Approval given for AstraZeneca vaccine use

·1-min read


* The Therapeutic Goods Administration has granted provisional approval to AstraZeneca for its COVID-19 vaccine, meaning it can now be supplied in Australia.

* It will initially be imported before supplies start coming out of CSL's facility in Melbourne.

* Two doses will be needed, ideally separated by a period of 12 weeks.

* AstraZeneca will need to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials.

* The vaccine has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease.

* Elderly patients over 65 years of age showed a strong immune response in clinical trials but there were too few participants infected by COVID-19 to conclusively determine the efficacy in this age group. However there are no safety concerns in this age group.

* The TGA says the decision to immunise an elderly patient should be case-by-case with consideration of age, co-morbidities and their environment taking into account the benefits of vaccination and potential risks.

* The TGA says of the vaccine: "Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard."