Abstract
The assessment of rare adverse events following vaccination may not be possible within a single country due to an insufficiently large denominator population. In 2008 a European consortium (VAESCO) was funded to perform collaborative vaccine safety studies. To help assess the feasibility of multi-country collaboration England and Denmark, who have established vaccine safety research infrastructures, undertook to work to a common protocol and share results and data to estimate the risk of a known true adverse event, thrombocytopenic purpura (TP) following measles-mumps-rubella (MMR) vaccination. TP is a known rare reaction to MMR and therefore provided an opportunity to assess whether two countries would produce similar results when working collaboratively. Despite some initial problems with ensuring data were comparable, the two countries gave very similar estimates of the relative incidence in the 6 weeks after vaccination and a pooled relative incidence estimate of 2.13 (95% confidence interval 1.55-2.94) and attributable risk of 1 in 50,000 doses. Both countries used hospital admissions for TP and the analysis was performed using the self controlled case series method which is particularly suited to collaborative studies because of its implicit control for individual level confounding. The study therefore shows the potential for vaccine safety collaborations across Europe to detect true associations through use of common protocols and sharing of results or data.
Original language | English |
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Pages (from-to) | 3042-3046 |
Number of pages | 5 |
Journal | Vaccine |
Volume | 30 |
Issue number | 19 |
DOIs | |
Publication status | Published - 19 Apr 2012 |
Bibliographical note
Funding Information:The VAESCO consortium is funded by the European Centre for Disease Prevention and Control (GRANT/2009/003 and Specific agreement No. 1.-ECD.1656). This study formed Work Package 3 – TP/MMR. The funding source suggested a study addressing detection of a true adverse and commented on the manuscript but had no role in the study design, data collection or analysis. The coordinating partner for the VAESCO consortium is the Brighton collaboration. We thank all the VAESCO members and the Brighton collaboration coordinating staff for their supportive contributions.
Keywords
- Data linkage
- European collaboration
- MMR vaccine
- Meta analysis
- Thrombocytopenic purpura
- VAESCO
- Vaccine safety