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.

To read the press release in full follow the link below:

TGA provisionally approves AstraZeneca’s COVID-19 vaccine