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- Title
An analysis of rotavirus vaccine reports to the vaccine adverse event reporting system: more than intussusception alone?
- Authors
Haber, Penina; Chen, Robert T; Zanardi, Lynn R; Mootrey, Gina T; English, Roseanne; Braun, M Miles; VAERS Working Group
- Abstract
The rhesus-human rotavirus reassortant-tetravalent vaccine (RRV-TV) was licensed on August, 31, 1998, and subsequently recommended for routine infant immunizations in the United States. After approximately 1 million doses had been administered, an increase in acute risk of intussusception in vaccinees led to the suspension of the use of RRV-TV and its withdrawal from the market. These postmarketing safety studies focused on a single adverse event (intussusception) and, to minimize the risk of a false-positive finding, accepted only cases that met a strict case definition. Safer rotavirus vaccines are needed to prevent the substantial global morbidity and mortality caused by rotavirus infections; their development and future use may benefit from a better understanding of the postmarketing safety profile of RRV-TV beyond intussusception.
- Publication
Pediatrics, 2004, Vol 113, Issue 4, pe353
- ISSN
1098-4275
- Publication type
Journal Article
- DOI
10.1542/peds.113.4.e353