TGA provisionally approves AstraZeneca's COVID-19 vaccine

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 separate doses. "TGA's regulatory approval allows the second dose to be administered from 4 to 12 weeks after the first. 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.

Elderly patients over 65 years of age demonstrated a strong immune response (high seroconversion rates) to the vaccine in clinical trials, however there were an insufficient number of participants infected by COVID-19 to conclusively determine the efficacy in this subgroup. In this sub-population, efficacy has been inferred from immunogenicity data and efficacy demonstrated in the general population. 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. 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).

Initial supply of this vaccine will be imported into Australia from overseas, however it is anticipated that ongoing supply will be manufactured in Australia. Prior to supply of vaccines manufactured onshore, AstraZeneca will submit further information and data to the TGA to confirm that onshore manufacturing will meet strict quality standards.

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.

As with all vaccine approvals, the TGA will:

• Continue to actively monitor the vaccine in Australia and overseas and will not hesitate to take action if safety concerns are identified.
• Undertake laboratory batch assessment of each batch of the vaccine before it can be supplied in Australia.

The TGA has published a series of regulatory documents that relate to this decision, including the Australian Public Assessment Report (AusPAR) and the decision summary, which provide details about the evidence that the TGA reviewed to support the provisional approval of the vaccine. The Product Information, FAQs and information on labelling and batch testing are also available on the COVID-19 vaccines hub.

Further information on the COVID-19 vaccine rollout is available on the Department of Health website.