Anke L Stuurman1, Thomas Verstraeten1, Antoon De Schryver2. 1. a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium. 2. b IDEWE Occupational Health Services , Leuven , Belgium.
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.
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.
Authors: Alexis J Pillsbury; Catherine Glover; Peter Jacoby; Helen E Quinn; Parveen Fathima; Patrick Cashman; Alan Leeb; Christopher C Blyth; Michael S Gold; Thomas Snelling; Kristine K Macartney Journal: BMJ Open Date: 2018-10-18 Impact factor: 2.692