Moscow, November 11
Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with Western drugmakers in the race for a shot.
The initial results are only the second to be published from a late-stage human trial in the global effort to produce vaccines that could halt a pandemic that has killed more than 1.2 million people and ravaged the world economy.
Russia registered its COVID-19 vaccine for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September.
“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.
The interim results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine, the Russian Direct Investment Fund (RDIF), which has been backing the vaccine and marketing it globally, said.
The interim analysis was conducted after 20 participants in the trial developed COVID-19 and examined how many had received the vaccine versus a placebo.
That is significantly lower than the 94 infections in the trial of a vaccine being developed by Pfizer Inc and BioNTech. To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases.
The Russian trial will continue for six more months, RDIF said in a statement, and data from the trial will also be published in a leading international medical journal following a peer review.
The so-called Phase III trial of the shot developed by the Gamaleya Institute is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.
The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said.
That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.
Russia’s announcement follows swiftly on from results posted on Monday by Pfizer and BioNTech, who said their shot was also more than 90% effective.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.
The Sputnik V vaccine is designed to trigger a response from two shots administered 21 days apart each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.
The drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Putin.
Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.
“Studies have already shown and confirmed that, firstly, these vaccines are safe and have no serious side effects after use, and secondly, they are all effective,” the RIA news agency quoted Putin as saying.
RDIF said no serious side effects had been reported during the Sputnik V Phase III trial so far.
Successful vaccines are seen as a crucial to restoring daily life around the world by helping end the health crisis that shuttered businesses and put millions out of work.
Russia registered the vaccine for domestic use in August, prior to the start of the large-scale trial, and has also inoculated 10,000 people considered at high risk of COVID-19 outside of the trial
Putin has said that Russia expects to start mass vaccinations by the end of the year.
“The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks,” Alexander Gintsburg, director of the Gamaleya Institute, said.
Moscow is rolling out a large network of vaccination rooms and residents who want the shot may be able to get it as early as next month if large volumes of doses are supplied by then, Deputy Mayor Anastasia Rakova said on Oct. 30.
However, production challenges remain. Earlier estimates that Russia could produce 30 million doses of the vaccine this year have since been scaled down.
Moscow aims to produce 800,000 doses this month, industry minister Denis Manturov has said, followed by 1.5 million in December. But significantly higher volumes of output per month are expected from early 2021.
Manturov cited issues with scaling up production from small to large-volume bioreactors, while Putin last month cited issues with the availability of equipment.
Officials have said that domestic production of the vaccine will be used first to meet Russia’s needs.
RDIF, however, has also struck several international supply deals, amounting to 270 million doses in total.
It is expected that these will in large part be produced in other countries and RDIF has previously announced a deal to manufacture 300 million doses in India and an undisclosed amount of doses in Brazil, China and South Korea.
Trials of the vaccine have also begun in Belarus, and are on track to begin soon in the United Arab Emirates, Venezuela and India.
Russia reported 19,851 new coronavirus infections in the past 24 hours and a record high of 432 deaths. At 1,836,960, its overall case tally is the fifth largest in the world, behind the United States, India, Brazil and France.
Authorities, however, have been adamant that severe lockdown restrictions, like those seen in the spring, will not be reintroduced. Reuters