Two million doses surpassed

Five new reports of blood clots and low blood platelets are likely linked to the AstraZeneca COVID-19 vaccine, says TGA

More than 2.3 million doses of COVID-19 vaccine have now been administered in Australia, according to the TGA’s latest report.

There have been around 15,000 reports of adverse events, and nearly 80% of these have been common, short-lived and expected side effects such as headache, muscle and joint pain, fever and pain at the site of injection.

The reporting rate of adverse events is 6.6 per 1000 doses of COVID-19 vaccine administered in Australia as of 2 May 2021.

There has been a 60-fold increase in the number of adverse event reports received directly from consumers compared to 2020 – expected due to the large number of COVID-19 vaccinations being carried out and promotion of adverse event reporting as part of the roll-out.

Meanwhile five additional reports of blood clots and low blood platelets have been assessed as thrombosis with thrombocytopenia syndrome (TTS), likely to be linked to the AstraZeneca COVID-19 vaccine.

The cases were in a 74-year-old man and a 51-year-old woman from Victoria, a 66-year-old man from Queensland, a 64-year-old woman from Western Australia and a 70-year-old man from Tasmania.

These take the total Australian reports assessed as TTS following the AstraZeneca COVID-19 vaccine to 11.

“Encouragingly, of the five cases reported in our statement on 23 April 2021 as hospitalised with thrombosis with thrombocytopenia following vaccination, four have now been discharged from hospital and are either at home or have returned to work,” the TGA said.

So far, of the 11 total TTS cases, one woman has died.

Archie Clements, a professor of infectious disease epidemiology at Curtin University in Perth, emphasised that the TTS cases are severe but rare.

“Despite the small number of adverse reactions to the Astra Zeneca COVID-19 vaccine, including rare but severe reactions, for the vast majority of people the vaccine is perfectly safe,” said Professor Clements.

“To protect our communities, particularly the elderly and the vulnerable, people should take up the offer to be vaccinated.

“Remember, being vaccinated is not just about protecting your own health, but the health of your loved ones and others in your community and provides the only path out of the current global public health crisis.”

The TGA continues to carefully review any Australian reports of thrombosis and thrombocytopenia following vaccination with the AstraZeneca COVID-19 vaccine to identify any further possible cases.

It is actively investigating a further three possible cases of TTS.

In Europe and the United Kingdom, where many more doses of the AstraZeneca vaccine have been given, more than 200 cases involving thrombosis and thrombocytopenia have been reported to medicine regulators.

Health professionals are encouraged to be alert to the signs and symptoms of thromboembolism and thrombocytopenia, as well as coagulopathies (bleeding disorders).

People who have been vaccinated should seek immediate medical attention if a few days after vaccination they develop:

  • severe or persistent headache or blurred vision

  • shortness of breath, chest pain, leg swelling or persistent abdominal pain

  • unusual skin bruising and/or pinpoint round spots beyond the site of vaccination.

In a statement, AstraZeneca said it was “aware that there have been additional cases of thrombosis with thrombocytopaenia (TTS) reported in people who recently received the AstraZeneca COVID-19 vaccine, and that they are receiving treatment”.

“Patient safety remains AstraZeneca’s highest priority and we continue to support regulators in Australia and overseas. Tens of millions of people have now received our vaccine across the globe. The extensive body of data from two large clinical datasets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis.

Our global commitment remains to play an important role in addressing the current global health emergency posed by COVID-19 by providing a safe and effective vaccine, at no profit during the pandemic”.

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