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First results of Betuvax-CoV-2 jab clinical trials likely to appear by March — developer

"The first step is to tackle the safety issues, and the second one is to find the correct dosage," CEO of Russia’s Institute of Human Stem Cells Artur Isaev noted

MOSCOW, September 27. /TASS/. Russia’s Institute of Human Stem Cells, one of the Betuvax-CoV-2 COVID-19 vaccine’s developers, is likely to receive clinical confirmation of its efficiency in late February-March 2022, according to Artur Isaev, the Founder and CEO of the institute, which developed the jab together with the Betuvax company.

The Russian Health Ministry on Monday approved the first and second stages of clinical trials, the relevant document was published by the authorization register. The clinical trials, which will last until August 31, 2022, are expected to involve 170 volunteers aged from 18 to 60 without chronic diseases. They are going to be conducted in the Smorodintsev Research Institute of Influenza, the Eco-Safety Medical Center in Russia’s second-largest city St. Petersburg as well as the Professional Medicine Center in Perm.

"The first step is to tackle the safety issues, and the second one is to find the correct dosage. <...> The final conclusions can be made after the third phase of clinical trials. <...> The preliminary report will definitely take four months. <...> I think that if we do it very quickly, then by late February or March, we will pass an interim stage and will be ready with a draft report," Isaev said.

The Betuvax-CoV-2 is a split recombinant vaccine based on spherical particles with the coronavirus surface antigen (protein). The developers say the jab can be used to inoculate those at risk and can be used for revaccination.

"This vaccine is for everyone. But <...> first of all, it is for people from the risk group, the elderly, children. <...> Currently, only clinical trials can answer this question. Now we are talking about our intentions based on the animal testing results," the institute’s CEO noted.

About the developer

The Institute of Human Stem Cells is a Russian biotechnology company, which incorporates several companies active in the area of gene therapy, regenerative medicine, genetic diagnostics, and consultancy. It is a strategic investor in the biomedical technology and healthcare industries.