Russia’s Sputnik V vaccine is 92 per cent effective at protecting people from Covid-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday.
The first interim data analysis of the Sputnik V vaccine against Covid-19 Phase 3 clinical trials in the Russian Federation demonstrated 92 per cent efficacy.
Currently, Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, UAE, Venezuela and other countries, as well as Phase II-III in India.
Trials conducted under the civil use of the vaccine in Russia (not being a part of clinical trials) based on the monitoring of 10,000 vaccinated confirmed vaccine efficacy at a rate of over 90 per cent.
There were no unexpected adverse events during the trials. The monitoring of the participants is ongoing.
Efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection.
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.
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