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Active surveillance of adverse events following childhood immunization in Singapore
Koh Cheng Thoon1, Sally Bee Leng Soh2, Woei Kang Liew3
1Department of Paediatric Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore 229899, Singapore; Duke-National University of Singapore Graduate Medical School, 8 College Road, Singapore 169857, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, National University Health System Building (NUH), Singapore 119228, Singapore.
Insights
Active surveillance for adverse events following immunization (AEFI) in Singapore identified a 5-fold increase in BCG-associated lymphadenitis. This system enhances vaccine safety monitoring and public confidence in immunization programs.
Area of Science:
- Public Health
- Immunization Safety
- Pediatric Medicine
Background:
- Singapore historically relied on passive reporting of adverse events following immunization (AEFI).
- A collaboration between Health Sciences Authority and KK Women's and Children's Hospital initiated active AEFI surveillance in 2009.
- This study focuses on the methodology and initial findings of this active surveillance for childhood vaccines.
Purpose of the Study:
- To implement and evaluate a hospital-based active surveillance system for AEFI in children.
- To identify and assess potential vaccine-associated adverse events following childhood immunizations.
- To improve the detection and management of AEFI to maintain public trust in vaccination.
Main Methods:
- Screened pediatric admissions for potential AEFI, excluding elective cases, between April 2010 and March 2012.
- Conducted causality assessments using standardized definitions (certain, probable, possible, unlikely).
- Collected data on demographics, implicated vaccines, clinical details, severity, and outcomes to calculate AEFI rates.
Main Results:
- Evaluated 1988 children (4.4%) out of 45,571 screened admissions.
- Identified 311 children (15.6%) with AEFI considered vaccine-associated; 98.8% recovered without sequelae.
- Detected a 5-fold increase in BCG-associated regional lymphadenitis, prompting further safety analysis.
Conclusions:
- Hospital-based active surveillance effectively enhances AEFI signal detection and investigation.
- This system supports public health bodies in maintaining confidence in vaccination programs.
- Improved understanding of vaccine risks and benefits aids policy generation and physician counseling.
Introduction:
In Singapore, reporting of adverse events following immunization (AEFI) was historically passive. In 2009, Health Sciences Authority collaborated with KK Women's and Children's Hospital to perform active surveillance for AEFI. We report the methodology and initial findings of this surveillance following childhood vaccines.
Methods:
From April 2010 to March 2012, we screened all paediatric admissions for possible relationships to vaccination, excluding elective admissions, and performed causality assessment for each case using standardized definitions for certain, probable, possible and unlikely. Baseline demographics, data on implicated vaccines and clinical details including severity and outcomes were collected. Total hospital admissions were used to calculate rates of AEFI.
Results:
We screened 45,571 (80%) of 56,526 admissions, and evaluated 1988 (4.4%) children. Median age at presentation was 3.1 months, while median interval from vaccination to symptom onset was 6 days. There were 311 (15.6%) children with AEFI that were considered possibly, probably or certainly associated with vaccines. However, 98.8% recovered without any long-term sequelae. The hospital-based active surveillance of AEFI enabled the detection of a 5-fold increase (95% CI 1.2-33.1) in BCG-associated regional lymphadenitis in April 2010, which triggered follow-up safety analysis to guide public health advice.
Conclusions:
Hospital-based active surveillance can enhance signal detection and follow-up investigations of AEFI. Subsequently, public health bodies are better equipped to maintain public confidence in vaccination programmes and physicians are able to provide relevant advice to parents. It also allows for a better understanding of risk-benefit ratios of specific vaccines and aids the generation of public health vaccination policy.
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