Clinical trials

Clinical trials

Before the start of clinical trials the vaccine had gone through all stages of pre-clinical trials with experiments on different types of animals, including 2 types of primates.

Phase 1 and 2 clinical trials of the vaccine have been completed on August 1, 2020. All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine. The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including an analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.

Post-registration clinical trials involving more than 31,000 people in Russia and Belarus were launched on August 25, 2020. A number of countries, such as UAE, India and Venezuela joined the clinical trials of Sputnik V locally. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia.

In Phase III clinical trials, Sputnik V showed strong efficacy, immunogenicity and safety results.

Efficacy of Sputnik V against COVID-19 was reported at 91.6%. The figure is based on the analysis of data on 19,866 volunteers, who received both the first and second doses of the Sputnik V vaccine or placebo at the final control point of 78 confirmed COVID-19 cases. Sputnik V’s efficacy was validated by internationally peer reviewed data published in The Lancet.

Sputnik V provides full protection against severe cases of COVID-19. Sputnik V guarantees robust humoral (antibodies which are first line of defense) and cell mediated (long term protection) immune response.

The Phase III clinical trial results proved high levels of safety and immunogenicity of the Sputnik V vaccines including elderly group.

• Over 98% of volunteers in the vaccine group developed humoral immune response and 100% cellular immune response.

• The level of virus neutralizing antibodies of volunteers vaccinated with Sputnik V is 1.3x-1.5x times higher than the level of antibodies of patients who recovered from COVID-19.

• Vaccine efficacy for the elderly group was shown at 91.8% and did not differ statistically from the 18-60 group.

The Vaccine showed excellent safety profile. Most adverse events (94%) were mild and included flu-like syndromes, injection site reactions, headache and asthenia.

• No serious adverse events associated with the vaccination, as confirmed by Independent Data Monitoring Committee.

• No strong allergies, no anaphylactic shock.

The unique substance of the Sputnik V and method of using it has a patent protection in Russia, obtained by Gamaleya National Research Institute of Epidemiology and Microbiology.

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