Rotavirus Intussusception

About Rotavirus Intussusception

RotaShield, the first rotavirus vaccine, was licensed in August 1998. Within months, VAERS identified an association between RotaShield and intussusception, a form of bowel obstruction. The excess risk was estimated at roughly 1 in 10,000 vaccinated infants. The vaccine was withdrawn in October 1999 after only 14 months on the market. The withdrawal was controversial because the vaccine also prevented many hospitalizations. US authorities withdrew their recommendation, while some experts argued that in countries with high rotavirus mortality the benefits might have outweighed the risk. The withdrawal delayed rotavirus vaccination for 7 years. New rotavirus vaccines were developed with extensive safety testing. RotaTeq and Rotarix have a much lower intussusception risk, estimated at roughly 1 in 20,000 to 1 in 100,000 vaccinated infants. The case illustrates how vaccine safety monitoring works but also how risk benefit calculations differ by setting.