TGA still waiting for ‘further data’ on AstraZeneca vaccine
Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval and rollout of vaccines in Australia, with the local regulator still waiting on further data from AstraZeneca about its vaccine.
The Oxford-AstraZeneca product is the only vaccine set to be made in Australia at this stage, with biotechnology giant CSL set to produce 50 million doses this year, subject to approvals.
The government has previously expressed optimism that the AstraZeneca product will be approved at the end of January, however, neither the Therapeutic Goods Administration (TGA) nor AstraZeneca have confirmed when they expect the process to be completed.
A resurgence of COVID-19 cases has prompted pressure from the opposition, including Labor Leader Anthony Albanese, for Australia to speed up plans for vaccine rollout, which has long been slated to begin around March.
An AstraZeneca spokeswoman told The Sydney Morning Herald and The Age on Monday the company is engaged in an ongoing process to secure approval for the vaccine and expects to deliver updated data to the TGA this month.
A spokesperson for the TGA said, “[The] TGA’s rolling review of COVID-19 vaccines is being undertaken with the greatest priority without compromising on our strict standards of safety, quality, and efficacy.
“The TGA is expecting further data from AstraZeneca in regard to their COVID-19 vaccine in late January 2021.”
The federal government’s deal for the vaccine also includes 3.8 million doses of the Oxford-AstraZeneca product that will be imported directly from Europe.
An AstraZeneca spokeswoman said these doses are expected to land onshore next month.
“By the end of February, we expect the 3.8 million doses of AZD1222 will be in Australia for rollout, according to the Government’s vaccination strategy pending approval of the vaccine,” she said.
CSL has turned all of its attention towards the production of the Oxford-AstraZeneca product last month after this masthead revealed the company was abandoning development of the COVID-19 vaccine designed by the University of Queensland.
It has commenced production on doses of the AstraZeneca product, which the Department of Health has said is set to be produced in monthly batches.
CSL has been contacted for comment on when it expects doses to be ready and whether accelerated production is possible.
Beyond the AstraZeneca product, Australia will still also be waiting for 10 million doses of the Pfizer/BioNTech vaccine and 50 million doses of the vaccine from US biotech Novavax to be imported into the country.
The department of health has previously flagged that Pfizer will be available “from early 2021”. Novavax, which is still in phase 3 trials, is expected to be ready during this calendar year.
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Emma reports on healthcare companies for The Age and Sydney Morning Herald. She is based in Melbourne.
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Source: Thanks smh.com