- The Russian coronavirus vaccine, called Sputnik V, is 91.6% effective in preventing symptomatic COVID-19, according to a peer-reviewed analysis published on Tuesday.
- The country approved its vaccine in August before conducting clinical trials in the late stages.
- Experts are concerned that the controversial approach misses out on potentially dangerous side effects, but the new results suggest that Russia’s risky bet may have borne fruit.
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Russia became the first country to approve a coronavirus vaccine in August and began spreading shots in early December. Now there is reliable data that the vaccines can be about as effective as those allowed for emergency use in the US and UK.
Unlike the US or the UK, Russia approved its vaccine – called Sputnik V – before conducting Phase 3 trials. These late-stage trials usually evaluate a medical treatment in tens of thousands of people to determine how well it works, to ensure it is safe, and to detect side effects.
When Russia approved Sputnik V for distribution, only 38 people received the vaccine in clinical trials. All produced antibodies, and side effects were mostly mild – including elevated temperatures and headaches. However, this research did not undergo peer review.
Since Sputnik V was distributed to frontline health workers in December, medical experts warned that the data were insufficient to determine whether the vaccine was safe and effective. Some scientists suggested that the political approval of the vaccine could be approved.
But Russia’s risk seems to be bearing fruit. An interim analysis of phase 3 trials published in The Lancet on Tuesday suggests that Sputnik V is 91.6% effective in preventing symptomatic COVID-19.
“I think everything is done perfectly and this moment is in some ways a moment of justice,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), told Insider in an exclusive interview on Tuesday. The RDIF is one of the world’s largest sovereign wealth funds and oversaw and funded the development of Sputnik V.
Dr. Julian Tang, a consultant virologist at the University of Leicester, told Insider that the country’s risky approach was ‘to some extent justified’.
Russia, despite setbacks, vaccinated over vaccinations
Medical workers are preparing to draw blood from volunteers participating in a coronavirus trial insurance on 15 July 2020 at the Budenko Main Military Hospital outside Moscow, Russia.
Russian Defense Ministry press service via AP, File
Sputnik V is given in two doses. Each dose depends on a different adenovirus – relatively harmless cold-related viruses – to produce a gene that encodes the coronavirus’ ear protein, which helps it bind and invade cells. In theory, it should train the immune system to produce antibodies that prevent symptomatic diseases.
The Gamaleya Institute in Moscow and the Russian Ministry of Defense have developed the vaccine in tandem.
Russian President Vladimir Putin announced on August 11 that the country’s health agency had approved the new vaccination after Phase 1 and 2 clinical trials. Some virus experts feared that serious side effects missed in the early trials could also undermine public confidence in other vaccines.
“This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous, as well as the negative consequences for health, but also because of the acceptance of vaccinations in the population, ‘said Francois Balloux, a geneticist at University College London, in a statement released by the UK Science Media Center.
Despite these concerns, the Russian Ministry of Health began producing groups of the vaccine in August. By December, the country had offered its first doses to essential workers such as teachers and health workers.
“We registered it in August. Why? Because we know it is a safe human adenoviral platform that has been tested for decades. It is very different from an mRNA vaccine that has not been tested at all in the long term,” Dmitriev said. . “So we do it and give it only to high-risk staff who want to take it. And that’s why we were able to save people, protect lives and create this basic safety net for some of the high-risk staff as early as September.”
Phase 3 trials were underway at the time, but it would take months before it yielded reliable results.
‘Good news’ from phase 3
A medical specialist holds a vial of Sputnik V on January 18, 2021 in Moscow, Russia.
Shamil Zhumatov / Reuters
In November, Russia announced that preliminary data from Phase 3 trials showed that the vaccine was 92% effective in preventing COVID-19. But the data were based on only 20 confirmed COVID-19 cases, divided between the group of participants who were vaccinated and the group that received a placebo, according to a press release. It has not yet undergone a peer review.
However, the peer-reviewed analysis published on Tuesday was based on a group of nearly 15,000 people who received the dose of Sputnik V. Of the group, only 16 people confirmed COVID-19 cases 21 days after their first dose, compared with 62 out of 4,902 people in the placebo group. None of the vaccinated had moderate or severe symptoms.
The phase 3 trial indicated that participants had to report symptoms themselves to test and identify new cases after vaccination. But researchers do not yet know how effective Sputnik V is in preventing asymptomatic infection or transmission. The US lacks the same data for both the Pfizer and Moderna vaccines.
“The development of the Sputnik V vaccine has been criticized for insignificant haste, cutting corners and the absence of transparency,” British virologists Ian Jones and Polly Roy wrote Tuesday in an editorial accompanying the new study. “But the outcome reported here is clear and the scientific principle of vaccination is being shown, which means another vaccine can now fight to reduce the incidence of COVID-19.”
Ashish Jha, dean of the Brown University School of Public Health, calls the results ‘good news’.
“We need all the safe, effective vaccines we can get,” he said. wrote on Twitter.
On January 28, 2021, workers unload containers carrying the first batch of Sputnik V at El Alto International Airport, Bolivia.
David Mercado / Reuters
Sixteen foreign countries or sovereign states have already approved Russia’s shootings: Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, Guinea and Tunisia.
Dmitriev said he expected Sputnik V to be registered in 25 countries by next week, but not to apply for regulatory approval in the US and UK.
Andrew Dunn, dr. Catherine Schuster-Bruce, Sinéad Baker and Susie Neilson reported.