COVID-19 vaccine safety data for 12 to 19 year olds consistent with that seen in older Australians

New COVID-19 vaccine safety data from AusVaxSafety has shown adolescents aged 12–19 years are reporting similar short-term vaccine side effects to those reported by older Australians. Commonly reported adverse events among adolescents aged 12–19 years following COVID-19 vaccination include local reaction including pain at injection site, headache and fatigue. These common adverse events are linked to the immune response following immunisation, are expected to occur and are generally mild and short-lived, with the overwhelming majority of recipients recovering within 3 days.

These new safety data, highlighting the short-term adverse event profile of the Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) COVID-19 vaccines in Australians aged 12–19 years, have been released as part of the ongoing AusVaxSafety COVID-19 vaccine surveillance program. This follows a recent change in eligibility criteria that allows all Australians aged 12 years and older to receive a COVID-19 vaccine.

AusVaxSafety has received more than 150,000 completed day 3 safety surveys from adolescents aged 12–19 years who received their COVID-19 vaccine and to date, the data analysis has not detected any safety signals for this age group. On the whole, data reported by this age group were largely consistent with those seen in AusVaxSafety analysis of COVID-19 vaccine safety at a population-wide level.

Associate Professor Nick Wood, Associate Director of Clinical Research and Services at the National Centre for Immunisation Research and Surveillance, said, “AusVaxSafety will continually monitor COVID-19 vaccine safety data for any potential safety signals for individuals aged 12–19 years in near-real time, ensuring COVID-19 vaccines are performing as safely and effectively as we expect them to in this younger cohort.”

“The data generated provides individuals aged 12–19 years and their parents, with real-world information on what to expect following COVID-19 vaccination,” continued Associate Professor Wood.

Adolescents aged 12–19 years reported fewer adverse events and had similar rates of medical attendance in the 3 days following Pfizer COVID-19 vaccination when compared to the adult Pfizer COVID-19 vaccine recipient population.

Conversely, 18 to 19 year olds reported more adverse events and had slightly higher rates of medical attendance, following dose 1 only, in the 3 days following AstraZeneca COVID-19 vaccination, compared to the adult AstraZeneca COVID-19 vaccine recipient population; medical attendance in 18 to 19 year olds following dose 2 was in line with the broader population.

AusVaxSafety uses vaccine safety surveillance tools – SmartVax, Vaxtracker and CVMS – to send a short online survey via SMS or email to individuals (or where appropriate a parent/carer) who receive their COVID-19 vaccine at a participating AusVaxSafety immunisation provider or vaccination hub. 

AusVaxSafety surveys are designed by vaccine experts and allow participants to report any adverse events they may have experienced at different intervals – day 3, day 8 and day 42 – after their vaccination. Once a survey is completed, de-identified data are provided to AusVaxSafety in near-real time, to be analysed and monitored for any potential vaccine safety signals.

AusVaxSafety active vaccine safety surveillance system complements the enhanced safety surveillance activities of the Therapeutic Goods Administration (TGA). Find out more about how the TGA monitors the safety of COVID-19 vaccines and how you can report side effects on the TGA website. 

Pfizer COVID-19 vaccine and AstraZeneca COVID-19 vaccine safety data for those adolescents aged 12–19 years will be updated on the AusVaxSafety website weekly.