-
JAMA Pediatrics Jul 2021Rotavirus vaccines have been introduced worldwide, and the clinical association of different rotavirus vaccines with reduction in rotavirus gastroenteritis (RVGE) after... (Meta-Analysis)
Meta-Analysis
Association of Rotavirus Vaccines With Reduction in Rotavirus Gastroenteritis in Children Younger Than 5 Years: A Systematic Review and Meta-analysis of Randomized Clinical Trials and Observational Studies.
IMPORTANCE
Rotavirus vaccines have been introduced worldwide, and the clinical association of different rotavirus vaccines with reduction in rotavirus gastroenteritis (RVGE) after introduction are noteworthy.
OBJECTIVE
To evaluate the comparative benefit, risk, and immunogenicity of different rotavirus vaccines by synthesizing randomized clinical trials (RCTs) and observational studies.
DATA SOURCES
Relevant studies published in 4 databases: Embase, PubMed, the Cochrane Library, and Web of Science were searched until July 1, 2020, using search terms including "rotavirus" and "vaccin*."
STUDY SELECTION
Randomized clinical trials and cohort and case-control studies involving more than 100 children younger than 5 years that reported the effectiveness, safety, or immunogenicity of rotavirus vaccines were included.
DATA EXTRACTION AND SYNTHESIS
A random-effects model was used to calculate relative risks (RRs), odds ratios (ORs), risk differences, and 95% CIs. Adjusted indirect treatment comparison was performed to assess the differences in the protection of Rotarix and RotaTeq.
MAIN OUTCOMES AND MEASURES
The primary outcomes were RVGE, severe RVGE, and RVGE hospitalization. Safety-associated outcomes involved serious adverse events, intussusception, and mortality.
RESULTS
A meta-analysis of 20 RCTs and 38 case-control studies revealed that Rotarix (RV1) significantly reduced RVGE (RR, 0.316 [95% CI, 0.224-0.345]) and RVGE hospitalization risk (OR, 0.347 [95% CI, 0.279-0.432]) among children fully vaccinated; RotaTeq (RV5) had similar outcomes (RVGE: RR, 0.350 [95% CI, 0.275-0.445]; RVGE hospitalization risk: OR, 0.272 [95% CI, 0.197-0.376]). Rotavirus vaccines also demonstrated higher protection against severe RVGE. Additionally, no significant differences in the protection of RV1 and RV5 against rotavirus disease were noted in adjusted indirect comparisons. Moderate associations were found between reduced RVGE risk and Rotavac (RR, 0.664 [95% CI, 0.548-0.804]), Rotasiil (RR, 0.705 [95% CI, 0.605-0.821]), and Lanzhou lamb rotavirus vaccine (RR, 0.407 [95% CI, 0.332-0.499]). All rotavirus vaccines demonstrated no risk of serious adverse events. A positive correlation was also found between immunogenicity and vaccine protection (eg, association of RVGE with RV1: coefficient, -1.599; adjusted R2, 99.7%).
CONCLUSIONS AND RELEVANCE
The high protection and low risk of serious adverse events for rotavirus vaccines in children who were fully vaccinated emphasized the importance of worldwide introduction of rotavirus vaccination. Similar protection provided by Rotarix and RotaTeq relieves the pressure of vaccines selection for health care authorities.
Topics: Child, Preschool; Gastroenteritis; Humans; Infant; Infant, Newborn; Randomized Controlled Trials as Topic; Rotavirus Infections; Rotavirus Vaccines
PubMed: 33970192
DOI: 10.1001/jamapediatrics.2021.0347 -
Vaccine Nov 2019Rotavirus disease is a leading global cause of mortality and morbidity in children under 5years of age. The effectiveness of the two globally used oral rotavirus... (Review)
Review
Rotavirus disease is a leading global cause of mortality and morbidity in children under 5years of age. The effectiveness of the two globally used oral rotavirus vaccines quickly became apparent when introduced into both developed and developing countries, with significant reductions in rotavirus-associated mortality and hospitalizations. However, the effectiveness and impact of the vaccines is reduced in developing country settings, where the burden and mortality is highest. New rotavirus vaccines, including live oral rotavirus candidates and non-replicating approaches continue to be developed, with the major aim to improve the global supply of rotavirus vaccines and for local implementation, and to improve vaccine effectiveness in developing settings. This review provides an overview of the new rotavirus vaccines in development by developing country manufacturers and provides a rationale why newer candidates continue to be explored. It describes the new live oral rotavirus vaccine candidates as well as the non-replicating rotavirus vaccines that are furthest along in development.
Topics: Animals; Developing Countries; Humans; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Virus Replication
PubMed: 28396207
DOI: 10.1016/j.vaccine.2017.03.076 -
Current Opinion in Infectious Diseases Oct 2019As of 2019, four rotavirus vaccines have been prequalified by the WHO for use worldwide. This review highlights current knowledge regarding rotavirus vaccines available,... (Review)
Review
PURPOSE OF REVIEW
As of 2019, four rotavirus vaccines have been prequalified by the WHO for use worldwide. This review highlights current knowledge regarding rotavirus vaccines available, and provides a brief summary of the rotavirus vaccine pipeline.
RECENT FINDINGS
Data generated from use of currently available products supports their effectiveness and impact in diverse settings. Rotavirus vaccines have a favorable risk-benefit profile, but previous associations of rotavirus vaccination with intussusception necessitate continued monitoring for this rare but serious adverse event. Implementation of rotavirus vaccines was jeopardized in late 2018 and 2019 by a shortage of vaccine supply. Fortunately, with the prequalification of two additional vaccines in 2018, countries have increased choice in products with different characteristics, pricing, and implementation strategies. Other vaccines currently in development may open up further immunization strategies, such as neonatal vaccination schedules or parenteral administration.
SUMMARY
Rotavirus vaccines have demonstrated impact in reducing diarrheal morbidity and mortality worldwide. As countries begin to introduce the newly prequalified vaccines, additional data will become available on the safety and effectiveness of those products. Products in the pipeline have distinct profiles and could be an essential part of the expansion of rotavirus vaccine use worldwide.
Topics: Diarrhea; Drug Development; Drug-Related Side Effects and Adverse Reactions; Humans; Intussusception; Rotavirus Infections; Rotavirus Vaccines; Survival Analysis; Treatment Outcome
PubMed: 31305493
DOI: 10.1097/QCO.0000000000000572 -
Human Vaccines & Immunotherapeutics 2019The difference noted in Rotavirus vaccine efficiency between high and low income countries correlates with the lack of universal access to clean water and higher... (Review)
Review
The difference noted in Rotavirus vaccine efficiency between high and low income countries correlates with the lack of universal access to clean water and higher standards of hygiene. Overcoming these obstacles will require great investment and also time, therefore more effective vaccines should be developed to meet the needs of those who would benefit the most from them. Increasing our current knowledge of mucosal immunity, response to Rotavirus infection and its modulation by circadian rhythms could point at actionable pathways to improve vaccination efficacy, especially in the case of individuals affected by environmental enteropathy. Also, a better understanding and validation of Rotavirus entry factors as well as the systematic monitoring of dominant strains could assist in tailoring vaccines to individual's needs. Another aspect that could improve vaccine efficiency is targeting to M cells, for which new ligands could potentially be sought. Finally, alternative mucosal adjuvants and vaccine expression, storage and delivery systems could have a positive impact in the outcome of Rotavirus vaccination.
Topics: Clinical Trials as Topic; Developing Countries; Enterocytes; Gastroenteritis; Humans; Immunity, Mucosal; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccination; Vaccine Potency; Vaccines, Attenuated
PubMed: 30215578
DOI: 10.1080/21645515.2018.1520583 -
The Pediatric Infectious Disease Journal Jul 2017
Review
Topics: Global Health; Humans; Immunization Schedule; Rotavirus Infections; Rotavirus Vaccines
PubMed: 28383393
DOI: 10.1097/INF.0000000000001594 -
World Journal of Pediatrics : WJP Nov 2015Rotaviruses remain the major cause of childhood diarrheal disease worldwide and of diarrheal deaths of infants and children in developing countries. The huge burden of... (Review)
Review
BACKGROUND
Rotaviruses remain the major cause of childhood diarrheal disease worldwide and of diarrheal deaths of infants and children in developing countries. The huge burden of childhood rotavirus-related diarrhea in the world continues to drive the remarkable pace of vaccine development.
DATA SOURCES
Research articles were searched using terms "rotavirus" and "rotavirus vaccine" in MEDLINE and PubMed. Articles not published in the English language, articles without abstracts, and opinion articles were excluded from the review. After preliminary screening, all articles were reviewed and synthesized to provide an overview of current vaccines and vaccination programs.
RESULTS
In this review of the global rotavirus vaccines and vaccination programs, the principles of rotavirus vaccine development and the efficacy of the currently licensed vaccines from both developed and developing countries were summarized.
CONCLUSIONS
Rotavirus is a common cause of diarrhea in children in both developed and developing countries. Rotavirus vaccination is a cost-effective measure to prevent rotavirus diarrhea.
Topics: Child; Child, Preschool; Cost-Benefit Analysis; Developing Countries; Gastroenteritis; Humans; Infant; Infant, Newborn; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccines, Attenuated
PubMed: 26454434
DOI: 10.1007/s12519-015-0038-y -
Viral Immunology Mar 2018Rotavirus is the most important cause of gastroenteritis worldwide. In developing countries, the virus is a major cause of death in infants and young children. In the... (Review)
Review
Rotavirus is the most important cause of gastroenteritis worldwide. In developing countries, the virus is a major cause of death in infants and young children. In the United States, before the licensure of vaccines, rotavirus infections accounted for ∼2.7 million cases of gastroenteritis annually. Here are described the history and challenges surrounding the development of a rotavirus vaccine.
Topics: Animals; Disease Models, Animal; Drug Discovery; Drug Evaluation, Preclinical; Gastroenteritis; History, 20th Century; History, 21st Century; Humans; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; United States
PubMed: 29265955
DOI: 10.1089/vim.2017.0121 -
Indian Journal of Pediatrics Jan 2018Pertussis and rotavirus vaccines have been the subject of several controversies over the years. In this paper the authors discuss facts and myths behind these... (Review)
Review
Pertussis and rotavirus vaccines have been the subject of several controversies over the years. In this paper the authors discuss facts and myths behind these controversies and also suggest solutions to overcome some limitations of these vaccines. The whole-cell pertussis vaccine (wPV) came into disrepute due to the associated adverse reactions, resulting in its replacement by acellular pertussis vaccine (aPV) in industrialized nations in 1990s. Although wPV is known to have more side effects; but they are usually minor. Whole-cell pertussis containing vaccine is being used safely in the National Immunization programme in India from many years. Another controversy erupted during 2009-2010, when there were reports of resurgence of pertussis cases among adolescents and adults, from developed nations. Present literature review raises doubts about long term protection offered by aPV, when compared with wPV. In spite of prevailing controversy, acellular pertussis containing vaccines should be acceptable, if timely delivery of primary and booster doses is ensured; including vaccination of adolescents and pregnant women. Initial rotavirus vaccine was withdrawn from the market because of increased risk of intussusception. Although three new generation rotavirus vaccines are currently available for use in India, but doubts about their efficacy, long term protection and safety still exists. Present literature review found them to be safe and moderately efficacious because of reasonable good cross protection. Even a moderately efficacious vaccine like rotavirus vaccine could significantly improve the outcome if disease burden is high. Therefore, it is being included in National Immunization Programme of India.
Topics: Child; Humans; India; Pertussis Vaccine; Rotavirus Infections; Rotavirus Vaccines; Whooping Cough
PubMed: 28623456
DOI: 10.1007/s12098-017-2393-2 -
The Pediatric Infectious Disease Journal Oct 2021Live, oral rotavirus vaccines are more effective at preventing rotavirus disease in countries with low child mortality compared with high child mortality. Among several... (Review)
Review
Live, oral rotavirus vaccines are more effective at preventing rotavirus disease in countries with low child mortality compared with high child mortality. Among several hypotheses, poorer protection in malnourished children, who are more prevalent in countries with high child mortality, may partially explain this difference. We conducted a literature search to identify articles with a laboratory-confirmed rotavirus endpoint that evaluated differences by malnutrition status in rotavirus vaccine effectiveness and vaccine efficacy (VE) or the prevalence of rotavirus infection or illness among children <5 years old. We identified 7 analyses from 11 countries published from 2007 to 2019 that stratified rotavirus VE by malnutrition status. Among well-nourished children, VE point estimates ranged from 71% to 84% in observational studies and 26% to 61% in clinical trials. Among malnourished children, they ranged from -28% to 45% in observational studies and -3% to 61% in clinical trials. The relative difference between VE in well-nourished and malnourished children by length-for-age ranged from 37% to 64%, by weight-for-age ranged from 0% to 107%, and by weight-for-height ranged from -65% to 137%. We identified 3 cohort and 6 cross-sectional studies of natural rotavirus infection and illness and none reported that malnourished children were more susceptible to rotavirus infection or illness than well-nourished children. Overall, rotavirus vaccines may offer less protection to children with malnutrition than well-nourished children. As malnourished children often have worse outcomes from diarrhea, high rotavirus vaccine coverage and a better understanding of the performance of oral rotavirus vaccines in this population is important, though our finding that malnourished children may be less susceptible to rotavirus provides important context and information for vaccine evaluation design.
Topics: Child; Child Nutrition Disorders; Clinical Trials as Topic; Cross-Sectional Studies; Gastroenteritis; Global Health; Hospitalization; Humans; Malnutrition; Observational Studies as Topic; Rotavirus Infections; Rotavirus Vaccines; Vaccine Efficacy
PubMed: 34117200
DOI: 10.1097/INF.0000000000003206 -
Pediatrics in Review Mar 2023
Topics: Humans; Rotavirus Vaccines
PubMed: 36854827
DOI: 10.1542/pir.2022-005565