Question Number: 117
PDR Number: SQ22-000191
Date Submitted: 24/02/2022
Department or Body: Department of Health
The Therapeutic Goods Administration (TGA) has, and continues to, provided accurate and balanced information about the seriousness of myocarditis following COVID-19 vaccination. This information is based on the TGA’s analysis of Australian adverse event reports, as well as a growing body of evidence from international safety monitoring of COVID-19 vaccines, based on millions of doses given worldwide.
Monitoring to date indicates that in the vast majority of cases myocarditis following COVID-19 vaccination is temporary, with most people getting better within a few days after treatment and rest. In Australia, about half the patients with suspected myocarditis have been admitted to hospital, with a small number treated in intensive care. There have been no fatal cases of myocarditis attributed to COVID-19 vaccination reported in Australia.
Vaccine safety monitoring bodies around the world, including in Australia, are conducting follow-up of cases of myocarditis to assess longer-term outcomes for patients. Preliminary results from follow-up of cases reported to the United States’ Vaccine Adverse Event Reporting System (VAERS) show that most patients had fully or probably recovered by 90 days after their diagnosis and reported no impact on their quality of life. The TGA is monitoring the emerging evidence for possible longer-term effects of myocarditis following COVID-19 vaccination so that it can continue to provide accurate and objective information.
Myocarditis is more common with COVID-19 infection than vaccination with COVID-19 vaccines, and damage to the heart is frequently severe after infection. The Australian Technical Advisory Group on Immunisation (ATAGI) have emphasised that the protective benefits of the COVID-19 vaccines outweigh the risk of these rare side effects.