- The Russian coronavirus vaccine is 91.6% effective, according to an interim analysis of phase 3 data published in The Lancet.
- Russia approved the drug for emergency use in August, ahead of Phase 3 studies, and began giving it to the public in December.
- An expert said the study had some caveats, but the results seem to support Russia’s strategy.
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The Russian coronavirus vaccine Sputnik V is 91.6% effective, an interim analysis of the Phase 3 data shows, five months after the country approved the vaccine for use and started giving it to humans.
The peer-reviewed study was published Tuesday in The Lancet. According to The Lancet, many of the study’s authors are affiliated with the Russian Ministry of Health.
Dr. Julian Tang, a consultant virologist at the British University of Leicester, said the interim analysis found the vaccine to be 91.6% effective after two doses.
But he noted that the trial was only conducted on participants who self-reported symptoms and then tested, meaning the results included only people with COVID-19 symptoms.
“Further research is needed to understand the vaccine’s efficacy on asymptomatic COVID-19 and transmission,” said Tang.
He added that the mean follow-up with participants was 48 days after the full dose, so the study provides no evidence for how long vaccine protection lasts.
Russia approved the Sputnik V emergency vaccine in August 2020, becoming the first country in the world to approve a coronavirus vaccine.
Approval came before the vaccine had undergone phase 3 studies, which are considered essential to ensure the safety of a drug and may reveal rarer side effects.
At the time, medical experts suggested vaccine production may have been rushed for political reasons, and warned of dangerous side effects.
Read more: What’s Next for COVID-19 Vaccines? Here’s the latest on 11 leading programs.
Tang said Tuesday’s interim results to some extent justify Russia giving the vaccine to humans ahead of the results of the Phase 3 trial.
“So despite previous doubts about how this Russian Sputnik V vaccine was being rolled out more widely – pending sufficient phase 3 research data – this approach is now to some extent justified,” he said.
He added that while Russia’s strategy has been criticized, other countries have also made “compromises” in rolling out their vaccines.
He pointed to the UK, where the government decided to delay people’s second vaccination dose in order to give as many people their first dose as soon as possible, and where it approved the vaccine for 55-year-olds, although few people of that age were included in clinical studies.
“So we have to be more careful not to be overly critical of vaccine designs / programs in other countries,” he said.