MOSCOW, April 10. /TASS/. A new domestically produced allergy vaccine against birch pollen and a number of other allergens developed by scientists from Russia’s Federal Medical-Biological Agency (FMBA) will be made available to the public by the end of 2025 or the beginning of 2026, Musa Khaitov, director of the FMBA’s Institute of Immunology and president of the Russian Association of Allergology and Clinical Immunology, said.
"Its registration and subsequent rollout is planned for late 2025-early 2026," he said at a presentation at TASS dedicated to the causes, consequences and treatment of allergies within the framework of an open session of the Scientific Council of the Russian Academy of Sciences.
According to him, all pre-clinical trials for the vaccine are nearing completion, with its safety and effectiveness already confirmed, and the manufacturing process laid down. The scientist added that the vaccine’s clinical trials were launched last year, as it is now at the end of stage two following a successful first phase. Data on the trials’ results may be presented in July or August of this year. Additionally, the agency is currently developing a vaccine against ragweed allergies, which are common in Russia’s southern regions.
The vaccine’s pre-clinical trials determined its immunogenicity (the antigen’s ability to elicit an immune response). During in vivo trials, the researchers compared the domestic vaccine with existing extract-based analogues tested on rabbits. "We have shown that only one extract-based commercial model generated a similar level of IgG antibodies. But this was achieved with seven injections, while our vaccine generated a higher level of IgG antibodies after five injections, and this is very important, because we know that all vaccines on the market today require about 20 injections per season, which is definitely inconvenient both for patients and specialists, so it is very important that the vaccine developed by us needs to be administered only about three-five times in order to achieve the protective level of IgG antibodies," Khaitov explained.
About vaccine
The birch pollen allergy vaccine was developed by the FMBA’s Institute of Immunology jointly with the Medical University of Vienna. It requires a mere three-five injections as opposed to today’s extract-based therapies, where up to 30 injections are needed.
The vaccine was developed on the basis of a unique recombinant molecular construct. Fundamental studies were conducted before its development, including the mapping of the major allergen in birch pollen. The mapping results helped determine the sections responsible for developing an immune response to birch pollen which were then included in the vaccine’s composition.