The Federal Medical and Biological Agency (FMBA) of Russia has announced that the submission of documents for registration of its vaccines for the prevention of pneumococcal and meningococcal infections is scheduled for December 2025. The vaccine against pneumococcal infection is currently in late-stage clinical trials, and the one against meningococcal infection is in phase I, said Veronika Skvortsova, head of the FMBA. Her statements are quoted by TASS.
«Phase 3 clinical trials of the 16-valent pneumococcal vaccine and phase I clinical trials of a five-valent meningococcal vaccine are currently underway. <…> The submission of documents for registration of both vaccines is planned for December 2025», — Skvortsova said at an expanded meeting of the final board of the FMBA of Russia.
She added that over the past 3 years, the FMBA centers have registered 21 products, of which 12 were registered in 2024, including three original ones. According to her, the Flu-M vaccine, created by the Institute of Vaccines and Serums, has been found to comply with international quality standards. The domestic product has successfully passed the WHO prequalification in 2025. It can be purchased by leading UN organizations, including the Pan American Health Organization (PAHO) and UNICEF. According to Skvortsova, registration certificates for the product have been obtained in three countries of the Latin American and Caribbean region.
Skvortsova also said that phase 2 of clinical trials of the Russian vaccine against allergy to birch pollen and similar allergens (apple, peach, peanut, and soy) is going to be completed soon, and that the results of preclinical trials showed safety, good tolerability and high immunogenicity of the vaccine. Earlier, it was reported that there are plans to register the domestic vaccine before 2026.
