Questions over data transparency around Australian doctor?s $1m GoFundMe Covid-19 vaccine

A South Australian doctor who has raised hundreds of thousands of dollars in crowdfunding for a potential Covid-19 vaccine has been given permission to submit clinical data for assessment by Australia's medicines regulator.

Prof Nikolai Petrovsky, who has been publicly critical of Covid-19 vaccines approved by the Therapeutic Goods Administration, has raised more than $850,000 on the fundraising website GoFundMe for Covax-19, a vaccine candidate developed by his company, Vaxine Pty Ltd.

Petrovsky has previously published many peer-reviewed papers on diabetes, genomics and vaccine development, but he has been criticised for advocating for Covax-19 to be approved for use in Australia without making publicly available substantial peer-reviewed clinical evidence to support its efficacy.

Covax-19, also known as Spikogen, is made from synthetically manufactured spike proteins and completed a phase I clinical trial - a small safety study of 40 patients - in Australia last year.

To date, no results from Covax-19 human clinical trials have been published in peer-reviewed journals, evidence of which is usually required for regulatory approval in Australia. One study on Covax-19's effects in mice and ferrets has been published in the peer-reviewed journal Vaccine. Covax-19 has been approved for emergency use in Iran, where phase II and III clinical trials are currently under way.

The lack of publicly available data from clinical trials to support statements about Covax-19's efficacy has raised concerns among experts, particularly while Vaxine is soliciting donations from the public. They are pushing for more transparency around the timeline of clinical trials conducted in Iran, and calling on Petrovsky to publish the results of his research in peer-reviewed journals.

As his company raises funds for Covax-19's development and TGA approval, Petrovsky has criticised competing vaccines already provisionally approved by the regulator, leaving experts concerned confidence in those Covid vaccines may be undermined. His GoFundMe has also sought support for a clinical trial in Australia, describing previous government funding of the vaccine as "hush money". A later petition has asked the federal government to provide Vaxine with more financial support.

Petrovsky, an endocrinologist at Flinders Medical Centre in Adelaide, runs Vaxine Pty Ltd with his wife, Sharen Petrovsky, the company's business manager. Sharen, who also goes by Sharen Pringle, created the GoFundMe in October.

The professor has refused to personally receive a TGA-approved vaccine because he says he has been vaccinated with Covax-19.

"It has been agreed that I am taking long service leave from Flinders Medical Centre until such time as I can receive a vaccination exemption or the vaccine mandates are withdrawn," he said in a statement to Guardian Australia in November.

SA Health - which runs Flinders Medical Centre - said it was "unable to comment on matters relating to the employment of individuals".

Petrovsky, who also holds an unpaid academic title as a professor at Flinders University, has spoken in recent months against policies imposed to control the pandemic.

A viral clip of him speaking at an anti-vaccine mandate event in Adelaide, in which he describes being "extremely uncomfortable" with the TGA-approved vaccines and "not fully confident about what's happened over the past 18 months", has been shared widely online including by Craig Kelly, Rod Culleton and apparent vaccine sceptics.

In that video, Petrovsky described mRNA vaccines as "very new technologies in their infancy", and asked "what level of confidence do we have that they have been through the usual process [of rigorous testing]".

Petrovsky's GoFundMe page is critical of government funding for the biotech firm CSL and the "AstraZeneca vaccine that has been linked to deaths from central venous thrombosis".

In a recent podcast interview, he claimed Australians would be able to import his vaccine from overseas to administer themselves, though he acknowledged this would not qualify people as vaccinated under Australian Covid-19 vaccine policies.

"Even in Australia, there are routes that people can get access to unapproved products if they are approved somewhere else, so people can personally import a vaccine for their own use," Petrovsky said.

In that interview, Petrovsky said about 1m doses of Covax-19 had been distributed in Iran, and that a Covid-19 vaccine for cats was in development in Kazakhstan. Guardian Australia has not been able to independently verify the number of doses distributed in Iran.

He has also referred to mRNA vaccines as "gene therapy vaccines", saying the technology was developed "to put new genes inside people".

The TGA told Guardian Australia: "Any suggestion that mRNA vaccines are 'gene therapy' is categorically rejected. mRNA vaccines do not interact with DNA to change our genetic code in any way so the assertion is patently false."

On 15 December the TGA granted "provisional determination" to Covax-19 - a status which lasts for six months and serves as a preliminary step that allows a company to submit clinical data for the regulator to assess. The status is no guarantee that the vaccine will be approved for use.

Advice published by the TGA says the regulatory body considers phase III clinical trial data published in a peer-reviewed journal to be "baseline" evidence for a vaccine's efficacy.

In a statement on 14 December, the TGA said: "Comprehensive data demonstrating the safety, quality and effectiveness of COVAX-19 (also known as Spikogen) has not [yet] been submitted to the TGA for assessment."

In announcing Vaxine's provisional determination status, the TGA said it had considered "factors such as the evidence of a plan to submit comprehensive clinical data".

Associate Prof Paul Griffin, director of infectious diseases at Mater Health Services in Brisbane, said it was unusual that Covax-19's regulatory approval was being crowdfunded, given the "tremendous" funding opportunities provided to promising Covid vaccines throughout the pandemic.

In a Conversation article in June, Griffin described Covax-19 as a "potentially promising" local candidate, but now says he is troubled by the lack of publicly available clinical data to substantiate claims about its effectiveness.

"While it's great to see Australian scientists having a go and trying to develop new vaccines, particularly for Covid at the moment, I'm quite concerned about [the lack of publicly available data about] that vaccine," Griffin said.

A $100m deal to sell Vaxine to biopharmaceutical firm Immuron previously fell through, according to a report in the AFR in September.

Petrovsky's crowdfunding effort initially sought money to apply for TGA approval, and now has a target of $1m to run a "post approval" trial. Initial application and evaluation fees for a new prescription medicine total more than $250,000.

An update on the fundraising page said the "Phase 4/post approval Trial [sic]" - also referred to elsewhere as a "Phase 2/3b Study" - was "anticipated to commence mid-to-late January 2022".

Sharen Petrovsky is described as the "clinical trial manager" in letters sent to those interested in participating in any trial, which have been seen by Guardian Australia.

In November, people who had registered for the company's trial received letters on Vaxine letterhead informing them of South Australia's then policy that participation in a Covid-19 vaccine trial was a valid exemption from South Australia's vaccine requirements.

The letter said: "In order to preserve the integrity of the clinical trial, it is an enrolment criterion that you be Covid-19 vaccine naive at the time of your entry into the trial. Hence receipt of any other Covid-19 vaccine is a key trial exclusion criteria."

SA Health was forced on 27 November to issue a statement clarifying that simply registering for a proposed trial was not grounds for an exemption to vaccine mandates.

"South Australia does not just recognise being on a waiting list for a proposed vaccine trial as a reason for exemption from a vaccination requirement," it said.

In a new direction issued on 8 December, SA police said taking part in Covid vaccination trial was no longer a valid reason for vaccination exemption.

An update posted to the GoFundMe page on 8 December said the company had submitted an ethics approval application to conduct the study.

But as of 22 December, SA Health said it had not received an application for ethics approval. "At this stage, the Southern Adelaide Clinical Human Research Ethics Committee (SAC-HREC) has received no submission for Vaxine's Covax-19 vaccine Phase 4 trial," it said in a statement.

Petrovsky did not respond to requests for comment to clarify what ethics committee the company had submitted an application to.

In a statement, the National Health and Medical Research Council said: "An informal registration process, or providing information about a future trial to generate interest in it, does not necessarily require ethics approval."

All human research in Australia is expected to conform to the requirements of a national statement on ethical research conduct, it added.

Dr Kyle Sheldrick, a medical doctor and researcher, would like Petrovsky to make the results of the clinical trials in Iran publicly available.

Petrovsky's GoFundMe describes Covax-19 as "showing protection against the Delta virus variant in a Phase 3 clinical trial in 16,876 subjects in Iran", but that trial is not set to be completed until March 2022. No peer-reviewed interim results have been published.

Sheldrick was critical of the timeline of the phase III trial, telling Guardian Australia it was unusual for a vaccine to be approved so rapidly in any country.

The trial is listed on the US ClinicalTrials.gov registry as having started on 7 August 2021 - the date on which the first participant was enrolled.

According to listed information, it has an estimated primary completion date of 1 March 2022. This is when all participants have been monitored for six months after receiving their second dose - corresponding to 201 days from the last patient receiving their first dose.

Working backwards, 201 days before 1 March gives a date of 12 August. "[That] would then imply they were planning to recruit their entire population base in five days," Sheldrick said.

The trial defined the vaccine's efficacy based on the number of Covid infections between 35 and 201 days after people received their first dose. Assuming the first enrolled participant was on 7 August, an infection would count only if it occurred after September 11. Covax-19 was approved in Iran on 6 October. Based on that date, Sheldrick estimated the maximum time participants were followed up after their second jab was 25 days. "We're talking about an incredibly short period of follow up," he said.

Griffin said: "There's a reason we have a process in terms of sharing results and publishing in peer-reviewed journals, so we can be assured of the quality of the content and see for ourselves that this vaccine is potentially safe and effective."

Petrovsky told Guardian Australia in November that publishing clinical trial results in scientific journals had "no bearing on whether a product is approved or not".

Petrovsky also said claims Covax-19's efficacy were unsubstantiated was "an outrageous claim".

He said the Iranian FDA had "independently peer-reviewed all the phase 3 outcome data". An official document Petrovsky provided to Guardian Australia did confirm the Iranian FDA had given emergency approval for the vaccine but it did not contain information to verify this statement.

According to GoFundMe's website, money can be withdrawn from a campaign at any time.

Vaxine was last year awarded $1m - the same amount as the crowdfunding target - to develop Covax-19 by the Australian government's Biomedical Translation Bridge initiative.

A previous version of Petrovsky's fundraising page described the grant as "a single small token grant provided by the govt [sic] as hush money when we complained of their complete lack of support".

"We initially refused this funding as we saw it as too little, too late and just an excuse to fob us off and be able to claim they had in fact 'supported' our program," Petrovsky told Guardian Australia in November. Accepting the funding was "a decision we regret to this day," he said.

On December 21, Vaxine sent an email to its supporters with the subject "A call to action", asking people to sign an e-petition to the parliament of Australia.

That petition, which closed for signatures on 22 December, called on the federal government to provide "necessary financial support and advance purchase commitments" to Vaxine for Covax-19.

Meanwhile, experts continue to push for transparency in clinical data. "I am always suspicious of companies talking about their science without publishing their science, while actively fundraising based on that science," Sheldrick said.

Griffin said: "We don't know this vaccine is safe and effective yet. It might prove to be in the future, but we have insufficient [publicly available] evidence at this point in time."