FMBA applies for registration of a birch pollen allergy vaccine

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The Federal Medical and Biological Agency (FMBA) of Russia has applied for registration of the Allergarda vaccine for the prevention of birch pollen allergy and pollen food allergy syndrom. This was announced by the head of the agency, Veronika Skvortsova, in an interview with the TV channel Russia-24.

“Phase III of clinical trials for the allergovaccine developed by the FMBA’s Immunology Research Center is underway. The results of Phases I and II proved not only the safety and good tolerability of the vaccine but also its very high efficacy. Despite the fact that this year’s pollen season was abnormally high, with pollen particle density five times above normal, 25% of the test subjects suffering from severe allergies observed no reaction to these particles. In the others, the allergic reaction decreased sixfold. We have already applied for the registration of the vaccine,” she said.

The development of this birch pollen allergy vaccine, a joint project of the FMBA’s Institute of Immunology and Vienna Medical University, was announced in 2023. Upon completion of trials, the vaccine may be included in the National Calendar of Vaccinations. It is expected that three to five injections will be sufficient to get rid of the allergic reaction, whereas existing treatments require up to 30 administrations.

According to Skvortsova, this year the agency also registered a Haemophilus influenzae type B vaccine, and a 16-valent pneumococcal infection vaccine and a pentavalent meningococcal infection are undergoing registration.