Accelerated development and implementation of the prophylactic vaccine Sputnik V in the conditions of the COVID-19 pandemic

To achieve the goal of the project on accelerated development and implementation of Sputnik V, an intensive plan was designed, implying the parallel execution of tasks in all areas of development, which allows for a reduction in the time of transition from stage to stage and advance the study of each of the new stages in a proactive mode. A classic application development plan includes a relatively small number of stakeholders, allows for the use of competitive principles when defining affiliate programs, and is tied to a relatively small number of sponsors. This standard development bar is completely unsuitable for accelerating vaccination development and deployment in a pandemic. Sputnik V vaccine development plan envisioned a dramatic acceleration of research and development at great risks. The priority of the project in close connection with the sponsor represented by the Ministry of Health of the Russian Federation was set as maximum. The best research groups of the Gamaleya Center were involved in the project to carry it out, including about 70 researchers from the Gamaleya Center, as well as two dozen specialists from various organizations. All tasks were divided into component blocks, including the development of a vaccine preparation, production of preparation for preclinical and clinical studies, virus isolation and creation of an infectious model, conducting experiments to assess safety, working out protocols for assessing immunogenicity, creating analytical systems such as RT-PCR and ELISA, evaluating the effectiveness in animal models, preparing a clinical trial protocol, launching clinical trial protocols, communicating with all interested external parties. Multisource funding principles were involved, including federal and local budgets, as well as sponsorship funding.