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COVID-19 vaccine: AstraZeneca ChAdOx1-S
The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia.
COVID-19 Vaccine AstraZeneca is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The use of this vaccine should be in accordance with official recommendations and given in two doses 4 to 12 weeks apart. The Australian Technical Advisory Group on Immunisation has recommended that the interval between first and second dose is 12 weeks. However if this interval is not possible, for example because of imminent travel, cancer chemotherapy, major elective surgery, a minimum interval of 4 weeks between doses can be used.
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment. COVID-19 Vaccine AstraZeneca has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease.
There are currently limited data available for the efficacy and safety in individuals over 65 years of age. However, the vaccine has been shown to create an immune response in this group and can be used based on the efficacy and safety demonstrated in the general clinical trial population. 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. Further information from ongoing clinical trials and post-market monitoring is expected in coming months. Additional details can be found in the Product Information and Australian Public Assessment Report (AusPAR).
Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product Information (PI) (pdf,172kb)
- Consumer Medicine Information (CMI) (pdf,82kb)
- COVID-19 Vaccine AstraZeneca Decision Summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
- AusPAR: COVID-19 Vaccine AstraZeneca
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
- Advisory Committee on Vaccines meeting statement, meeting 19, 3 February 2021
An independent expert committee that provides advice on an application to register a new vaccine
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine AstraZeneca) Labelling Exemption 2021