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TGA approves AstraZeneca COVID-19 vaccine

JMR WITH HEALTH MINISTER HUNT

The Therapeutic Goods Administration (TGA) has approved (on 16 February 2021) the AstraZeneca COVID-19 vaccine for use in Australia following a full and thorough assessment process.

Senator for Victoria Sarah Henderson said this welcomed news means Australia will now have two safe and effective COVID-19 vaccines available.

“The approval of the AstraZeneca vaccine for the people of Victoria and for the whole of Australia comes after rigorous assessment from our independent medical regulator,” Senator Henderson said.

“Every safety and regulatory box has been ticked for provisional approval – and further ones will now be ticked in the lead up to March.”

The Australian Government has secured 53.8 million doses of the AstraZeneca vaccine, with 50 million doses being manufactured here in Australia.

While the initial supply into Australia will be imported from overseas, in the coming months, the AstraZeneca vaccine will be manufactured in Australia.

“Our nation is one of a small number of countries in the world that can manufacture its own COVID-19 vaccine and that is a point of pride to all around our country,” Senator Henderson said.

The AstraZeneca vaccine can be handled and stored like most other vaccines. For a large country like Australia, this provides some distinct benefits in relation to distribution and storage, particularly in rural and remote areas, including Indigenous communities.

Today’s announcement follows independent assessment of the vaccine’s safety, quality and efficacy by the TGA. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on the safety, efficacy and quality of the vaccine.

Minister for Health and Aged Care Greg Hunt said the AstraZeneca vaccine will help save lives and protect lives.

“Data from clinical trials tells us that the AstraZeneca vaccine will stop people becoming seriously unwell with COVID-19. This is – and must – be our first priority. It would be irresponsible of us to put anything ahead of this,” Minister Hunt said.

“The global evidence is of overwhelming protection against serious illness, hospitalisation and loss of life.”

“Importantly the TGA has conducted a full and thorough, and world class assessment process.”

“As the rollout begins, the people in priority groups who need the most protection will receive a vaccine first. This includes aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers.”

The Pfizer vaccine remains on track to be rolled out from 22 February 2021.

Further details are available at aus.gov.au

17 February 2021

 

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