10/02/2026 | DGRJ Editorial Team

https://dgrj.com.br/mundo/russia-registra-nova-vacina-contra-alergia-ao-polen-de-betula 

Allergarda uses recombinant technology and was developed to treat allergies caused by pollen sensitization.

A new vaccine developed in Russia has been registered for the treatment of birch pollen-related allergies. Named Allergarda, the technology was presented by Russian authorities as a new approach to allergen-specific immunotherapy, primarily targeting cases of allergic rhinoconjunctivitis and cross-reactive food allergies associated with pollen sensitization.

The product's temporary registration was announced on September 30, 2026. According to information released by Russian agencies, the vaccine was developed by the Institute of Allergology and Immunology of Russia's Federal Medical-Biological Agency (FMBA), in partnership with the company Generium.

The technology's key feature is the use of a genetically engineered recombinant protein. Instead of using the complete natural allergen, the formulation employs specific fragments associated with the immune response—a strategy that seeks to stimulate a response against the allergen without directly using the allergenic protein in its natural form.

Clinical study results
Prior to registration, Allergarda underwent clinical research stages. A study published in September 2026 in the scientific journal *Allergy* evaluated a recombinant formulation for birch pollen allergy, identified as GNR-127.

In Phase II, participants received doses prior to the pollination season. Researchers observed a reduction in symptoms and the need for anti-allergy medications compared to the placebo group, with a more pronounced effect at the 80-microgram dose. The study also recorded a safety profile considered acceptable under the conditions evaluated.

The research utilized a recombinant fusion protein composed of allergen fragments from birch pollen and apples linked to a carrier protein. The goal was to induce a specific immune response and increase the production of antibodies capable of interfering with the allergic reaction.

By 2025, the Russian Ministry of Health had already authorized the start of Phase III clinical trials, which compared the treatment against a placebo in patients with allergic rhinitis sensitized to birch pollen.

How immunotherapy works
Allergen-specific immunotherapy aims to gradually modify the immune system's response to the substance causing the allergy. Unlike medications that merely control symptoms, this strategy seeks to target the mechanisms involved in the immune reaction.

Allergic rhinoconjunctivitis can cause sneezing, runny nose, nasal congestion, nasal itching, and eye irritation or watering. In the case of Allergarda, the indication relates to sensitization to birch pollen and the cross-reactive food reactions associated with this type of allergy.

The development of recombinant vaccines is one of the avenues being explored in allergen immunotherapy. The study published in 2026 indicated promising clinical results for the formulation evaluated; however, the data must be interpreted within the specific conditions of the trials and the approved indications for the product.

Registration allows for use in Russia
With the temporary registration announced by Russian authorities, Allergarda can now begin to be used in the country's healthcare institutions. The official announcement stated that the product could become available as early as the Russian autumn for patients undergoing treatment prior to the next birch pollen season, expected in 2027.

The development of the immunotherapeutic agent represents an application of genetic engineering to allergy immunotherapy. Despite the results shown in studies, its clinical use remains subject to the indications and conditions specified in the drug's registration.