Veronika Skvortsova, head of the Federal Medical and Biological Agency (FMBA), said that phase II of clinical trials of the Russian vaccine against allergy to birch pollen and similar allergens (apple, peach, peanut, and soy) is going to be completed soon, and that the results of preclinical trials showed safety, good tolerability and high immunogenicity of the vaccine. The minister’s words were quoted by TASS. Earlier, it was reported that there are plans to register the domestic vaccine before 2026.
«Preclinical trials have been fully completed, and have proven the good tolerability and safety of the vaccine, its high immunogenicity, and the production of antibodies that protect against the allergen», — Skvortsova said.
The head of the FMBA noted that the effectiveness of the vaccine against allergy to birch pollen and several other sources can be evaluated as early as June-July 2025. According to her, the international community has highly appreciated the Russian development as early as at the preclinical level.
«In fact, we have now entered the beginning of the pollen season. We have fully vaccinated the required number of participants. In June, it will be clear, and in July, how effective the allergovaccine is», — Skvortsova added.
The development of a vaccine for birch pollen allergy was first reported in 2023. Scientists from the Institute of Immunology at FMBA collaborated with researchers from the Medical University of Vienna to create it. When the trials are finished, the drug could be included in the National Vaccination Calendar. It is expected that a new drug will be able to prevent future allergic reactions in three to five injections, whereas the current allergy remedies require up to 30 injections.
In August 2024, Skvortsova announced the development of a domestic vaccine set to begin at the end of September that year. In February 2025, it was reported that the project had successfully passed phase 1 of clinical trials. The first official results of clinical trials are planned to be presented to the scientific community at the 19th International Congress of Immunology to be held in Vienna in August 2025.
