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Risk of Intussusception After Rotavirus Vaccination: Meta-analysis of Postlicensure Studies.
Dominique Rosillon1, Hubert Buyse, Leonard R Friedland
1From *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.
Both rotavirus vaccines (RV1 and RV5) show a small increased risk of intussusception after dose 1 and dose 2. This suggests intussusception is a class effect of oral rotavirus vaccines.
Area of Science:
- Pediatric infectious diseases
- Vaccine safety and surveillance
- Gastroenterology
Background:
- Postlicensure studies indicate a slight increase in intussusception risk with rotavirus vaccines (RV1 and RV5).
- Existing data necessitates a consolidated risk assessment for these widely used vaccines.
Purpose of the Study:
- To determine the overall relative risk of intussusception following administration of RV1 and RV5.
- To evaluate the risk associated with specific vaccine doses (1 and 2).
Main Methods:
- Meta-analysis of 5 postlicensure studies using relative risk estimates and confidence intervals.
- Inclusion of studies with confirmed intussusception cases (Brighton or other methods).
- Pooled analysis using fixed-effect and random-effect models.
Main Results:
- Increased relative risk of intussusception within 7 days post-dose 1: 5.4 for RV1 and 5.5 for RV5.
- Increased relative risk of intussusception within 7 days post-dose 2: 1.8 for RV1 and 1.7 for RV5.
- Similar risk estimates observed for both vaccine types.
Conclusions:
- A similar increased risk of intussusception is associated with both rotavirus vaccines, particularly after the first dose.
- The findings suggest that the increased intussusception risk may be a class effect common to currently available oral rotavirus vaccines.
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