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Rheumatology (Oxford, England) Oct 2022Transplacental passage of certain biologic and targeted synthetic DMARDs leads to detectable levels in the neonate, which may impact on the safety of live vaccines....
OBJECTIVES
Transplacental passage of certain biologic and targeted synthetic DMARDs leads to detectable levels in the neonate, which may impact on the safety of live vaccines. Guidelines advise delaying live vaccine administration in biologic-exposed infants until they are 7 months old.
METHODS
A systematic review of Embase, Medline and Cochrane identified live vaccine outcomes in infants exposed to biologic or targeted synthetic DMARDs in utero.
RESULTS
Studies included 276 in utero exposures to adalimumab, certolizumab, etanercept, infliximab, golimumab, tocilizumab and ustekinumab. Live vaccine exposures at <12 months of age included Bacille Calmette-Guérin (BCG) (n = 215), rotavirus (n = 46), and measles, mumps and rubella (MMR) (n = 12). We identified no reactions following MMR, seven mild reactions to rotavirus vaccination and eight reactions to BCG, including one death. All infants with an adverse reaction to BCG had been exposed to infliximab in utero, and six had received BCG in the first month of life. A freedom of information request to the Medicines and Healthcare products Regulatory Agency revealed four fatal disseminated BCG infections in infants exposed to TNF inhibitors in utero, including infliximab, adalimumab and one unspecified TNF inhibitor.
CONCLUSION
Most evidence for a clinically harmful effect was for early administration of the BCG vaccine to infants exposed in utero to TNF inhibitors with high transplacental transfer rates.
Topics: Adalimumab; Antirheumatic Agents; BCG Vaccine; Etanercept; Humans; Infant; Infant, Newborn; Infliximab; Tumor Necrosis Factor Inhibitors; Ustekinumab
PubMed: 35258557
DOI: 10.1093/rheumatology/keac141 -
Vaccine May 2021Rotavirus (RV) infection is the leading cause of diarrhoea-associated morbidity and mortality globally among children under 5 years of age. RV vaccination is available,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Rotavirus (RV) infection is the leading cause of diarrhoea-associated morbidity and mortality globally among children under 5 years of age. RV vaccination is available, but has not been implemented in many national immunisation plans, especially in highly developed countries. This systematic review aimed to estimate the prevalence and incidence of health care use for RV gastroenteritis (RVGE) among children aged under 5 years in highly developed countries without routine RV vaccination.
METHODS
We searched MEDLINE and Embase databases from January 1 2000 to December 17 2018 for publications reporting on incidence or prevalence of RVGE-related health care use in children below 5 years of age: primary care and emergency department (ED) visits, hospitalisations, nosocomial infections and deaths. We included only studies with laboratory-confirmed RV infection, undertaken in highly developed countries with no RV routine vaccination plans. We used random effects meta-analysis to generate summary estimates with 95% confidence intervals (CI) and prediction intervals.
RESULTS
We screened 4033 abstracts and included 74 studies from 21 countries. Average incidence rates of RVGE per 100 000 person-years were: 2484 (95% CI 697-5366) primary care visits, 1890 (1597-2207) ED visits, 500 (422-584) hospitalisations, 34 (20-51) nosocomial infections and 0.04 (0.02-0.07) deaths. Average proportions of cases of acute gastroenteritis caused by RV were: 21% (95% CI 16-26%) for primary care visits; 32% (25-38%) for ED visits; 41% (36-47%) for hospitalisations, 29% (25-34%) for nosocomial infections and 12% (8-18%) for deaths. Results varied widely between and within countries, and heterogeneity was high (I > 90%) in most models.
CONCLUSION
RV in children under 5 years causes many healthcare visits and hospitalisations, with low mortality, in highly developed countries without routine RV vaccination. The health care use estimates for RVGE obtained by this study can be used to model RV vaccine cost-effectiveness in highly developed countries.
Topics: Child; Child, Preschool; Developed Countries; Humans; Infant; Patient Acceptance of Health Care; Rotavirus; Rotavirus Infections; Rotavirus Vaccines
PubMed: 33934916
DOI: 10.1016/j.vaccine.2021.04.039 -
Human Vaccines Jul 2011The pentavalent rotavirus (RV) vaccine RotaTeq™ has been available in industrialized countries since 2006. Several studies have been conducted to evaluate the benefit... (Review)
Review
Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries.
The pentavalent rotavirus (RV) vaccine RotaTeq™ has been available in industrialized countries since 2006. Several studies have been conducted to evaluate the benefit of RV vaccination under routine conditions of use. A systematic review of all publicly available data from RotaTeq™ vaccine-effectiveness and vaccination-impact studies in the USA, Europe and Australia between 2006 and February 2010 was undertaken. Depending on the population studied, effectiveness of up to 100% (95% confidence interval 85-100%) associated with decreased hospitalizations for RV gastroenteritis (RVGE) was seen. Vaccination-impact studies demonstrated that the burden of RVGE has been reduced significantly since the introduction of RV vaccination. Evidence included reductions in healthcare utilization due to RVGE (hospitalizations and emergency-department visits reduced by up to 90%), reductions in the magnitude and duration of the RV season as assessed by laboratory testing for RV, and the possible induction of herd immunity.
Topics: Administration, Oral; Australia; Europe; Gastroenteritis; Humans; Immunity, Herd; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; United States; Vaccination; Vaccines, Attenuated
PubMed: 21734466
DOI: 10.4161/hv.7.7.15511 -
Pathogens and Global Health Feb 2023Rotavirus is responsible for most cases of gastroenteritis and mortality in children below 5 years of age, especially in developing countries, including Nigeria.... (Meta-Analysis)
Meta-Analysis
Rotavirus is responsible for most cases of gastroenteritis and mortality in children below 5 years of age, especially in developing countries, including Nigeria. Nonetheless, there is limited data on the nationwide estimate for the prevalence of rotavirus. This systematic review and meta-analysis sought to determine the pooled prevalence of rotavirus infections and its relative risk among children below 5 years of age in Nigeria. Eligible published studies between 1982 and 2021 were accessed from 'PubMed', 'Science Direct', 'Google Scholar' and 'African Journal Online', 'Web of Science', 'Springer', 'Wiley' were systematically reviewed. The pooled prevalence, relative risk and regional subgroup analyses were calculated using the random effects model at 95% confidence interval (CI). A total of 62 selected studies, including 15 studies case-control studies, were processed in this review from a pooled population of 18,849 children. The nationwide pooled prevalence of rotavirus among children below 5 years of age in Nigeria was 23% (CI 95%; 19-27). Regional subgroup analysis showed that the Southern region had a prevalence of 27% (CI 95%; 21-32) while the Northern region had a 20% (CI 95%; 16-25%) prevalence, although the difference was not significant ( = 0.527). Rotavirus was implicated in most cases of acute gastroenteritis with a relative risk of 5.7 (95% CI: 2.9-11.2). The high prevalence and relative risk of rotavirus infections among children in Nigeria shows that rotavirus is an important cause of acute gastroenteritis in Nigeria. Thus, there is a need for further surveillance, especially at community levels together with the introduction of rotavirus vaccines into the national immunization program.
Topics: Humans; Child; Infant; Child, Preschool; Rotavirus Infections; Rotavirus; Risk; Nigeria; Prevalence; Gastroenteritis; Hospitalization
PubMed: 35249468
DOI: 10.1080/20477724.2022.2043223 -
Danish Medical Bulletin Oct 2011Rotavirus infections are the most common cause of severe diarrhoea in children worldwide. Two internationally licensed rotavirus vaccines have proven to be efficacious... (Review)
Review
Rotavirus infections are the most common cause of severe diarrhoea in children worldwide. Two internationally licensed rotavirus vaccines have proven to be efficacious in middle and high-income countries and they could potentially be valuable tools for the prevention of rotavirus-associated diarrhoea in low-income countries where the disease burden is greatest. However, before the vaccines can be introduced into the national immunisation programmes in these countries, many challenges related to the financing of vaccine purchase, the cold chain capacity and vaccine efficacy must be overcome. There is also a need for political commitment to prevent rotavirus infections as well as a need for an overall strengthening of the health systems in low-income countries. If these challenges were met, rotavirus vaccination could substantially improve child health and survival from rotavirus-associated diarrhoea.
Topics: Child; Developing Countries; Diarrhea; Humans; Immunization Programs; Poverty; Rotavirus; Rotavirus Infections; Rotavirus Vaccines
PubMed: 21975154
DOI: No ID Found -
JAMA Network Open Oct 2019The conclusions from the multiple randomized clinical trials exploring the relationship between development of intussusception and rotavirus vaccination among neonates... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The conclusions from the multiple randomized clinical trials exploring the relationship between development of intussusception and rotavirus vaccination among neonates and infants have been controversial.
OBJECTIVE
To evaluate the association between rotavirus vaccination and risk of intussusception.
DATA SOURCES
For this systematic review and meta-analysis, PubMed, Web of Science, Cochrane library, and Embase databases were searched from January 1, 1999, through December 31, 2018, using no language restrictions. The search terms were rotavirus or RV (rotavirus vaccine) or HRV (human rotavirus vaccine), vaccin*, and intussusception.
STUDY SELECTION
Randomized clinical trials of neonates and infants that compared the risk of intussusception after the vaccination with a placebo group were included.
DATA EXTRACTION AND SYNTHESIS
A fixed-effects model was used to pool the data. Statistical heterogeneity was assessed with Q test and I2 statistic; relative risk (RR), risk difference (RD), and 95% CIs were calculated using the Mantel-Haenszel method.
MAIN OUTCOMES AND MEASURES
The main outcome was the diagnosis of intussusception in the analysis. The pooled and subtotal results of RR, RD, and 95% CI for the risk of intussusception were estimated at 31 days, 1 year, and 2 years after vaccination.
RESULTS
A total of 25 randomized clinical trials including 200 594 participants (104 647 receiving vaccine and 95 947 receiving placebo) in 33 countries from 4 continents were included in this meta-analysis. Twenty cases of definite intussusception were diagnosed within 31 days after rotavirus vaccination, with 11 cases (55%) in the vaccine group and 9 cases (45%) in the placebo group (RD, 0.17 per 10 000 infants [95% CI, -1.16 to 1.50 per 10 000 infants], P = .80; RR, 1.14 [95% CI, 0.49 to 2.64], P = .77). Seventy-four cases were reported within 1 year, with 37 cases (50%) in the vaccine group and 37 cases (50%) in the placebo group (RD, -0.65 per 10 000 infants [95% CI, -2.68 to 1.39 per 10 000 infants], P = .53; RR, 0.84 [95% CI, 0.53 to 1.32], P = .45). Fifty-nine cases were reported within 2 years, with 29 cases (49%) in the vaccine group and 30 cases (51%) in the placebo group (RD, -0.48 per 10 000 infants [95% CI, -3.64 to 2.69 per 10 000 infants], P = .77; RR, 0.91 [95% CI, 0.55 to 1.52], P = .73).
CONCLUSIONS AND RELEVANCE
Results of this systematic review and meta-analysis suggest that monovalent, pentavalent, monovalent human-bovine, oral bovine pentavalent, and human neonatal rotavirus vaccination was not associated with an elevated risk of intussusception among neonates or infants.
Topics: Female; Humans; Infant; Infant, Newborn; Intussusception; Male; Randomized Controlled Trials as Topic; Risk Factors; Rotavirus; Rotavirus Infections; Rotavirus Vaccines
PubMed: 31584679
DOI: 10.1001/jamanetworkopen.2019.12458 -
The Lancet. Infectious Diseases Feb 2012WHO recommends routine use of rotavirus vaccines in all countries, particularly in those with high mortality attributable to diarrhoeal diseases. To establish the burden... (Meta-Analysis)
Meta-Analysis Review
2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis.
BACKGROUND
WHO recommends routine use of rotavirus vaccines in all countries, particularly in those with high mortality attributable to diarrhoeal diseases. To establish the burden of life-threatening rotavirus disease before the introduction of a rotavirus vaccine, we aimed to update the estimated number of deaths worldwide in children younger than 5 years due to diarrhoea attributable to rotavirus infection.
METHODS
We used PubMed to identify studies of at least 100 children younger than 5 years who had been admitted to hospital with diarrhoea. Additionally, we required the studies to have a data collection midpoint of the year 2000 or later, to be done in full-year increments, and to assesses diarrhoea attributable to rotavirus with EIAs or polyacrylamide gel electrophoresis. We also included data from countries that participated in the WHO-coordinated Global Rotavirus Surveillance Network (consisting of participating member states during 2009) and that met study criteria. For countries that have introduced a rotavirus vaccine into their national immunisation programmes, we excluded data subsequent to the introduction. We classified studies into one of five groups on the basis of region and the level of child mortality in the country in which the study was done. For each group, to obtain estimates of rotavirus-associated mortality, we multiplied the random-effect mean rotavirus detection rate by the 2008 diarrhoea-related mortality figures for countries in that group. We derived the worldwide mortality estimate by summing our regional estimates.
FINDINGS
Worldwide in 2008, diarrhoea attributable to rotavirus infection resulted in 453,000 deaths (95% CI 420,000-494,000) in children younger than 5 years-37% of deaths attributable to diarrhoea and 5% of all deaths in children younger than 5 years. Five countries accounted for more than half of all deaths attributable to rotavirus infection: Democratic Republic of the Congo, Ethiopia, India, Nigeria, and Pakistan; India alone accounted for 22% of deaths (98,621 deaths).
INTERPRETATION
Introduction of effective and available rotavirus vaccines could substantially affect worldwide deaths attributable to diarrhoea. Our new estimates can be used to advocate for rotavirus vaccine introduction and to monitor the effect of vaccination on mortality once introduced.
Topics: Child, Preschool; Diarrhea; Humans; Infant; Infant, Newborn; Rotavirus; Rotavirus Infections; Rotavirus Vaccines
PubMed: 22030330
DOI: 10.1016/S1473-3099(11)70253-5 -
Vaccine Jun 2017World Health Organization (WHO) recommends Rotavirus vaccines to prevent and control rotavirus infections. Economic evaluations (EE) have been considered to support... (Review)
Review
INTRODUCTION
World Health Organization (WHO) recommends Rotavirus vaccines to prevent and control rotavirus infections. Economic evaluations (EE) have been considered to support decision making of national policy. Summarizing global experience of the economic value of rotavirus vaccines is crucial in order to encourage global WHO recommendations for vaccine uptake. Therefore, a systematic review of economic evaluations of rotavirus vaccine was conducted.
METHODS
We searched Medline, Embase, NHS EED, EconLit, CEA Registry, SciELO, LILACS, CABI-Global Health Database, Popline, World Bank - e-Library, and WHOLIS. Full economic evaluations studies, published from inception to November 2015, evaluating Rotavirus vaccines preventing Rotavirus infections were included. The methods, assumptions, results and conclusions of the included studies were extracted and appraised using WHO guide for standardization of EE of immunization programs.
RESULTS
104 relevant studies were included. The majority of studies were conducted in high-income countries. Cost-utility analysis was mostly reported in many studies using incremental cost-effectiveness ratio per DALY averted or QALY gained. Incremental cost per QALY gained was used in many studies from high-income countries. Mass routine vaccination against rotavirus provided the ICERs ranging from cost-saving to highly cost-effective in comparison to no vaccination among low-income countries. Among middle-income countries, vaccination offered the ICERs ranging from cost-saving to cost-effective. Due to low- or no subsidized price of rotavirus vaccines from external funders, being not cost-effective was reported in some high-income settings.
CONCLUSION
Mass vaccination against rotavirus was generally found to be cost-effective, particularly in low- and middle-income settings according to the external subsidization of vaccine price. On the other hand, it may not be a cost-effective intervention at market price in some high-income settings. This systematic review provides supporting information to health policy-makers and health professionals when considering rotavirus vaccination as a national program.
Topics: Cost-Benefit Analysis; Health Policy; Humans; Mass Vaccination; Quality-Adjusted Life Years; Rotavirus Infections; Rotavirus Vaccines; World Health Organization
PubMed: 28504193
DOI: 10.1016/j.vaccine.2017.04.051 -
PharmacoEconomics Jan 2018In low- and middle-income countries, budget impact is an important criterion for funding new interventions, particularly for large public health investments such as new...
Capturing Budget Impact Considerations Within Economic Evaluations: A Systematic Review of Economic Evaluations of Rotavirus Vaccine in Low- and Middle-Income Countries and a Proposed Assessment Framework.
BACKGROUND
In low- and middle-income countries, budget impact is an important criterion for funding new interventions, particularly for large public health investments such as new vaccines. However, budget impact analyses remain less frequently conducted and less well researched than cost-effectiveness analyses.
OBJECTIVE
The objective of this study was to fill the gap in research on budget impact analyses by assessing (1) the quality of stand-alone budget impact analyses, and (2) the feasibility of extending cost-effectiveness analyses to capture budget impact.
METHODS
We developed a budget impact analysis checklist and scoring system for budget impact analyses, which we then adapted for cost-effectiveness analyses, based on current International Society for Pharmacoeconomics and Outcomes Research Task Force recommendations. We applied both budget impact analysis and cost-effectiveness analysis checklists and scoring systems to examine the extent to which existing economic evaluations provide sufficient evidence about budget impact to enable decision making. We used rotavirus vaccination as an illustrative case in which low- and middle-income countries uptake has been limited despite demonstrated cost effectiveness. A systematic literature review was conducted to identify economic evaluations of rotavirus vaccine in low- and middle-income countries published between January 2000 and February 2017. We critically appraised the quality of budget impact analyses, and assessed the extension of cost-effectiveness analyses to provide useful budget impact information.
RESULTS
Six budget impact analyses and 60 cost-effectiveness analyses were identified. Budget impact analyses adhered to most International Society for Pharmacoeconomics and Outcomes Research recommendations, with key exceptions being provision of undiscounted financial streams for each budget period and model validation. Most cost-effectiveness analyses could not be extended to provide useful budget impact information; cost-effectiveness analyses also rarely presented undiscounted annual costs, or estimated financial streams during the first years of programme scale-up.
CONCLUSIONS
Cost-effectiveness analyses vastly outnumber budget impact analyses of rotavirus vaccination, despite both being critical for policy decision making. Straightforward changes to the presentation of cost-effectiveness analyses results could facilitate their adaptation into budget impact analyses.
Topics: Budgets; Cost-Benefit Analysis; Decision Making; Developing Countries; Health Policy; Humans; Policy Making; Rotavirus Infections; Rotavirus Vaccines; Vaccination
PubMed: 28905279
DOI: 10.1007/s40273-017-0569-2 -
Human Vaccines & Immunotherapeutics Nov 2022Globally, an estimated 23 million children missed vaccination in 2020 due to the coronavirus disease 2019 (COVID-19) pandemic. We analyzed vaccination coverage trends...
Globally, an estimated 23 million children missed vaccination in 2020 due to the coronavirus disease 2019 (COVID-19) pandemic. We analyzed vaccination coverage trends and catch-up strategies/recommendations implemented in Latin America during the pandemic. We performed a national administrative database analysis and a systematic literature review to evaluate vaccination coverage data and identify catch-up strategies for missed vaccinations in selected countries in Latin America (Argentina, Brazil, Chile, Colombia, Mexico and Peru). Data were extracted from national health ministry vaccination coverage and supranational databases to identify coverage of rotavirus (RV), pentavalent/hexavalent, measles, Bacillus Calmette-Guérin (BCG) and pneumococcal conjugate vaccines (PCV) at country level before and during the COVID-19 pandemic. A systematic literature review of published papers was conducted to identify vaccination catch-up strategies published in January 2020-June 2021. National administrative database-reported data showed that vaccination coverage trends were declining prior to 2020. The change in vaccination coverage before and during the COVID-19 pandemic ranged from 2.5% to -11.5% (RV), -3.0% to -11.0% (measles), 1.5% to -7.5% (PCV), 9.0% to -14.0% (pentavalent/hexavalent), and 3.0% to -18.5% (BCG). Among 696 identified studies, 14 studies were included in this review. Catch-up vaccination strategies included prioritizing routine vaccinations as per the national immunization schedule. Overall vaccination coverage declined by varying degrees among the countries investigated. This trend was observed prior to 2020, suggesting multifactorial reasons for declining vaccination rates in Latin America.
Topics: Child; Humans; Pandemics; COVID-19; Vaccination; Immunization Schedule; Measles; Vaccines, Conjugate; Immunization Programs
PubMed: 36084255
DOI: 10.1080/21645515.2022.2102353