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Evaluation of the Intussusception Risk after Pentavalent Rotavirus Vaccination in Finnish Infants

Tuija Leino1, Jukka Ollgren2, Nina Strömberg1

  • 1Department of Health Protection, National Institute for Health and Welfare (THL), Helsinki, Finland.

Plos One
|March 8, 2016
PubMed

Insights

Rotavirus vaccination is associated with a small increase in intussusception risk, particularly after the first dose. However, the benefits of rotavirus immunization programs significantly outweigh these potential risks.

Area of Science:

  • Pediatric Infectious Diseases
  • Vaccinology
  • Public Health Surveillance

Background:

  • Post-licensure studies have suggested a link between rotavirus vaccination and intussusception (IS).
  • Finland implemented a national rotavirus vaccination program in September 2009 using a pentavalent rotavirus vaccine.
  • Extensive vaccination data (719,000 doses by 2013) allows for robust safety evaluations.

Purpose of the Study:

  • To evaluate the association between rotavirus vaccination and the risk of intussusception (IS) in Finland.
  • To quantify the potential increase in IS cases following rotavirus immunization.
  • To compare the benefits of the vaccination program against potential adverse events.

Main Methods:

  • Utilized the National Hospital Discharge Register to identify intussusception (IS) cases from 1999-2013.
  • Confirmed IS cases under 250 days of age diagnosed between 2009-2013 through medical chart review.
  • Employed a self-controlled case-series method to assess IS risk in the 1-21 days post-vaccination period compared to 22-42 days.

Main Results:

  • Register data indicated a significant increase in IS incidence at 2 months of age in the post-vaccination era (Relative Incidence 9.1).
  • Identified 22 verified IS cases within 43 days of any rotavirus vaccine dose.
  • Estimated 1.04 excess IS cases per 100,000 first vaccine doses (95% CI 0.0-2.5), with no increased risk observed after second or third doses.

Conclusions:

  • Findings align with existing estimates regarding rotavirus vaccine and intussusception risk.
  • The study suggests a small but statistically significant increase in IS risk primarily after the first rotavirus vaccine dose.
  • The public health benefits of the rotavirus immunization program are considered to outweigh the identified small risks of intussusception.
Abstract

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