Russia's Sputnik V at least 91% effective, early data suggests
The Russian vaccine for COVID-19, called Sputnik V, has been found at least 91% effective in the second interim analysis. According to a press release, the vaccine was found to be 91.4% effective seven days after the second dose was administered, and 95% effective two weeks later. Notably, human trials for the vaccine are set to begin in India this week.
An analysis conducted seven days after the second dose (28 days after the first dose) found the vaccine to be 91.4% effective. Out of the 18,794 trial participants, 14,095 had received the vaccine dose while 4,699 were in the placebo group (in a 3:1 ratio). Of the 39 confirmed COVID-19 infections among participants, only eight were those who had received the vaccine.
Preliminary data from volunteers obtained 21 days after the second dose—42 days after the first dose—indicated efficacy of above 95%, the press release stated. Notably, as of Tuesday, over 22,000 participants had received the first dose, while over 19,000 had received first and second doses.
As per protocol, Sputnik V's interim efficiency is to be calculated when COVID-19 infections among trial participants reach 20, 39, and 78. The latest data is from the second interim analysis when 39 cases have been confirmed. The next interim data will be conducted when there are 78 COVID-19 cases among participants. Final data will be available after Phase III trials conclude.
Currently, there are 40,000 participants in Phase III double-blind, randomized, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia. There were no unexpected adverse events during the trials, the release said. However, participants continue to be monitored currently. Gamaleya Center will provide access to the full clinical trial report after the Phase III trials are complete.
Mikhail Murashko, Minister of Health of the Russian Federation, said, "The data demonstrating high efficacy of the Sputnik V vaccine gives us hope that we will soon obtain the most important tool in the fight against the pandemic of the novel coronavirus infection." Meanwhile, Alexander Gintsburg, Gamaleya Center Director, said they had "every reason to believe that the (final) results will exceed our expectations."
RDIF CEO Kirill Dmitriev said, "Gamaleya Center has developed one of the most efficient vaccines against coronavirus in the world with an efficacy rate of more than 90% and a price that is two times lower than that of other vaccines with similar efficacy rate." Dmitriev said the "use of two different human adenoviral vectors...allows for a stronger and longer-term immune response."
Among other leading vaccine candidates, Moderna has said that its product has 94.5% efficacy. Pfizer and BioNTech's vaccine candidate has been found 95% effective, while Oxford University and AstraZeneca's candidate—dubbed 'Covishield' in India—has an average efficacy of 70%, which can be increased to 90% through dosing.
Earlier it had been reported that Phase II-III combined trials for Sputnik V will start in India this week. The Hyderabad-based Dr. Reddy's Laboratories has struck a deal to conduct vaccine trials and distribution of the vaccine in India. India is expected to receive 100 million doses of the potential vaccine, developed jointly by the Russian Direct Investment Fund (RDIF) and the Gamaleya Institute.
