Australia has a third coronavirus vaccine option with more than 50 million doses from Novavax on order, but it may be several months before the product is ready for distribution.
Pharma giant Novavax does not have a commercial presence in Australia, but the $17 billion US company has been laying the groundwork to import doses of its product once it gets approved.
It has started the approvals process with the Therapeutic Goods Administration and formed a partnership with a local sponsor, Sydney-based pharmaceuticals company Biocelect, to help bring the product to Australia.
Australia’s access to more vaccine options came into focus over the past week, with the government’s reliance on the AstraZeneca product questioned amid conflicts over the release of doses from Europe and a review of possible links between the AstraZeneca vaccine and rare blood clots.
Novavax’s product is the third pillar of Australia’s vaccine strategy, but there is no set timeline for the delivery of its contracted 51 million doses.
“It is anticipated [the vaccine], NVX-CoV2373, will be ready for the Australian market and distribution before the end of this year,” a Novavax spokesman said.
Novavax is in the late stages of its clinical trial program and data from its British phase 3 study released last month showed 100 per cent protection against severe disease and 96.4 per cent effectiveness against mild and moderate illness in the original coronavirus strain, and 86.4 per cent effectiveness against the UK variant.
The company has also completed dosing participants in an Australian trial However, the vaccine does not yet have approvals anywhere in the world, and Australia will not be the first jurisdiction where the company will seek regulatory approval.
“Novavax expects to file for regulatory authorisation with the Medicines and Healthcare products Regulatory Agency in the UK first. This will be followed by the US in the second quarter of the year, followed by other countries,” the spokesman said.
The business hopes to file US approvals by June.
“It is anticipated [the vaccine], NVX-CoV2373, will be ready for the Australian market and distribution before the end of this year.”Novavax spokesman
Novavax has previously told The Sydney Morning Herald and The Age that if all goes to plan, Australia could see doses arrive onshore in the middle of this year. If the Maryland-based firm receives approvals to sell its vaccine, it will be the first product the company has brought to market in its 33-year history.
The vaccine is protein-based and could in theory be made in Australia. Home-grown vaccine maker CSL has said it would consider its capacity to make Novavax’s product, but only after it has completed all doses of the AstraZeneca vaccine.
The government has said it continues to monitor both vaccine product and manufacturing options for Australia, but has only inked formal dose agreements with Pfizer, AstraZeneca and Novavax.
The only other candidate which has started the process towards local TGA registration is Johnson & Johnson’s one-shot vaccine, which was granted a “provisional determination” by the local health regulator last November to fast-track any future approval.
“As we move forward with clinical development, we continue to work closely with the Therapeutic Goods Administration (TGA), to facilitate provisional registration on the Australian Register of Therapeutic Goods, so our vaccine can be made available in the future to Australians if proven safe and effective,” a spokesperson for Johnson & Johnson’s pharmaceuticals arm Janssen said.
The company says it’s open to discussions with governments around the world for future supplies. However, no formal agreements are in place for Australia.
A concise wrap of the day on the markets, breaking business news and expert opinion delivered to your inbox each afternoon. Sign up here.
Source: Thanks smh.com