Russia’s Sputnik V coronavirus vaccine has so far been shown to be 92 percent effective, the country’s sovereign wealth fund, which is backing the program, said in a statement Wednesday.
The assessment was based on interim results of ongoing Phase III trials, the Russian Direct Investment Fund said.
“The Sputnik V vaccine efficacy amounted to 92%,” RDIF said based on a calculation of 20 confirmed virus patient cases divided between those who received the vaccine and those who were given a placebo, out of 40,000 volunteers participating in the trial.
“There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing,” RDIF said.
Russian Health Minister Mikhail Murashko lauded the results as demonstrating that the vaccine “is an efficient solution to stop the spread of coronavirus infection, а preventive healthcare tool, and this is the most successful path to defeat the pandemic,” according to an English-language statement.
“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev.
Sputnik V is being developed by the Gamaleya Institute, which will publish the interim research data in one of the leading international peer-reviewed medical journals following a further six months of testing, RDIF added.
Alexander Gintsburg, director of the Gamaleya Institute, said the vaccine will soon be available for a wider population.
“This will break the current trend and lead to an eventual decrease in COVID-19 infection rates, first in Russia, then globally,” he predicted.
Russia registered the vaccine for public use in August, in an unusual move, before the Phase III trials were started in September.
The Phase III trial involved 40,000 volunteers in 29 clinics in Moscow. A quarter received a placebo. In addition, 10,000 people considered at high risk from the virus were also inoculated.
With its reported efficacy of 92%, Sputnik V is high above the 50% effectiveness threshold for a COVID-19 vaccine set by the US Food and Drug Administration. It requires two shots spaced 21 days apart.
The vaccine was named after the Sputnik space program, which saw Russia first to put a satellite into orbit in 1957, an indication of the importance Russian officials see in beating the US to produce a working vaccine.
Requests for more than 1.2 billion doses of Sputnik V vaccine have come so far from over 50 countries, RDIF said.
Israel has shown interest in the vaccine ever since Russia announced that it was ready for human trials, and last week the director of Jerusalem’s Hadassah Medical Center said the hospital had ordered 1.5 million units of the vaccine and would apply for Health Ministry approval for their use, pending the Phase III trials.
Hadassah Medical Center in Moscow, a branch of the Israeli hospital, is involved in the administration and monitoring of the Phase III vaccine trial. Jerusalem Hadassah Medical Center CEO Zeev Rotstein said Russian authorities had asked Hadassah to file the paperwork for approval of the vaccine with Israel’s Health Ministry.
Israel is also working on its own locally produced vaccine and began human trials last week.
Russia was the first country to register a vaccine when it announced it had a ready-to-use product in August. At the time, Israel’s Health Minister Yuli Edelstein said that Israel would be interested in talking with Russia about the vaccine, if it is shown to work.
On Monday, US-based pharmaceutical company Pfizer and its German partner BioNTech reported that its vaccine, being developed with BioNTech, has been 90% effective in trials.
A vaccine is seen as the best hope to break the cycle of deadly virus surges and severe restrictions across much of the world since COVID-19 first emerged in China late last year and unleashed devastation on the global economy.
So far 1.2 million people have died of COVID-19, the disease caused by the virus.
Source: Stuart Winer – TOI. AFP contributed to this report.