Before starting human clinical trials for the vaccine, pre-clinical studies on different animal species have been completed at all stages.

Phase 1 and 2 clinical trials of the vaccine were completed on August 1, 2020 According to the study results, no unforeseen or undesirable side effects were observed, and all volunteers felt well. It was found that the vaccine stimulates a strong antibody and cellular immune response.

The result of clinical studies conducted after the vaccine was administered showed no COVID-19 infection was in any of the participants. High sensitivity tests for antibodies in the blood serum of volunteers (including analysis for antibodies that neutralize the coronavirus) and the generation of both antibodies and cellular immune responses, which reveal the ability of the volunteers' immune cells to activate against the spiky S protein of the coronavirus, confirmed the high efficacy of the vaccine.

On August 25, 2020, clinical trials began involving more than 31,000 people in Russia and Belarus. However, countries such as the United Arab Emirates, India, and Venezuela have also locally participated in Sputnik V's clinical trials. On August 11, it was confirmed that the vaccine, which received approval from the Russian Ministry of Health, could be used to vaccinate the population in Russia under emergency rules adopted during the COVID-19 outbreak.