Russia Moves Toward Launch of First Recombinant Allergy Vaccine

Russia is preparing to grant temporary registration to a new allergy vaccine during the second quarter of 2026, signaling a major step forward in the country's efforts to develop advanced immunological treatments.

The announcement was made by Veronika Skvortsova, head of the Federal Medical-Biological Agency, during a scientific press conference focused on key achievements in life sciences and the implementation of Russia's national research strategy.

Temporary Approval Expected in Mid-2026

"We expect temporary registration in the second quarter of this year. At the same time, patient recruitment for the third phase of clinical trials is nearing completion. After the 2026 pollen season, we hope to apply for permanent registration of this vaccine,” Skvortsova said.

She emphasized that the regulatory process is moving in parallel with ongoing clinical research, allowing developers to accelerate access while maintaining oversight.

Vaccine Targets Birch Pollen and Food Allergies

The vaccine, named Allergarda, was developed at the State Research Center Institute of Immunology under the Federal Medical-Biological Agency. It is a recombinant vaccine designed to prevent allergies caused by birch pollen, as well as cross-reactive food allergies associated with it.

In October, the Russian Ministry of Health authorized the start of the third phase of clinical trials. In December, the agency formally submitted documentation for the vaccine's registration.

Plans to Expand Allergy Vaccine Portfolio

According to the agency, the birch pollen vaccine represents only the first step in a broader program. Researchers plan to develop additional recombinant vaccines aimed at preventing and treating allergies linked to ragweed pollen, which affects millions of people worldwide.

Officials say the long-term goal is to create a new generation of targeted allergy treatments that can reduce reliance on symptomatic therapy and improve quality of life for patients.