Australia’s active vaccine safety system
As part of the AESI long term follow-up program, AusVaxSafety is actively engaging with individuals diagnosed with myocarditis and/or pericarditis following COVID-19 vaccination in Australia through follow-up interviews and surveys to assess their physical and psychological health over an 18-month period to better understand the long-term health impact of myocarditis and/or pericarditis.
Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart. In rare instances, myocarditis and pericarditis have been reported by individuals after receiving an mRNA COVID-19 vaccine – Pfizer or Moderna.
The AusVaxSafety long-term follow-up program will help us gain a greater understanding of the characteristics, progress and clinical outcomes of myocarditis and/or pericarditis by actively engaging with individuals in Australia affected by these conditions over an 18-month period following diagnosis.
The collection and analysis of clinical data from individuals affected by myocarditis and/or pericarditis will provide important information for clinicians treating myocarditis and/or pericarditis, and may inform future vaccination policies in Australia.
Individuals affected by myocarditis and/or pericarditis who meet the eligibility criteria will be invited to participate in this AusVaxSafety follow-up program. Those who agree to participate in the program will be contacted and sent surveys at different time points over an 18-month period. These surveys ask questions around general health, relevant follow-up tests and psychological health. With permission, the treating specialists of participants will also provide additional information regarding their care and progress.
Data collected from participants will be de-identified and analysed by clinical specialists and epidemiologists and results, highlighting key findings and recommendations for the future, will be published.
Any individual who has a confirmed case of myocarditis and/or pericarditis as per the Centers for Disease Control and Prevention (CDC) definition with symptom onset within 42 days after mRNA COVID-19 vaccination is eligible to participate in the myocarditis and/or pericarditis study arm.
Eligible individuals will be identified and contacted by a nurse or doctor from state/territory health departments.
Participation in the myocarditis and/or pericarditis study arm is voluntary and all individuals affected by myocarditis and/or pericarditis will receive the best possible care whether they participate or not.
AusVaxSafety is currently recruiting participants for the myocarditis and/or pericarditis study arm.
For more information, please contact AusVaxSafety at SCHN-AusVaxSafety@health.nsw.gov.au
AusVaxSafety receives fundingfrom the Australian Government
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We acknowledge that the National Centre for Immunisation Research and Surveillance (NCIRS) is on the land of the traditional owners the Aboriginal and Torres Strait Islander peoples, the First Australians, and recognise their culture, history, diversity and their deep connection to the land. Together, through research and partnership, we aim to move to a place of equity for all. NCIRS also acknowledges and pays respect to other Aboriginal and Torres Strait Islander nations from which our research, staff and community are drawn.
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We acknowledge that the National Centre for Immunisation Research & Surveillance (NCIRS) is on the land of the traditional owners the Aboriginal and Torres Strait Islander peoples, the First Australians, and recognise their culture, history, diversity and their deep connection to the land. Together, through research and partnership, we aim to move to a place of equity for all. NCIRS also acknowledges and pays respect to other Aboriginal and Torres Strait Islander nations from which our research, staff and community are drawn.