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Novavax vaccine could be ready within months


Jolyon Attwooll


15/06/2021 4:47:39 PM

Phase 3 clinical trial results confirm it will likely be a ‘very important’ part of Australia’s vaccination program.

Novavax vaccine.
New data suggests Novavax’s COVID vaccine is well tolerated, with tenderness around the injection site the most common symptom.

The results of Novavax’s phase 3 ‘PREVENT-19’ trial of the NVX-CoV2373 vaccine suggest it is 90.4 % effective, and also protective against many of the new COVID variants of concern that have emerged since the pandemic began.
 
The trial, which involved 29,960 participants spread across 119 sites in the US and Mexico, also indicates that the vaccine offers 100% protection against moderate and severe disease, shoring up interim findings announced in January.
 
The results suggest the vaccine could be rolled out in Australia by the start of next year, according to infectious diseases physician and microbiologist, Associate Professor Paul Griffin, who was a Principal Investigator for Novavax’s phase 1/2 study in Australia.
 
‘This is a vaccine that we’re getting more and more data to support the fact that it’s safe and effective,’ he told newsGP
 
‘It’s likely to become a very important part of our vaccination strategy moving forward.
 
‘Pending supply, I think it’s certainly a vaccine we should have by the end of the year, and maybe in as little as three months or so.’
 
In January, Novavax and the Australian Federal Government confirmed an advance purchase agreement for a total of 51 million doses of the vaccine, and the company is currently working with the Therapeutic Goods Administration to secure the vaccine’s approval.
 
And even considering recent orders placed with Moderna and Pfizer for more doses of their respective vaccines, Associate Professor Griffin said NVX-CoV2373 is still likely to play an important role, especially as it is stable at 2–8°C.  
 
‘It’s a very different type of vaccine to Moderna and Pfizer,’ he said. ‘Those mRNA vaccines do require to be frozen at quite cold temperatures so aren’t as easy to move around.
 
‘In a country like ours, particularly as we expand the roll-out to include more remote GP practices and even pharmacies, that makes Novavax ideally suited to those type of applications.’
 
Last month the Federal Government confirmed an agreement with Moderna to supply 25 million doses of its COVID-19 vaccine, while 4.5 million additional Pfizer doses are expected to arrive in Australia by the end of June.
 
But with Australia’s vaccine rollout running behind schedule, Associate Professor Griffin believes the Novavax candidate will still most likely to be used as a vaccine in its own right, rather than as a booster.
 
‘We would all like to think we would have enough people vaccinated by the time Novavax is available for it to be used as a booster, but I just don’t think we’re going to be there,’ he said.
 
‘I think it will have a really important role to play in being the primary vaccine for a significant proportion of the country.’
 
The trial of the vaccine’s efficacy was carried out from 25 January through 30 April this year when the Alpha (B.1.1.7) variant – identified in the UK – was the predominant strain in the US.
 
But even though that was before the Delta strain became widespread, Associate Professor Griffin is not concerned about this variant’s impact on the vaccine’s efficacy.
 
‘I think we have seen enough information from the other vaccines to suggest that while the efficacy is reduced, it still remains an efficacious vaccine,’ he said.
 
‘We wouldn’t expect this to be any different so it will still provide protection against those variants.’
 
Associate Professor Griffin added that further studies will help to give a clearer indication of how protective the vaccine is against evolving variants. 
 
While the earlier phase 1/2 trial showed very promising antibody responses, the phase 3 trial was set up to establish how effective the vaccine is, as well as its safety and immunogenicity, in communities Novavax said had been the most affected by the disease.
 
Data suggests the vaccine candidate is ‘well tolerated’, with adverse events ‘low in number and balanced between vaccine and placebo groups’, Novavax reported in its announcement.
 
Tenderness in the area of the injection, described as generally mild-to-moderate, was cited as the most common symptom, lasting less than three days. Fatigue, headache and muscle pain featured as the common systemic symptoms, reported as lasting less than two days.
 
Once wide-scale manufacturing begins, the vaccine is expected to come in a ready-to-use liquid format in 10-dose vials.
 
As of yet, there is no deal in place to manufacture the vaccine on Australian soil, but Associate Professor Griffin said he is still hopeful that one might eventuate.
 
‘A lot of people are speculating [manufacturing in Australia] is a possibility,’ he said. ‘It would be great to see as supply remains a significant restraint.’
 
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coronavirus COVID-19 Novavax vaccine rollout


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newsGP weekly poll Have you encountered patients who say they are ‘waiting for Novavax’?

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Getafix   16/06/2021 9:51:37 PM

Some good news to shore up what has already been accomplished !