In an interim analysis of a Phase III clinical trial, Sputnik V showed strong efficacy, immunogenicity and safety results.
- Efficacy of Sputnik V against COVID-19 was reported at 91.6%.
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- Analysis included 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.
- Efficacy in the elderly group of 2,144 volunteers over 60 years old was 91.8% and did not differ statistically from the 18-60 group.
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- Sputnik V provides full protection against severe cases of COVID-19.
- Among the cases analyzed, over 98% of volunteers developed humoral immune response and 100% – cellular immune response.
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- The level of virus neutralizing antibodies of volunteers vaccinated with Sputnik V is 1.3-1.5 times higher than the level of antibodies of patients who recovered from COVID-19.
- 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 vaccination, as confirmed by Independent Data Monitoring Committee.
- No strong allergies, no anaphylactic shock.
- Sputnik V is one of the three vaccines in the world with efficacy of over 90%. Furthermore, Sputnik V stands out among these vaccines thanks to a number of key advantages:
- Based on a platform of human adenoviral vectors proven to be safe over decades of use.
- Easy distribution worldwide: storage temperature of between two and eight degrees Celsius.
- One of the most affordable vaccines in the world with a price of less than $10 per shot.
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- Sputnik V is already registered in 16 countries: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia and Armenia.
- In the first week of February, vaccination with Sputnik V will start in the following 12 countries: Bolivia, Kazakhstan, Turkmenistan, Palestine, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela and Iran.
- In 10 countries out of 12, Sputnik V will be the first coronavirus vaccine approved for civil circulation.
Moscow, February 2, 2021 – The Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announce that the Lancet, one of the world’s oldest and most respected medical journals, has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine’s high efficacy and safety. Sputnik V, which is based on a well-studied human adenoviral vectors platform, is the world’s first registered vaccine against coronavirus.
In the interim efficacy analysis of the randomized, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo), the two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6% against COVID-19. The calculation is based on the analysis of 78 confirmed cases of COVID-19 identified in the placebo group (62 cases) and in the vaccine group (16 cases). Sputnik V generated a robust humoral and cell mediated immune response.
Alexander Gintsburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology, said “The publication of internationally peer reviewed data on Sputnik V’s clinical trial results is a great success in the global battle against the COVID-19 pandemic. The Russian vaccine’s safety and high efficacy are shown by the hard scientific data presented and I congratulate the entire team of Gamaleya National Research Center for this monumental achievement. Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for development of new vaccines in the future.”
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented “This is a great day in the fight against the COVID-19 pandemic. The data published by The Lancet proves that not only Sputnik V is the world’s first registered vaccine, but also one of the best. It fully protects against severe COVID-19 according to data which has been independently compiled and reviewed by peers and then published in The Lancet. Sputnik V is one of only three vaccines in the world with efficacy of over 90% but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees and a more affordable price. Sputnik V is a vaccine for all mankind.”
According to the peer-reviewed study results, the vaccine provides full protection against severe cases of the novel coronavirus infection. Among the confirmed severe cases of COVID-19, 20 were recorded in the placebo group, while none were recorded in the vaccine group. Due to the time needed for the immune response to develop, in the first.
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