AstraZeneca becomes second COVID vaccine to get TGA approval

The Therapeutic Goods Administration (TGA) has granted provisional approval for the University of Oxford and AstraZeneca's COVID-19 vaccine.

In a statement, TGA said Australians can be confident that the regulator's review process was rigorous and of the highest standard.

It was approved for any person over the age of 18.

The regulator said elderly patients over 65 years of age demonstrated a strong immune response to the vaccine in clinical trials but added there was an insufficient number of participants infected by COVID-19 to conclusively determine the vaccine’s efficacy for the age group.

“Reassuringly, there were no safety concerns in this age group in the clinical studies, nor in the large numbers of elderly people who have been vaccinated to date in overseas rollouts.

"The decision to immunise an elderly patient should be decided on a case-by-case basis with consideration of age, co-morbidities and their environment taking into account the benefits of vaccination and potential risks."

Various Europeans countries have put an upper limit of 65 for the AstraZeneca vaccine, while Italy restricted its use to people under 55.

Adjunct Professor John Skerritt, who heads up the TGA, said the jab’s rollout in the UK, where there was no upper age limit, showed a strong immune response among the elderly.

“Our analysis of the data gives us no reason to suspect that the vaccine would not be fully efficacious in older groups,” he said.

Skerritt clarified a time when the jab should not be recommended was when administering it would be futile.

“If someone only has a few weeks to live, you won’t give them a hip replacement and may not give them a vaccine,” he said.

“That’s what we’re talking about, but the vaccine is recommended for use in all ages.”

The news comes a day after Australia’s first doses of the Pfizer coronavirus vaccine arrived in the country.

The shipment came via a Singapore Airlines flight that landed at Sydney’s international airport shortly after noon on Monday. The doses were then taken to a secure location.

Health Minister Greg Hunt revealed the development, saying “the eagle has landed”.

“The advice that I have is that 142,000 doses have arrived in Australia,” Hunt said.

The TGA will now test the vaccines to ensure they meet Australia’s strict quality standards ahead of a vaccine rollout beginning from February 22.

Hunt said about 60,000 vaccines were expected to be administered by the end of February.

About 50,000 doses will be allocated to the states, who will prioritise hotel quarantine workers and frontline health workers most likely to come into contact with positive international arrivals.

An additional 30,000 doses will be made available for elderly and disability residents, their carers and staff.

Australia has secured 20 million doses of the Pfizer vaccine. Shipments containing 50,000 doses are now expected to arrive weekly.

A vaccine operation centre has also been established in Canberra to ensure that the rollout is effective.

“While we’re taking the time to get the rollout right, I am confident all Australians who wish to be vaccinated against COVID-19 will receive a vaccine this year,” Morrison said.

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