How will Novavax fit into Australia’s COVID-19 vaccine plans?

The news general practice will be part of the Novavax COVID-19 vaccine rollout if it is approved follows the pre-print publication of phase 3 clinical trial results for the company’s NVX-CoV2373 vaccine this week.
 
Researchers found it had more than 90% efficacy in preventing COVID-19 infection and was 100% effective at preventing severe cases of the disease among the study cohort.
 
The trial of the protein-based vaccine included 29,949 participants across Mexico and the US, with a placebo group of 9868 individuals. It ran from 27 December 2020 to 18 February this year.
 
The pre-print article, an extensive write-up of initial findings released in June, reinforces previous studies that show promising results for the vaccine. In an announcement this week, Novavax reported that severe reactions ‘were infrequent and there were no safety concerns related to vaccination’.
 
The Australian Government placed 51 million doses of the vaccine on order in January, subject to its approval by the Therapeutic Goods Administration (TGA).
 
The vaccine, developed by the US-based biotechnology company, has not currently been approved anywhere in the world. However, infectious diseases physician and microbiologist Associate Professor Paul Griffin, who was a Principal Investigator for the Novavax vaccine’s phase 1/2 study in Australia, believes that could soon change.
 
‘I wouldn’t be surprised if approvals start to flow with that vaccine in a number of countries,’ Associate Professor Griffin told newsGP.
 
‘Given the very rigorous regulatory process here, it’s likely to be a little bit of time after, but I wouldn’t be surprised if the approval comes before the end of the year at this rate.’
 
A Department of Health (DoH) spokesperson told newsGP the TGA will be ready to proceed with an application as soon as Novavax supplies the required data.
 
‘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,’ the spokesperson said.
 
‘It is, therefore, not possible to speculate on timeframes at this stage.’
 
The spokesperson said if the vaccine is found to be safe and effective, its rollout could begin in December – and that general practice would be involved. 
 
‘If approved, GPs will assist in the rollout of the Novavax vaccine as with other vaccines in the current rollout,’ the spokesperson said.
 
The vaccine can be stored at normal refrigerator temperatures, which would help facilitate its use in general practice and remote areas.
 
Booster or primary dose?
The DoH says it is still considering whether the vaccine would be used as a primary dose or a booster.
 
While the clinical trial – which used two doses of the vaccine – took place before the dominant Delta variant had fully emerged, the company reported trials in August suggesting it would also be an effective booster.
 
If the vaccine is approved and moves to the mass manufacture stage, most – if not all – Australians aged over 12 will have had the chance to be vaccinated by the time it is ready for wide distribution.


Associate Professor Paul Griffin was a Principal Investigator for the Novavax vaccine’s phase 1/2 study in Australia. (Image: Supplied) 
 
Anecdotally, newsGP is aware of people ‘waiting for Novavax’ due to its different formulation to the mRNA vaccines produced by Moderna and Pfizer, as well as AstraZeneca’s viral vector vaccine.
 
Associate Professor Griffin warned against such an approach.
 
‘I don’t think that strategy of waiting for Novavax is an acceptable one right now,’ he said. ‘I think it’s very clear as we open up we need as many people protected as possible. And we do know that the mRNA vaccines and AstraZeneca are performing very well.
 
‘Novavax is likely to be more a booster vaccine in our hands than for a primary course of vaccination.
 
‘There may still be some people that have been, for whatever reason, reluctant to get those other vaccines and may elect to have [Novavax] as a primary vaccine. But that’s certainly not a recommended approach given that uncertainty on availability.’
 
Where would Novavax be manufactured?
The potential for the vaccine to be made in Australia has been discussed for some time, as the DoH confirmed this week.
 
‘The Government continues to meet regularly with a range of COVID-19 vaccine and treatment developers and manufacturers to discuss options for onshore manufacture,’ a spokesperson said.
 
‘The nature of these discussions [is] commercial-in-confidence but takes into account the likely timing of supply, cost and recommendations from Government medical experts.’
 
While CSL, the biotechnology company that is currently making the AstraZeneca vaccine in Australia, has been touted as a possibility, it said it would be unable to make both the AstraZeneca and Novavax vaccines at the same time.
 
CSL confirmed this week it will continue making the AstraZeneca vaccine until early next year, but that it remains open to the possibility of making a different COVID-19 vaccine.
 
‘For now, CSL is fully committed to completing its contract with the Australian Government to manufacture 50 million doses of the AstraZeneca vaccine,’ a spokesperson told newsGP.
 
‘CSL would, if requested by the Australian Government, reassess its ability to manufacture other vaccines such as the Novavax vaccine in the future.’
 
Associate Professor Griffin believes onshore vaccine manufacturing is an important option to pursue.  
 
‘We need to look at local manufacturing of ideally a number of vaccines, so as we move forward and rely on boosters regularly we’re not suffering in the hands of [the] global supply constraints that have impacted our rollout thus far,’ he said.
 
‘I would really like to see us have local mRNA manufacturing capacity and capacity to manufacture other vaccines, possibly including Novavax, or other ones as they get approved.’
 
Joint flu–COVID-19 protection?
Novavax also announced last month it is undertaking phase 1 and 2 clinical trials combining a flu vaccine with its COVID-19 vaccine.
 
It is a development welcomed by Associate Professor Griffin.
 
‘I think it’s a great idea,’ he said. ‘And I think that’s what the future looks like.
 
‘I really wouldn’t be surprised if we show that the immune response to both of those vaccines is the same, or even greater if we’re lucky, by combining [them].
 
‘That’d be a really neat way of giving people an annual booster to both of those very important pathogens.
 
‘I think if we can do both at once, that would be a really good way of maintaining good levels of immunity moving forward.’
 
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