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Postmarketing monitoring of intussusception after RotaTeq[TM] vaccination--United States, February 1, 2006-February 15, 2007.

Article Excerpt
Rotavirus is the leading cause of severe gastroenteritis in children aged <5 years worldwide. In February 2006, a new rotavirus vaccine, RotaTeq[TM] (Merck and Co., West Point, Pennsylvania), was licensed in the United States, and the Advisory Committee on Immunization Practices (ACIP) recommended it for routine vaccination of U.S. infants with 3 doses, administered orally at ages 2, 4, and 6 months (1). Because a previous rotavirus vaccine, Rotashield[TM] (Wyeth Laboratories, Marietta, Pennsylvania), was withdrawn from the U.S. market in 1999 after postmarketing surveillance identified an association* with intussusception (a rare type of bowel obstruction) (2), the safety of RotaTeq was evaluated in a prelicensure clinical trial involving 71,725 infants who received either vaccine or placebo (3). In this controlled trial, no statistically significant elevated risk for intussusception was observed within a 42-day period after RotaTeq vaccination. However, postmarketing monitoring for intussusception after RotaTeq vaccination is necessary because of possible differences in the characteristics of infants who received the vaccine in routine use compared with the infants in the clinical trials. Also, the large numbers of infants being vaccinated provides an opportunity to detect intussusception occurring at a low rate after vaccination. This report presents data from the first year of postmarketing monitoring for intussusception after RotaTeq vaccination in the United States, with particular focus on all intussusception reports received by the Vaccine Adverse Event Reporting System (VAERS) during February 1, 2006-February 15, 2007. As of February 15, 2007, postmarketing surveillance did not suggest association of RotaTeq vaccination with intussusception. CDC reaffirms vaccine policy recommendations to routinely vaccinate U.S. infants with RotaTeq at ages 2, 4, and 6 months.

In the United States, the postmarketing safety of RotaTeq is being monitored jointly by CDC and the Food and Drug Administration (FDA) through both evaluation of reports to VAERS and active surveillance using data from the Vaccine Safety Datalink (VSD) (4,5). Merck and Co. also is conducting a postmarketing observational study, which will monitor for occurrence of intussusception within 30 days of RotaTeq vaccination in 44,000 infants in the United States. VAERS is a passive national surveillance system that receives reports of adverse events after vaccination from various sources, including vaccine manufacturers, health-care providers, immunization programs, and vaccine recipients (4). VAERS reports of serious adverse events after RotaTeq vaccination are reviewed daily by staff physicians and epidemiologists at CDC and FDA. Health-care providers are contacted to verify diagnoses and obtain additional clinical information and vaccination history. VSD is a collaborative project between CDC and several large U.S. health maintenance organizations (HMOs) in which computerized vaccination data can be...

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