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Three COVID-19 vaccines are currently in use in Australia - Comirnaty (Pfizer), Spikevax (Moderna) and Vaxzevria (AstraZeneca). These vaccines meet the TGA's high standards for quality, safety and effectiveness. The TGA has also recently given provisional approval for a protein-based vaccine for adults called Nuvaxovid (Novavax). The roll out of this vaccine is planned to start in February 2022.
The TGA closely monitors reports of suspected side effects (also known as adverse events) to the COVID-19 vaccines. This is the most intense safety monitoring ever conducted in Australia.
We encourage people to report suspected side effects, even if there's only a very small chance a vaccine was the cause. This provides valuable data that helps us identify potential safety issues. Often, however, these events are not caused by the vaccines. Learn more about causality and our COVID-19 vaccine safety monitoring and reporting activities.
Summary
- Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination continue to 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.
- We are carefully monitoring and reviewing reports of:
- myocarditis and pericarditis following mRNA vaccines, particularly in younger age groups
- thrombosis with thrombocytopenia syndrome (TTS) following Vaxzevria (AstraZeneca)
- Guillain-Barre Syndrome (GBS) following Vaxzevria (AstraZeneca)
- immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca).
- Myocarditis is a known but very rare side effect of Comirnaty (Pfizer) and Spikevax (Moderna). It is usually temporary, with most people getting better within a few days. Myocarditis is reported in 1–2 in every 100,000 people who receive Comirnaty (Pfizer) and Spikevax (Moderna). However, it is more common after the second dose in teenage boys (11 cases per 100,000 Comirnaty doses and 16 cases per 100,000 Spikevax doses) and men under 30 (6 cases per 100,000 Comirnaty doses and 12 cases per 100,000 Spikevax doses).
- To 23 January 2022, the TGA has received 431 reports which have been assessed as likely to be myocarditis from about 31.6 million doses of Comirnaty (Pfizer) and 46 reports which have been assessed as likely to be myocarditis from about 2.7 million doses of Spikevax (Moderna).
- Thrombosis with thrombocytopenia syndrome (or TTS) is a very rare but serious side effect of Vaxzevria (AstraZeneca). Our analysis shows it is reported in about 2 in every 100,000 vaccinated people following the first dose. The risk of TTS is much lower after the second dose (0.3 in every 100,000 vaccinated people).
- No new cases of vaccine-related TTS related have been reported since 16 December last year.
- On 21 January 2022, an external expert Vaccine Safety Investigation Group (VSIG) discussed 2 fatal cases of suspected TTS following a second dose of the Vaxzevria (AstraZeneca) vaccine. Both cases were complex and involved patients with underlying conditions that could have caused their symptoms. After extensive deliberation, the panel concluded there was not sufficient evidence to link either case to vaccination.