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Evaluation of Intussusception After Oral Monovalent Rotavirus Vaccination in South Africa

Michelle J Groome1,2, Jacqueline E Tate3, Marion Arnold4,5

  • 1Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|May 25, 2019
PubMed

Insights

This study found no increased risk of intussusception after rotavirus vaccination (RV1) in South African infants. Rotavirus vaccine safety is confirmed, showing no link to this serious bowel condition.

Area of Science:

  • Pediatric Gastroenterology
  • Vaccine Safety Research
  • Public Health Surveillance

Background:

  • Postlicensure studies suggest a link between rotavirus vaccination and intussusception.
  • Rotarix (RV1) is a rotavirus vaccine administered at 6 and 14 weeks of age.
  • Understanding vaccine safety is crucial for public health programs.

Purpose of the Study:

  • To assess the risk of intussusception following Rotarix (RV1) vaccination in South African infants.
  • To evaluate the association between RV1 administration and intussusception in an upper-middle-income country setting.

Main Methods:

  • Active prospective surveillance for intussusception across 8 hospitals (Sept 2013–Dec 2017).
  • Retrospective case enrollment at 1 hospital (July 2012–Aug 2013).
  • Self-controlled case-series method to estimate incidence rate ratios within 1-21 days post-vaccination, with age-matched controls for secondary analysis.

Main Results:

  • 346 intussusception cases were analyzed.
  • No increased risk of intussusception was observed within 1-7 or 8-21 days after the first or second dose of RV1.
  • Relative incidence (RI) values and 95% confidence intervals (CI) did not indicate a significant association.

Conclusions:

  • The risk of intussusception within 21 days post-RV1 vaccination was not elevated compared to the background risk in South African infants.
  • Findings support the safety profile of Rotarix in the studied population.
  • This study contributes to the global understanding of rotavirus vaccine safety.
Abstract

Keywords:
infantintussusceptionrotavirus vaccinesafety

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