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Pentavalent Rotavirus Vaccine Not Associated with Increased Risk of Intussusception in Infants

Rotavirus is a virus that causes vomiting and diarrhea. It can be a serious condition in young children. Fortunately, there are rotavirus vaccines that have proven effective at preventing this infection. One of the first rotavirus vaccines was associated with an increased risk of intussusception in first few weeks after vaccine. Intussusception is a condition where the intestine folds on itself which can cause blockage or damage. It is one of the more common abdominal emergencies in young children. This original rotavirus vaccine was removed from use and newer versions of rotavirus appear to be much safer. The vaccines are given in either 2 or 3 dose series.

Researchers from the United States wanted to assess any remaining risk of intussusception with the one of the newer generations of rotavirus vaccines, the pentavalent rotavirus vaccine (RotaTeq). The study, published in Journal of American Medical Association, did not find an increased risk of intussusception in infants receiving the pentavalent rotavirus vaccine.

About the Study

The prospective cohort study included 786,725 doses of the pentavalent rotavirus vaccine of which 309,844 were first doses. Infants included in the study were aged 4-34 weeks who received the vaccine between 2006-2010. Researchers then gathered historical data on rates of intussusception in children from 2001-2005 when the vaccine was not given. This value was called the expected case rate and was compared to rate of intussusception in children who received the vaccine. Intussusception developed:
  • 1-30 days after the vaccine was given in 21 infants that had received the vaccine compared to the expected 20.9 (not significant)
  • 1-7 days after the vaccine was given in 4 infants that received the vaccine compared to the expected 4.3 infants (not significant)
Results were similar whether it was first dose or follow-up doses.

How Does This Affect You?

Rotavirus vaccine is an effective method of reducing incidence and serious side effects of a rotavirus infections in infants. Its use has been associated with significant reductions in the number of infants needing medical care for these types of infections. This type of study is an observational study which can decrease its reliability. However, there was a large number of infants in this trial and side effects for vaccines are carefully monitored. The lack of difference between that actual rates and expected rates makes the safety of the vaccine likely.

RotaTeq appears safe. It has also been shown to be effective in reducing risk of a rotavirus infection. Vaccines as with any medical procedures are delivered based on assessments of benefits an risk. Make sure you talk to your childs doctor about getting appropriate vaccines for your child.




  • Shui IM, Baggs J, et al. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA. 2012 Feb 8;307(6):598-604.

Last reviewed April 2012 by Brian P. Randall, MD

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