Russia's FMBA registers Allergarda, a recombinant birch pollen allergy vaccine given in five injections
The vaccine from the Institute of Immunology and Generium received a temporary registration certificate; the course is five monthly injections for adults.
Russia's Federal Medical-Biological Agency (FMBA) has registered Allergarda, a preparation against birch pollen allergy, according to naukatv.ru. The product has received a temporary registration certificate, which allowed it to enter civil circulation in autumn 2026 naukatv.ru
naukatv.runaukatv.ruOpen source ↗. It was developed by the State Research Center Institute of Immunology of the FMBA and the biotechnology company Generium.
Research on the vaccine has appeared, among others, in the journal Allergy and in the Russian journal Immunologiya.
How the recombinant vaccine differs from allergen immunotherapy
Classical allergen-specific immunotherapy (ASIT) uses natural pollen extracts that contain whole allergen proteins. This leaves a risk of a severe allergic reaction, up to anaphylactic shock.
Allergarda is fully recombinant, that is, synthesized artificially. The developers isolated the main protein fragments responsible for immune responses to birch and apple allergens and chemically removed the parts of the molecule that provoke severe side effects naukatv.ru
naukatv.runaukatv.ruOpen source ↗. According to the material, once in the body this molecule prompts the immune system to produce protective IgG antibodies instead of the allergic IgE class.
An expert told Nauka that the fragments are obtained by genetic engineering and do not trigger an allergic reaction themselves. The IgG antibodies bind the allergen when pollen is inhaled, before symptoms such as runny nose and watery eyes develop.
Course, clinical data and registration timeline
A classical ASIT course may include about 30 injections, or daily sublingual drops taken for several months over several years. The Allergarda course consists of five subcutaneous injections given at one-month intervals.
According to clinical study data cited in the material, this regimen reduces manifestations of seasonal allergy by about 6–7 times. The preparation was also reported effective against cross-reactive food allergy, which keeps many people with pollinosis from eating fresh apples, peaches and nuts naukatv.ru
naukatv.runaukatv.ruOpen source ↗.
The preparation is approved for adults aged 18 and older. As with traditional immunotherapy, the course should start well before the tree flowering season, in autumn and winter, and all procedures must be carried out under the supervision of an allergist.
The developers plan to obtain a full permanent registration certificate by the end of 2027.
