American drugmaker Novavax has announced it is ready to begin shipping COVID-19 vaccines to Australia as soon as the federal government gives its approval.
The delivery could further quicken the country’s accelerating vaccine rollout or provide the ‘foundation’ of a booster shot program.
Novavax said it has resolved production issues that threatened to derail plans to deliver millions of jabs in 2021.
Australia has a deal for 51 million doses of the Novavax vaccine, which is not in general use anywhere else in the world.
The vaccine has shown 96.4% efficacy in tests in protecting against the original strain of the virus, with federal Health Minister Greg Hunt flagging the shipment would most likely be used as part of “a booster and variant strategy”.
The drugmaker had specifically chosen Australia as a trial site for a combination vaccine against COVID-19 and influenza, however its production has been heavily delayed due to a shortage of raw materials.
Novavax now says its production is back on track, flagging it would be able to begin shipping doses to Australia once the Therapeutic Goods Administration (TGA) gives approval.
A Novavax spokesperson told The New Daily the company was given a ‘provisional determination’ by the TGA in January, and has been accepted into a ‘rolling submission’ process of review.
“Our initial delivery of vaccine is dependent upon an authorisation for use by the TGA, and we will be ready to begin shipping doses once we have this authorisation,” the spokesperson said.
Novavax said it had been giving “clinical and non-clinical data to the TGA on an ongoing basis”.
The statement suggests the Australian regulator was supplied with new clinical trial and testing data, so that it could make an expedited decision.
“We expect to deliver the doses included in our current agreement with the Australian government this year and into 2022,” the spokesperson said, adding it hoped to have its final submission to the federal government completed “within weeks”.
While the company could not give a timeline on when it hoped the TGA’s approval consideration would be completed, it said it hoped to have its side of the process completed very shortly.
Federal Health Minister Greg Hunt last month acknowledged the production delays, and said the government expected first doses to arrive “on the latest advice, this year, some of which are available for next year”.
And in an interview in August, Hunt said Novavax’s vaccines could “either be used this year or next year”.
The federal government’s vaccine supply horizons documents do not currently factor in deliveries of Novavax in 2021, due to previous uncertainty over the company’s production.
Australia is already expecting between 25 million and 35 million doses of Pfizer and Moderna in the final quarter of 2021, which it says is more than enough to vaccinate the remaining population.