Calculation was based on the analysis of data of volunteers who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol
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General Information
Sputnik V is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. It currently ranks among top-10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organization’s (WHO) list.
The ongoing Sputnik V post-registration clinical trial in Russia involves 40,000 volunteers.
Clinical trials of Sputnik V have been announced in the UAE, India, Venezuela and Belarus.
Sputnik V vaccine efficacy
Russia’s Sputnik V coronavirus vaccine has shown 91.4 efficacy, according to data analysis of the final control point of clinical trials. The state-run Gamaleya research centre and the Russian Direct Investment Fund (RDIF) said in a statement on Monday that the calculations were based on the final control point analysis of data obtained 21 days after administering the first dose.
The analysis of the Sputnik V vaccine efficacy at the final control point was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases). The ratio of the placebo group to the vaccinated group was 1 to 3.
“Calculation was based on the analysis of data of volunteers (n = 22 714) who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol,” the release said.
Meanwhile, the vaccine demonstrated 100 per cent efficacy against severe coronavirus cases. There were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.
As per the release, the vaccine showed efficacy rate of above 90 per cent at each of the three control points of clinical trials. The calculated efficacy rate of the Sputnik V vaccine at the first control point was 92 per cent (20 cases) and 91.4 per cent at the second point (39 cases).
As of December 14, more than 26,000 volunteers were vaccinated at 29 medical centers in Russia as part of the ongoing clinical trials. Currently, Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India.
“As of December 14, no unexpected adverse events were identified as part of the research. Some of those vaccinated had short-term minor adverse events such as pain at the injection point and flu-like symptoms including fever, weakness, fatigue, and headache,” it said.
Further Information
This website has been created to provide accurate and up-to-date information about Sputnik V.
Russian Health Ministry registration certificate
The vaccine is named after the first Soviet space satellite. The launch of Sputnik-1 in 1957 reinvigorated space research around the world, creating a so called “Sputnik moment” for the global community.
Currently there are over 200 different COVID-19 vaccines under development around the world.
RDIF jointly with partners and manufacturers is ramping up the production of Sputnik V. The cost of one dose of the vaccine for international markets will be less than $10 (Sputnik V is a two dose vaccine). The lyophilized (dry) form of the vaccine can be stored at a temperature of +2 to +8 degrees Celsius.
Requests for more than 1.2 billion doses of the Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.
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