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Study affirms AusVaxSafety’s value for monitoring vaccine safety in older adults

AusVaxSafety provides active, near–real time monitoring of vaccine safety through automated surveys of vaccinated individuals in Australia. The system was developed in 2014 to monitor influenza vaccine in children but now monitors all vaccines on the National Immunisation Program (NIP) and COVID-19 vaccines. 

A new study published in BMJ Open has shown the strength of AusVaxSafety in the surveillance of vaccine safety in older adults. The safety of the shingles vaccine (Zostavax) was monitored in adults aged 70 to 79 years for 2 years from its inclusion on the NIP for this age group. Researchers found the participation rate among this age group was high, with most participants responding quickly to a survey sent via short message service (SMS) (73%) within 7 days of vaccination. This enabled AusVaxSafety to efficiently monitor the rollout of the vaccine in near–real time.

Using AusVaxSafety, Zostavax was found to have a very good safety profile in the first week after vaccination among older adults. The most commonly reported adverse event was local pain, swelling or redness at the injection site in 2.3% of participants. The proportion of people who saw a doctor for an adverse event was very low (0.3%). Zostavax should be not be given to people with immunocompromise. Healthcare providers should assess a patient's immune status before administering this vaccine. A Zostavax vaccine screening tool is available to providers to help with this assessment. Refer to the Therapeutic Goods Administration (TGA) advisory and the Australian Immunisation Handbook for detailed guidance.

The AusVaxSafety system complements the existing passive vaccine safety surveillance system of the Therapeutic Goods Administration (TGA). While vaccines used in Australia have been shown to be safe and effective in large clinical trials, ongoing post-marketing surveillance through the TGA and systems like AusVaxSafety is important to identify rare potential adverse events and provide transparent data to optimise community and healthcare provider confidence in the safety of vaccines.

This study provides confidence that AusVaxSafety is valid and useful for actively monitoring vaccine safety in older adults, who are a priority group for COVID-19 vaccines. AusVaxSafety is currently monitoring the safety of COVID-19 vaccines and provides important safety information regularly on its website. 

Read full study here

Access COVID-19 vaccine safety data here