KUALA LUMPUR, Dec 15 — Russia’s Sputnik V vaccine is 91.4 per cent effective at preventing Covid-19 infection, developers said yesterday, citing new analysis of data from Phase 3 trials.
Russia’s state-run Gamaleya National Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) said in a statement that efficacy of the Sputnik V coronavirus vaccine was determined from data obtained 21 days after study participants received the first dose of the two-dose regimen.
Gamaleya and RDIF said that among the 17,302 individuals that received the Sputnik V vaccine, 16 of them contracted the coronavirus, while 62 out of 5,682 individuals who got the placebo shot contracted Covid-19. This translates to an efficacy rate of 91.4 per cent.
“The data analysis at the third and final control point of the Sputnik V vaccine clinical trials confirmed the efficacy of the vaccine of over 90 per cent,” RDIF CEO Kirill Dmitriev said in a statement.
“The data obtained will lay a basis for a report that will be used to submit applications for accelerated registration of the Russian vaccine in other countries.”
Besides that, the Sputnik V vaccine has also been proven to be 100 per cent effective at preventing severe cases of Covid-19.
Among the 22,714 individuals who were involved in the trial, a total of 20 severe Covid-19 cases were reported among those who received the placebo shot, while no severe Covid-19 cases were reported among those who received the vaccine.
The Sputnik V vaccine uses two different human adenoviral vectors-engineered viruses, which will shuttle a gene from the coronavirus into the body, where the cells will read it and make spike proteins that provide stronger and long-term immunity.
With the Sputnik V vaccine, the coronavirus itself cannot enter the body as the vaccine only contains genetic information about part of the virus’s outer protein coat. Hence, this eliminates the possibility of getting infected with the coronavirus after getting the vaccine.
During the Phase Three clinical trial, the safety of the Sputnik V vaccine was constantly monitored and the information was also analysed by an independent monitoring committee comprising leading scientists, said vaccine developers.
As of December 14, over 26,000 volunteers across Belarus, the United Arab Emirates (UAE), Venezuela and other countries, including India, have been a part of the Phase Three clinical trial.
Only short-term minor adverse events have been reported, like pain at the injection site, flu-like symptoms including fever, weakness, fatigue, and headache. However, there has not been any unexpected adverse events reported so far.
Gamaleya Center deputy director Denis Logunov said that they will continue to monitor the participants’ conditions for at least six months after receiving the first jab, and will share the results with the scientific community.
Russia will be selling one dose of the vaccine at a cost of less than US$10 (RM40.61) for international markets, which means for two doses of the vaccine, it will cost less than US$20 (RM81.22).
The Sputnik V vaccine will also be produced in a dry form (lyophilized) that can be stored at a temperature of between two and eight degrees Celsius, enabling easier distribution of the vaccine.
Gamaleya Center director Alexander Gintsburg said in the statement that he believes that Russia will be able to vaccinate most of its population by 2021.
Over 50 countries have requested for 2.4 billion doses of the Sputnik Vaccine to vaccinate 1.2 billion people. The Sputnik V vaccine will be produced with RDIF’s international partners in India, Brazil, China, South Korea and other countries.
RDIF is a Russian sovereign wealth fund developed in 2011 to make equity co-investments and acts as a catalyst for direct investment for the Russian economy. RDIF has established partnerships with leading international co-investors from 18 over countries that total more than US$40 billion.