Risk of Intussusception After Rotavirus Vaccination: Meta-analysis of Postlicensure Studies.

Pediatr Infect Dis J

From *GlaxoSmithKline Vaccines, Wavre, Belgium; †GlaxoSmithKline, Philadelphia, PA; and ‡Medical Research Unit on Infectious Diseases, Pediatrics Hospital, National Medical Center-Century-XXI, Mexican Institute of Social Security (IMSS), Mexico City, D.F., Mexico.

Published: July 2015

AI Article Synopsis

  • The meta-analysis assessed the risk of intussusception (a type of bowel obstruction) after vaccination with two rotavirus vaccines: RV1 (Rotarix) and RV5 (RotaTeq).
  • The analysis included data from five studies focused on the risk of intussusception during the first week after the first and second doses of these vaccines.
  • Findings indicated a higher risk (5.4 for RV1 and 5.5 for RV5) of intussusception within 7 days post-dose 1, and a lower risk (1.8 for RV1 and 1.7 for RV5) post-dose 2, suggesting this risk is a common issue associated with both vaccines.

Article Abstract

Background: Postlicensure surveillance studies suggest a small temporal increase in the risk for intussusception with both currently available rotavirus vaccines (RV1; Rotarix, GSK and RV5; RotaTeq, Merck & Co., Inc.). This meta-analysis was undertaken to provide a single overall estimate of the relative risk of intussusception during the 7-day period after administration of RV1 and RV5.

Methods: Meta-analysis based on estimates of relative risk and corresponding 95% confidence intervals from 5 postlicensure studies providing an estimate of risk of intussusception during the 7-day period after administration of dose 1 and/or dose 2 of RV1 and/or RV5, based on active and/or passive surveillance, for confirmed intussusception cases (Brighton or other method of case confirmation). For each vaccine, the relative risk of intussusception was estimated postdose 1 and postdose 2. Results were pooled using the inverse variance method using both fixed-effect and random-effect models.

Results: The overall estimate of relative risk of intussusception during the 7 days postdose 1 was 5.4 (95% confidence interval: 3.9-7.4, 3 studies) for RV1 and 5.5 (3.3-9.3, 3 studies) for RV5. The overall estimate of relative risk of intussusception during the 7 days postdose 2 was 1.8 (1.3-2.5, 4 studies) for RV1 and 1.7 (1.1-2.6, 3 studies) for RV5.

Conclusions: This meta-analysis showed a similar increased risk of intussusception, during the first 7 days after administration of dose 1 and, to a lesser extent, dose 2, for both currently available rotavirus vaccines. This suggests that intussusception may be a class effect of currently available oral rotavirus vaccines.

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Source
http://dx.doi.org/10.1097/INF.0000000000000715DOI Listing

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