1. Section Editor(s): STOKOWSKI, LAURA A. RN, MS

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Rotavirus causes yearly epidemics of disease in the United States, infecting thousands of children from 3 months to 3 years of age with severe, dehydrating gastroenteritis.1 Research has shown that immunization early in life, which mimics a child's first natural infection, will not prevent all subsequent disease but should prevent most cases of severe rotavirus disease and their sequelae (eg, dehydration, physician visits, hospitalizations, and death).1


Early in 2006, a bovine-based pentavalent oral rotavirus vaccine (RotaTeq, Merck & Co Inc, West Point, Pa) was licensed by the US Food and Drug Administration for use in infants in the United States.2 The American Academy of Pediatrics (AAP) recommends routine immunization of infants with 3 doses of RotaTeq at 2, 4, and 6 months of age.1 The vaccination series should not be initiated for infants older than 12 weeks of age, and all 3 doses of vaccine should be administered by 32 weeks of age. RotaTeq can be coadministered with other childhood vaccines.1 Practitioners working with high-risk populations should become familiar with the precautions to be observed when administering pentavalent rotavirus vaccine, such as delaying administration for 42 days following a blood transfusion, including immune globulin. Regarding infants born at less than 37 weeks' gestation, the AAP guidelines state that practitioners should consider the potential benefits and risks of immunizing preterm infants against rotavirus.1 Preterm infants may be at increased risk of viral gastroenteritis during their first year of life. The safety and efficacy of pentavalent rotavirus vaccine seem to be similar for preterm and term infants, although a relatively small number of preterm infants were included in clinical trials. The AAP supports immunization of preterm infants under the following conditions: the infant is at least 6 weeks of age, the infant is clinically stable, and the first dose of vaccine is given at the time of discharge or after the infant has been discharged from the hospital nursery. Until further data are available, the AAP considers the benefits of pentavalent rotavirus vaccine immunization of preterm infants to outweigh the theoretical risks.1


In February 2007, the US Food and Drug Administration issued a Public Health Notification to inform healthcare providers and consumers about 28 postmarketing reports of intussusception (telescoping or prolapse of one portion of the bowel into an immediately adjacent segment) following administration of RotaTeq.3 However, postmarketing surveillance conducted between February 1, 2006 and February 15, 2007 did not suggest association of RotaTeq vaccination with intussusception.4 The Centers for Disease Control and Prevention reaffirms vaccine policy recommendations to routinely vaccinate U.S. infants with RotaTeq at ages 2, 4, and 6 months.4


Healthcare professionals and others are encouraged to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to the Vaccine Adverse Event Reporting System ( Parents should be instructed to contact their child's doctor immediately if their child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception.




1. American Academy of Pediatrics, Committee on Infectious Disease. Prevention of rotavirus disease. Guideline for use of rotavirus vaccine. Pediatrics. 2007;119:171-182. Available at: Accessed January 2, 2007. [Context Link]


2. US Food and Drug Administration. FDA approves new vaccine to prevent rotavirus gastroenteritis in infants. FDA News. February 3, 2006. Available at: Accessed January 2, 2007. [Context Link]


3. US Food and Drug Administration. Center for Biologics Evaluation and Research. FDA Public Health Notification. "Information on RotaTeq and Intussusception." February 13, 2007. Available at: Accessed March 14, 2007. [Context Link]


4. Belongia E, Izurieta H, Braun MM, Ball R, Haber P, Baggs J, et al. Postmarketing surveillance after RotaTeq vaccination-United States, February 1, 2006-February 15, 2007. MMWR Wkly Rep 2007;56:218-222. [Context Link]