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Four main COVID-19 vaccines are currently in use in Australia - Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Nuvaxovid (Novavax). Bivalent vaccines for both mRNA vaccines are also now registered in Australia - Spikevax bivalent vaccine and Comirnaty bivalent vaccine. All of these COVID-19 vaccines have met the TGA's high standards for quality, safety and effectiveness.
The TGA closely monitors reports of suspected side effects (also known as adverse events) to the COVID-19 vaccines. This is the most intensive safety monitoring ever conducted of any vaccines in Australia.
We encourage people to report suspected side effects, even if there’s only a very small chance a vaccine was the cause. Learn more about causality and our COVID-19 vaccine safety monitoring and reporting activities.
Report a suspected side effect.
This is an abbreviated version of the COVID-19 vaccine safety report. For full details, go to the report published on 15 December 2022.
A snapshot - vaccine safety monitoring since the rollout began
Since February 2021, 64 million COVID-19 vaccine doses have been given to Australians. During this time, the TGA has received just over 137,000 suspected adverse event reports. These have come from members of the public, health professionals and local health authorities and the vaccine pharmaceutical companies.
Like other medicine regulators overseas, we monitor these reports, and look at the latest medical literature, media and other potential sources of new safety information. This surveillance acts as an early warning system to identify reporting patterns or trends that need to be investigated for safety concerns.
Since the beginning of the roll out, we have investigated over 120 potential vaccine safety signals. This analysis has resulted in over 55 regulatory actions including 39 safety-related warnings and updates to the Product Information documents for COVID-19 vaccines. This is on top of safety updates initiated by the pharmaceutical companies that sponsor the vaccines. These regulatory actions have been communicated to the general public in this vaccine safety report.
Being able to provide credible and up-to-date information about the benefits and risks associated with the vaccines has been our top priority. We have provided information about what we do know and where there may be uncertainty and responded to dispel misinformation about the safety of the vaccines.
We thank both health professionals and the general public for taking the time to report to us when they have suspected an adverse reaction following vaccination. This has helped us to monitor the safety of the vaccines and take action when needed.
Summary
- Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks.
- The most up-to-date recommendations for use of the COVID-19 vaccines are available from the Australian Technical Advisory Group on Immunisation (ATAGI).
- Like all medicines, COVID-19 vaccines may cause some side effects. The most frequently reported include injection-site reactions (such as a sore arm) and more general symptoms, like headache, muscle pain, fever and chills. This reflects what was seen in the clinical trials.
- Reporting rates of adverse events following COVID-19 vaccination are very stable. Information on vaccine safety in children, adolescents and adults following vaccination is available in the safety report published on 15 December 2022.
- We are carefully monitoring and reviewing reports of myocarditis and pericarditis (inflammation of the heart or membrane around the heart) following vaccination. These are usually temporary conditions, with most people getting better within a few days.
- Myocarditis is a known but very rare side effect of the mRNA vaccines. It is reported in around 1-2 in every 100,000 people who receive Comirnaty (Pfizer) and around 2 in every 100,000 of those who receive Spikevax (Moderna). It occurs in males and females but is more common after the second dose in boys aged 12-17 years (13 cases per 100,000 Comirnaty doses and 24 cases per 100,000 Spikevax doses) and men under 30 (9 cases per 100,000 Comirnaty doses and 20 cases per 100,000 Spikevax doses).
- We are also closely monitoring reports of thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre syndrome (GBS) and immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca) in adults. However, since the end of 2021 very few doses of this vaccine are being used. Detailed information of our analysis of these adverse effects is available in a previous vaccine safety report.