Risk for Intussusception After Rotavirus Vaccine, Revisited

January 22, 2014

Risk for Intussusception After Rotavirus Vaccine, Revisited

  1. Deborah Lehman, MD

Two studies demonstrate a slight increase in risk.

  1. Deborah Lehman, MD

The first rotavirus vaccine, a tetravalent rhesus–human reassortant vaccine (RotaShield), was withdrawn from the U.S. market in 1999 after postlicensure surveys revealed an increase in intussusception rates (1–2 additional cases per 10,000 vaccine recipients, highest following the first dose). In 2006 and 2008, two new rotavirus vaccines were introduced — a pentavalent bovine–human reassortant vaccine (RV5-RotaTeq) and a monovalent human rotavirus vaccine (RV1-Rotarix), respectively. A recent review of the Vaccine Adverse Event Reporting System detected a small increase in risk for intussusception (0.79 per 100,000 recipients) following RotaTeq administration. (NEJM JW Pediatr Adolesc Med Jun 5 2013). Two new studies confirm a slight increase in risk.

In an FDA-sponsored study, investigators examined the risk for intussusception following >1.2 million doses of RotaTeq and >100,000 doses of Rotarix administered between January 2004 and September 2011. All potential cases of intussusception were identified and reviewed by physicians unaware of the infant's vaccination status. Among 267 cases of intussusception reviewed, 124 were found to be definitive. Analysis of RotaTeq demonstrated a statistically significant increase of 1 to 1.5 cases of intussusception per 100,000 recipients during the week following the first vaccine dose. Analysis of Rotarix was underpowered, but suggested an increase in risk following the second dose.

Another study reviewed >200,000 doses of the monovalent rotavirus vaccine (Rotarix) in the Vaccine Safety Datalink. The attributable risk for intussusception was 5 per 100,000 vaccinated infants, although confidence limits were large because of the small sample size. Risk for intussusception after RotaTeq was not significantly increased.


These two reports seem to confirm a slightly increased risk for intussusceptions after rotavirus vaccination. The results are not consistent, primarily because of variable study technique and sample size. The FDA study is a robust analysis that demonstrates a small but significant risk following the first dose. The second, smaller study found a small increase in risk after the monovalent vaccine but not after the pentavalent vaccine. Given the substantial morbidity attributed to rotavirus in the prevaccine era (http://www.cdc.gov/rotavirus/index.html), the small risk for intussusception associated with vaccine must be weighed against the clear benefits of vaccination. Clinicians should be aware of the association, particularly after the first dose, and inform families of the benefits as well as risks.

Editor Disclosures at Time of Publication

  • Disclosures for Deborah Lehman, MD at time of publication Nothing to disclose


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