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Vaccine. 2017 Dec 18;35(51):7101-7106. doi: 10.1016/j.vaccine.2017.10.091. Epub 2017 Nov 8.

Active SMS-based influenza vaccine safety surveillance in Australian children.

Author information

1
National Centre for Immunisation Research and Surveillance, Westmead, NSW 2145, Australia. Electronic address: alexis.pillsbury@health.nsw.gov.au.
2
National Centre for Immunisation Research and Surveillance, Westmead, NSW 2145, Australia; Discipline of Paediatrics and Child Health, University of Sydney, Sydney, NSW 2006, Australia. Electronic address: helen.quinn@health.nsw.gov.au.
3
Hunter New England Population Health, Newcastle, Australia. Electronic address: patrick.cashman@hnehealth.nsw.gov.au.
4
Illawarra Medical Centre, Ballajura, Western Australia 6066, Australia. Electronic address: alan@illawarramedical.com.au.
5
National Centre for Immunisation Research and Surveillance, Westmead, NSW 2145, Australia; Discipline of Paediatrics and Child Health, University of Sydney, Sydney, NSW 2006, Australia. Electronic address: kristine.macartney@health.nsw.gov.au.

Abstract

INTRODUCTION:

Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration.

METHODS:

Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles.

RESULTS:

7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6-71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands.

DISCUSSION:

Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually.

KEYWORDS:

Active surveillance; Adverse event following immunisation; Influenza vaccine; Vaccine safety

PMID:
29128379
DOI:
10.1016/j.vaccine.2017.10.091
[Indexed for MEDLINE]

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