Clinical trials of another Russian coronavirus vaccine, Betuvax-CoV-2 developed by the Institute of Human Stem Cells, may begin in September after a Russian health ministry issues a corresponding permit, the press service of the National Technological Initiative (NTI) Platform told TASS on Sunday.
The Institute of Human Stem Cells (a participant in the NTI HealthNet market), the developer of the Betuvax-CoV-2 recombinant coronavirus vaccine jointly with Betuvax LLC, is getting prepared to begin clinical trials in September. <…> The Russian health ministry is currently considering its application for clinical trials of the vaccine and is asking additions questions to the developers under a standardized procedure, it said.
The Betuvax-CoV-2 is a split recombinant vaccine of the basis of spherical particles with the coronavirus surface antigen (protein). The developers say they jab can be used to inoculate risks groups and for revaccination. The vaccine development works began in the summer of 2020.
“Betuvax-CoV-2 pre-clinical trials have demonstrated good safety and efficacy profiles, with the generation of high SARS-CoV-2 antibody titers in animals,” the press service said.
The clinical trials are expected to involve 116 volunteers aged from 18 to 60 without chronic diseases.