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Wellcome Open Research 2020Randomized controlled trials of licensed oral rotavirus group A (RVA) vaccines, indicated lower efficacy in developing countries compared to developed countries. We...
Randomized controlled trials of licensed oral rotavirus group A (RVA) vaccines, indicated lower efficacy in developing countries compared to developed countries. We investigated the pooled effectiveness of Rotarix in Africa in 2019, a decade since progressive introduction began in 2009. A systematic search was conducted in PubMed to identify studies that investigated the effectiveness of routine RVA vaccination in an African country between 2009 and 2019. A meta-analysis was undertaken to estimate pooled effectiveness of the full-dose versus partial-dose of Rotarix (RV1) vaccine and in different age groups. Pooled odds ratios were estimated using random effects model and the risk of bias assessed using Newcastle-Ottawa scale. The quality of the evidence was assessed using GRADE. By December 2019, 39 (72%) countries in Africa had introduced RVA vaccination, of which 34 were using RV1. Thirteen eligible studies from eight countries were included in meta-analysis for vaccine effectiveness (VE) of RVA by vaccine dosage (full or partial) and age categories. Pooled RV1 VE against RVA associated hospitalizations was 44% (95% confidence interval (CI) 28-57%) for partial dose versus 58% (95% CI 50-65%) for full dose. VE was 61% (95% CI 50-69%), 55% (95% CI 32-71%), 56% (95% CI 43-67%), and 61% (95% CI 42-73%) for children aged <12 months, 12-23 months, <24 months and 12-59 months, respectively. RV1 vaccine use has resulted in a significant reduction in severe diarrhoea in African children and its VE is close to the efficacy findings observed in clinical trials. RV1 VE point estimate was higher for children who received full dose than those who received partial dose, and its protection lasted beyond the first year of life.
PubMed: 33215049
DOI: 10.12688/wellcomeopenres.16174.2 -
Drug Safety Nov 2020Understanding the balance between the benefits and risks of vaccination is essential to ensure informed and adequate public health decision making. Quantitative...
INTRODUCTION
Understanding the balance between the benefits and risks of vaccination is essential to ensure informed and adequate public health decision making. Quantitative benefit-risk models (qBRm) represent useful tools to help decision makers with supporting benefit-risk assessment throughout the lifecycle of a medical product. However, few initiatives have been launched to harmonise qBRm approaches, specifically for vaccines.
OBJECTIVES
The aim of this paper was to identify publications about qBRm applied to vaccines through a systematic literature review, and to describe their characteristics.
METHODS
Medline, Scopus and Institute for Scientific Information Web of Knowledge databases were searched to identify articles in English, published from database inceptions up to December 2019. The search strategy included the combination of three key concepts: 'benefit-risk', 'modelling' and 'vaccines'. Data extracted included the modelling context and the methodological approaches used.
RESULTS
Of 3172 publications screened, 48 original publications were included. Most of the selected studies were published over the past decade and focused on rotavirus (15), dengue (10) and influenza (6) vaccines. The majority (30) of studies reported analyses related to high-income countries. The methodology of the studies differed, particularly in modelling techniques, benefit-risk measures, and sensitivity analyses. The present work also pointed out a high level of variability in the quality of reporting across studies, with particular regard to input parameters and methodological approaches.
CONCLUSIONS
This review provides an extensive list of qBRm applied to vaccines. Discrepancies across studies were identified during our review. While the number of published qBRm studies is increasing, no reporting guidance for qBRm applied to vaccines is currently available. This may affect decision makers' confidence in the results and their benefit-risk assessment(s); therefore, the development of such reporting guidance is highly needed.
Topics: Communicable Disease Control; Humans; Models, Biological; Risk Assessment; Vaccines
PubMed: 32914292
DOI: 10.1007/s40264-020-00984-7 -
Human Vaccines & Immunotherapeutics Mar 2021A systematic literature review of Medline and Embase databases was conducted to describe rotavirus (RV) vaccine coverage for a complete series, timing of receipt of all...
A systematic literature review of Medline and Embase databases was conducted to describe rotavirus (RV) vaccine coverage for a complete series, timing of receipt of all doses in the series, and predictors of RV vaccination coverage in the US for two licensed RV vaccines (RV1, RV5). Nine publications were included in the review. RV vaccination coverage rates of under 80% suggest RV vaccines are underutilized relative to the Healthy People 2020 target and other childhood vaccines. About 50-90% of children initiating RV vaccination complete the series and coverage for a complete series is lower for black and Hispanic children (vs. whites), uninsured or Medicaid insured (vs. privately insured), and for foreign-born (vs. US-born) children. Series completion is significantly greater in children receiving DTaP, RV1 (vs. RV5), and for those receiving routine care from a pediatrician. There is a need to design and implement better RV immunization strategies for US children.
Topics: Child; Humans; Infant; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; United States; Vaccination; Vaccination Coverage; Vaccines, Attenuated
PubMed: 32845792
DOI: 10.1080/21645515.2020.1794440 -
Zhonghua Yu Fang Yi Xue Za Zhi [Chinese... Jul 2020In 1999, since the Rotashield, the first generation of oral Rotavirus vaccine has been confirmed that there is a link to intussusception, mainly occurs in 7 days after...
In 1999, since the Rotashield, the first generation of oral Rotavirus vaccine has been confirmed that there is a link to intussusception, mainly occurs in 7 days after first dose. With the second generation of RV vaccine has been listed globally and intussusception monitoring has continued. This study reviewed the current phase Ⅲ clinical and post-marketing studies of rotavirus vaccines on the market and found that the two most widely used rotavirus vaccines, RV1 and RV5, were found the risk of intussusception increased within 7 days of ORV. The Lanzhou lamb rotavirus vaccine (LLR), which manufactured by Lanzhou Institute of Biological Products Co, also lacks Epidemiological surveies. With the introduction of RV5 in 2018, the role of rotavirus vaccine in the prevention and efforts of severe rotavirus diarrhea is increasing. It is urgent to establish an intussusception active monitoring system to monitor the incidence of intussusception after rotavirus vaccine and provide more evidence for the post-marketing evaluation of the rotavirus vaccine.
Topics: Humans; Infant; Intussusception; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccines, Attenuated
PubMed: 32842305
DOI: 10.3760/cma.j.cn112150-20191115-00860 -
PloS One 2020Over 34 countries in Africa have introduced rotavirus vaccine to their national immunization programs: monovalent (Rotarix®, RV1) and pentavalent (RotaTeq®, RV5) after... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Over 34 countries in Africa have introduced rotavirus vaccine to their national immunization programs: monovalent (Rotarix®, RV1) and pentavalent (RotaTeq®, RV5) after South Africa introduced it in 2009. Since then several studies assessing the impact of the vaccine have been conducted. The principal aim of this study was to evaluate the impact of rotavirus vaccine in sub-Saharan Africa.
METHODS
A Literature search was performed using Mendeley, PubMed, ScienceDirect, grey literature and Web of Science databases of published studies from January 1, 2017, as years of recent publications on rotavirus vaccine impact in sub-Saharan Africa. A meta-analysis was conducted for rotavirus infection in children under 5 years using proportions of pre and post-vaccine introduction in these populations. Random-effect estimates were considered since the samples were from universal populations.
RESULTS
Out of the 935 articles identified, 17 studies met the inclusion for systematic review and meta-analysis. The pooled proportion for pre-vaccination period was 42%, 95% (CI: 38-46%), and reduced to 21%, 95% (CI: 17-25%) during post-vaccination period. Rotavirus diarrhea significantly reduced in children < 12 months as compared to children 12-24 months old. Seasonal peaks of rotavirus diarrhea were between June-September. However, data is limited to one year of post-vaccine introduction, and bias may present due to early vaccine impact.
CONCLUSION
We observed that the introduction of the rotavirus vaccine was partly responsible for the significant reduction in the burden of rotavirus-associated diarrhea in sub-Saharan Africa. Therefore, there is a need to encourage the remaining countries to introduce the vaccine to their routine national immunization programs.
Topics: Africa South of the Sahara; Diarrhea; Humans; Immunization Programs; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccination; Vaccines, Attenuated
PubMed: 32339187
DOI: 10.1371/journal.pone.0232113 -
Human Vaccines & Immunotherapeutics Nov 2020This study is aimed to review the published evidence on safety, immunogenicity, and efficacy of rotavirus vaccines when co-administered with meningococcal vaccines in...
This study is aimed to review the published evidence on safety, immunogenicity, and efficacy of rotavirus vaccines when co-administered with meningococcal vaccines in infants. A systematic literature search was performed in four databases containing peer-reviewed articles and conference abstracts. In total, twelve articles were included in the review; 11 provided information on safety and five on the immunogenicity of rotavirus vaccines following co-administration. No paper was found on efficacy. Additional routine vaccines were administered in all studies. The safety analysis was mainly focused on fever, vomiting, diarrhea, intussusception, and changes in eating habits. Overall, safety profiles and immune responses associated with rotavirus vaccination were comparable between infants co-administered with rotavirus and meningococcal vaccines and infants receiving rotavirus vaccines without meningococcal vaccines. Although data are limited, co-administration of rotavirus and meningococcal vaccines does not appear to interfere with the safety or immunogenicity of rotavirus vaccines.
Topics: Antibodies, Bacterial; Humans; Infant; Meningococcal Vaccines; Rotavirus Vaccines; Vaccination
PubMed: 32298219
DOI: 10.1080/21645515.2020.1739485 -
Open Forum Infectious Diseases Apr 2020Although rotavirus vaccines have proven to prevent the risk of rotavirus gastroenteritis (RVGE) in children under 5 years old, they are also associated with an increased... (Review)
Review
BACKGROUND
Although rotavirus vaccines have proven to prevent the risk of rotavirus gastroenteritis (RVGE) in children under 5 years old, they are also associated with an increased transient risk of intussusception (IS). Several quantitative benefit-risk models (qBRm) are performed to measure this balance in hospitalizations and deaths prevented versus the ones induced.
METHOD
In this study, our objective was to provide a complete overview of qBRm used for rotavirus vaccination. We systematically searched 3 medical literature databases to identify relevant articles, in English, that were published between 2006 and 2019.
RESULTS
Of the 276 publications screened, 14 studies using qBRm for rotavirus vaccination were retained, based on preselected criteria. Four were performed in low- and middle-income countries. Almost all (13 of 14) displayed the following characteristics: force of infection assumed to be constant over time (static model), indirect effect of rotavirus vaccination (herd effect) not considered, closed model (individuals not allowed to enter and/or exit the model over time), and aggregated level (no tracking of individual's behavior). Most of the models were probabilistic (9 of 14) and reported sensitivity and/or scenario analyses (12 of 14). Input parameter values varied across studies. Selected studies suggest that, depending on the models used, for every IS hospitalization and death induced, vaccination would prevent, respectively, 190-1624 and 71-743 RVGE-related hospitalizations and deaths.
CONCLUSIONS
The benefits of rotavirus vaccination were shown to largely exceed the increased risk of IS, across all studies. Future research aiming to harmonize qBRm for rotavirus vaccination should ensure the comparability of studies and provide additional information for regulatory authorities, physicians, and patients.
PubMed: 32296726
DOI: 10.1093/ofid/ofaa087 -
Epidemiology and Infection Mar 2020Gastroenteritis remains a serious health condition among children under 5 years especially in Africa. We conducted a systematic review and meta-analysis to investigate... (Meta-Analysis)
Meta-Analysis
Gastroenteritis remains a serious health condition among children under 5 years especially in Africa. We conducted a systematic review and meta-analysis to investigate the aetiologic pathogens of gastroenteritis in the region. We did a systematic search for articles with original data on the aetiology of gastroenteritis and acute diarrhoea among children younger than 5 years. Pooled results were extracted and analysed in STATA version 12.0 using random-effects for statistical test for homogeneity following the guidelines provided in the Cochrane Collaboration and Preferred reporting items for systematic reviews and meta-analyses. Overall, viruses accounted for 50.2% of the cases followed by bacteria with 31.6% of the cases. Parasites accounted for 12.1% of the case. Rotavirus was the most common cause of acute diarrhoea in all regions resulting in 29.2% of the cases followed by E. coli (15.6%) of diarrhoeal cases and Adenovirus (10.8%). The most prevalent parasite detected was Giardia lamblia (7.3%). Acute diarrhoea remains rampant with Rotavirus still being the major pathogen responsible for the disease in children less than 5 years old despite the introduction of vaccine. It is recommended that the vaccine should be promoted much more widely in the region.
Topics: Adenoviridae; Adenovirus Infections, Human; Africa South of the Sahara; Child, Preschool; Diarrhea; Escherichia coli; Escherichia coli Infections; Gastroenteritis; Giardia lamblia; Giardiasis; Humans; Infant; Infant, Newborn; Rotavirus; Rotavirus Infections
PubMed: 32115003
DOI: 10.1017/S0950268820000618 -
Viruses Jan 2020Rotavirus infection is the major cause of acute gastroenteritis among children globally. Sub-Saharan Africa including Ethiopia is disproportionally affected by the... (Meta-Analysis)
Meta-Analysis
Rotavirus infection is the major cause of acute gastroenteritis among children globally. Sub-Saharan Africa including Ethiopia is disproportionally affected by the disease. The aims of this review were to determine the pooled prevalence of rotavirus infection among children under-five and to identify the dominant rotavirus genotypes in Ethiopia. Twelve studies were included to estimate the pooled prevalence of rotavirus acute gastroenteritis and five studies were used to determine predominantly circulating genotypes of rotavirus. The pooled prevalence of rotavirus infection was 23% (95% CI = 22%-24%). G3 (27.1%) and P[8] (49%) were the dominant G and P types, respectively. The G8 G-type uncommon in humans but highly prevalent in cattle was also reported accounting for 1% of all cases. The major G/P combinations were G12P[8] (15.4%), G3P[6] (14.2%), G1P[8] (13.6%) and G3P[8] (12.9%) collectively accounting for 56.1% of rotavirus strains. Similar to other parts of the world, the dominance of G1, G3, P[6] and P[8] genotypes was noted in Ethiopia. The increased prevalence of G12P[8] strains observed in Ethiopia was similar to observations in other geographic regions in the post-vaccine introduction period. Thus, further studies are required on the vaccine effectiveness, genotype distribution and inter-species transmission potential of rotaviruses in Ethiopia.
Topics: Animals; Child, Preschool; Ethiopia; Gastroenteritis; Genetic Variation; Genotype; Humans; Infant; Prevalence; Rotavirus; Rotavirus Infections; Rotavirus Vaccines
PubMed: 31947826
DOI: 10.3390/v12010062 -
Salud Publica de Mexico 2020To analyze the epidemiological aspects of AID through Mexican history and the potential strategies to pre- vent AID in Mexican population.
OBJECTIVE
To analyze the epidemiological aspects of AID through Mexican history and the potential strategies to pre- vent AID in Mexican population.
MATERIALS AND METHODS
A systematic review was performed exploring the key words, diarrhea, morbidity, mortality, Mexico, health promotion for the last 20 years (1978-2018).
RESULTS
Over 8 600 articles were obtained; all of them were evaluated to consider those follow the aim of the present work.
CONCLUSIONS
The result of the performed systematic review denoted the influence of AID in Mexican public health policy; the adopted actions diminished the AID's associated risks and allowed future strategies to prevent it; those actions must include hygienic and dietetic measures, pharmaceutical innovations and technological tools applied to health policies.
Topics: Acute Disease; Child, Preschool; Diarrhea; Gastroenteritis; Health Policy; Health Promotion; History, 16th Century; History, 19th Century; History, 20th Century; History, 21st Century; Humans; Hygiene; Infant; Infant, Newborn; Mexico; Morbidity; Primary Health Care; Risk Factors; Rotavirus Infections; Rotavirus Vaccines
PubMed: 31869558
DOI: 10.21149/10002