TGA opens the first door on the COVID vaccine registration pathway for AZ option
The Therapeutic Goods Administration (TGA) has granted a provisional determination to AstraZeneca for its COVID-19 Vaccine, ChAd0x1-S [recombinant].
The granting of a provisional determination means that the TGA has made a decision that AstraZeneca is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).
Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG, the TGA said.
Normally for a vaccine to be registered in Australia, a sponsor (usually a pharmaceutical company) is required to submit a complete and comprehensive package of data to the TGA. A formal evaluation is then carried out in multiple stages by technical experts, prior to a decision being made.
“The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data. In order to apply for provisional registration, the sponsor must first apply for a provisional determination,” the TGA said.
In making its decision to grant AstraZeneca a provisional determination, the TGA said it considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current pandemic.
AstraZeneca signed a Letter of Intent with the Australian Government on 19 August, to supply the COVID-19 vaccine.
Health Minister Greg Hunt has indicated, in the wake of last week’s Federal Budget, that the government believes a vaccine would be available at some time early next in 2021.
Mr Hunt said, under its COVID-19 Vaccine and Treatment Strategy, the government was “investing $1.7 billion to pre-order 84.8 million doses of vaccine with leading Australian manufacturer CSL Limited (Seqirus) and UK-based AstraZeneca”.
“On 7 September 2020, the Australian Government announced that should promising trials prove successful for the University of Oxford/Astra Zeneca and the University of Queensland vaccine candidates, more than 80 million doses of the two potential COVID-19 vaccines would be made available for the Australian population, almost entirely manufactured in Melbourne,” he said.