Following a thorough review process, informed by expert and independent advice from the Advisory Committee on Vaccines (ACV), the TGA has granted provisional approval for the University of Oxford/AstraZeneca COVID-19 vaccine.
Provisional registration will allow COVID-19 Vaccine AstraZeneca to be administered to individuals 18 years and over for the prevention of COVID-19 disease caused by SARS-CoV-2. The 2 dose course may be administered with a 4-12 week interval, with ATAGI preferring doses separated by 12 weeks. In certain circumstances an interval of 4 weeks is acceptable.
Of note, there were no safety concerns revealed in clinical trials involving patients >65 years of age and a strong immune response was demonstrated. However due to insufficient numbers of participants infected with SARS-CoV-2 in this age group, efficacy could not be conclusively determined. As a result, the immunisation of individuals in this age group should be decided on a case-by-case basis.
Supply of this vaccine will initially be imported from overseas, with ongoing supply of vaccines to be manufactured in Australia.
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