Vaxine seeks Australian approval for Covid-19 protein subunit vaccine – Community News
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Vaxine seeks Australian approval for Covid-19 protein subunit vaccine

Vaxine files for Australian approval of Covid-19 protein subunit vaccine
Vaxine chairman and research director Nikolai Petrovsky. An ongoing GoFundMe raise for SpikoGen to become available in Australia has exceeded its target of A$400,000. Credit: Vaxine

Vaxine wants to take home its Australian-developed Covid-19 vaccine. The Adelaide-based company aims to submit preliminary approval of its protein subunit Covid-19 vaccine SpikoGen to the Australian Therapeutic Goods Administration (TGA) this week, says vaccine developer Nikolai Petrovsky. The application will be based on Phase III data collected in Iran.

The submission would be the start of a TGA rolling review, which could last up to six months, said Petrovsky, who is also the chairman of the company. There is an ongoing GoFundMe raise for SpikoGen that will be made available in Australia, with a draw of A$414,700 at the time of writing, exceeding its goal of A$400,000.

Vaccine Passes 60% Efficacy Bar

The Australian application will be based on interim data from a Phase III SpikoGen study 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 pre-specified 88 PCR-confirmed infection events, explains Petrovsky. Participants received SpikoGen or placebo in a 3:1 ratio.

SpikoGen has a favorable safety profile, Petrovsky says. While rarer side effects may not occur in a relatively small trial, side effects such as heart inflammation are not expected with this vaccine technology, he explains. “The trial is unlikely to see a side effect that affects one in 12,000 people.”

Petrovsky declined to add further details on efficacy data as the manuscript is currently being translated from Farsi into English. There were no deaths in placebo or vaccine arms, he notes. Nevertheless, participants will continue to be monitored for safety and efficacy in the coming months, with the option of blinding the trial for placebo recipients to also be vaccinated, he adds.

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

SpikoGen authorized in Iran

Based on phase III data, Vaxine’s Iran employee CinnaGen was granted an emergency permit for SpikoGen from the Iranian Food and Drug Administration on Oct. 6. Petrovsky notes that the local regulatory agency has set the bar at 60%, which is 10 points higher than the benchmarks of the World Health Organization (WHO), the US FDA and EMA. The vaccine still exceeds this higher bar, despite the Delta variant being common in Iran, he adds.

CinnaGen is now in talks with the Iranian government about vaccine orders, with CinnaGen to produce the vaccine in the country, Petrovsky said. Locally made vaccines help break through any import delays. The vaccine does not have strict cold chain requirements because it is stable between 2-8°C, he adds.

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