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COVID-19 vaccine: AstraZeneca Vaxzevria
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine.
On 8 February 2022 the TGA provisionally approved a booster dose of the AstraZeneca COVID-19 vaccine, Vaxzevria, for individuals aged 18 years and older. The third (booster) dose may be given if clinically indicated with reference to official guidance regarding the use of a heterologous third dose (e.g. mRNA vaccine).
This means that the decision to receive Vaxzevria as a booster must be made in consultation with a medical professional. The mRNA COVID-19 vaccines (Comirnaty (Pfizer) or Spikevax (Moderna) are preferred as the booster dose in Australia, irrespective of the primary COVID-19 vaccine used. This includes for people who received the AstraZeneca COVID-19 vaccine for their primary course.
The Australian Government continues to encourage individuals to have a booster (third dose) following their initial two vaccination doses to enables strong protection against severe illness and hospitalisation, particularly from the omicron variant.
The Australian Public Assessment Report for this decision will be published in the coming days.
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Viral vector vaccines
The AstraZeneca viral vector vaccine uses a modified, non-pathogenic, weakened animal virus that contains the genetic code for the coronavirus' unique spike protein. When this enters our body, the genetic material contained in the viral vector instructs our cells to make the copies of the coronavirus spike protein. Our body then recognises the spike protein as being foreign and mounts an immune response against it.
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.
The TGA will continue to monitor the safety of Vaxzevria both in Australia and overseas and will not hesitate to take action if safety concerns are identified. As an extra check, the TGA laboratories will undertake a batch assessment of each batch of the vaccine before it can be supplied in Australia.
Information about Australia's vaccine roll out can be found on the Department of Health's webpage.
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)
- Consumer Medicine Information (CMI)
- VAXZEVRIA (previously 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: VAXZEVRIA (previously 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.
- AusPAR: VAXZEVRIA - Booster dose in individuals 18 years and older
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine AstraZeneca) Labelling Exemption 2021
Post-approval changes to VAXZEVRIA
- Post-approval changes to VAXZEVRIA
- Addition of Australian sites of manufacture
- Name change from COVID-19 Vaccine AstraZeneca to VAXZEVRIA