Resources and Research
Featured Resources
Rotavirus resources on PATH's Vaccine Resource Library
Along with general materials on rotavirus disease and vaccines, our rotavirus resource library links to documents from the world’s premier scientific journals addressing surveillance and disease burden, cost-effectiveness, vaccine efficacy, and vaccine introduction.
Introduction of rotavirus vaccine with support from the GAVI Alliance: Information to assist the national decision-making and application process, January 2008
As a supplement to GAVI’s detailed guidelines, this document aims to support decision-making by GAVI-eligible countries in the WHO European region and provides information on the burden of rotavirus disease; efficacy, safety, and cost-effectiveness of available rotavirus vaccines; eligibility criteria; application procedures; co-financing requirements; and health system considerations.
Diarrheal Disease Advocacy: Findings from a scan of the global funding and policy landscape
WHO position paper, August 2007
The World Health Organization (WHO) most recent position on rotavirus disease and vaccines takes into account the latest disease burden estimates and country experiences introducing rotavirus vaccines into routine immunization programs.
Postmarketing surveillance after rotavirus vaccination
Manufacturers presented post-marketing surveillance data to the WHO's Global Advisory Committee on Vaccine Safety. This report in the Weekly Epidemiologic Record summarizes the committee's conclusions that the data on intussusception are reassuring and the need for careful surveillance of Kawasaki disease—the US FDA stated that the reported cases were no more frequent than expected natural occurrence.
Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis (2006)
Ruiz-Palacios G, et al. New England Journal of Medicine. 354(1):11-22.
This study evaluated the safety and efficacy of GlaxoSmithKline’s rotavirus vaccine (Rotarix®), with a focus on determining risk of intussusception.
- Download file (233 KB PDF)
- Download file, Español (233 KB PDF)
- Download file, Français (244 KB PDF)
- Download file, Russian (253 KB PDF)
Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine (2006)
Vesikari T, et al. New England Journal of Medicine. 354(1):23-33.
This study evaluated the safety and efficacy of Merck’s rotavirus vaccine (RotaTeq®), with a focus on determining risk of intussusception.
- Download file (1.17 MB PDF)
- Download file, Español (216 KB PDF)
- Download file, Français (221 KB PDF)
- Download file, Russian (254 KB PDF)
Safety of Rotarix® and RotaTeq® vaccines (2006)
The WHO's update on newly developed rotavirus vaccines notes their excellent safety and efficacy profiles and emphasizes the need for post-marketing surveillance following vaccine introduction.
Key rotavirus surveillance publications
WHO. Global networks for surveillance of rotavirus gastroenteritis, 2001–2008. Weekly Epidemiological Record. 2008; 83(47):421-425.
US CDC. Rotavirus surveillance—Worldwide, 2001-2008. Morbidity and Mortality Weekly Report. 2008;57(46):1255-1257.
Nelson EAS, Bresee JS, Parashar UD, Widdowson M-A, Glass RI, members of ARSN. Rotavirus epidemiology: The Asian Rotavirus Surveillance Network. Vaccine. 2008; 26(26):3192-3196.
US CDC. Delayed onset and diminished magnitude of rotavirus activity—United States, November 2007–May 2008. Morbidity and Mortality Weekly Report. 2008;57(25):697-700.
US CDC. Postmarketing monitoring of intussusception after RotaTeq™ vaccination—United States, February 1, 2006–February 15, 2007. Morbidity and Mortality Weekly Report. 2007; 56(10);218-222. (Also available in Spanish [56 KB PDF] and Russian [336 KB PDF].
Parashar UD, Gibson CJ, Bresee JS, Glass RI. Rotavirus and Severe Childhood Diarrhea. Emerging Infectious Diseases. 2006; 12(2):304-306.
Asian Rotavirus Surveillance Network. Rotavirus in Asia (supplement). Journal of Infectious Diseases. 2005; 192(Suppl 1).
US CDC. Rotavirus surveillance news.
Parashar UD, 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.
Other Resources
Acute intussusception in infants and children (2002)
In 1999, nine months after the first rotavirus vaccine was introduced in the US, an association was detected between the vaccine and intussusception, a common bowel obstruction in infants. Subsequent studies questioned the exact risk attributable to the vaccine.
This report is based on an extensive review of published literature from 70 countries. It aims to define the baseline incidence of acute intussusception in infants and children, clinical presentation, and trends in its management.
The development of live, attenuated rotavirus vaccines: A manufacturer's resource guide
A comprehensive compilation of publicly available information about the manufacturing process of rotavirus vaccines, this guide is a resource for manufacturers interested in developing and registering an attenuated, oral rotavirus vaccine. Highlights cover various decisions to be made during development; examples of preclinical studies, manufacturing processes, assay procedures, and clinical trial strategies; and advantages and disadvantages of multiple scenarios at each development milestone.
Diarrhoea treatment guidelines including new recommendations for the use of ORS and zinc supplementation for clinic-based healthcare workers (2005)
Produced by the US Agency for International Development, WHO, and UNICEF, these guidelines prepare clinic-based health workers for implementing new recommendations on the use of ORS and zinc supplementation for clinical management of diarrhea. The information is meant to complement more comprehensive policy guidance from WHO.
Generic protocols for hospital-based rotavirus surveillance
The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) developed a standard protocol for health officials and researchers in determining the extent and nature of local rotavirus disease. The protocol provides a framework using a simple diagnostic test to screen for rotavirus among children hospitalized with severe diarrhea. The resulting data should be useful for policymakers in evaluating the need for rotavirus vaccination in their countries.
- Download file, English (1.4 MB PDF)
- Download file, Español (1.4 MB PDF)
- Download file, Français (417 KB PDF)
- Download file, Russian (876 KB PDF)
The Global Framework for Immunization Monitoring and Surveillance
WHO recently released a new comprehensive approach to tackle challenges in immunization monitoring and disease surveillance. The Global Framework for Immunization Monitoring and Surveillance was developed by WHO and the US CDC. It responds to the need for timely and valid epidemiological and program information that is crucial in measuring progress towards immunization goals and controlling vaccine-preventable diseases
Key Facts about Rotavirus Disease and Vaccines
Proceedings of the Sixth International Rotavirus Symposium, July 7-9, 2004, Mexico City
The Sixth International Rotavirus Symposium held in Mexico City in July 2004 brought together experts from around the world working on rotavirus prevention. Convened by the Pan American Health Organization/WHO, the Albert B. Sabin Vaccine Institute, the CDC, and the U.S. National Institutes of Health (NIH), the symposium was a watershed in the efforts to advance a rotavirus vaccine and resulted in 16 Latin American countries signing a declaration to prioritize and support rotavirus prevention.
Rotavirus and severe childhood diarrhea (2006)
Parashar U, Gibson C, Bresee J, Glass R. Emerging Infectious Diseases. 12(2): 304-306.
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 continues to increase.
Worldwide diarrheal deaths and hospitalizations
The number of annual deaths from diarrheal disease, including rotavirus, varies widely between countries, with more than 80% of deaths due to rotavirus occuring in the developing world.
Links
Centers for Disease Control and Prevention
Merck & Co., Inc.'s Rotavirusinfo.com
U.S. Food & Drug Administration's "Bad Bug Book": Rotavirus
Pan American Health Organization (PAHO)
Healthy Mothers, Healthy Babies rotavirus resources
Top photo by Richard Lord.