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Brand specific, near real time, enhanced safety surveillance of influenza vaccines in general practice winter 2015/16: feasibility study
Simon de Lusignan;
Ana Correa;
Gaël Dos Santos;
Nadia Meyer;
François Haguinet;
Rebecca Webb;
Christopher McGee;
Rachel Byford;
Ivelina Yonova;
Sameera Pathirannehelage;
Filipa Matos Ferreira;
Simon Jones
ABSTRACT
Background:
The European Medicines Agency (EMA) requires vaccine manufactures conduct enhanced real-time surveillance of seasonal influenza vaccination for a pre-specified list of adverse events of interest (AEIs).
Objective:
To provide results of reported adverse events of interest (AEIs) by specified age strata and AEI type.
Methods:
Data were extracted from nine computerised general practices in England between weeks 35-49 (24/08/2015 to 06/12/2015), the main period of influenza vaccination. Three practices also issued adverse drug reaction (ADR) cards. We conducted weekly analysis and end of study analyses.
Results:
20.7% of registered patients were vaccinated, with an end of study AEI rate of 11.9% (95%CI 11.38%-12.42%). There were no differences in AEI rates between the different vaccine brands: 3.02% (95% CI 2.72-3.33) for GSK and 2.63% (95% CI 2.13-3.15) for non-GSK brand vaccine; and no signal of excess AEI in weekly data. 1.2% of ADR cards were returned, reporting extra local side effects.
Conclusions:
Enhanced surveillance was feasible, though could be refined further. Despite their low return rate, the ADR card enhanced AEI recording
Citation
Please cite as:
de Lusignan S, Correa A, Dos Santos G, Meyer N, Haguinet F, Webb R, McGee C, Byford R, Yonova I, Pathirannehelage S, Ferreira FM, Jones S
Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study