Pharmacy Daily | AZ to seek TGA evaluation for COVAX

ASTRAZENECA (AZ) is set to submit data from two phase II/III clinical trials of its COVID-19 candidate vaccine (COVAX) to the Therapeutic Goods Administration (TGA) for review and evaluation.

The vaccine developed by AZ and Oxford University was the first of three COVAX candidates to be granted a provisional determination by the TGA last month (PD 12 Oct), paving the way for it to be registered on the Australian Register of Therapeutic Goods (ARTG).

The data from the trials found the vaccine efficacy was 90% for patients who received an initial half-dose followed by a full dose of the a month later, while the efficacy for those who received two full doses was 62%.

AZ Australia and New Zealand Country President, Liz Chatwin, said the vaccine would need to pass the TGA's rigorous assessment and approval process before being made available in Australia.

"Through our global partnership with Oxford University, AstraZeneca has committed to providing broad and equitable access to the vaccine, at no profit during the pandemic, to address an urgent global public health need and support economic recovery," she said.

"We have committed to supplying 33.8 million doses for the Australian Government; 30 million doses will be produced onshore by CSL and manufacturing is already underway here in Australia."

The company added that while the development program was "faster than typical, patient safety is of paramount importance".

"Timelines have been accelerated by investing in building manufacturing capacity of the vaccine in advance," AZ said.

"AstraZeneca has the largest manufacturing network around the world, and with its manufacturing partners, has capacity for more than three billion doses of the vaccine for broad and equitable global distribution."

Under the Federal Government's Australian COVID-19 Vaccination Policy, the vaccines are likely to be administered only by doctors for an initial period of three to six months in case of adverse events, before pharmacists and other qualified immunisers are authorised to vaccinate patients (PD 23 Nov).