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.
Prof Nikolai Petrovsky, who has been critical of Covid-19 vaccines approved by the Therapeutic Goods Administration, has raised more than $850,000 for a vaccine that his company developed.
He has published many peer-reviewed papers on diabetes, genetics and vaccine development, but he has been criticized 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 a synthetically manufactured spike proteins that was used in a phase I clinical trial in Australia last year.
Results from Covax-19 human clinical trials have not been published in peer-reviewed journals, which is required for regulatory approval in Australia. A study on the effects of Covax-19 on mice and ferrets has been published. In Iran, phase II and III clinical trials are currently underway for Covax-19.
The lack of publicly available data from clinical trials to support statements about Covax-19's efficacy has raised concerns among experts. They want more transparency around the timelines of clinical trials conducted in Iran, and want the results of his research to be published.
Experts are concerned that the confidence in the Covid vaccines may be undermined by the criticism of competing vaccines that have been approved by the regulators. He has asked for support for a clinical trial in Australia, which he described as "hush money". The federal government has been asked to provide more financial support for Vaxine.
The claim was categorically rejected.
The business manager of Vaxine is Sharen Petrovsky, the husband of an endocrinologist at the Flinders Medical Centre. Sharen created the GoFundMe in October.
The professor refused to receive the vaccine because he said he had been shot with Covax-19.
He said in a statement to Guardian Australia that he would be taking long service leave from the medical centre until he could get a vaccine exemption.
SA Health said it was unable to comment on matters relating to the employment of individuals.
Ian Tindall was injected with the Covax-19 vaccine by Prof Guy Ludbrook. David Mariuz/AAP
In recent months, Petrovsky has spoken out against policies imposed to control the Pandemic.
A video of him speaking at an anti-vaccine event in Adelaide in which he describes being "extremely uncomfortable" with the vaccines has been shared widely online.
In that video, Petrovsky asked what level of confidence he had that the vaccines had been through the usual testing.
CSL and the AstraZeneca vaccine have been linked to deaths from central venous thrombosis, according to the GoFundMe page.
He acknowledged in a recent interview that Australians wouldn't be eligible for the Covid-19 vaccine policy because they wouldn't be able to import his vaccine from overseas.
If a vaccine is approved in another country, people can import it for their own use.
In that interview, he said that about 1m doses of Covax-19 had been distributed in Iran and that a Covid-19 vaccine for cats was being developed in the country. Guardian Australia has not been able to verify the number of doses.
He said the technology was developed to put new genes inside people.
The TGA told Guardian Australia that any suggestion that the vaccine isgene therapy is categorically rejected.
Unusual funding route.
On December 15th, the TGA granted a status calledprovisional determination to Covax-19, which allows a company to submit clinical data for the regulator to assess. The vaccine will not be approved for use if the status is not changed.
The regulatory body considers the data published in a peer-reviewed journal to be the basis of evidence for a vaccine.
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 been submitted to the TGA for assessment."
The TGA said it had considered the evidence of a plan to submit comprehensive clinical data when determining Vaxine's status as a provisional determination.
The director of infectious diseases at the hospital said it was unusual that Covax-19's regulatory approval was being crowdfunded.
In a Conversation article in June, he described Covax-19 as a potentially promising local candidate, but now says he is troubled by the lack of publicly available clinical data to back up claims about its effectiveness.
People wait to receive a vaccine at a station at a shopping centre. Iran approved the Covax-19 vaccine in October of 2021. Abedin Taherkenareh/EPA
While it is great to see Australian scientists trying to develop new vaccines, I am concerned about the lack of publicly available data about that vaccine.
He said that people need to have some confidence that the claims are substantiated. It would be very easy to get more funding if that was forthcoming, according to Griffin, citing government grants as an example.
The Covid vaccines that have already been approved could be undermined by the criticism of other vaccines and the promotion of his own. He said that Petrovsky had created a large following of people who were holding off on getting licensed vaccines because they were hearing that the vaccine was the solution for them.
Australian trial plans.
A $100m deal to sell Vaxine to Immuron fell through, according to a report.
The goal of the project is $1 million to run a trial after approval. Initial application and evaluation fees for a new medicine are over $250,000.
An update on the fundraising page said that the Phase 4/post approval trial was expected to start in January of 2022.
Guardian Australia has seen letters sent to people who are interested in participating in a trial that describe Sharen Petrovsky as the "clinical trial manager".
In November, Vaxine sent letters to people who had registered for the trial that they were exempt from South Australia's vaccine requirements.
To preserve the integrity of the clinical trial, you must be naive at the time of your entry into the trial. A key trial exclusion criteria is the receipt of any other Covid-19 vaccine.
SA Health was forced to clarify that simply registering for a trial was not grounds for an exemption from vaccine mandates.
Being on a waiting list for a vaccine trial is not a reason for exemption from a vaccine requirement, it said.
SA police said taking part in the Covid vaccine trial was no longer a valid reason for exemption.
An update posted to the GoFundMe page said the company had submitted an ethics approval application to conduct the study.
SA Health said it had not received an application for ethics approval. The Southern Adelaide Clinical Human Research Ethics Committee has not received a submission for Vaxine's Covax-19 vaccine Phase 4 trial.
The company had submitted an application to the ethics committee.
The National Health and Medical Research Council said that 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 follow the ethical research conduct guidelines of the national statement on ethical research conduct.
There is no obligation to publish all clinical data.
The results of the clinical trials in Iran should be made public.
The trial for Covax-19 in Iran is not expected to be completed until March 2022. Interim results have not been peer reviewed.
Sheldrick told Guardian Australia that it was unusual for a vaccine to be approved so quickly in any country.
The trial was listed on the US ClinicalTrials.gov registry as having started on August 7, 2021.
It has an estimated primary completion date of 1 March 2022. All participants have been monitored for six months after receiving their second dose, and the last patient to receive their first dose has been included.
The date of 12 August is the date before 1 March.
The vaccine's efficacy was determined by the number of Covid infections after people received their first dose. If the first participant was on 7 August, an infection would only count if it happened after September 11. Iran approved Covax-19 on October 6. Sheldrick estimated the maximum time that participants would be followed up was 25 days. He said that they were talking about a short period of follow up.
The process of sharing results and publishing in peer-reviewed journals is a reason why we can be sure of the quality of the vaccine.
He said that that had not been forthcoming. There was a lot of talk about the data coming through. There are lots of claims of higher levels of safety and efficacy, but we haven't seen good data to verify them.
The Australian government gave Vaxine $1m to develop Covax-19, something that was initially refused by Petrovsky. David Mariuz/AAP
In November, Petrovsky told Guardian Australia that publishing clinical trial results in scientific journals had no bearing on whether a product is approved or not.
Despite being under no obligation to do so, we plan to publish all the clinical data on our vaccine in a high profile scientific journal, but it will take time to write.
The claims that Covax-19's efficacy was not substantiated was an outrageous claim.
He said the Iranian FDA had peer-reviewed the data. The Iranian FDA gave emergency approval for the vaccine, but the official document that was provided to Guardian Australia did not contain information to verify this.
Money can be withdrawn from a campaign at any time.
The Australian government gave Vaxine $1m to develop Covax-19, the same amount as the crowd funding.
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The grant was described as a single small token grant provided by the government when we complained of their lack of support.
The funding was initially refused as we saw it as too little, too late and just an excuse to back off and say they supported our program. Accepting the funding was a mistake, he said.
Vaxine sent an email to its supporters asking them to sign an e-petition to the parliament of Australia.
The petition called on the federal government to provide necessary financial support and advance purchase commitments to Vaxine for Covax-19.
Experts are pushing for transparency in clinical data. Sheldrick said that he was always suspicious of companies talking about their science without publishing it.
We don't know if this vaccine is safe or effective. It might prove to be in the future, but we don't have enough evidence at the moment.
