Sydney startup to help vaccine hopeful Novavax roll out jab

Multibillion-dollar US vaccine maker Novavax has selected a Sydney company to help it secure approval for its coronavirus vaccine and plan for its Australian rollout, in a significant boost for the local biotech sector.

The Australian government has inked a purchasing agreement for 51 million doses of the coronavirus vaccine designed by Novavax, which is currently undergoing phase III trials in the United States and Mexico.

Scientists at work at the Novavax labs in Maryland.

The Therapeutic Goods Administration last week granted "provisional determination" to Novavax for the vaccine, paving the way for the company to start applying to register the product in Australia.

Novavax does not have a presence in the Asia Pacific region and has chosen Biocelect, a small private pharmaceuticals commercialisation firm based in Macquarie Street, Sydney, to be the vaccine's sponsor.

Biocelect will assist Novavax in providing data to the Australian regulator ahead of approval, as well as helping plan for delivery and rollout of doses across the country.

Biocelect chief executive Karl Herz, a local pharmaceuticals industry veteran who has more than two decades of experience with companies including Sigma Pharmaceuticals, Sanofi and GSK, said his company was "extremely pleased" to be chosen to work with Novavax.

"As we await the data from Novavax’s phase III clinical trials, we are very hopeful the Novavax vaccine candidate will be approved by regulatory authorities and play a significant role in protecting the Australian and New Zealand populations against COVID-19," Mr Herz said.

Over the past 12 months vaccine industry experts have argued smaller firms like Biocelect have specialised knowledge that will be critical to the vaccine rollout.

Novavax executive vice president John Trizzino said the company had reached an "important milestone" in gaining a provisional determination from the TGA and was glad to be able to work with Biocelect. The two firms have previously worked together on other Novavax research projects.

"Novavax is committed to advancing NVX-CoV2373 through the development and regulatory process quickly and we appreciate Biocelect’s support on our behalf,” he said.

Novavax has never brought a vaccine to market in its 33-year history but Australian experts have said early data suggests the firm’s COVID-19 product could play a significant role in the nation's pandemic strategy.

Doses of the vaccine are expected to be available in the second half of 2021, should phase III trials be successful. Novavax has a range of global production hubs and it is not yet known where doses for Australia and New Zealand will be produced.

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