The St. Petersburg Research Institute of Vaccines and Sera and an enterprise (part of the Federal Medical and Biological Agency) is seeking a contractor to conduct Phase III clinical trials of an analogue of the pneumococcal vaccine Prevenar-13 from the American company Pfizer. According to information on the public procurement website, the starting contract price is 230.4 million rubles.
It has to be a multicenter, double-blind, randomized study of the immunogenicity, safety, and tolerability of the PCV-16 vaccine for the prevention of pneumococcal infections in comparison with the Prevenar-13 vaccine in children aged 2 to 17 years is required. According to the procurement documents, up to 894 people will take part in the CT, including 774 aged 6 to 17 years, and 120 aged 2 to 6 years.
The service provider will be selected through an electronic tender, and only small and medium-sized businesses not listed in the register of unscrupulous suppliers will be able to participate. Applications for the tender are accepted until January 15, 2026, and the results will be summed up on January 19.
The Research Institute received permission for the project at the beginning of last month. Testing of the institute’s drug started late in 2023; in December 2024, the institution signed a contract worth 245.5 million rubles with the contract research laboratory “Excellena” and also received permission from the Russian Ministry of Health to implement the project until the end of 2025 with volunteers over 18 years of age.
The Institute received permission from the Russian Ministry of Health to conduct these clinical trials in early November 2025. The studies will take place at eight organizations.
The development of a vaccine against pneumococcal infection based on a domestic substance was first reported three years ago; the FMBA initially planned to bring the drug to market in 2025-2026.