The makers of Russia’s flagship Covid-19 vaccine said on Tuesday that interim results from phase 3 trials showed efficacy rates of “above 95 per cent”, overperforming some of the most effective of the western vaccines that have released results.
Moscow’s state-run Gamaleya Institute said data from nearly 19,000 volunteers showed the vaccine’s efficacy was 91.4 per cent 28 days after they received the first dose of the two-shot jab, rising beyond 95 per cent in preliminary results after 42 days.
The Kremlin is trumpeting the two-shot jab, known as Sputnik V after the Soviet satellite that kicked off the space race, as an alternative to vaccines from Moderna, Oxford university and AstraZeneca, and Pfizer/BioNTech.
Russia’s vaccine is the fourth in the past two weeks to show efficacy of 90 per cent or greater. None of these results have been confirmed by peer reviews. As a result, much hinges on what companies or institutions decide to disclose in press releases.
Countries including Saudi Arabia, Hungary, the UAE, Indonesia, the Philippines, Brazil, Mexico and India as well as former Soviet republics have registered interest in obtaining Sputnik V, while Russia said existing agreements would allow its partner countries to produce up to 500m doses of the vaccine next year.
But some experts have criticised Moscow’s rush to approve it and small sample sizes in its trials compared with western-made vaccines.
Stephen Evans, a professor in pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said there was an “element of uncertainty” in the Russian results.
He noted however that the Russian efficacy numbers added to preliminary evidence an effective coronavirus vaccine could be devised. “A month ago, we didn’t know that.”
Russia was the first country to register a Covid-19 vaccine in August when President Vladimir Putin approved Sputnik V for use — before any research into it had been published or phase 3 trials had begun.
A second vaccine manufactured by Vektor, a former bioweapons research lab in Siberia, was approved in October, while a third vaccine is expected to receive government approval in December.
Gamaleya Institute director Alexander Gintsburg said he expected “the efficacy rate to be even higher based on the data three weeks after the second immunisation when the body’s strongest and most stable response is achieved”.
Russia is conducting so-called phase 3 trials on the vaccine’s efficiency in Moscow with more than 40,000 volunteers, of whom half received a placebo, as well as parallel trials in Belarus, Venezuela, the UAE and India.
Deputy prime minister Tatiana Golikova said on Tuesday that the country had already produced 117,000 doses of Sputnik V and expected that number to rise to nearly 3m before a mass vaccination campaign begins next year.
As infections in Russia, the fifth worst-hit country in the world by the pandemic, reached more than 2m in total — and 25,173 on Tuesday alone — the Kremlin admitted Russia’s healthcare system was “coming under heavy strain”.
Yet although Russia claims its vaccine is “safe”, Mr Putin has yet to decide whether to inoculate himself, his spokesman Dmitry Peskov told reporters on Tuesday.
“The president can’t very well use an uncertified vaccine,” Mr Peskov said, according to Interfax. “All the procedures will be completed and if he deems it necessary he will inform us.”
The state-run Russian Direct Investment Fund, which is financing the vaccine, said it would cost less than $20 for foreign countries to purchase the two-dose jab, which it claimed was significantly cheaper than its western counterparts.
Researchers claim to have found “no unexpected adverse events” among volunteers during the tests. Denis Logunov, the institute’s deputy director, said “30 to 40 per cent” of volunteers showed minor side effects including temperatures, headaches, and pain at the jab site.
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The Gamaleya Institute said it would publish interim research data in a peer-reviewed medical journal in December and release the full clinical trial report at the conclusion of the phase 3 trials.
The World Health Organization said on Tuesday it welcomed any efforts to find a way out of the pandemic, and that it looked forward to seeing the data.
The European Medicines Agency said it had been contacted by the developer, with whom it was discussing “further engagement”.
