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


Jolyon Attwooll


15/10/2021 4:07:43 PM

GPs will be involved in the rollout of Novavax if it is approved for use in Australia, the Federal Government has confirmed.

A needle in a vial of Novavax.
There are 51 million doses of Novavax’s COVID-19 vaccine on order.

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.

Novavax-article.jpg
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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Dr Andrew John Booker   16/10/2021 9:21:18 AM

Some people genuinely don’t want to inject themselves with ‘new technology’ that has 18 months safety data.
If ‘all n sundry’ really wanted to vaccinate everybody then why not make available a vaccine those would have ‘novavax’ available to them ASAP instead of the harm of attempting to force or coerce them into another path???


Dr Vishal Kohli   16/10/2021 10:19:43 AM

I have hundreds of patients who do not want "new technology" vaccines. They're ALL worried about effects 10yrs down the line. Novavax will be a TOTAL game changer. There is very high trust in the community for his jab n I genuinely believe that overnight our vax rate will be the highest in the world with this. We need this now! Most of patients have been asking me when /if this will be combined with the flu jab. Makes complete sense because as predicted our flu jab uptake is back to below pre-covid days because no one can be bothered with 3 jabs this yr.


Dr Matthew Hugh Routley   16/10/2021 4:40:10 PM

I concur with Dr Bookers comment: many patients and healthcare workers have legitimate long term safety concerns over the new mRNA/DNA vaccines- we have absolutely NO long term safety data on this novel technology. And we are recommending them to pregnant women and now children. Why discourage them from waiting for a more traditional style vaccine such as novavax? Why would Prof Griffin recommend it as a booster, but not as a primary course? If a person is at low risk of Covid then waiting several months for Novavax. is probably a reasonable risk-benefit decision


Dr Raymond Yeow   17/10/2021 2:46:24 PM

AMA president OMAR KHORSHID says "...The AMA has called for all health care workers to be vaccinated and for that to be mandatory...."

https://www.ama.com.au/media/dr-omar-khorshid-hospitals-and-opening-vaccinating-children-under-12-over-60s-and-mandatory
on 2 Sep 2021

So those "...... healthcare workers have legitimate long term safety concerns over the new mRNA/DNA vaccines....." --- Please Read AMA president statement on above link


Dr Christopher Roy Chowdhury   22/10/2021 11:48:18 AM

Many patient of mine requesting Novavax and keen to have the vaccine. They all say that it is old style vaccine and happy to get the vaccine even I tell them that mRNA/DNA vaccine is safe . I thing our vaccination rate will definitely up. I think our health minister and TGA should look into the issue. Definitely most of the patient do not want to give Covid 19 vaccine to their children .


Dr Emma Kate Vieira   28/10/2021 11:46:13 AM

I've lost track of the number of patients who have asked me when Novovax will be available, including many patients who are hesitant to receive any of the mRNA vaccines but much more open to Novovax.
In any case, given the lack of long term safety data (by definition) of any of the mRNA vaccines, why on earth would we utilise Novovax only for boosters? "We don't know the long-term side effects" can be applied to any COVID vaccine in the world. By definition they have not been around long enough to HAVE long-term safety data. And don't get me started on college statements that the mRNA vaccines are safe in pregnancy - ondansetron is still considered category B1 in pregnancy!
If this government is serious about encouraging vaccine uptake in the hesitant, they would do well to listen to those of us on the ground who have had this conversation with patients day in, day out, EVERY DAY for the last 18 months....


Dr Cathryn Leembruggen   28/10/2021 9:35:58 PM

Somebody has done a great job marketing Novavax to the vaccine hesitant... but in reality it is still a new vaccine with less real world safety and effectiveness data than any of the other vaccines. What our patients need is protection now - as case numbers increase, as we open up and there are more asymptomatic cases of covid, waiting for the " grass is greener" vaccine is risking severe Covid. The best vaccine is the one they can get NOW.


Dr Brendan Leslie   30/10/2021 9:30:40 PM

Well said Cathryn!

The Sars-cov-2 virus has also not been around all that long, and people seem to forget that it also forces us to make mRNA- which makes our cells not only produce a spike protein, but the entire coronavirus itself!

Even if I was worried about long term side effects (which I'm not), I'd much rather take mRNA from a new vaccine than from a new virus.


Dr Jessica Legrand   7/11/2021 8:46:45 PM

Who knows if efficacy of Novavax is accurate? There are so many people in the USA and Mexico who already had Covid and they might have been included in the trial. There is also a possibility that the trial participants not knowing if they got placebo or the real vaccine, went secretly to their nearest pharmacy and got Pfizer/Moderna vaccines to protect themselves from Covid illness.


Dr Edgard Arslan   12/11/2021 7:20:56 PM

Novovax has release the trial results , it sound promising ,very similar to the other vaccines , i understand that some of my patient reason for being hesitant to try new tech vaccines , and they have been compliant with all other traditional vaccines, we have been offering for years . i think making a traditional effective vaccine may increase the level of vaccination rate .even though we have reached a mile stone with our vaccination rate compare to the rest of the world . having an extra 3-5% more with Novovax it doesn't hurt . i would strongly agree of having the novovax available in Australia ASAP.


Dr Alan Graham MacKenzie   13/11/2021 12:16:52 PM

51 million doses in Jan 2022 of a vaccine which was developed before Delta seems to be a further waste of time and money.
Each year our Influenza vaccine is upgraded to encompass protection against the most recent variant strain.
Why is this not happening with Covid?