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Opinion: Safety of Australians our No. 1 priority

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Read the opinion piece by Australian Government Chief Medical officer, Professor Paul Kelly.

Throughout the COVID-19 pandemic, the highest priority in our response has been to protect the Australian population and keep people safe.

It is why we have always followed our well established and thorough decision-making processes – without taking any shortcuts.

It is why Australia’s response has consistently been based on the advice of our medical experts.

It is why we ensured our medical regulator, the Therapeutics Goods Administration (TGA), undertook a rigorous, independent assessment of the safety and efficacy of COVID-19 vaccine candidates before we started to roll them out.

And it is why we have again heeded the latest expert advice from the Australian Technical Advisory Group on Immunisation (ATAGI) about the AstraZeneca COVID-19 vaccine.

ATAGI very carefully considered the latest vaccination findings out of Europe and the UK – which followed extremely rare instances of people, having taken the AstraZeneca vaccine, developing a very specific syndrome involving blood clots with low platelet counts.

The syndrome is called “thrombosis with thrombocytopenia”.

Based on these updated medical findings out of Europe and the UK, ATAGI recommended some additional precautions for the ongoing use of the AstraZeneca vaccine.

ATAGI recommended a preference that the COVID-19 Pfizer vaccine be dispensed to adults under the age of 50 instead of the AstraZeneca vaccine.

That recommendation was based on the increasing risk of severe outcomes from COVID-19 in older adults – and hence a higher benefit from vaccination – and a potentially increased risk of “thrombosis with thrombocytopenia” following AstraZeneca vaccination among those aged under 50.

ATAGI further recommended the AstraZeneca vaccine can be used in adults aged under 50 where the benefits clearly outweigh the risk for that individual and the person has made an informed decision based on an understanding of the risks and benefits.

It also recommended people who have had the first dose of the AstraZeneca vaccine without any serious adverse effects can be given the second dose, including adults under 50 years.

The Australian Government accepted ATAGI’s recommendations and will move swiftly to ensure Australia’s vaccination program and advice to patients is adjusted accordingly.

In addition, the TGA also carefully considered the European and UK findings, as well as the single Australian case reported at this time, and has now required the blood-clot syndrome be listed in the information for healthcare professionals and patients as a very rare side effect of taking the AstraZeneca vaccine.

The decision by the Government to accept the ATAGI advice will have implications for the vaccine rollout program.

The Australian Government will work through these implications with the states and territories as an urgent priority.

We remain absolutely committed to preventing severe COVID-19 hospitalisations and deaths among our vulnerable populations through vaccination – as soon as possible.

For our Australians aged 50 and over, it is very important they know the AstraZeneca vaccine is highly effective at preventing death and severe illness among people who have contracted COVID-19 – and that the incidence of the blood-clotting syndrome is very rare.

To put this into context, the experience in Europe is that approximately one in every 250,000 people vaccinated with AstraZeneca is diagnosed with these rare blood clots. It is not yet clear if age and sex are risk factors. It must also be noted that the risk of severe illness and death from COVID-19 if a vaccine is not administered is significantly higher than the risk of these clots.

The reality is that COVID-19 remains a major risk around the world. While Australia has so far avoided the nationwide, tragic circumstances others have experienced and continue to experience in this pandemic, we have had few people who have already been exposed to the virus or are currently protected by vaccination.

This means we remain at risk if there is an outbreak, and every outbreak can put our most vulnerable people – especially older Australians – at risk of severe illness and death.  For this reason, the vaccine is even more important.

My unequivocal advice to Australians remains that when your time comes to get vaccinated – take the vaccine you are offered.  It is safe and effective. The risk of a severe side effect will be very small. And it will prevent you from severe illness – or even death – at the hands of COVID-19. If you have any questions or concerns speak to your health professional.

ATAGI met on 7 and 8 April.

Throughout the COVID-19 pandemic, the highest priority in our response has been to protect the Australian population and keep people safe.

It is why we have always followed our well established and thorough decision-making processes – without taking any shortcuts.

It is why Australia’s response has consistently been based on the advice of our medical experts.

It is why we ensured our medical regulator, the Therapeutics Goods Administration (TGA), undertook a rigorous, independent assessment of the safety and efficacy of COVID-19 vaccine candidates before we started to roll them out.

And it is why we have again heeded the latest expert advice from the Australian Technical Advisory Group on Immunisation (ATAGI) about the AstraZeneca COVID-19 vaccine.

Last week, ATAGI very carefully considered the latest vaccination findings out of Europe and the UK – which followed extremely rare instances of people, having taken the AstraZeneca vaccine, developing a very specific syndrome involving blood clots with low platelet counts.

The syndrome is called “thrombosis with thrombocytopenia”.

Based on these updated medical findings out of Europe and the UK, ATAGI recommended some additional precautions for the ongoing use of the AstraZeneca vaccine.

ATAGI recommended a preference that the COVID-19 Pfizer vaccine be dispensed to adults under the age of 50 instead of the AstraZeneca vaccine.

That recommendation was based on the increasing risk of severe outcomes from COVID-19 in older adults – and hence a higher benefit from vaccination – and a potentially increased risk of “thrombosis with thrombocytopenia” following AstraZeneca vaccination among those aged under 50.

ATAGI further recommended the AstraZeneca vaccine can be used in adults aged under 50 where the benefits clearly outweigh the risk for that individual and the person has made an informed decision based on an understanding of the risks and benefits.

It also recommended people who have had the first dose of the AstraZeneca vaccine without any serious adverse effects can be given the second dose, including adults under 50 years.

The Australian Government accepted ATAGI’s recommendations and will move swiftly to ensure Australia’s vaccination program and advice to patients is adjusted accordingly.

In addition, the TGA also carefully considered the European and UK findings, as well as the single Australian case reported at this time, and has now required the blood-clot syndrome be listed in the information for healthcare professionals and patients as a very rare side effect of taking the AstraZeneca vaccine.

The decision by the Government to accept the ATAGI advice will have implications for the vaccine rollout program.

The Australian Government will work through these implications with the states and territories as an urgent priority.

We remain absolutely committed to preventing severe COVID-19 hospitalisations and deaths among our vulnerable populations through vaccination – as soon as possible.

For our Australians aged 50 and over, it is very important they know the AstraZeneca vaccine is highly effective at preventing death and severe illness among people who have contracted COVID-19 – and that the incidence of the blood-clotting syndrome is very rare.

To put this into context, the experience in Europe is that approximately one in every 250,000 people vaccinated with AstraZeneca is diagnosed with these rare blood clots. It is not yet clear if age and sex are risk factors. It must also be noted that the risk of severe illness and death from COVID-19 if a vaccine is not administered is significantly higher than the risk of these clots.

The reality is that COVID-19 remains a major risk around the world. While Australia has so far avoided the nationwide, tragic circumstances others have experienced and continue to experience in this pandemic, we have had few people who have already been exposed to the virus or are currently protected by vaccination.

This means we remain at risk if there is an outbreak, and every outbreak can put our most vulnerable people – especially older Australians – at risk of severe illness and death.  For this reason, the vaccine is even more important.

My unequivocal advice to Australians remains that when your time comes to get vaccinated – take the vaccine you are offered.  It is safe and effective. The risk of a severe side effect will be very small. And it will prevent you from severe illness – or even death – at the hands of COVID-19. If you have any questions or concerns speak to your health professional.

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