Russia says its Sputnik V COVID-19 vaccine is 92% effective

Russia’s Sputnik V vaccine is 92 percent effective in 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 vaccine race.

The first results are only the second to be published from a late-stage human trial in the global effort to produce vaccines that could end a pandemic that has killed more than 1.2 million people and devastated the global economy.

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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.

“We are showing, based on the data, that we have a very effective vaccine,” said RDIF director Kirill Dmitriev, adding that this was the kind of news the vaccine developers would one day discuss with their grandchildren. .

The interim results are based on data from the first 16,000 trial participants to receive the two injections of the two-dose vaccine, said the Russian Direct Investment Fund (RDIF), which supports the vaccine and markets it globally. whole.

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The interim analysis was conducted after 20 trial participants developed COVID-19 and looked at how many of them had received the vaccine compared to a placebo.

This is significantly lower than the 94 infections in the trial of a vaccine under development by Pfizer Inc and BioNTech. To confirm the rate of effectiveness, Pfizer said it would continue its trial until there are 164 cases of COVID-19.

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The Russian trial will continue for another six months, RDIF said in a statement, and data from the trial will also be published in a leading international medical journal following peer review.

SPUTNIK V

The so-called phase III trial of the vaccine developed by the Gamaleya Institute is taking place in 29 clinics in Moscow and will involve a total of 40,000 volunteers, a quarter of whom will receive a placebo.

The odds of contracting COVID-19 were 92% lower in people vaccinated with Sputnik V than in 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 quickly follows results released Monday by Pfizer and BioNTech , who said their shot was also over 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 real viral particles.

The Sputnik V vaccine is designed to elicit a response from two injections given 21 days apart each on the basis of different viral vectors that normally cause colds: the human adenoviruses Ad5 and Ad26.

The drug is named Sputnik V after the Soviet-era satellite that started the space race, a nod to the project’s geopolitical importance to Putin.

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Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is close to registering a third, Putin said on Tuesday, adding that all vaccines in the country were effective.

“Studies have already shown and confirmed that, on the one hand, these vaccines are safe and have no serious side effects after use, and on the other hand, they are all effective,” Putin said, quoted by the RIA news agency.

RDIF said no serious side effects have been reported during the Phase III Sputnik V trial so far.

MASS VACCINATIONS

Effective vaccines are seen as essential to restoring daily life around the world by helping to end the health crisis that has closed businesses and put millions of people out of work.

Russia registered the vaccine for home use in August, before the large-scale trial began, and also inoculated 10,000 people considered to be at high risk of COVID-19 outside of the trial.

Putin said Russia plans to start mass immunizations by the end of the year.

“The publication of interim results from post-registration clinical trials that convincingly demonstrate the effectiveness 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.

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Moscow is deploying a large network of immunization rooms and residents who want the vaccine may be able to get it as early as next month if large volumes of doses are provided 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 revised downwards.

Moscow aims to produce 800,000 doses this month, Industry Minister Denis Manturov said, followed by 1.5 million in December. But significantly higher production volumes per month are expected from the start of 2021.

Manturov spoke of problems with increasing production of small to large volume bioreactors, while Putin last month raised issues with equipment availability.

Officials said domestic production of the vaccine would first be used to meet Russia’s needs.

However, RDIF 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 manufacture 300 million doses in India and an undisclosed amount of doses in Brazil, China and Korea. from South.

Trials of the vaccine have also started in Belarus and are expected to begin soon in the United Arab Emirates, Venezuela and India.

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Russia has reported 19,851 new coronavirus infections in the past 24 hours and a record 432 deaths. At 1,836,960, its case total is the fifth in the world, behind the United States, India, Brazil and France.

Authorities, however, have insisted that severe lockdown restrictions, like those seen in the spring, will not be reintroduced.

(Reporting by Polina Ivanova; Editing by David Clarke)