American drugmaker Novavax says it is ready to begin shipping COVID vaccines to Australia as soon as the federal government gives it the official tick of approval, claiming it has resolved production issues that threatened to derail plans to deliver millions of jabs in 2021.
The promising news, which could further quicken the nation’s accelerating rollout or provide the ‘foundation’ of a booster shot program, comes as Novavax chooses Australia as a trial site for a combination vaccine against COVID-19 and influenza.
“We expect to deliver the doses included in our current agreement with the Australian government this year and into 2022,” a Novavax company spokesperson told The New Daily, saying it hoped to have its final submission to the federal government completed “within weeks”.
But the Therapeutic Goods Administration says it is still waiting for more paperwork from Novavax, and can’t give its approval until those forms and trial data were officially lodged.
Where is the Novavax vaccine?
Novavax’s NVX-CoV2373 jab, a protein recombinant vaccine, has shown very strong results in trials.
One test showed 96.4 per cent efficacy against the original COVID-19 strain, while others have shown 100 per cent protection against moderate and severe disease.
Phase 2 studies from the United States and Australia showed it had very strong results as a “booster” or third shot if given six months after an initial two-dose vaccination, including a sixfold increase in antibodies reactive to the Delta variant.
Australia has contracted 51 million doses of Novavax, and federal Health Minister Greg Hunt has spoken of its potential use in a booster shot program.
However, Novavax’s production has been heavily delayed – in part due to a shortage of raw materials – and it is not yet in general use anywhere in the world.
But Novavax has told TND its production is back on track, flagging it would be able to begin shipping doses to Australia once the Therapeutic Goods Administration gives approval.
“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,” a Novavax spokesperson said.
The company was given a ‘provisional determination’ by the TGA in January, and accepted into a ‘rolling submission’ process of review.
This means the Australian regulator was regularly supplied with new clinical trial and testing data, in hopes of being able to make an expedited decision.
Novavax said it had been giving “clinical and non-clinical data to the TGA on an ongoing basis”.
The company could not give a timeline on when it hoped the TGA’s approval consideration would be completed, but said it hoped to have its side of the process completed very shortly.
“Novavax is targeting the completion of its rolling submission with the UK (MHRA) in the third quarter of 2021, with multiple other markets to follow within weeks, including Australia,” Novavax said.
In a statement, the TGA said it was currently “assessing preliminary data” for Novavax, but couldn’t give a timeframe for approval as the company was still submitting ongoing paperwork and trial results.
“The TGA can only make a regulatory decision on the Novavax vaccine once the complete data package has been provided by the sponsor to enable the required regulatory processes,” a TGA spokesperson said.
“Therefore, it is not possible to speculate on timeframes at this time.”
“With rolling submissions and review, collaboration with international regulators, and proactively working with sponsors, the TGA’s evaluation of COVID-19 vaccines continues to be significantly expedited without compromising on our strict standards of safety, quality and efficacy.”
Novavax production problems ‘resolved’
Mr Hunt, acknowledging production delays, said last month the government expected first doses to arrive “on the latest advice, this year, some of which are available for next year”.
Novavax claimed it would be able to produce 150 million doses per month globally, once its full production capacity is reached. The company said previous production issues – including difficulties sourcing materials – had been overcome.
“During the pandemic there have been industry-wide global shortages of raw materials such as 2000-litre bioreactor bags, depth filters and growth media that have impacted our production; however, the shortages have generally been resolved at this time,” Novavax admitted.
In May, the company had tamped down hopes of getting vaccines to Australia in 2021.
Novavax’s chief executive told investors the company was “not able to predict a date with precision” as to when it might submit its vaccine to regulators in Australia, admitting “we are delayed from where we thought we’d be”.
The federal government’s vaccine supply horizons documents do not factor in deliveries of Novavax in 2021, due to previous uncertainty over the company’s production.
But Australia is already expecting between 25 million and 35 million doses of Pfizer and Moderna in the final quarter of 2021, more than enough to vaccinate the remaining population.
Therefore, Mr Hunt has raised Novavax’s potential as the “foundation of a booster and variant strategy” in future, rather than being used for first doses.
In an interview in August, Mr Hunt said Novavax’s vaccines could “either be used this year or next year”.
Leading epidemiologists expect COVID-19 to require annual or regular booster shots, like influenza, so ongoing supplies of vaccines will be required.
Novavax, citing its latest trial results, spruiked its potential for this task, and said it was also working on vaccines to specifically target new virus variants like Delta.
“We expect our ability to boost will be critical in helping combat COVID-19,” the spokesperson said.
“Novavax initiated development of new constructs against the emerging strains in January 2021. We have tested them in pre-clinical models and expect to move forward into early clinical testing.”
The TGA told TND it was still assessing the best use of Novavax’s jab in Australia, but that it was “likely this vaccine will be used as part of the Government’s ongoing booster dose strategy”.
The spokesperson said this would mean Australia “can be ready to address longer term immunity or emerging variants of the virus.”
Australian trials for new Novavax
Among the company’s new projects is a combination COVID-flu jab.
The jab, combining the NVX-CoV2373 and NanoFlu vaccines, is “the first of its kind”, according to Novavax’s president of research and research, Gregory M Glenn.
The trial will be held at 12 sites in Australia, Novavax announced on Thursday, taking in 640 participants aged over 50.
Results are expected in the first half of 2022.
“The combination of these two vaccines, which have individually delivered outstanding results with favourable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen,” Mr Glenn said.