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MOSCOW (REUTERS) – Russia’s Sputnik V vaccine is 92 percent effective in protecting people from Covid-19 based on the results of interim trials, the country’s sovereign wealth fund said on Wednesday (November 11), as Moscow rushes to keep pace with Western pharmaceutical companies in the race for a shot.
The initial results are only the second to be published of a late-stage human trial in the global effort to produce vaccines that could stop a pandemic that has killed more than 1.2 million people and devastated the world economy.
Russia registered its Covid-19 vaccine for public use in August, the first country to do so, although 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 the director of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, adding that it was the kind of news that the developers of the vaccine would one day talk to their grandchildren.
Interim results are based on data from the first 16,000 trial participants who received both injections of the two-dose vaccine, said the RDIF, which has been endorsing the vaccine and marketing it globally.
The interim analysis was performed after 20 trial participants developed Covid-19 and examined how many had received the vaccine versus a placebo.
That’s significantly lower than the 94 infections in a vaccine trial being developed by Pfizer and BioNTech. To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 cases of Covid-19.
The Russian trial will continue for a further six months, the RDIF said in a statement, and the trial data will also be published in a leading international medical journal after peer review.
The so-called phase III trial of the vaccine developed by the Gamaleya Institute is being carried out in 29 Moscow clinics and will involve 40,000 volunteers in total, and a quarter will receive a placebo injection.
The chances of contracting Covid-19 were 92 percent lower among people vaccinated with Sputnik V than among those who received the placebo, the RDIF said.
That was well above the 50 percent effectiveness threshold for Covid-19 vaccines set by the US Food and Drug Administration.
Russia’s announcement quickly follows results published Monday by Pfizer and BioNTech, who said their injection was also more than 90 percent 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 elicit a response from two injections given 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 to Russian President Vladimir Putin.
Russia is also testing a different vaccine, produced by the Institute of Vectors in Siberia, and is about to register a third, Putin said 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,” Putin said, citing the RIA news agency.
The RDIF said that so far no serious side effects had been reported during the phase III trial of Sputnik V.
Vaccine success is seen as critical to restoring daily life around the world by helping to end the health crisis that shuttered businesses and put millions of people out of work.
Russia registered the vaccine for home use in August, prior to the start of the large-scale trial, and has also inoculated 10,000 people deemed at high risk for Covid-19 outside of the trial. Putin has said that Russia hopes to start mass vaccinations by the end of the year.
“The publication of interim results of post-registration clinical trials convincingly demonstrating the efficacy of the Sputnik V vaccine ushers in mass vaccination in Russia against Covid-19 in the coming weeks,” said microbiologist Alexander Gintsburg, director of the Gamaleya Institute.
Moscow is rolling out a large network of vaccination rooms and residents who want the injection can receive it next month if large volumes of doses are delivered by then, Deputy Mayor Anastasia Rakova said on October 30.
However, production challenges remain. Previous estimates that Russia could produce 30 million doses of the vaccine this year have since been lowered.
Moscow aims to produce 800,000 doses this month, said Industry Minister Denis Manturov, followed by 1.5 million in December. But significantly higher production volumes per month are expected from early 2021.
Manturov cited problems with increasing the production of bioreactors from small to large volume, while Putin last month cited problems with the availability of equipment.
Officials have said that domestic production of the vaccine will be used first to meet Russia’s needs.
The RDIF, however, has also closed several international supply agreements, for a total of 270 million doses.
These are expected to be produced largely in other countries and the RDIF has previously announced an agreement to manufacture 300 million doses in India and an undisclosed number of doses in Brazil, China and South Korea.
Trials of the vaccine have also started 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 432 deaths. At 1,836,960, its overall case count is the fifth-largest in the world, behind the United States, India, Brazil, and France.
However, authorities have insisted that severe confinement restrictions, such as those seen in the spring, will not be reintroduced.
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