 10 were noncases. Of the 97 cases, 91% were children<5 years. There was no clustering of onset intervals after day 1 postvaccination. Before the RotaTeq label revision, the KD PRR was elevated only for Pediarix (DTaP, hepB, and IPV combined) but the KD reporting rate for Pediarix (0.59/100,000 person-years) was much lower than the background incidence rate (9-19/100,000 person-years) for children<5 years in the United States. After the revision, reporting of KD for RotaTeq was stimulated but the reporting rate for RotaTeq (1.47/100,000 person-years) was still much lower than the background rate.
Our review does not suggest an elevated KD risk for RotaTeq or other vaccines. Continued postmarketing monitoring for KD is ongoing.
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ABSTRACT: Kawasaki disease (KD) is now the commonest cause of acquired heart disease in children in developed countries. KD occurs all over the world, including developing countries. The present study steps out to explore our hypothesis, driven by clinical observation over the last 18 years, whether children with KD in North India are of a higher socioeconomic status than children with other rheumatologic diseases. One hundred consecutive children with KD, registered in Pediatric Rheumatology Clinic before January 2011, were enrolled as cases. Children with other rheumatologic diseases were taken as controls. Assessment of socioeconomic status was done by administering the Aggarwal scale. Data were collected through interview. Statistical analysis was done using SPSS package version 16. On univariate analysis, male sex, higher educational status of parents, urban residence, immunization status being complete, and higher scores on Aggarwal scale were found to be significantly associated with KD. On multivariate analysis, only male sex and urban residence were found to be significantly associated with KD (p < 0.001). Families of children with KD tend to have a better sociodemographic profile when compared with other pediatric rheumatologic disorders in North India. These results, however, need to be replicated in a multicentric study for any firm conclusions to be drawn.Clinical Rheumatology 11/2014; DOI:10.1007/s10067-014-2825-6 · 1.77 Impact Factor
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ABSTRACT: Two very effective and safe vaccines have convincing preventive effectiveness in relation to morbidity measured by the number of cases of diarrhoea, physician consultations and hospital admissions. Implementing vaccination against rotavirus is a rational intervention based on a socioeconomic perspective that includes the societal value of parents’ absence from work. In contrast, the cost of implementing vaccination against rotavirus would not be offset by a similar reduction in treatment costs, and the intervention would thus not save money within the narrow perspective of the health sector. Implementing the two-dose vaccination in the current childhood vaccination programme would be the simplest and least expensive option, but public procurement tendering in accordance with European Union rules with the participation of both vaccine manufacturers would probably reduce the final cost of the vaccine considerably. Many of the parents who participated in the qualitative interviews as part of investigating the perspectives of citizens and patients said that they do not consider acute gastroenteritis to be severe enough to warrant implementing vaccination against rotavirus in Denmark’s childhood vaccination programme and raised the issue of a possible saturation point for vaccination. Based on this and based on the views expressed by the Danish Health and Medicines Authority on Denmark’s childhood vaccination programme, discussing and clarifying the severity principle in the childhood vaccination programme will be decisive for deciding whether the childhood vaccination programme should include this vaccination. Nevertheless, the vaccines are clearly effective and safe and can be relatively easily be added to Denmark’s childhood vaccination programme. The modelling shows that the vaccination has an overall socioeconomic benefit for society but a net cost to the health system.1 edited by Christian Wejse, 06/2012; Danish National Board of Health., ISBN: 1399-2481
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ABSTRACT: Two rotavirus (RV) vaccines were introduced to the European market in 2006. To support the decision-making process of the German Standing Committee on Vaccination ("Standige Impfkommission", STIKO) regarding adoption of routine RV vaccination into the national vaccination schedule in Germany relevant scientific background was reviewed. According to STIKO's Standard Operating Procedures for the development of evidence-based vaccination recommendations, a set of key questions was addressed and systematic reviews were performed with a focus on the efficacy, effectiveness, impact and safety of RV vaccines. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was applied to assess the quality of available evidence. Data from 5 randomized controlled trials demonstrated a high efficacy of RV vaccines in preventing severe RV-associated gastroenteritis (91%) and hospitalization (92%) in settings comparable to Germany. Post-marketing observational studies confirmed these findings. In several countries, impact studies suggest that age groups not eligible for vaccination might also benefit from herd effects and demonstrated a decrease in the number of nosocomial RV infections after RV vaccine introduction. The vaccines were considered safe, except for a slightly increased risk of intussusception shortly after the first dose, corresponding to 1-2 additional cases per 100,000 infants vaccinated (relative risk = 1.21, 95% confidence interval [CI] 0.68-2.14). RV case-fatality is extremely low in Germany. However, RV incidence among children aged <5 years is high (reported 8-14 cases per 1000 children annually), and of these almost half require hositalization. In view of the available evidence and expected benefits, STIKO recommends routine rotavirus vaccination of children under the age of 6 months with the main goal of preventing RV-associated hospitalizations in Germany, especially among infants and young children.Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 07/2013; 56(7-7):957-84. DOI:10.1007/s00103-013-1777-3 · 1.01 Impact Factor