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Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. Two COVID-19 vaccines are currently in use in Australia – Vaxzevria (AstraZeneca) and Comirnaty (Pfizer). Recently, the Therapeutic Goods Administration (TGA) granted provisional approval for another vaccine called Spikevax (Moderna).
Like all medicines, COVID-19 vaccines have some side effects. These need to be continuously balanced against the expected benefits in preventing illness and death from COVID-19 disease. The overwhelming majority of side effects are mild and resolve within a few days.
The TGA closely monitors reports of suspected side effects (also known as adverse events). Importantly, adverse events reported to the TGA are often not caused by the vaccine itself. Learn more about causality and the TGA’s COVID-19 vaccine safety monitoring and reporting activities.
Summary
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To 29 August 2021, over 19 million vaccine doses have been given in Australia – approximately 12 million first doses and 7 million second doses.
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The TGA is continually monitoring the safety of the COVID-19 vaccines. The most frequently reported side effects suspected to be associated with the vaccines reflect what was seen in the clinical trials and include injection-site reactions such as a sore arm, and more general symptoms such as headache, muscle pain, fever and chills.
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We are closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) which have been found to be linked to the Vaxzevria (AstraZeneca) vaccine. Early detection of this syndrome may help to prevent more serious complications developing and guidance for health professionals is now available.
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In the last week, an additional 9 reports of blood clots and low blood platelets have been assessed as confirmed or probable TTS. Sadly, two people died this week – a 59-year-old woman from Queensland with confirmed TTS and a 54-year-old man from NSW with probable TTS. Both were following their first dose of the AstraZeneca vaccine. The TGA extends its sincerest condolences to her family and loved ones. We are in close communication with the Queensland and NSW authorities who are undertaking further investigation of these cases.
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The protective benefits of vaccination against COVID-19 far outweigh the potential risks of vaccination.
The Database of Adverse Event Notifications (DAEN) is currently unavailable due to performance issues resulting from high rates of access. This is being investigated as a priority. We will provide further information on our website when it is available again.
Reported side effects for COVID-19 vaccines
Gathering reports of adverse events following immunisation (AEFI) is just the first step in determining whether the effect is related to the vaccine and whether a significant safety issue is involved. Learn more about how the TGA identifies and responds to safety issues.
In the week of 23-29 August 2021, staff at the TGA have accepted an additional 2,167 AEFI reports into our internal database for COVID-19 vaccines.
Large scale vaccination means that coincidentally some people will experience a new illness or die within a few days or weeks of vaccination.
The TGA reviews all deaths reported in people who have received the vaccination. We also monitor reports for signals that may relate to vaccine safety to distinguish between coincidental events and possible side effects of the vaccine. As the number of vaccinated people has increased, so has reporting of fatal events with a coincidental association with vaccination. This does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.
Since the beginning of the vaccine rollout to 29 August 2021, over 19 million doses of COVID-19 vaccines have been given. So far, the TGA has found that 9 reports of deaths were linked to immunisation from 495 reports received and reviewed. These deaths occurred after the first dose of the Vaxzevria (AstraZeneca) vaccine – 8 were TTS cases and 1 was a case of immune thrombocytopenia (ITP).