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- Pollen column: the FMBA revealed the details of the study of the first allergy vaccine
Pollen column: the FMBA revealed the details of the study of the first allergy vaccine
Clinical trials of the first Russian vaccine against birch pollen allergy are successfully underway in Russia. The drug relieves or significantly reduces painful symptoms in 25% of cases, and for most of the participants, the flowering season is noticeably easier, the Institute of Immunology of the FMBA said. Experts note that this is an important result: previously, allergen-specific immunotherapy, which takes about three years, was the only way to combat it. According to the developers, Allergarda treatment will take place over two seasons, but a good effect can be achieved in one. Read more about the unique preparation and the upcoming flowering season in the Izvestia article.
The first Russian allergy vaccine
The third phase of clinical trials of the world's first Allergard birch pollen allergy vaccine is taking place in accordance with the protocol approved by the Ministry of Health of the Russian Federation, the Institute of Immunology of the Russian Federal Medical Academy told Izvestia. All patients participating in the study have already received subcutaneous injections of the drug, and some have completed a full course of five injections. There are no severe side effects.
Previous studies have shown that the majority of patients who received allergovaccine had significantly reduced symptoms, while 25% had no symptoms at all, Musa Khaitov, director of the Institute and Academician of the Russian Academy of Sciences, told Izvestia. According to him, the flowering season was easier for many participants, despite the fact that in 2025 the concentration of pollen exceeded the usual level by more than five times. The vaccine is also recognized as safe with a five-fold subcutaneous injection.
— Unlike commercially available analogues on the market, which contain a whole extract of the major allergen of birch, the Allergarda recombinant vaccine contains only immunodominant antigen sites of the main allergen of birch and apple pollen. These epitopes in a linear non-allergenic form induce the production of protective IgG antibodies (responsible for the protective functions of the immune system) in the body of vaccinated patients. These antibodies block the interaction of IgE antibodies (responsible for the formation of an allergic reaction) with the allergen," he said.
The new approach has made it possible to increase safety, that is, significantly reduce the likelihood of anaphylaxis, and increase the effectiveness of therapy. At the same time, the course of immunotherapy was reduced from 30 to five injections, which is more convenient for both patients and doctors, the scientist said.
Is it possible to completely cure allergies?
Allergarda will be available to patients over the age of 18. This does not mean that it is contraindicated in children and adolescents, the director of the institute explained. It's just that there are special requirements for drugs for these groups, so additional clinical trials are needed, which will take time, the scientific organization noted.
— Now we plan to carry out treatment for two seasons. This question can only be definitively answered after monitoring patients over several birch pollination seasons. However, clinical trials of the combined Phase I/II have demonstrated effectiveness even after one vaccination season," Musa Khaitov said.
Pollen allergies often cause cross-reactions to certain foods. The new drug has been developed with these features in mind. In preclinical studies, its effectiveness has been confirmed against allergies to apple, peach, soy and peanuts.
Elimination of allergy symptoms in 25% of cases is an excellent result for a new vaccine, says Andrey Prodeus, chief pediatric allergist and immunologist at the Ministry of Health of the Moscow Region.
— A quarter of patients with an allergy to birch pollen will receive a pronounced clinical effect, and with simple methods. Their quality of life will improve significantly. I'm allergic myself and I'm going to get vaccinated," he said.
According to the specialist, now the majority of patients use symptomatic treatment. There is also allergen-specific immunotherapy, the effectiveness of which reaches 70% for pollen allergies, but the course lasts at least three years.
Plant pollen, which provokes hay fever, appears every year at different times. The earliest is April-May, and the next wave begins in May –August and then in August-September, which means that a fairly long period is obtained, Olga Shuppo, founder and scientific director of the Grand Clinic network of immunorehabilitation, adaptive and preventive medicine clinics, explained to Izvestia.
— It is completely impossible to cure allergies. Modern therapy can reduce the severity of symptoms and prevent complications. Moreover, the effectiveness of treatment will directly depend on the lifestyle and individual adaptive capabilities of the body. Allergy is considered a diagnosis. But in fact, this is a "tantrum" of the immune system. When the immune system is not balanced and reacts to any impact," the doctor said.
When to wait for the flowering season
Andrey Mirgorodsky, an expert at the Pollen Club service, told Izvestia that every year the flowering schedule is "in the usual segments."
— First there will be early-flowering trees such as alder and hazel, then birch, then cereals, and then multicolored, — he said. — At the same time, the first ones have already started their activities in Europe and in the southern regions, and we are already feeling this call, although it is not very intense yet. For individual allergy sufferers, this is enough to feel the symptoms.
Birch blossoming, he said, will begin in mid-April and may last until the end of May.
— Therefore, the period associated with the most aggressive hay fever will be closer to the middle or end of spring, – said the expert.
He noted that according to the service, birch is the most common allergen that users are monitoring.
— But there is cross-allergenicity, and it often happens that people suffering from pollen will also react to related allergens. These include, among others, alder and hazel. They begin to bloom almost simultaneously. And the dusting of early—flowering plants is usually expected in mid-March and until the first decade of April," said Andrey Mirgorodsky.
It is impossible to predict the exact date of the beginning of dusting in 2026: it depends on weather conditions (temperature, precipitation, etc.). In central Russia, hazels usually begin to dust first in late February or early March, said Konstantin Letts–Orletsov, head of the Virtual Clinic project at Ingosstrakh.
— An integrated approach is recommended in the fight against seasonal allergy to flowering: first of all, minimize contact with pollen. In parallel, medications are used as prescribed by a doctor — antihistamines, nasal and eye drops with anti—inflammatory effects, and in severe cases, topical corticosteroids," he noted.
According to various sources, pollen allergy occurs in 30-60% of people, the expert added.
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