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November 9, 2021

Vaxine to file for Australian approval of protein subunit Covid-19 vaccine

An Iran-staged trial shows SpikoGen exceeded the 60% efficacy bar in the primary endpoint of prevention of symptomatic disease.

By Reynald Castañeda

Vaxine is looking to bring its Australia-developed Covid-19 vaccine home. The Adelaide-based company is aiming to file for provisional approval of its protein subunit Covid-19 vaccine SpikoGen to the Australian Therapeutic Goods Administration (TGA) this week, vaccine developer Nikolai Petrovsky says. The application will be based on Phase III data collected in Iran.

The submission would start a TGA rolling review, which could run for a maximum of six months, says Petrovsky, who is also the company chairman. There is an ongoing GoFundMe raise for SpikoGen to be made available in Australia, drawing A$ 414,700 at the time of writing, exceeding its A$400,000 target.

Vaccine passes 60% efficacy bar

The Australian application will be based on interim data from a Phase III SpikoGen trial that recruited 16,876 volunteers. Interim data shows that SpikoGen exceeded the 60% efficacy bar in the primary endpoint of preventing symptomatic Covid-19 disease, based on a prespecified 88 PCR-confirmed infection events, Petrovsky explains. Participants received either SpikoGen or placebo in a 3:1 ratio.

SpikoGen has a favourable safety profile, Petrovsky says. While rarer side effects may not appear in a relatively small trial, adverse events like heart inflammation are not expected with this vaccine technology, he explains. “The trial is unlikely to see an adverse event that is in one out of 12,000 people.”

Petrovsky declines to add further detail on efficacy data as the manuscript is currently being translated from Farsi to English. There were no death events in either placebo or vaccine arms, he notes. Nonetheless, participants will still be monitored in the coming months for safety and efficacy, with the possibility of unblinding the trial for placebo recipients to also be vaccinated, he adds.

In Australia, there are four Covid-19 vaccines with provisional approval: the mRNA vaccines by Moderna and Pfizer/BioNTech, and the adenovirus-vectored vaccines by AstraZeneca and Johnson & Johnson.

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SpikoGen authorised in Iran

Based on Phase III data, Vaxine’s Iran collaborator CinnaGen secured an emergency permit for SpikoGen from the Iranian Food and Drug Administration on 6 October. Petrovsky notes that the local regulatory authority set the bar at 60% – which is 10 points higher than benchmarks by the World Health Organization (WHO), the US FDA and EMA. The vaccine still passed this higher bar despite the Delta variant being prevalent in Iran, he adds.

CinnaGen is now in talks with the Iranian government on vaccine orders, with CinnaGen to manufacture the vaccine in the country, Petrovsky says. Locally made vaccines assist in cutting through any import delays. The vaccine does not have rigorous cold chain requirements as it is stable between 2–8 °C, he adds.

On 21 October, this news service reported Novavax may be at risk of losing its frontrunner status of being the largest distributor of protein subunit Covid-19 vaccines. While Vaxine secured its first regulatory win on 6 October, Novavax won its first emergency authorisation on 1 November in Indonesia, in collaboration with Serum Institute of India.

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