AusVaxSafety

2016 Influenza Vaccine Early Report: good safety profile in children

With winter coming soon, it’s time to remind parents and patients to be vaccinated against influenza now. Influenza is a viral respiratory illness that is responsible for thousands of children and adults of all ages each year being admitted to hospital in Australia.

Active vaccine safety surveillance is conducted nationally in young children to monitor for the type and rate of reactions to each year’s new influenza vaccine. This program is called AusVaxSafety.  As of mid-May 2016, the families of more than 1200 children aged 6 months to 5 years from more than 100 ‘sentinel’ locations across Australia have responded to SMS or email messages to give us feedback on how their child felt days after vaccination.

This is the first year that the new quadrivalent vaccines (containing 2 influenza A and 2 influenza B strains) are being provided under the National Immunisation Program.

Results of this surveillance indicate that the safety profile of the 2016 influenza vaccines in children is excellent and the type and rate of vaccine reactions is within usual limits. Only 9% of participants have reported any reaction. Reactions recorded have been mild and resolved within 1-2 days. The most commonly reported symptoms include tiredness, irritability, and pain, swelling or redness at the injection site. A fever was reported in less than 3% of children. A small proportion of children (1%) have sought medical attention for symptoms following immunisation, and these have generally not been directly related to vaccination.

No vaccine-attributable serious adverse events have been recorded for the patients in this program. It is also important to note that safety demonstrated in children provides assurance that the vaccine is safe among all age groups.

All Australians can benefit from receiving influenza vaccine. Across Australia, health departments, clinicians and other researchers are conducting ongoing surveillance activities to monitor vaccine uptake, safety and effectiveness, and influenza activity. The success of AusVaxSafety surveillance is due to the active engagement of the public whose participation allows for real-time feedback on the safety of each year’s influenza vaccine.

Overview

AusVaxSafety surveillance is a collaborative initiative led by NCIRS and involves vaccine safety experts, state and territory public health systems, general practitioners and children’s hospitals across Australia. It is funded by the Australian Government Department of Health. AusVaxSafety partners with and makes use of several computer-based surveillance systems, Vaxtracker, SmartVax, and STARSS, which send SMSs or web-based surveys to parents and carers seeking information on how their child felt after receiving the influenza vaccine. 

Real-time reporting

Data compiled by AusVaxSafety are summarised in reports for the Australian Government Department of Health (HEALTH) Immunisation Branch and the Therapeutic Goods Administration (TGA) and shared with participating state and territory health departments. Reports are written and distributed weekly for influenza vaccine-associated reactions (during influenza season only) and monthly for pertussis-containing vaccine-associated reactions.

2015 influenza surveillance

Between 1 April 2015 and 31 August 2015, a total of 4,441 parents/carers were offered participation and 4,396 (99.0%) participants were enrolled and sent SMS and/or emails. Of those enrolled, there were 3,340 (76.0%) survey completions, noting that some children completed the survey for both dose 1 and dose 2.

Overall, the safety profile of the 2015 influenza vaccines was good, with 4.4% reporting fever, 11.5% reporting any systemic and/or local reaction within 3 days of receiving an influenza vaccine, and 1.1% reporting that they sought medical attention for adverse events following influenza vaccine receipt.

For full results, please refer to our Eurosurveillance article: Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015.

For more information

For further information on AusVaxSafety:
E: alexis.pillsbury@health.nsw.gov.au or helen.quinn@health.nsw.gov.au or kristine.macartney@health.nsw.gov.au

 

Last updated May 2016