The tuberculosis vaccine under development in Russia has demonstrated good tolerability during phase III clinical trials, Vladimir Gushchin, Deputy Director for Scientific Research at the Gamaleya Centre, told TASS. According to him, the drug has already been administered to 1,146 patients.
“The vaccine is based on recombinant technology, and vaccines of this type have a very good tolerability profile,” Gushchin stated.
In 2025, the centre’s director, Alexander Gintsburg, said that the submission of documents for registration of the new vaccine to the Ministry of Health was planned for 2026. “If everything goes according to plan, the documents for registration of this vaccine product will be submitted to the Ministry of Health during 2026,” Gintsburg emphasised at the time.
Currently, the BCG vaccine, based on live mycobacteria, is used for tuberculosis prevention in Russia. The Gamaleya Centre’s development is a recombinant vaccine created using laboratory‑synthesised proteins. The absence of a live pathogen will allow the drug to be used in immunocompromised patients and in children, broadening the indications compared with the existing vaccine. The components of the new product selectively stimulate specific components of the immune response. The vaccine is planned to be used both for tuberculosis prevention and for its treatment.
Earlier, Rospatent (the Russian Federal Service for Intellectual Property) included the Gamaleya Centre’s tuberculosis vaccine in the top 10 best Russian inventions of 2020.