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Rotavirus Vaccines
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Worldwide, almost every child will have at least one rotavirus infection before he or she is five years old. The virus is so contagious and resilient that providing clean water and promoting proper hygiene do not significantly reduce incidence, which is nearly the same in industrialized and developing countries. Additionally, because rotavirus usually causes profuse vomiting, ORS/ORT is difficult to administer. Rotaviruses are a genus of viruses belonging to the Reoviridae family. Seven major groups have been identified, three of which (groups A, B, and C) infect humans, with group A being the most common and widespread one.

Rotavirus disease

Rotavirus is the most common cause of severe gastroenteritis in children worldwide.
  • Rotavirus (pronounced "row-tuh-virus") is the most common cause of severe gastroenteritis in children worldwide.
  • Rotavirus is responsible for the deaths of an estimated 600,000 children each year, 80 percent of whom live in developing countries.
  • Rotavirus is found in all countries. Most children have had one or more rotavirus infections by the age of 5.
  • In young children, rotavirus disease is characterized by diarrhea, vomiting, fever, and severe dehydration. Death is caused by dehydration due to rotavirus infection, not by the virus itself.
  • Rotavirus disease cannot be treated with antibiotics or other drugs. Regardless of hygiene practices or access to clean water, nearly every child in the world will be infected with rotavirus before age 5. Vaccination is the only viable measure to prevent severe rotavirus illness.

Rotavirus vaccines

  • Studies of two new rotavirus vaccines recently demonstrated their safety and efficacy among children in middle- and high-income countries.
  • Clinical trials have been launched, and additional studies are planned, to evaluate the impact of vaccines as a method for the prevention of severe rotavirus disease in developing countries. Results generated from these trials will help national governments make informed decisions about introducing the vaccines into the public sector.
  • Enhancing diarrheal disease control through a combined prevention and treatment strategy—incorporating rotavirus vaccine; new, low-osmolarity formulations of oral rehydration solution; and zinc supplementation during diarrhea episodes—can rapidly and significantly reduce child mortality where diarrheal disease is a serious burden.


The 10th International Rotavirus Symposium - 19-21 September, 2012 - Bangkok, Thailand

The 10th International Rotavirus Symposium - 19-21 September, 2012 - Bangkok, ThailandThe 10th International Rotavirus Symposium will be held 19-21 September, 2012 in Bangkok, Thailand. It will bring together interested stakeholders to provide an update on new data and relevant research that will inform public health agendas related to prevention of rotavirus gastroenteritis. Main Session Topics: Participants will discuss the latest results of trials of new rotavirus vaccines in developing country settings, issues in vaccine policy and introduction, and early post-marketing data on vaccine impact and safety.


Rotavirus: The Killer Disease You've Never Heard Of Can Be Easily StoppedHistory in the Making! A lifeline for children across the African continent and beyond

27 September, 2011
GAVI approves rotavirus vaccine funding for 16 new countries, 12 in Africa Until today, life-saving rotavirus vaccines were not accessible for most children in Africa, the continent with a staggering burden of rotavirus disease and where vaccines are desperately needed to prevent severe rotavirus diarrhea and save children’s lives: • Where nearly a quarter of a million children die of rotavirus disease each year.
• Where roughly 40% of children hospitalized for severe diarrhea have rotavirus.
• Where urgent care and treatment for severe rotavirus diarrhea is often limited or unavailable. Now there is a new story of hope and promise to tell about Africa—a story of a future where children who need the vaccine most will have a chance at a healthy and happy life, free from the threat of severe rotavirus disease.

Today the GAVI Alliance approved rotavirus vaccine funding for 16 new countries, 12 in Africa, including Angola, Burundi, Cameroon, Congo DR, Djibouti, Ethiopia, Ghana, Madagascar, Malawi, Niger, Rwanda, and Tanzania—and four other countries, including Armenia, Georgia, Moldova, and Yemen. On July 17, 2011, Sudan became the first African country to introduce rotavirus vaccines with GAVI Alliance funding—just two years after the World Health Organization recommended all countries introduce the vaccine into their national immunization programs. People have heard about Sudan’s introduction and have seen the news around the world that vaccines against rotavirus are saving lives in countries where children have access to them. They eagerly await the vaccine's arrival.


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
25 October 2011 - The Lancet Infectious Diseases, Early Online Publication
doi:10.1016/S1473-3099(11)70253-5 - downloaddownload pdf pdf


image: Countries with the greatest number of rotavirus-related deaths Rotavirus remains a major killer of children under five years of age worldwide, taking the lives of 453,000 children in 2008 according to the latest estimates, published today in the Lancet Infectious Diseases journal. This translates into the staggering fact that more than 1,200 young children will die from rotavirus diarrhea each day. Rotavirus-related deaths accounted for 37% of all diarrheal deaths and 5% of all deaths in children under five years of age. One of every 260 children born each year will die from rotavirus diarrhea by their fifth birthday.

Tragically, approximately 95% of rotavirus deaths occurred in countries that are eligible to receive GAVI-support to introduce rotavirus vaccines. Five countries–India, Nigeria, Pakistan, Democratic Republic of Congo, and Ethiopia–all GAVI-eligible, accounted for more than half of all rotavirus deaths globally. 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.

Diarrhea vaccines

In the developing world, where treatment can be hard to access and safe water is scarce, diarrhea can be deadly. Prevention of diarrheal disease through immunization is a relatively new intervention, but is becoming an essential and lifesaving part of diarrhea control strategies. Vaccines against bacterial causes of diarrhea such as Shigella and enterotoxigenic Escherichia coli (ETEC) are under development, and new vaccines against rotavirus are increasingly available in low-resource settings. PATH is working with partners to increase access to existing rotavirus vaccines, develop new rotavirus vaccines, and accelerate the development of other new vaccines against causes of diarrhea. To learn more, please visit the PATH website. UNICEF is the world’s leading agency for vaccine procurement and procures vaccines and immunization supplies on behalf of the GAVI Alliance, which provides subsidized funding for rotavirus vaccine introduction in eligible countries.

Key resources

Below are some key documents on diarrhea vaccines. Please also visit our partners’ websites for more resources.

Other helpful websites

References

1 Parashar U, Hummelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases. 2003;9(5):565-572. Photo: PATH/Mike Wang.


Reproduced from the PATH Resources for Diarrheal Disease Control website at www.eddcontrol.org, [6 November, 2009].


A complete and up-to-date list of the following and related resources can be found at
Enhanced Diarrheal Disease Control Resource Center


Featured Resources

The effect of rotavirus vaccine on diarrhoea mortality
Melinda K Munos, Christa L Fischer Walker and Robert E Black
Approximately 39% of the global diarrhoea deaths in children aged 5 years may be attributable to rotavirus infection. Two rotavirus vaccines were recently introduced to the market, with evidence of efficacy in the USA, Europe and Latin America. We sought to estimate the effectiveness of these vaccines against rotavirus morbidity and mortality. Rotavirus Vaccine — A Powerful Tool to Combat Deaths from Diarrhea
Mathuram Santosham, M.D., M.P.H.
Rotavirus infection, the leading cause of severe childhood diarrhea in both developed and developing countries, results in over half a million deaths each year.1 Currently, two rotavirus vaccines (Rotarix [GlaxoSmithKline Biologicals] and RotaTeq [Merck]) are licensed in many countries and used routinely in several. Until recently, available efficacy data were from developed and developing countries with relatively low mortality rates among children younger than 5 years of age.
The New England Journal of Medicine - Volume 362:358-360 - January 28, 2010 - Number 4
Rotavirus Vaccine — A Powerful Tool to Combat Deaths from Diarrheapdf English 94 kb
Anticipating new vaccines in the Americas (2004)
This editorial supports accelerated rotavirus vaccine introduction and addresses related issues, such as health inequities, program sustainability, and vaccine affordability.
Andrus, et al. Pan American Journal of Public Health. 16(6):369-370.
Anticipating new vaccines in the Americas (2004)pdf English 43 kb
Cost-effectiveness of rotavirus vaccines (2005)
This paper reviews economic evaluations of Rotarix® and RotaTeq® and offers suggestions for future analyses of cost-effectiveness.
Walker D, Rheingans R. Expert Review Pharmacoeconomics Outcomes Research. 5(5):593-601.
Cost-effectiveness of rotavirus vaccines (2005)pdf English 309 kb
Key facts about rotavirus disease and vaccines (2006)
Basic, essential information about rotavirus disease and vaccines against rotavirus.
PATH
Key facts about rotavirus disease and vaccines (2006)pdf English 24 kb | Key facts about rotavirus disease and vaccines (2006)pdf Español 32 kb | Key facts about rotavirus disease and vaccines (2006)pdf Russian 174 kb
The promise of new rotavirus vaccines (2006)
This editorial summarizes findings from successful safety and efficacy studies of Rotarix® and RotaTeq® vaccines, while also emphasizing the need for clinical trials to evaluate the vaccines’ performance in developing country settings.
Glass R, Parashar U. New England Journal of Medicine. 354(1): 75-77.
English - The promise of new rotavirus vaccinespdf English 694 kb | Español - The promise of new rotavirus vaccinespdf Español 230 kb | Français - The promise of new rotavirus vaccinespdf Français 232 kb | Português - The promise of new rotavirus vaccinespdf Português 247 kb | Russian - The promise of new rotavirus vaccinespdf Russian 245 kb
Rotavirus and severe childhood diarrhea (2006)
Study authors reviewed literature on hospitalizations related to severe diarrhea and rotavirus and found that, while diarrheal disease incidence has reduced in recent years, due in part to improved hygiene practices, incidence of rotavirus infection has continued to increase.
Parashar U, Gibson C, Bresee J, Glass R. Emerging Infectious Diseases. 12(2):13-17.
Rotavirus and severe childhood diarrhea (2006)pdf English 141 kb
Rotavirus: Questions and answers (2006)
Expanded information on rotavirus incidence and interventions, including vaccines.
PATH
Rotavirus: Questions and answers (2006)pdf English 34 kb | Rotavirus: Questions and answers (2006)pdf Español 41 kb
Rotavirus Vaccine Program
This collaboration between PATH, the World Health Organization (WHO), and the US Centers for Disease Control and Prevention (CDC) aims to accelerate the availability of rotavirus vaccines in the developing world.
Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)
This study evaluated the safety and efficacy of GSK’s rotavirus vaccine (Rotarix®), with a focus on determining risk of intussusception.
Ruiz-Palacios G, Pérez-Schael I, Velázquez F, et al. New England Journal of Medicine. 354(1):11-22.
English - Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)pdf English 233 kb | Español - Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)pdf Español 233 kb | Français - Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)pdf Français 244 kb | Russian - Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)pdf Russian 253 kb
Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine (2006)
This study evaluated the safety and efficacy of Merck’s rotavirus vaccine (RotaTeq®), with a focus on determining risk of intussusception.
Vesikari T, Matson D, Dennehy P, et al. New England Journal of Medicine. 354(1):23-33.
English - Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine (2006)pdf English 1.17 mb | Español - Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine (2006)pdf Español 216 kb | Français - Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine (2006)pdf Français 221 kb | Russian - Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine (2006)pdf Russian 254 kb

General information

Overview of RotaTeq® human-bovine reassortant rotavirus vaccine (2005)
This presentation reported on studies of the safety and efficacy of the RotaTeq® vaccine manufactured by Merck.
Shaw A, Heaton P. Merck & Co., Inc.
Overview of RotaTeq® human-bovine reassortant rotavirus vaccine (2005)pdf English 182 kb
Proceedings of the Sixth International Rotavirus Symposium (2005)
An overview of the symposium’s sessions, presentations, and discussions.
The Albert B. Sabin Vaccine Institute
Proceedings of the Sixth International Rotavirus Symposium (2005)pdf English 799 kb | Proceedings of the Sixth International Rotavirus Symposium (2005)pdf Español 820 kb
Rotarix® (2005)
This presentation from the director of worldwide medical affairs at GSK offers a profile of Rotarix® and outlines its potential value.
De Vos B. Presented at: GlaxoSmithKline (GSK) R&D Day, London.
Rotarix® (2005)pdf English 2.2 mb
RotaShield® vaccine and intussusception Q&A
Answers to common questions about RotaShield®, an earlier vaccine against rotavirus, and the decision of the CDC Advisory Committee on Immunization Practices to no longer recommend it for use.
CDC
RotaShield® vaccine and intussusception Q&Apdf English 59 kb
Rotavirus fact sheet (2005)
General information about rotavirus disease.
CDC
Rotavirus fact sheet (2005)pdf English 19 kb | Rotavirus fact sheet (2005)pdf Español 23 kb

Treatment guidelines

Acute intussusception in infants and children. Incidence, clinical presentation and management: A global perspective (2002)
This report from the WHO estimates global incidence of acute intussusception in developing countries, the condition’s clinical presentation, and trends in clinical management.
World Health Organization (WHO) Department of Immunization, Vaccines, and Biologicals
Acute intussusception in infants and children. Incidence, clinical presentation and management: A global perspective (2002)pdf English 317 kb
Draft recommendations for pentavalent bovine-human rotavirus vaccine (2006)
This presentation outlines recommendations of the CDC's Advisory Committee on Immunization Practices for introduction of Merck's rotavirus vaccine, RotaTeq®, into the routine US immunization schedule.
CDC Advisory Committee on Immunization Practices Rotavirus Working Group
English PowerPoint presentation 174 kb
Generic protocols for (i) hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children and (ii) a community-based survey on utilization of health care services for gastroenteritis in children (2002)
WHO developed this guide for use in country activities aimed at collecting data on local rotavirus disease burden.
WHO Department of Immunization, Vaccines, and Biologicals
pdf English 1.5 mb | pdf Español 1.5 mb
Rotarix® international data sheet (2004)
This informational sheet contains prescription information for administration of Rotarix® in Latin American countries, among others.
GSK
Rotarix® international data sheet (2004)pdf English 67 kb
RotaTeq® package insert (2006)
This document provides information on and directions for administration of Merck’s rotavirus vaccine.
Merck & Co., Inc.

RotaTeq® package insert (2006)pdf English 132 kb

Research

Global Illness and Deaths Caused by Rotavirus Disease in Children
Parashar UD, Hummelman EG, Bresee JS, Miller MA, Glass RI. Emerg Infect Dis [serial online] 2003 May.
Epidemiology of rotavirus diarrhoea in Africa: A review to assess the need for rotavirus immunization (1998)
This study reviewed the epidemiology and disease burden of rotavirus diarrhea among children at hospitals and clinics in African countries. The long-term review was conducted from 1975 to 1992.
Cunliffe NA, Kilgore PE, Bresee JS, et al. Bulletin of the World Health Organization. 76(5):525-537.
Epidemiology of rotavirus diarrhoea in Africa: A review to assess the need for rotavirus immunization (1998)pdf English 562 kb
The epidemiology of rotavirus diarrhea in Latin America: Anticipating new vaccines (2004)
This paper outlines a literature review performed to assess the disease burden and epidemiology of rotavirus diarrhea in Latin America.
Kane E, Turcios R, Arvay M, et al. Pan American Journal of Public Health. 16(6):371-377.
The epidemiology of rotavirus diarrhea in Latin America: Anticipating new vaccines (2004)pdf English 100 kb
Evaluation of anatomic changes in young children with natural rotavirus infection: is intussusception biologically plausible? (2004)
This study explores the plausibility of intussusception caused by natural rotavirus infection.
Robinson C, Hernanz-Schulman M, Zhu Y, et al. Journal of Infectious Diseases. 189:1382-1387.
Evaluation of anatomic changes in young children with natural rotavirus infection: is intussusception biologically plausible? (2004)pdf English 300 kb
Global illness and deaths caused by rotavirus disease in children (2003)
This seminal paper estimates global incidence of rotavirus disease and related deaths, based on a review of studies published from 1986 – 2000.
Parashar U, Hummelman E, Bresee J, et al. Emerging Infectious Diseases. 9(5).
Global illness and deaths caused by rotavirus disease in children (2003)pdf English 742 kb
Hospitalizations associated with rotavirus diarrhea in the United States, 1993 through 1995: Surveillance based on the new ICD-9-CM rotavirus-specific diagnostic code (1998)
This study examined trends in rotavirus-associated hospitalizations among US children.
Parashar U, Holman R, Clarke M, et al. Journal of Infectious Diseases. 177:13-17.
Hospitalizations associated with rotavirus diarrhea in the United Statespdf English 153 kb
Review of data from the REST and other Phase III studies of the pentavalent human-bovine reassortant rotavirus vaccine, RotaTeq® (2006)
This presentation from the senior director of clinical research at Merck Research Laboratories presents data on safety and efficacy clinical trials of Merck’s rotavirus vaccine. Presented at the CDC Advisory Committee on Immunization Practices meeting; Atlanta, GA.
Heaton P
English PowerPoint presentation


updated: 24 April, 2014

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