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Intussusception after monovalent rotavirus vaccine-United States, Vaccine Adverse Event Reporting System (VAERS),

Penina Haber1, Umesh D Parashar2, Michael Haber3

  • 1Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), United States.

Vaccine
|August 16, 2015
PubMed
Abstract

Insights

A study found a small increase in intussusception risk within 3-6 days after the first dose of Rotarix (RV1) vaccine. This risk is outweighed by the significant benefits of rotavirus vaccination in preventing severe illness.

Area of Science:

  • Pediatric Vaccinology
  • Public Health Surveillance
  • Gastroenterology

Background:

  • Two rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced in the US in 2006 and 2008.
  • Previous US studies on intussusception risk primarily focused on RV5, with limited data available for RV1.

Purpose of the Study:

  • To assess the risk of intussusception following the Rotarix (RV1) vaccine in the United States.
  • To quantify the excess risk of intussusception associated with RV1 vaccination using passive surveillance data.

Main Methods:

  • Analysis of intussusception events reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2008 to December 2014.
  • Self-controlled risk interval analysis using Poisson regression to estimate the daily reporting ratio (DRR) of intussusception after RV1 doses.
  • Calculation of excess intussusception risk per 100,000 vaccinations, with sensitivity analyses for reporting completeness and baseline rate accuracy.

Main Results:

  • 108 confirmed intussusception reports were identified after RV1 vaccination.
  • Significant clustering of intussusception occurred 3-8 days post-dose 1 (p=0.001) and 2-7 days post-dose 2 (p=0.001).
  • The DRR for days 3-6 post-dose 1 was 7.5, translating to an excess risk of 1.6 per 100,000 vaccinations; the DRR was elevated but not significant after dose 2.

Conclusions:

  • A significant increased risk of intussusception was observed 3-6 days after the first dose of RV1.
  • The estimated small number of intussusception cases linked to RV1 is considered to be outweighed by the substantial public health benefits of rotavirus vaccination.
Keywords:
IntussusceptionRotarix vaccinesSafety monitoringVaccine adverse event

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