The TGA has provisionally approved the Oxford/AstraZeneca COVID-19 vaccine, which will be administered in pharmacies and other settings
The Department of Health made the announcement Tuesday, noting that the first priority groups in Australia will be able to start receiving this vaccine in early March.
Two doses will be required.
“The TGA, from a regulatory perspective, has reviewed all the available evidence and determined that the AstraZeneca vaccine can be safely administered 4-12 weeks apart,” the Department of Health said in a statement.
“Drawing on the advice of the TGA and also from the implementation of the program internationally, our Australian Technical Advisory Group on Immunisation has determined that to create the very best immune response, ensure the most effective clinical protection and maximise broader community coverage, the vaccine should be administered 12 weeks apart.
“The approval is subject to strict conditions, and AstraZeneca will be required to continue providing information to the TGA on the safety, efficacy and quality of the vaccine.
“The AstraZeneca vaccine will be distributed through many more locations, including general practice clinics, GP respiratory clinics, vaccination clinics and pharmacies.”
The vaccine can be stored, transported and handled at normal refrigerated conditions (two -eight degrees Celsius) for up to six months, AstraZeneca says.
The Department said the next steps in the process will include batch testing of all doses, establishing cold storage facilities for the vaccine, training immunisers and finalising distribution sites.
The vaccine is set to be provided free to all Australian residents, and has been provisionally approved for people aged 18 and over.
The TGA’s own release notes that 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,” the TGA said.
“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.
Liz Chatwin, Country President AstraZeneca Australia and New Zealand, said, “Today is a momentous day that brings months of hard work and collaboration between government, AstraZeneca and scientific experts on vaccination to fruition for the people of Australia.
“We are very proud that, through our partnership with University of Oxford, AstraZeneca is able to provide broad and equitable access to its COVID-19 vaccine at no profit during the pandemic, and that through the agreements made with the Australian Government and manufacturing partner CSL, we can make this vaccine available for use in Australia throughout the year.”
AstraZeneca has an agreement with the Australian Government to supply 53.8 million doses of the vaccine, with the bulk of this manufactured at CSL’s Melbourne facilities.
It says that initial supply from overseas will be available for administration in Australia as swiftly as possible, in line with the Government’s strategy.