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Russia’s coronavirus vaccine, called Sputnik V, is 91.6% effective in preventing symptomatic COVID-19, according to a peer-reviewed analysis published on Tuesday.
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The country approved its vaccine in August, before conducting clinical trials in the final stage.
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Experts fear the controversial approach could ignore potentially dangerous side effects – but the new results indicate that Russia’s risky gamble may have paid off.
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Russia became the first country to approve a coronavirus vaccine in August and began distributing the vaccines in early December. There is now some reliable data that these vaccines can be just as effective as those authorized for emergency use in the United States and the United Kingdom.
Unlike the United States or the United Kingdom, Russia approved its vaccine – called Sputnik V – before conducting phase 3 tests. These end-stage tests generally evaluate medical treatment on tens of thousands of people to determine how it works, to ensure that is safe and discover any side effects.
When Russia approved Sputnik V for distribution, only 38 people had received the vaccine in clinical trials. They all produced antibodies and the side effects were mostly mild – including high temperatures and headaches. This research has not gone through peer review, however.
Watch: the Russian Sputnik V vaccine is 91.6% effective
As Sputnik V was distributed to frontline health professionals in December, medical experts warned that the data was insufficient to determine whether the vaccine was safe and effective. Some scientists have suggested that vaccine approval may have been rushed for political reasons.
But Russia’s risk seems to be paying off. An interim analysis of the phase 3 studies published in The Lancet on Tuesday suggests that Sputnik V is 91.6% effective in preventing symptomatic COVID-19.
“I think everything was done perfectly and this moment is, in a way, a moment of revenge,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), told Insider in an exclusive interview on Tuesday. RDIF is one of the largest sovereign wealth funds in the world and supervised and financed the development of Sputnik V.
Dr. Julian Tang, a consulting virologist at the University of Leicester in the UK, told Insider that the country’s risky approach “has been justified to some extent now”.
Russia has made progress in vaccines, despite the negative impact
Sputnik V is administered in two doses. Each dose depends on a different adenovirus – relatively harmless viruses associated with the common cold – to deliver a gene that encodes the coronavirus spike protein, which helps it bind and invade cells. In theory, this should train the immune system to produce antibodies that prevent symptomatic diseases.
The Gamaleya Institute in Moscow and the Russian Ministry of Defense developed the vaccine together.
Russian President Vladimir Putin announced on August 11 that the country’s health agency approved the new vaccine after phase 1 and 2 clinical trials. Some virus experts feared that any serious side effects missed in the first tests could harm the public confidence in other vaccines as well.
“This is an imprudent and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both for its negative health effects, but also because it would further delay the acceptance of vaccines. in, “said François Balloux, a geneticist at University College London, in a statement distributed by the UK’s Science Media Center.
Despite these concerns, the Russian health ministry began producing batches of the vaccine in August. In December, the country was offering its first doses to essential workers, such as teachers and health professionals.
“We recorded in August why? Because we know it is a safe human adenoviral platform tested for decades. It is very different from an mRNA vaccine that has not been tested in the long term,” said Dmitriev. “So, we do this and give it only to high-risk people who want to take it. And therefore, as early as September, we were able to save people, protect lives and create this safety net for basically some of the high-risk people. “
Phase 3 trials were ongoing at the time, but it would take months before they produced reliable results.
‘Good news’ from phase 3
In November, Russia announced that preliminary data from phase 3 trials showed that its vaccine was 92% effective in preventing COVID-19. But the data was based on just 20 confirmed cases of COVID-19, divided between the group of participants who were vaccinated and the group who received a placebo, according to a press release. It had not yet undergone peer review.
The peer-reviewed analysis published on Tuesday, however, was based on a group of nearly 15,000 people who received doses of Sputnik V. Of that group, only 16 people confirmed cases of COVID-19 21 days after their first dose, compared to 62 out of 4,902 people in the placebo group. None of the vaccinated people had moderate or severe symptoms.
The phase 3 study relied on participants to report any symptoms in order to test and identify new cases after vaccination. But researchers still don’t know how effective Sputnik V is in preventing infection or asymptomatic transmission. The US does not have the same data for the Pfizer and Moderna vaccines.
“The development of the Sputnik V vaccine has been criticized for improper haste, cutting corners and the lack of transparency,” British virologists Ian Jones and Polly Roy wrote in an editorial accompanying the new study on Tuesday. “But the result reported here is clear and the scientific principle of vaccination is demonstrated, which means that another vaccine can now join the fight to reduce the incidence of COVID-19.”
Ashish Jha, dean of the Brown University School of Public Health, called the results “good news”.
“We need all the effective and safe vaccines we can get,” he I wrote on twitter.
Sixteen foreign countries or sovereign states have already approved Russia’s photos: Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, Guinea and Tunisia.
Dmitriev said he expects Sputnik V to be registered in 25 countries by the end of next week, but requesting regulatory approval in the United States and the United Kingdom is not a priority.
Andrew Dunn, Dr. Catherine Schuster-Bruce, Sinéad Baker and Susie Neilson contributed to the report.
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Originally published