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.