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Vaccine News and Commentary from the University of Pennsylvania Center for Bioethics

Tuesday, June 10, 2008

No evidence of RotaTeq-intussusception link observed

Students of contemporary vaccine history are likely familiar with the story of RotaShield, a vaccine against rotavirus licensed in 1998 but withdrawn a year later following the apparent correlation between it and intussusception, a potential life-threatening bowel obstruction.

The clinical testing of RotaTeq, the Merck vaccine licensed in 2006, showed no such link, yet alarms were raised by a 'public health notification' titled "Information on RotaTeq and Intussusception" issued by FDA in February 2007. Despite its title, the announcement did not suggest that intussusception rates among vaccinees were any greater than what could be expected in the general population.

This month's issue of Pediatrics examines the topic in much greater detail, in a paper from CDC and FDA researchers titled, "Postlicensure Monitoring of Intussusception After RotaTeq Vaccination in the United States, February 1, 2006, to September 25, 2007". Based primarily on VAERS reports, the study concludes that there is no association between RotaTeq and intussusception.

Information about general trends in intussusception rates -- independent of a connection to vaccines -- appeared in a paper in the May issue of Pediatrics: "Trends in Intussusception Hospitalizations Among US Infants, 1993–2004: Implications for Monitoring the Safety of the New Rotavirus Vaccination Program".

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