In November, Australia’s Dr. Nikolai Petrovsky from Flinders University recently visited TrialSite to discuss the progress associated with his vaccine company, Vaxine. The renowned researcher, professor, and expert in the field of immunology, endocrinology, and vaccine development developed a protein subunit vaccine for COVID-19. He informed TrialSite that his research group just completed a Phase 4 booster study of their Spikogen vaccine and observed very good boost to neutralizing antibodies after three different COVID-19 vaccines were administered, including inactivated virus vaccine, adenoviral vector vaccine, and recombinant protein. Moreover, Iran’s Food and Drug Administration has approved Spikogen. The U.S. sanctions on that nation have precluded any shipments of U.S.-based vaccines to the Middle Eastern country. However, the country has received vaccine shipments from the World Health Organization (WHO) COVAX vaccine distribution facility for low-and moderate-income countries.

Corresponding with TrialSite, Dr. Petrovsky shared that he and his team are “now looking to get their COVID-19 vaccine approved by the WHO and in various other nations.” Regarding the Omicron variant of concern, which is highly transmissible and has led to skyrocketing cases including record breakthrough infections and hospitalizations, Dr. Petrovsky noted his group “is well advanced in developing an Omicron booster.” The Iranian study was led by Khashayar Roshanzamir, head of R&D for CinnaGen, one of Iran’s biggest biotech firms and licensor of the vaccine.

TrialSite recently accessed the press release associated with the recent regulatory approval, providing a breakdown below.

When was Dr. Petrovsky’s vaccine authorized in Iran?

Spikogen was authorized as a COVID-19 vaccine Thursday, January 20th.Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

What’s the terms of the license?

The license covers the first and second dose for the age cohort 18 to 50 while the third booster dose is approved for those people aged 18 and up.

In this deal, the vaccine is manufactured in Iran.

Is this current deal between Vaxine, the maker of Spikogen and the Iranian biotech for internal use, export, or both?

Initially, it is for internal use, but that could change as the deal includes export license. Roshan Zamir shared that the vaccine would be used to meet third dose boost needs and once that’s complete, they will consider exports.

What’s the current COVID-19 situation in Iran?

This nation has experienced multiple surges, yet cases have been on the decline since September, although there has been a slight uptick in infections. With a population of 84 million people, this Middle Eastern country has reported 6.2 million SARS-CoV-2 cases with approximately 132, 000 deaths.  

About 64% of the population has received two doses and just under 20% a third booster shot. By December 2021, the authorities in that nation, long under the U.S. and other Western sanctions [with ongoing tensions] announced plans to restrict unvaccinated access in public spaces.

How many doses have shipped thus far?

To date, CinnaGen reports that the company has a monthly production capacity of 4 million doses with 6 million doses already delivered to the Ministry of Health.

How did Spikogen do in the latest clinical trials?

According to Petrovsky and TrialSite research, the Australian-based vaccine triggers 25X boost in neutralizing antibodies. Moreover, according to one of the researchers involved with the study, Payam Tabarsi, “The results of a booster dose study show that people whose initial jab was a recombinant protein vaccine experienced an 11-fold increase in the neutralizing antibody by injecting a booster dose of this vaccine.”

For comparative purposes a boost from AstraZeneca and Russia’s Sputnik generated a 14X increase in antibodies, while China’s Sinovac led to a 25X boost in antibodies.

Overall, the vaccine offers 87% immunity according to the accessed reports.

How might WHO authorize Spikogen?

Iran would manufacture and export to WHO countries. For example, Iran and WHO are now in talks to consider this arrangement. In fact, local media reported that Jaffar Hussain, WHO representative to this country, reported that by September 2021, WHO and the Middle Eastern nation were talking about potential certification.

Note, that Iran is partnered with Russia and Cuba to develop vaccines as well.

Lead Research/Investigator

Dr. Nikolai Petrovsky is a renowned researcher, professor, and expert in the field of immunology, endocrinology, and vaccine development. He is founder of the vaccine company, Vaxine, a company funded by the US NIH to develop novel vaccine technologies. Dr. Petrovsky has developed a protein subunit vaccine for COVID-19. He also serves as director of endocrinology at Flinders Medical Centre, Australia, and is vice-president and secretary-general of the international immunomics society.

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