Rotavirus is the leading cause of severe
gastroenteritis in children aged <5 years worldwide. In February 2006, a new
rotavirus vaccine,
RotaTeq (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. Because a previous
rotavirus vaccine, Rotashield (Wyeth Laboratories, Marietta, Pennsylvania), was withdrawn from the U.S. market in 1999 after postmarketing surveillance identified an association with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), the safety of
RotaTeq was evaluated in a prelicensure clinical trial involving 71,725 infants who received either
vaccine or placebo. 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.