New Delhi (NVI): Russia’s Sputnik V coronavirus vaccine is 95 per cent effective according to a second interim analysis of clinical trial data, its developers said today.
“The preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95%,” read the official statement.
The two-dose vaccine will be available in international markets for less than USD 10 (8.40 euros) per dose, they said, and will be free for Russian citizens.
It can be stored at between two and eight degrees Celsius (between 35.6 and 46.4 degrees Fahrenheit), instead of the temperatures below freezing required for some other vaccines, the statement said.
It has been manufactured by the Gamaleya Research Institute in collaboration with the Russian Health Ministry. Gamaleya Center experts confirmed the high efficacy of the Sputnik V vaccine after double-blind, randomised, placebo-controlled Phase 3 clinical trials.
As per the protocol of Phase III clinical trials of the Sputnik V coronavirus vaccine, its interim efficacy is calculated at three statistically significant representative checkpoints – 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.
The second interim analysis of the Sputnik V vaccine efficacy was carried out on the basis of 39 confirmed cases identified in the placebo group (31 cases) and in the vaccine group (8 cases). The ratio of the placebo group to the vaccinated group is 1 to 3.
Russia said that the next interim data analysis will be conducted upon reaching the third checkpoint of 78 confirmed coronavirus cases among the study participants.
Subsequently, the final data analysis will be available by the end of Phase III 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.