THE Therapeutic Goods Administration (TGA) is paving the way for the sponsors of a third COVID-19 candidate vaccine (COVAX) to seek provisional registration on the Australian Register of Therapeutic Goods (ARTG).
In a statement issued yesterday, the TGA announced it has granted a provisional determination to Janssen Cilag Pty Ltd in relation to its Ad26.COV2.S vaccine.
The move follows similar determinations on 09 Oct for Pfizer's BNT162 [mRNA] and on 14 Oct for AstraZeneca's ChAdOx1-S vaccines.
"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.
"Provisional determinations are effective for six months.
"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.
"In making its decision to grant these provisional determinations, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic."
Meanwhile, Pfizer has announced that data from an ongoing Phase III trial of its COVAX showed a 95% efficacy rate, with the company expected to submit a request for Emergency Use Authorisation to the Food and Drug Administration in the coming days.
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