Researchers have been forced to rely on donations just to make a “highly successful” homegrown Covid vaccine available to Australians.
The creator of an Australian-developed Covid-19 vaccine, which has proven to be effective against the Delta variant, has accused the Australian government of offering no support to bring the jab to Aussies, despite it being approved overseas.
Covax-19, created by biotech company Vaxine, is the first synthetic protein Covid vaccine developed in the Southern hemisphere.
A recent Phase 3 clinical trial of almost 17,000 subjects in the Middle East was “highly successful” and remains Australia’s most advance locally created vaccine.
It’s now been approved for use in Iran but there are still thousands of Aussies who have never heard of the homegrown jab.
Flinders Medical Centre director of endocrinology Nikolai Petrovsky told news.com.au a lack of support and interest from the Australian government has forced his team to turn to crowd funding just to apply for approval from our Therapeutic Goods Administration (TGA).
Professor Petrovsky said it costs approximately $350,000 just for the TGA to consider the vaccine for approval, a fee he said is usually paid by the government.
“In this case we would actually have to be paying the Australian government for the privilege of looking at our vaccine, which we don’t think is fair or appropriate, but is the current situation we are in,” he told news.com.au.
The GoFundMe campaign has now raised over $310,000.
Vaxine was previously granted $1 million for Covax-19’s development through the Biomedical Translation Bridge (BTB), which is an initiative of the Australian government’s Medical Research Future Fund (MRFF).
However, the company claims since then they have received no support in helping make Covax-19 available to Aussies.
‘It’s crazy’: Professor blasts lack of support
Prof Petrovsky said the fact that Covax-19 has had successful Phase 3 trials and has been approved overseas limits the government’s excuses for not backing the jab.
While the data from the trial hasn’t officially been published yet, Professor Petrovsky said Iran’s Food and Drug Administration said the vaccine had to prove to be more than 60 per cent effective against Covid-19.
He said Covax-19 “exceeded” that benchmark.
“It takes away any ability for (the federal government) to say ‘Oh, well, we don’t believe will work’ for instance, the even though the evidence was always very strong,” he said.
“This is the first successful Australian developed vaccine in 40 years. It is crazy in this current situation they just turning a blind eye to it.
“I think they have to look seriously at the advice they’ve been getting.”
A spokesperson for the Department of Health said Professor Petrovsky assertions are “absolutely and categorically rejected”.
They noted that Prof Petrovsky received the $1 million of funding through the BTB program, saying to date the government has invested over $96 million from the MRFF into funding vaccines and Covid-19 treatments.
The current agreements with Pfizer, AstraZeneca, Novavax, Moderna and the international COVAX Facility “will ensure Australia has access to more than 280 million vaccine doses throughout 2021, 2022 and 2023”, the Health Department spokesperson said.
“If a sponsor holds the appropriate evidence they are welcome at any time to make an application to the TGA to register their vaccine in the Australian Register of Therapeutic Goods (ARTG),” they said.
“However, the Government cannot compel a sponsor to make an application, nor can a regulatory approval be granted in the absence of an application.
“All COVID-19 vaccine applications are being treated with the greatest priority as part of the Department of Health’s response to the pandemic.”
How Covax-19 is different to Pfizer and AZ
Prof Petrovsky said Covax-19 is “very different” to the main vaccines – Pfizer, AstraZeneca and Moderna – currently being used in Australia.
“These vaccines are basically made up of genetic material that gets inside your cells when they’re injected, and it reprograms them to make spike protein and that triggers an immune response,” he said.
“In our case, we were not using genetic material. It’s a synthetic protein that in is manufactured in insect cells. So that being a protein, we know proteins are very safe and relatively inert when you inject them, they stay outside of the cells.
“They stimulate immune cells to make protective antibodies. So it’s very different to what’s currently out there.”
He said Covax-19 is made in a similar way to the hepatitis B vaccine and HPV vaccines, adding years of research show those together synthetic protein based vaccines are “exceptionally safe and well tolerated”.
It is still not known whether booster shots will be required for the Aussie-made jab.
“Obviously we’re hoping that the protection will be much longer lasting than we’re seeing with the current generation of genetic vaccines,” he said.
Professor facing sack after taking own jab
Despite being fully vaccinated, Prof Petrovsky revealed he is facing being fired from Adelaide’s Flinders Medical Centre.
This is because he has been vaccinated with his own jab, not one of the candidates currently approved for use in Australia.
From Monday, all South Australia Health staff will be required to have proof of vaccination with an approved vaccine in order to continue working.
Prof Petrovsky said this meant people who have been vaccinated with a vaccine other than those that have been approved have to get vaccinated with a new jab to be in line with the government mandates.
“So, obviously, there’s a safety issue there that there’s been no clinical trials done to say, is it safe,” he said.
“Therefore it would be inappropriate for anyone who’s had these other vaccines, arguably, to submit to that just as part of these mandates.”
Despite the current situation, Prof Petrovsky said he is still open to engaging with the Australian government.
“The door is open for them to come behind this and really support what what’s been a massive achievement,” he said.
“It’s only one of a handful of vaccines in the world that’s been proven effective, not only against the original strain, but against the Delta strain and it’s just extraordinary to be in this position.”
Source: News AU