Sputnik-V: Russia's Covid vaccine shows 91.4% efficacy, may offer 2-year protection, developer says
Moscow, Dec 14: The Russia-developed Sputnik V vaccine against coronavirus has been found to be over 95 percent effective based on the final control point analysis of data obtained 21 days after administering the first dose.
"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 went on to add.
According to reports, the shot is likely to offer two years of protection against the illness.
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 is 1 to 3.
The vaccine demonstrated 100% 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.
According to the protocol of Phase III clinical trials of the Sputnik V vaccine, its interim efficacy is calculated at three statistically significant representative control points - upon reaching 20, 39 and 78 cases of novel coronavirus infection among volunteers both in the placebo group and in the group that received the vaccine. High efficacy rate of the vaccine above 90% was confirmed at each of the three control points of clinical trials - the calculated efficacy rate of the Sputnik V vaccine at the first control point (20 cases) was 92% and 91.4% 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.
During the clinical trials, the safety of the vaccine is constantly being monitored; information is analyzed by the Independent Monitoring Committee comprising leading Russian scientists. Collection, quality control and data processing is conducted in line with ICH GCP standards and involves the active participation of Moscow's Health Department and Crocus Medical, the contract research organization (CRO).
The Sputnik V vaccine has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF.
Alexander Gintsburg, head of the Gamaleya Research Institute of Epidemiology and Microbiology, made the bold claim as the Pfizer/BioNTech jab was rolled out Sunday in the start of the biggest vaccination effort in US history.
Sputnik V has a unique set of parameters making it one of the most competitive vaccines globally. The efficacy rate is over 90% and the vaccine is based on a safe and proven platform of human adenoviral vectors.
Cost of one dose is less than $10 for international markets while the production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius, enables easier distribution of the vaccine in international markets.
Amid a global race to come out with an effective vaccine to check the pandemic that had ravaged the world, Pfizer Inc and its German partner BioNTech too had announced that their vaccine appears 95 percent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
US-based biotechnology giant Moderna also announced that its COVID-19 vaccine has shown to be 94.5 percent effective in preventing the deadly disease.