Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study

Abstract

Background: ​​The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. Objective: We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium. Methods: One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited. Results: Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction. Conclusion: Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.

Keywords

• adults
• enhanced safety surveillance
• european medicines agency guidance
• reactogenicity
• seasonal influenza vaccine