Diseases and vaccines

Rotavirus vaccine monitoring

In August 1998, a rotavirus vaccine, Rotashield®, was licensed in the United States, and approximately one million children were vaccinated within nine months. About 100 (0.01%) of these children developed a type of bowel obstruction called intussusception. Intussusception occurs for unknown reasons in about 1 child per 10,000, most often in infants four to ten months of age, regardless of whether or not they have received a vaccine. Because of the uncertainty about the relationship between Rotashield® and intussusception, the manufacturer voluntarily pulled the product off the market.

Today's rotavirus vaccines were tested extensively to determine any risk for adverse events, including intussusception. Researchers found that the risk of intussusception was similar among children who received the vaccine and those who received a placebo, indicating that the vaccines are safe for use. For more information, please browse our vaccine safety and efficacy resources.

Acute intussusception in infants and children. Incidence, clinical presentation and management: A global perspective (2002)
World Health Organization (WHO) Department of Immunization, Vaccines, and Biologicals. WHO/IVB/02.19
This report estimates the global incidence of acute intussusception, outlines clinical presentation, and offers guidelines for clinical management.

An analysis of rotavirus vaccine reports to the Vaccine Adverse Event Reporting System: More than intussusception alone? (2004)
Haber P, Chen R, Zanardi L, et al. Pediatrics. 113(4):e353-e359.
This study reviews cases presented to the Vaccine Adverse Event Reporting System in order to determine whether severe adverse events other than intussusception occurred after vaccination with an earlier rotavirus vaccine (RRV-TV).

Draft recommendations for pentavalent human-bovine reassortant rotavirus (RotaTeq®) vaccine (2006)
US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices, Rotavirus Working Group
Presented at a 2006 meeting of the CDC's Advisory Committee on Immunization Practices, this presentation

Evaluation of anatomic changes in young children with natural rotavirus infection: Is intussusception biologically plausible? (2004)
Robinson C, Hernanz-Schulman M, Zhu Y, et al. Journal of Infectious Diseases. 189:1382-1387.
This study explores the biological plausibility of intussusception caused by natural rotavirus infection.

A hexavalent human rotavirus–bovine rotavirus (UK) reassortant vaccine designed for use in developing countries and delivered in a schedule with the potential to eliminate the risk of intussusception (2005)
Kapikian A, Simonsen L, Vesikari T, et al. Journal of Infectious Diseases. 192(Suppl 1):s22-s29.
This paper outlines the development of a potentially universal rotavirus vaccine with multiple serotypes and also suggests a dose schedule to eliminate the risk of intussusception.

Postmarketing monitoring of intussusception after RotaTeq™ vaccination—United States, February 1, 2006 - February 15, 2007
CDC. Morbidity and Mortality Weekly Report. 56(10);218-222.
This report summarizes the Advisory Committee on Immunization Practices review of post-marketing safety surveillance data on RotaTeq®, the rotavirus vaccine by Merck & Co., Inc. The data reveal that cases of intussusception reported since its introduction in early 2006 did not exceed the expected background rate.

Record of the meeting of the Advisory Committee on Immunization Practices (2006)
CDC
The meeting report outlines the committee’s recommendations for introduction of RotaTeq® into the routine US immunization schedule and provides guidance on addressing special circumstances in relation to administration of the vaccine. The document also describes proposed activities by the US Food and Drug Administration and the CDC to monitor the safety of RotaTeq® vaccine following immunization and summarizes data from Phase III safety and efficacy studies of RotaTeq®.

RotaShield® vaccine and intussusception Q&A (2004)
CDC
This fact sheet was developed to answer common questions about RotaShield® and the decision of the US Advisory Committee on Immunization Practices to suspend its recommendation for use.

Will future rotavirus vaccines cause intussusception?
Offit P.
This presentation explores the theoretical causes of intussusception associated with the use of RotaShield® vaccine and identifies differences between RotaShield® and new rotavirus vaccines, particularly Rotarix® and RotaTeq®.