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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. These cover the Omicron BA.1 and BA.4-5 variants. 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.
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.
- 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.
- The most up-to-date recommendations for use of the COVID-19 vaccines are available from the Australian Technical Advisory Group on Immunisation (ATAGI).
- Reporting rates of adverse events following COVID-19 vaccination are very stable. More detail 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.