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

• Published in: Expert review of vaccines Vol. 16; no. 2; pp. 187 - 191
• Main Authors: Stuurman, Anke L, Verstraeten, Thomas, De Schryver, Antoon
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis Group 01.02.2017
• Subjects: Adolescent; Adult; adults; Aged; Belgium; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; enhanced safety surveillance; european medicines agency guidance; Feasibility Studies; Female; Humans; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza, Human - prevention & control; Male; Middle Aged; Product Surveillance, Postmarketing - methods; reactogenicity; seasonal influenza vaccine; Surveys and Questionnaires; Text Messaging; Time Factors; Young Adult; Adults; European Medicines Agency guidance; seasonal influenza vaccine; enhanced safety surveillance; reactogenicity
• ISSN: 1476-0584; 1744-8395
• DOI: 10.1080/14760584.2017.1264272

​​The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium. 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. 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. 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.