scholarly journals Rotavirus Vaccine Safety and Effectiveness in Infants With High-Risk Medical Conditions

PEDIATRICS ◽  
2021 ◽  
Author(s):  
Josephine A.P. van Dongen ◽  
Elsbeth D.M. Rouers ◽  
Rob Schuurman ◽  
Caterina Band ◽  
Shannon M. Watkins ◽  
...  
Keyword(s):  
High Risk ◽  
Concomitant Administration ◽  
Vaccine Safety ◽  
Routine Care ◽  
Rotavirus Vaccine ◽  
Event Analysis ◽  
Term Infants ◽  
Medical Risk ◽  
Adjusted Risk ◽  
Rotavirus Vaccination

OBJECTIVES Rotavirus vaccination has 87% to 100% effectiveness against severe rotavirus acute gastroenteritis (AGE) in healthy infants in high-income countries. Little is known whether infants with medical risk conditions (MRCs) are equally protected and if the vaccine is equally well tolerated. We conducted a quasi-experimental prospective multicenter before-after cohort study to assess the vaccine effectiveness (VE) and safety profile of the human rotavirus vaccine (HRV) among MRC infants that required prolonged or frequent postnatal care. METHODS The Netherlands has no national rotavirus immunization program, but HRV was implemented in routine care for MRC infants in 13 Dutch hospitals. Participants in the before and after cohort, HRV unvaccinated and vaccinated, respectively, were followed for occurrence of (rotavirus) AGE. VE of at least 1 dose was estimated by using time-to-event analysis for severe rotavirus AGE. Vaccine-related serious adverse event (AEs) after HRV were retrieved systematically from medical charts. Solicited AEs after vaccinations were prospectively collected and compared between vaccination time points with or without HRV. RESULTS In total, 1482 high-risk infants with MRC were enrolled, including 631 in the before and 851 in the after cohorts; 1302 infants were premature (88.3%), 447 were small for gestational age (30.2%), and 251 had at least 1 congenital disorder (17.0%). VE against severe rotavirus AGE was 30% (95% confidence interval [CI]: −36% to 65%). Overall, the observed number of rotavirus hospitalizations was low and not significantly different between the cohorts (2 and 2, respectively). The rate of vaccine-related serious AE was 0.24 per 100 vaccine doses. The adjusted risk ratio for any AE after HRV vaccination compared with other routine vaccinations was 1.09 (95% CI: 1.05 to 1.12) for concomitant administration and 0.91 (95% CI: 0.81 to 0.99) for single HRV administration. Gastrointestinal AEs were 10% more frequent after HRV. CONCLUSIONS In contrast to previous findings among healthy term infants, in routine use, HRV offered limited protection to vulnerable medical risk infants. HRV is generally well tolerated in this group in single administration, but when coadministered with routine vaccines, it is associated with higher risk of (mostly gastrointestinal) AE. Our study highlights the importance of studying vaccine performance in subgroups of medically vulnerable infants.

scholarly journals Rotavirus Vaccination of Infants Delayed and Limited within the National Immunization Programme in the Netherlands: An Opportunity Lost

Vaccines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 144
Author(s):  
Florian Zeevat ◽  
Evgeni Dvortsin ◽  
Abrham Wondimu ◽  
Jan C. Wilschut ◽  
Cornelis Boersma ◽  
...  
Keyword(s):  
High Risk ◽  
The Netherlands ◽  
Herd Immunity ◽  
Vaccination Strategy ◽  
Quality Adjusted Life Year ◽  
High Risk Group ◽  
Universal Vaccination ◽  
Birth Cohorts ◽  
Rotavirus Vaccination ◽  
Immunization Programme

In this study, we estimated the benefits of rotavirus vaccination for infants had the rotavirus vaccine been introduced in the Netherlands as of its market authorization in 2006. An age-structured, deterministic cohort model was developed to simulate different birth cohorts over a period of 15 years from 2006 until 2021, comparing both universal and targeted high-risk group vaccination to no vaccination. Different scenarios for the duration of protection (5 or 7 years) and herd immunity (only for universal vaccination) were analyzed. All birth cohorts together included 2.6 million infants, of which 7.9% were high-risk individuals, and an additional 13.2 million children between 1–15 years born prior to the first cohort in 2006. The costs and health outcomes associated with rotavirus vaccination were calculated per model scenario and discounted at 4% and 1.5%, respectively. Our analysis reveals that, had rotavirus vaccination been implemented in 2006, it would have prevented 356,800 (51% decrease) and 32,200 (5% decrease) cases of rotavirus gastroenteritis after universal and targeted vaccination, respectively. Over the last 15 years, this would have led to significant avoided costs and quality-adjusted life year losses for either vaccination strategy with the most favorable outcomes for universal vaccination. Clearly, an opportunity has been lost.

scholarly journals Paediatric rotavirus vaccination, coeliac disease and type 1 diabetes in children: a population-based cohort study

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Thomas Inns ◽  
Kate M. Fleming ◽  
Miren Iturriza-Gomara ◽  
Daniel Hungerford
Keyword(s):  
Type 1 Diabetes ◽  
Cohort Study ◽  
Coeliac Disease ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Rotavirus Vaccine ◽  
Rotavirus Vaccination ◽  
Increased Risk ◽  
The Uk

Abstract Background Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK. Methods A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices. Results There were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86–1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68–1.19). Conclusions Rotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.

scholarly journals Benign Convulsions with Mild Rotavirus and Norovirus Gastroenteritis: Nationwide Data from the Health Insurance Review and Assessment Service in South Korea

Children ◽  
2021 ◽  
Vol 8 (4) ◽  
pp. 263
Author(s):  
Dong Hyun Kim ◽  
Dong Jun Ha ◽  
Yeong Seok Lee ◽  
Min Jun Chun ◽  
Young Se Kwon
Keyword(s):  
Health Insurance ◽  
South Korea ◽  
Large Scale ◽  
Rotavirus Vaccine ◽  
Annual Increase ◽  
Rotavirus Vaccination ◽  
Rotavirus Gastroenteritis ◽  
Norovirus Gastroenteritis ◽  
Increasing Trend

There have been no large-scale studies on the epidemiology of benign convulsions with mild gastroenteritis (CwG) since the introduction of the rotavirus vaccine in South Korea in 2007. This study aimed to analyze the trends in rotavirus gastroenteritis (RVGE) and rotavirus-associated CwG (RaCwG) after rotavirus vaccination. Further, we aimed to analyze changes in norovirus gastroenteritis (NVGE) and norovirus-associated CwG (NaCwG) using nationwide data from the Korean Health Insurance Review and Assessment Service. Between 2007 and 2019, this study analyzed children aged <6 years who were diagnosed with RVGE, NVGE, RaCwG and NaCwG. The changes in the prevalence of each disease and the ratio of CwG to enteritis were analyzed and the effects of age, sex and season were also analyzed. RVGE, RaCwG, NVGE and NaCwG were diagnosed in 273,898, 4246, 35,593 and 337 patients, respectively. The prevalence of RVGE was on a decreasing trend every year, but the prevalence of NaCwG and NVGE was on an increasing trend. There was a significant annual increase in the ratio of CwG to enteritis in both viruses. In order to control the prevalence of RaCwG, measures other than the rotavirus vaccine are required and measures to prevent norovirus are necessary.

Implementing a Successful Hepatitis B Vaccination Program

1985 ◽  
Vol 6 (8) ◽  
pp. 306-309 ◽  
Author(s):  
Linda J. Hanacik ◽  
Timothy R. Franson ◽  
Jill D. Gollup ◽  
Michael W. Rytel
Keyword(s):  
High Risk ◽  
Hepatitis B ◽  
Administrative Support ◽  
Health Benefit ◽  
Vaccine Safety ◽  
Vaccination Program ◽  
Hepatitis B Vaccination ◽  
Vaccination Programs ◽  
B Virus ◽  
Key Steps

AbstractHealth care personnel with frequent blood contact are at high risk for being exposed to and developing hepatitis B infection. Exposure to unidentified infectious patients may lead to personnel inadvertently foregoing appropriate, passive immunoprophylaxis. For these reasons, our hospital elected to conduct an aggressive program to administer hepatitis B vaccine to all employees at high risk for exposure to hepatitis B virus, thus protecting such employees from inadvertent occupational exposure. Administrators agreed to offer the vaccine as a free employee health benefit. “High-risk” employees attended mandatory inservice presentations covering hepatitis B disease, vaccine safety and efficacy, and related concerns. High-risk individuals were required to either receive vaccine or sign “informed refusal” forms. The vaccine clinic was organized to accommodate employee work schedules. Of high-risk employees eligible for vaccination, 90% completed a three-dose vaccine course. Extensive inservice education, financial and administrative support, and careful advance planning are all crucial in achieving high compliance with vaccination programs. A description of key steps in designing a successful vaccination program is outlined.

In-Hospital Mortality and Related Outcomes for Elevated Risk Acute Pulmonary Embolism Treated With Mechanical Thrombectomy Versus Routine Care

2021 ◽  
pp. 088506662110364
Author(s):  
Jennifer R. Buckley ◽  
Brandt C. Wible
Keyword(s):  
Pulmonary Embolism ◽  
High Risk ◽  
Length Of Stay ◽  
Hospital Mortality ◽  
Routine Care ◽  
Hospital Length ◽  
Elevated Risk ◽  
Hospital Length Of Stay ◽  
Icu Length Of Stay

Purpose To compare in-hospital mortality and other hospitalization related outcomes of elevated risk patients (Pulmonary Embolism Severity Index [PESI] score of 4 or 5, and, European Society of Cardiology [ESC] classification of intermediate-high or high risk) with acute central pulmonary embolism (PE) treated with mechanical thrombectomy (MT) using the Inari FlowTriever device versus those treated with routine care (RC). Materials and Methods Retrospective data was collected of all patients with acute, central PE treated at a single institution over 2 concurrent 18-month periods. All collected patients were risk stratified using the PESI and ESC Guidelines. The comparison was made between patients with acute PE with PESI scores of 4 or 5, and, ESC classification of intermediate-high or high risk based on treatment type: MT and RC. The primary endpoint evaluated was in-hospital mortality. Secondary endpoints included intensive care unit (ICU) length of stay, total hospital length of stay, and 30-day readmission. Results Fifty-eight patients met inclusion criteria, 28 in the MT group and 30 in the RC group. Most RC patients were treated with systemic anticoagulation alone (24 of 30). In-hospital mortality was significantly lower for the MT group than for the RC group (3.6% vs 23.3%, P < .05), as was the average ICU length of stay (2.1 ± 1.2 vs 6.1 ± 8.6 days, P < .05). Total hospital length of stay and 30-day readmission rates were similar between MT and RC groups. Conclusion Initial retrospective comparison suggests MT can improve in-hospital mortality and decrease ICU length of stay for patients with acute, central PE of elevated risk (PESI 4 or 5, and, ESC intermediate-high or high risk).

Impact of Monovalent Rotavirus Vaccine on Rotavirus Hospitalizations among Children Younger Than 5 Years of Age in the Ouest and Artibonite Departments, Haiti, 2013 to 2019

2021 ◽  
Author(s):  
Anne-Marie Desormeaux ◽  
Eleanor Burnett ◽  
Gérard Joseph ◽  
Mentor Ali Ber Lucien ◽  
Negar Aliabadi ◽  
...  
Keyword(s):  
Negative Binomial ◽  
Hospital Admissions ◽  
Absolute Number ◽  
Sensitivity Analyses ◽  
Rotavirus Vaccine ◽  
Vaccine Introduction ◽  
Rotavirus Vaccination ◽  
Before And After ◽  
Rotavirus Diarrhea ◽  
The Impact

Rotavirus is responsible for 26% of diarrheal deaths in Latin America and the Caribbean. Haiti introduced the monovalent rotavirus vaccine in April 2014. The objective of this analysis is to describe the impact of the rotavirus vaccine on hospitalizations among Haitian children younger than 5 years old during the first 5 years after introduction. This analysis includes all children with diarrhea who were enrolled as part of a sentinel surveillance system at two hospitals from May 2013 to April 2019. We compare the proportion of rotavirus-positive specimens in each post-vaccine introduction year to the pre-vaccine period. To account for the potential dilution of the proportion of rotavirus-positive specimens from a waning cholera outbreak, we also analyzed annual trends in the absolute number of positive stools, fit a two-component finite-mixture model to the negative specimens, and fit a negative binomial time series model to the pre-vaccine rotavirus-positive specimens to predict the number of rotavirus diarrhea hospital admissions in the absence of rotavirus vaccination. The overall percentage of rotavirus-positive specimens declined by 22% the first year after introduction, increased by 17% the second year, and declined by 33% to 50% the subsequent 3 years. All sensitivity analyses confirmed an overall decline. We observed a clear annual rotavirus seasonality before and after vaccine introduction, with the greatest activity in December through April, and a biennial pattern, with high sharp peaks and flatter longer periods of increased rotavirus activity in alternating years, consistent with suboptimal vaccination coverage. Overall, our study shows evidence that the introduction of the rotavirus vaccine reduced the burden of severe rotavirus diarrhea.

Vaccinations in Infants Born Preterm: An Update

2020 ◽  
Vol 16 (2) ◽  
pp. 148-155
Author(s):  
Areti Aphrodite Sioriki ◽  
Despoina Gkentzi ◽  
Evangelia Papadimitriou ◽  
Gabriel Dimitriou ◽  
Ageliki Karatza
Keyword(s):  
Preterm Infants ◽  
Vaccine Safety ◽  
Full Term ◽  
Morbidity And Mortality ◽  
Term Infants ◽  
Safety And Efficacy ◽  
Vaccine Preventable Diseases ◽  
Increased Risk ◽  
Protective Antibodies

Infants born prematurely (before completion of 37 weeks of gestation) are at increased risk of morbidity and mortality due to vaccine preventable diseases, mostly because of their immunological immaturity and failure of transfer of maternal protective antibodies. Despite their great need of being vaccinated, concerns on vaccine safety and efficacy, constitute the main reasons for which vaccinations are often delayed in this group. In this review we summarize the latest evidence on vaccine safety, efficacy and immunogenicity in preterm infants which is similar to full-term infants. Therefore there is no reason for delaying vaccination in this population.

119 Communicating Sensitive Information - An Exploration of Parental Perspectives on Prognostication of High Risk Infants

2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e85-e85
Author(s):  
Emily Fong ◽  
Ronit Mesterman
Keyword(s):  
High Risk ◽  
Preterm Infants ◽  
Average Length ◽  
Sensitive Information ◽  
Neurocognitive Deficits ◽  
Biological Father ◽  
Perinatal Medicine ◽  
Term Infants ◽  
Neurologic Recovery ◽  
High Risk Infants

Abstract Primary Subject area Neonatal-Perinatal Medicine Background Preterm infants are at high risk of experiencing a range of impairments that may contribute to long-term challenges such as neurocognitive deficits. Physicians are often expected to give an outlook on future developmental outcomes of high-risk infants, often before sufficient time has elapsed to observe whether that particular child will demonstrate neurologic recovery from the initial injury. Clinicians often struggle with communicating this information, especially a poor prognosis, because of the worry about how these conversations affect families and their future expectations of the child. Objectives Our aim was to capture parents' retrospective perceptions of how their infant’s prognosis was communicated to them during their NICU stay. Design/Methods Semi-structured interviews were conducted over the phone with parents of former preterm infants with a birthweight below 1500 grams or parents of term infants who have sustained HIE requiring cooling. Parents were invited to participate when their child was between 12-36 months old at the time of the interview, so that parents would be able to have a sense of their child’s development and possible impairments. The data was analyzed thematically, with particular focus around the discourse of communication and prognostication. Results Twenty-three interviews were conducted: 20 with the biological mother, two with both biological parents, and one with the biological father. The average length of the interviews was 30 minutes. The main themes that recurred in the interviews included parental loss of control, needing to prepare for the unexpected, the value of shared decision making between the health care practitioners and parents, recognition and conveyance of uncertainty by the physician, and the importance of celebrating the present. Above all, a recurring theme mentioned by the majority of interviewees was the power of hope. While wanting to receive transparent and honest updates, parents felt strongly that giving them realistic hope was of utmost importance. Conclusion Although clinicians often feel pressured to deliver answers, parents found it helpful when clinicians acknowledged and explained the uncertainty that surrounds prognostication. While healthcare providers may feel the need to prepare parents for the worst, the importance of balancing this information with hope and positivity is what families remember and value years after the prognosis was given.

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