The Russian Ministry of Health has approved a plan for the experimental use of a Russian personalized mRNA cancer vaccine. As noted by the Alexander Ginzburg, director of the Gamaleya National Research Center for Epidemiology and Microbiology under the Ministry of Health of Russia, the first melanoma patients are expected to receive the vaccine in the coming months. He noted that other countries have already expressed interest in the Russian development, with about a dozen such inquiries received so far, as quoted by RIA Novosti. Ginzburg’s words were quoted by RIA Novosti.
Ginzburg stated, “According to the existing plan agreed with the Ministry of Health, we should begin experimentally administering a cancer vaccine based on neoantigens to a group of melanoma patients in the coming months.” He clarified that the Gamaleya Center is responsible only for vaccine production, with the medication eventually to be transferred to the P. Hertsen Moscow Oncology Research Institute and the N.N. Blokhin Russian Cancer Research Center.
Ginzburg also explained that personalized biologics, which are developed based on a patient’s genetic data and intended solely for their treatment, require special regulatory oversight that is fundamentally different from the regulations for traditional medicines.
In response to these unique features, the government adopted a decree in February 2025 establishing a special legal regime for such drugs. Biologics are produced within medical institutions, which must obtain special permission from the Ministry of Health for both manufacturing and use.
Earlier, Ginzburg said that the first patients could begin receiving treatment with the domestic drug as early as September or October 2025. According to him, adjustments are possible during the development process, which may affect both the timing of the creation of the vaccine and its final cost.