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Russia’s Sputnik V vaccine is 92% effective in protecting people from COVID-19 according to results from the interim trial, the country’s sovereign wealth fund said Wednesday as Moscow rushes to keep pace with Western drug makers 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 stop a pandemic that has killed more than 1.2 million people and devastated the world economy.
The findings are based on data from the first 16,000 trial participants who received both shots of the two-dose vaccine, the Russian Direct Investment Fund (RDIF), which supported its development and marketed it globally, it said.
“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the kind of news that the vaccine developers would talk to their grandchildren one day.
The analysis was conducted after 20 study participants developed COVID-19 and looked at how many received the vaccine versus a placebo.
This is significantly lower than the 94 infections in a vaccine trial developed by Pfizer Inc and BioNTech. To confirm the effectiveness rate, Pfizer said it would continue its trial until there were 164 cases of COVID-19.
RDIF said the Russian trial will continue for another six months and that the study data will also be published in a leading international medical journal following a peer review.
European equities and US equity futures widened their gains slightly after Russia’s announcement.
Another push
Russia’s announcement quickly follows results released Monday by Pfizer and BioNTech, which said their coup was also more than 90% effective.
The Russian findings are another boost to other COVID-19 vaccines currently in development and are a proof of concept that the disease can be stopped with a vaccination.
Experts said knowledge of the study’s design and protocol was poor, making it difficult to interpret the data released on Wednesday.
Scientists raised concerns about the speed at which Moscow worked, giving the green light to regulations for shooting and launching a mass vaccination program before full trials to test its safety and effectiveness were completed.
Russia registered its COVID-19 vaccine for public use in August, the first country to do so, although approval came before the large-scale trial began in September.
The so-called phase three stroke trial developed by the Gamaleya Institute is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, of which a quarter will receive a placebo shot.
The chances of contracting COVID-19 were 92 percent lower among people vaccinated with Sputnik V than those who received placebo, the RDIF said.
This is well above the 50% efficacy threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.
“I see no a priori reasons not to believe these results, but it is very difficult to comment, because there is so little data there,” said Danny Altmann, professor of immunology at Imperial College London.
He said that while the Russian release was similar in its level of detail to Pfizer and BioNTech, the key difference is that Pfizer’s release took place against the backdrop of a wide range of published data on how the process was designed, the its protocol and what its endpoints were.
The results of the early stage studies were peer-reviewed and published in September in the medical journal The Lancet.
Sputnik V
The Russian drug is named Sputnik V from the Soviet-era satellite that triggered the space race, a nod to the geopolitical importance of the project for Russian President Vladimir Putin.
The vaccine is designed to trigger 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 Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as real virus particles.
Russia is also testing a different vaccine, made by the Vector Institute in Siberia, and is on the verge of registering a third, Putin said Tuesday, adding that all of the country’s vaccines have been effective.
RDIF said that as of November 11, no serious side effects have been reported during the phase III study of Sputnik V.
Some volunteers experienced minor short-term side effects such as injection site pain, flu-like symptoms including fever, weakness, fatigue, and headache, he said.
Mass vaccinations
Successful vaccines are seen as crucial to restoring daily life around the world, helping to end the health crisis that has closed businesses and put millions out of work.
Russia registered the vaccine for home use in August and also inoculated 10,000 people considered to be at high risk for COVID-19 outside the study.
Putin said Russia plans 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 gives way to mass vaccination in Russia against COVID-19 in the coming weeks,” said Alexander Gintsburg, director of the Gamaleya Institute.
Moscow is developing a large network of vaccination rooms, and residents who want the injection may be able to get it as early as next month if large volumes of doses are provided by that date, Deputy Mayor Anastasia Rakova said on Oct.30.
However, the manufacturing challenges remain. Previous estimates that Russia could produce 30 million doses of the vaccine this year have been reduced.
Moscow aims to produce 800,000 doses this month, Industry Minister Denis Manturov said, followed by 1.5 million in December. But since the beginning of 2021, significantly higher production volumes are expected per month.
Manturov cited problems with increasing production from small to large volume bioreactors, while Putin last month cited problems with equipment availability.
In late October, the vaccination of new volunteers was temporarily suspended due to high demand and dose shortages.
Officials said domestic production of the vaccine will be used first to meet Russia’s needs.
RDIF, however, has also entered into several international supply agreements, totaling 270 million doses.
These are expected to be largely produced in other countries, and RDIF previously announced a deal to produce 300 million doses in India and an undisclosed amount of doses in Brazil, China and South Korea.
Trials have also started in Belarus and are expected 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. With 1,836,960, its overall number of cases is fifth in the world, behind the United States, India, Brazil and France.
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