Active SMS-based influenza vaccine safety surveillance in Australian children
Alexis Pillsbury1, Helen Quinn2, Patrick Cashman3
1National Centre for Immunisation Research and Surveillance, Westmead, NSW 2145, Australia.
Insights
Australia's AusVaxSafety system found no safety concerns with seasonal influenza vaccines in children. Concomitant vaccines, particularly Meningococcal B, increased adverse event rates, with fever being a key indicator.
Area of Science:
- Immunology
- Vaccinology
- Public Health Surveillance
Background:
- Australia employs the AusVaxSafety active surveillance system for real-time post-market vaccine safety monitoring.
- Understanding vaccine safety in young children is crucial for public health initiatives.
Purpose of the Study:
- To analyze adverse event following immunisation (AEFI) rates in children aged 6 months to 4 years who received seasonal influenza vaccines in 2015 and 2016.
- To compare the safety profiles of trivalent influenza vaccine (TIV) and quadrivalent influenza vaccine (QIV) and assess the impact of concomitant vaccine administration.
Main Methods:
- Utilized parent/carer reports of AEFIs within 3 days of vaccination, collected via SMS and email surveys.
- Combined retrospective data from two years to examine specific AEFI rates, including fever and medical attendance as a proxy for serious adverse events (SAE).
Main Results:
- No safety signals or excess adverse events were detected in 7402 children.
- Concomitant vaccine administration, especially with Meningococcal B vaccine, was associated with a higher incidence of AEFIs, particularly fever (7.5% vs 2.8%).
- TIV and QIV demonstrated low and expected AEFI rates, with no significant difference in safety profiles between brands.
Conclusions:
- Active participant-reported data from AusVaxSafety provides timely, vaccine brand-specific safety information.
- The surveillance system is valuable for monitoring influenza vaccine safety, which can change annually due to composition variations.
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.
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