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Type: Journal article
Title: Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia
Author: Pillsbury, A.
Glover, C.
Jacoby, P.
Quinn, H.
Fathima, P.
Cashman, P.
Leeb, A.
Blyth, C.
Gold, M.
Snelling, T.
Macartney, K.
Citation: BMJ Open, 2018; 8(10):1-11
Publisher: BMJ
Issue Date: 2018
ISSN: 2044-6055
Statement of
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
Abstract: OBJECTIVE:To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety. DESIGN AND SETTING:Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia. PARTICIPANTS:Individuals aged ≥6 months who received a routine seasonal influenza vaccine at a participating site (n=102 911) and responded to a survey (via short message service or email) sent 3 days after vaccination about adverse events experienced (n=73 892; 71.8%). MAIN OUTCOME MEASURE:Near real-time and cumulative participant-reported rates of any adverse event, fever or medical attendance experienced within 3 days after vaccination overall, by brand, age, pregnancy status and concomitant vaccine receipt. RESULTS:Participant median age was 57 years (range: 6 months to 102 years); 58.1% (n=42 869) were female and 2.7% (n=2018) were pregnant. Near real-time fast initial response cumulative summation and Bayesian analyses of weekly event rates did not demonstrate a safety signal. Children aged 6 months to 4 years had higher event rates (522/6180; 8.4%) compared with older ages; participants aged ≥65 years reported fewer events (1695/28 154; 6.0%). There were no clinically significant differences in safety between brands, by age group or overall. Cumulative data analysis demonstrated that concomitant vaccination was associated with increased rates of fever (2.1% vs 0.8%) and medical attendance (0.8% vs 0.4%), although all rates were low and did not exceed expected levels. CONCLUSIONS:Novel, postmarketing AusVaxSafety surveillance demonstrated comparable and expected safety outcomes for the 2017 quadrivalent inactivated influenza vaccine brands used in Australia. These near real-time, participant-reported data are expected to encourage confidence in vaccine safety and promote uptake.
Keywords: Active surveillance
vaccine safety
Rights: This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:
DOI: 10.1136/bmjopen-2018-023263
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