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Published on: January 28, 2019
[Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception]
S Pérez-Vilar1, J Díez-Domingo1, J Gomar-Fayos2
1Área de Investigación en Vacunas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana, FISABIO-Salud Pública, Valencia. España.
Insights
Rotavirus vaccines show a good safety profile, with most adverse events being non-serious. Reporting sensitivity for intussusception, a rare event, was 50% in this surveillance system.
Area of Science:
- Pediatric Vaccinology
- Pharmacovigilance
- Public Health Surveillance
Context:
- Rotavirus vaccines are crucial for preventing severe gastroenteritis in infants.
- Understanding vaccine safety and reporting systems is vital for public trust and vaccine program success.
Purpose:
- To evaluate the safety of rotavirus vaccines by analyzing suspected adverse event reports.
- To assess the reporting sensitivity of intussusception following rotavirus vaccination.
Summary:
- A descriptive study analyzed adverse event reports in infants under 10 months from 2007-2011.
- The overall adverse event reporting rate was 20 per 100,000 doses; most events were non-serious (fever, vomiting, diarrhea).
- Two intussusception cases were reported within 7 days post-vaccination, yielding a 50% reporting sensitivity for this event.
Impact:
- Findings suggest rotavirus vaccines possess a generally favorable safety profile.
- Passive surveillance for intussusception demonstrates moderate sensitivity, comparable to other systems.
- Further epidemiological studies are recommended to investigate intussusception risk versus vaccine benefits.
Introduction:
The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception.
Material And Methods:
Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry.
Results:
The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%.
Conclusions:
Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines.
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