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Postmarketing Monitoring of Intussusception After RotaTeqTM Vaccination—United States, February 1, 2006–February 15, 2007
JAMA. 2007;297(18):1972-1976.
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MMWR. 2007;56:218-222
2 figures, 2 tables omitted
Rotavirus is the leading cause of severe gastroenteritis in children aged <5 years worldwide. In February 2006, a new rotavirus vaccine, RotaTeqTM (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4, and 6 months.1 Because a previous rotavirus vaccine, RotashieldTM (Wyeth Laboratories, Marietta, Pennsylvania), was withdrawn from the U.S. market in 1999 after postmarketing surveillance identified an association* with intussusception (a rare type of bowel obstruction),2 the safety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 . . . [Full Text of this Article] VAERS Reports
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