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AusVaxSafety begins COVID-19 vaccine safety monitoring in children under 5

With the rollout of the Moderna COVID-19 vaccine (25 microgram formulation) for Australian children aged 6 months to 5 years with complex medical conditions that put them at greater risk of severe COVID-19 now underway, AusVaxSafety has also commenced active monitoring of the safety of the vaccine in this younger age group to ensure the vaccine is performing as safely as we expect it to in this vulnerable population. 

The Australian Technical Advisory Group on Immunisation (ATAGI) recommends that children aged 6 months to 5 years who are severely immunocompromised receive 3 primary doses of the COVID-19 vaccine and those with the following or similar conditions receive 2 primary doses, given at least 8 weeks apart: 

  • severe primary or secondary immunodeficiency, including those undergoing treatment for cancer, or on immunosuppressive treatments as listed in the ATAGI advice on 3rd primary doses of COVID-19 vaccine in individuals who are severely immunocompromised
  • bone marrow or stem cell transplant, or chimeric antigen T-cell (CAR-T) therapy
  • complex congenital cardiac disease
  • structural airway anomalies or chronic lung disease
  • type 1 diabetes mellitus
  • chronic neurological or neuromuscular conditions
  • a disability that requires frequent assistance with activities of daily living, such as severe cerebral palsy or Down Syndrome (Trisomy 21). 

The addition of the Moderna COVID-19 vaccine for children aged 6 months to 5 years to the AusVaxSafety program ensures that all eligible individuals and all COVID-19 vaccines in Australia are being actively monitored to ensure continued safety. 

AusVaxSafety sends out a short online survey via SMS or email to parents/carers of individuals aged 6 months to 5 years who receive their paediatric Moderna COVID-19 vaccine at a participating AusVaxSafety site. This allows parents/carers to report any adverse events their child may have experienced at different time points after their vaccination, which is de-identified and analysed by epidemiologists and vaccine experts.

Since February 2021, more than 2.5 million Australians have participated in the AusVaxSafety COVID-19 vaccine surveillance program, by completing more than 6.5 million safety surveys, making this the largest scale active safety surveillance ever conducted on vaccines used in Australia.

Moderna COVID-19 vaccine safety data will be available on the AusVaxSafety website once enough data have been collected to publish. 

View the latest COVID-19 vaccine safety data here