We searched PubMed with the primary search terms “rotavirus” and “vaccine” or “rotavirus” and “impact” between Jan 1, 2006, and Sept 1, 2011. We did not limit our search by language. We included all studies that measured the effect of rotavirus vaccination on rotavirus events, the number of people admitted to hospital for gastroenteritis, or deaths after routine use of rotavirus vaccine. We excluded clinical trials from the pooled data.
ReviewFulfilling the promise of rotavirus vaccines: how far have we come since licensure?
Introduction
Rotavirus-related diarrhoea is one of the most common illnesses in children worldwide, causing 453 000 deaths and 2·4 million hospital admissions every year in children younger than 5 years.1, 2, 3 Identification of rotavirus in 19734 led to several decades of targeted research5 that culminated in the development of two live oral rotavirus vaccines. Results of two pivotal trials done in Europe and the Americas showed these vaccines to be safe and efficacious.6, 7 In 2006, WHO recommended these vaccines—Rotarix (two-dose series; GlaxoSmithKline Biologicals) and RotaTeq (three-dose series; Merck)—for use in children in these regions.8 A similar recommendation was not made for low-income settings in Africa and Asia where most of the yearly rotavirus deaths occur because of a shortage of efficacy data from these regions. Phase 2 studies showed that children in Bangladesh, India, and South Africa had a low immune response to oral rotavirus vaccines.9, 10, 11 The reduced efficacy of oral vaccines against poliomyelitis,12, 13 cholera,14 and typhoid15 in some low-income settings was also taken into account. In anticipation of vaccine introduction, we previously reviewed the global epidemiology of rotavirus disease, described the 20 year scientific development of rotavirus vaccines, and discussed the challenges facing their global use.16
Since then, the two licensed rotavirus vaccines have passed several crucial milestones, bringing them closer to the desired goal of reducing diarrhoea-related hospital admissions and death in children worldwide. First, the efficacy of both rotavirus vaccines was shown in trials in low-income countries in Africa and Asia.17, 18 Second, on the basis of these trials, WHO expanded their initial regional recommendation for rotavirus vaccination to all children worldwide.19, 20 Third, donor funding for rotavirus vaccination became available to the poorest countries through the GAVI Alliance, a public–private partnership created in 2000 to increase access to immunisation.21, 22 Fourth, 27 countries worldwide made these vaccines available through the public sector between 2006 and 2010 by including them in their routine national immunisation programmes (table 1).25 Rotavirus vaccination is generally initiated in children aged 2–4 months and completed by the time the child is about 7–8 months old.
In this Review, we assess the reported postlicensure data from the first countries to integrate rotavirus vaccination into their national immunisation programmes.
Section snippets
Rotavirus-related hospital admissions
Soon after rotavirus vaccines were introduced into publicly funded immunisation programmes, their rapid uptake in some high-income countries was noted, with vaccination coverage ranging from 54% to 93% in children younger than 1 year, and 37% to 90% in children younger than 2 years (table 2). The effects of rotavirus vaccination have been substantial (figure) and include reductions in the number of direct medical events (eg, admissions to hospital, deaths, doctor visits)25 and improvements in
Safety of rotavirus vaccines
A previously licensed rotavirus vaccine, RotaShield, was withdrawn 9 months after its introduction in the USA after postlicensure safety monitoring discovered that the vaccine was associated with intussusception, a rare but life-threatening form of bowel obstruction in infants.97 Both RotaTeq and Rotarix were assessed in large clinical trials with more than 60 000 infants each, but they were not associated with a rise in intussusception when compared with placebo.6, 7 However, monitoring of
Future challenges
Since the development and successful testing of the first rotavirus vaccine in the early 1980s,5, 105 research and development efforts have produced two new rotavirus vaccines prequalified for global use by WHO and recommended for the routine immunisation of all children. In the past 5 years, these vaccines have been adopted in national immunisation programmes in a number of mostly high-income and middle-income countries. Several of these countries have documented dramatic declines in severe
Search strategy and selection criteria
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Crude birth rate
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Cited by (121)
Molecular epidemiology, genetic diversity, and vaccine availability of viral acute gastroenteritis in the middle East and North Africa (MENA) region
2022, Journal of Infection and Public HealthCitation Excerpt :Four studies showed a significant reduction in rotavirus-positive cases (38.9–64.6 %) with a substantial impact against severe disease in the post-vaccination era with high vaccine coverage. These findings are comparable to those reported in other countries, including high-income countries [255], [259–261]. Indicating that in the MENA region, the vaccine was effective despite the presence of factors that reduce its efficiency, including lower socioeconomic status, hygiene standards, malnutrition, and other diseases.
Changes and remaining challenges for the Japanese immunization program: Closing the vaccine gap
2021, VaccineCitation Excerpt :As of December 2020, the market share for these 2 vaccines is 65% and 35%, respectively (unpublished data). These vaccines are highly effective in decreasing rotavirus-related diseases and complications [4]. After their introduction in Japan, several studies confirmed their effectiveness in different regions of Japan and in outpatient [5–7], inpatient [8–12], and both outpatient and inpatient settings [13,14].
The rotavirus vaccine development pipeline
2019, VaccineT Lymphocytes as Measurable Targets of Protection and Vaccination Against Viral Disorders
2019, International Review of Cell and Molecular Biology