Rotavirus Vaccine Not Associated with Increased Risk of Intussusception in Infants

Rotavirus causes severe vomiting and diarrhea. It can be a serious condition in young children. Fortunately, there is a rotavirus vaccine that has been 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 intestines folds on itself and cause a blockage or damage to the intestines. It is the most common abdominal emergency in children under 2 years of age. This original rotavirus vaccine was removed from use and newer versions of rotavirus appear to be much safer.
Researchers from the United States wanted to assess any remaining risk of intussusception with the newer generation of rotavirus vaccines. The study, published in Journal of American Medical Association, did not find an increased risk of intussusception in infants receiving the rotavirus vaccine.

About the Study

The retrospective cohort study included 786,725 doses of the pentavalent rotavirus vaccine (RV5) 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 rate of intussusception in children who did not receive vaccines during this same time period. This value was called expected case rate and was compared to rate of intussusception in children with vaccine to. Intussusception developed in:
  • 21 infants that had received vaccine vs. 20.9 infants without vaccination (not significant) during 1-30 days after vaccine
  • 4 infants with vaccine vs. 4.3 infants without vaccination (not significant) during 1-7 day window after vaccine
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 is a safe assumption of the vaccine's safety.
The cause of intussusception is not clear. While past rotavirus vaccines were associated with a small increase in risk, viral infections may also be associated with intussusception. So an unvaccinated child's increased risk of rotavirus infection may also increase their risk of intussusception. Vaccine's are an important step in your infants health. They are a widely used tools whose benefits and risk are carefully monitored. Talk to your child's pediatrician about the benefits and risks of vaccine for your child.


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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.

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