The Federal Medical-Biological Agency (FMBA) of Russia has officially filed an application to register “Allergarda,” a unique recombinant vaccine developed by the Institute of Immunology. The drug is designed to treat seasonal allergic rhinitis and associated cross-reactive food allergies.
Key Takeaways:
- Product: “Allergarda” (Recombinant vaccine).
- Efficacy: Complete relief in 25% of patients; 6-fold symptom reduction in the remaining group.
- Regimen: 3–5 injections (vs. 30 standard shots).
- Status: Phase III ongoing; commercial launch expected in H2 2026.
Clinical Trial Progress
The vaccine is currently in Phase III clinical trials, evaluating its efficacy against a placebo in patients with allergic rhinitis. Data from previous stages have already confirmed a high safety and efficacy profile:
- 25% of participants experienced complete disappearance of allergic reactions.
- For the remaining participants, symptom intensity decreased by more than 6 times.
- No severe adverse events were recorded during the trials.
Product Profile & Advantages
A key distinction of “Allergarda” from traditional allergen-specific immunotherapy (ASIT) is its hypoallergenicity and a significantly reduced treatment course. Furthermore, the vaccine provides protection against cross-reactive allergies to food products such as apples, peaches, peanuts, and soy.
| Feature | Details |
|---|---|
| Developer | Institute of Immunology (FMBA) |
| Drug Type | Recombinant vaccine |
| Target Conditions | Birch pollen allergy, cross-reactive food allergy |
| Dosing Regimen | 3–5 injections |
| Comparison | Standard therapy requires ~30 injections |
| Launch Timeline | H2 2026 (Forecast) |
Market Outlook
Experts predict the registration process will conclude by late 2025 or early 2026. Upon successful completion of the final trials, the vaccine is expected to enter the commercial market in the second half of 2026.
