Rotavirus Disease and Vaccines On-line Resources

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 (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.

 

Rotavirus News A new video about the promise and potential of rotavirus vaccines Stories of Hope From Nicaragua Learn about PATH's work in cervical cancer prevention, diarrhea control, and violence prevention in Latin America 29 Jan 2010 - At the World Economic Forum, Bill Gates announced that he would commit $10 billion over the next 10 years to help research, develop, and deliver vaccines to developing countries. The Gates Foundation cites PATH's Rotavirus Vaccine Program and the New England Journal of Medicine research on rotavirus vaccines as examples of the encouraging progress that inspired them to commit more resources to this endeavor. 28 Jan 2010 - The New England Journal of Medicine published two studies that provide ground-breaking data for accelerating the introduction of rotavirus vaccines. Click here to view PATH’s press release. 2 Jan 2010 - Bono, lead singer of U2 and co-founder of the ONE Campaign, published an editorial in the New York Times that proposed "10 ideas that might make the next 10 years more interesting, healthy, or civil." Rotavirus vaccines make the list. If you engage in social media outreach, we would also like to invite you to update your Facebook status with the video link and re-tweet some of the recent announcements we've been making on PATHtweets about rotavirus vaccines (http://twitter.com/PATHtweets).

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.

• Fact sheet: Advancing New Rotavirus Vaccines (available on the PATH website)).
• Fact sheet: Developing New Vaccines Against Diarrheal Disease (available on the PATH website).
• Enteric Infections and the Vaccines to Counter Them: Future Directions (948 KB PDF). Vaccine.
• Global Illness and Deaths Caused by Rotavirus Disease in Children (328 KB PDF). Emerging Infectious Diseases.
• Weekly Epidemiological Record: Meeting of the Diarrheal and Enteric Vaccines Advisory Committee (211 KB PDF). World Health Organization (WHO)
• Weekly Epidemiological Record: Rotavirus Vaccines – WHO Position Paper (295 KB PDF). WHO.

Other helpful websites

• PATH’s Vaccine Resource Library
• US Centers for Disease Control and Prevention (CDC): Rotavirus
• CDC: Shigellosis
• Enhanced Diarrheal Disease Control Resource Center
• WHO: ETEC
• WHO: Rotavirus infections
• WHO: Shigella

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].

 

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

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Featured Resources

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
pdf 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.
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.
pdf English 309 kb


Key facts about rotavirus disease and vaccines (2006)
Basic, essential information about rotavirus disease and vaccines against rotavirus.
PATH
pdf English 24 kb  |  pdf Español 32 kb  |  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.
pdf English 694 kb |  pdf Español 230 kb | pdf Français 232 kb | pdf Português 247 kb | pdf 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.
pdf English 141 kb


Rotavirus: Questions and answers (2006)
Expanded information on rotavirus incidence and interventions, including vaccines.
PATH
pdf English 34 kb  |  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.
pdf English 233 kb | pdf Español 233 kb | pdf Français 244 kb | 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.
pdf English 1.17 mb | pdf Español 216 kb | pdf Français 221 kb | 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.
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
pdf English 799 kb  |  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.
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
pdf English 59 kb


Rotavirus fact sheet (2005)
General information about rotavirus disease.
CDC
pdf English 19 kb  |  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
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
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.

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.
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.
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.
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).
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.
pdf 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