- Russia’s coronavirus vaccine is 91.6% effective, said an interim analysis of phase 3 data published in The Lancet.
- Russia approved the drug for emergency use in August, before the phase 3 tests, and began distributing it to the public in December.
- An expert said the study has some caveats, but that the results appear to endorse Russia’s strategy.
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The Russian Sputnik V coronavirus vaccine is 91.6% effective, concluded an interim analysis of its phase 3 data, five months after the country approved the use of the vaccine and started administering it to people.
The peer-reviewed study was published in The Lancet on Tuesday. Many of the study’s authors are affiliated with the Russian Ministry of Health, according to The Lancet.
Dr. Julian Tang, a consultant virologist at the University of Leicester in the United Kingdom, said the interim analysis showed that the vaccine is 91.6% effective after two doses.
But he noted that the test was conducted only on participants who reported symptoms and were tested, meaning that the results include only people with symptoms of COVID-19.
“More research is needed to understand the vaccine’s effectiveness in asymptomatic and transmission COVID-19,” said Tang.
He added that the average follow-up with the participants occurred 48 days after the full dose, so the study does not offer evidence of how long the vaccine is protected.
Russia approved the Sputnik V vaccine for emergency use in August 2020, making it the first country in the world to approve a coronavirus vaccine.
The approval came before the vaccine passed phase 3 tests, which are considered essential to ensure the safety of a drug and may reveal more rare side effects.
At the time, medical experts suggested that vaccine production may have been hastened for political reasons and warned of dangerous side effects.
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Tang said Tuesday’s provisional results justified, to some extent, that Russia gave people the vaccine before the results of the phase 3 trial.
“So despite previous doubts about how the Russian Sputnik V vaccine was launched more widely – before enough data from the phase 3 trial – this approach has been justified to some extent now,” he said.
He added that while Russia’s strategy has received criticism, other countries have also made “concessions” when launching their vaccines.
He pointed to the UK, where the government decided to postpone giving people the second dose of the vaccine to give as many people the first dose as soon as possible, and where he approved the vaccine for 55-year-olds, although few people of that age were included in clinical trials.
“Therefore, we must be more careful not to be overly critical of other countries’ vaccine projects / programs,” he said.