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Manufacturers of Russia’s flagship Covid-19 vaccine said Tuesday that interim results from phase 3 trials showed efficacy rates of “more than 95 percent,” outperforming some of the more effective Western vaccines that have published results. .
Moscow’s state Gamaleya Institute said data from nearly 19,000 volunteers showed that the vaccine’s efficacy was 91.4 percent 28 days after receiving the first dose of the two-injection jab, increasing beyond 95 percent in preliminary results after 42 days.
The Kremlin is touting the two-shot jab, known as Sputnik V after the Soviet satellite that started the space race, as an alternative to vaccines from Moderna, the University of Oxford and AstraZeneca, and Pfizer / BioNTech.
Russia’s vaccine is the fourth in the past two weeks to show an efficacy of 90 percent or more. None of these results have been confirmed by peer reviews. As a result, much depends on what companies or institutions choose to disclose in press releases.
Countries such as Saudi Arabia, Hungary, the United Arab Emirates, Indonesia, the Philippines, Brazil, Mexico and India, as well as the former Soviet republics, have shown interest in obtaining Sputnik V, while Russia said existing agreements would allow its partner countries produce up to 500 million doses. of the vaccine next year.
But some experts have criticized Moscow’s rush to pass it and the small sample sizes in its trials compared to Western-made vaccines.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said there was an “element of uncertainty” in the Russian results.
However, he noted that the Russian efficacy figures added to preliminary evidence that an effective vaccine against the coronavirus could be designed. “A month ago, we didn’t know.”
Russia was the first country to register a Covid-19 vaccine in August, when President Vladimir Putin approved the use of Sputnik V, before any research was published or phase 3 trials began.
A second vaccine manufactured by Vektor, a former biological weapons research laboratory in Siberia, was approved in October, while a third vaccine is expected to receive government approval in December.
The director of the Gamaleya Institute, Alexander Gintsburg, said he expected that “the efficacy rate will be even higher according to the data three weeks after the second immunization, when the strongest and most stable response of the body is achieved.”
Russia is conducting so-called phase 3 trials on the efficacy of the vaccine in Moscow with more than 40,000 volunteers, of which half received a placebo, as well as parallel trials in Belarus, Venezuela, the United Arab Emirates 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 3 million before a mass vaccination campaign begins next year.
Hungary is one of the countries that has registered interest in obtaining the Sputnik V vaccine © Orsi Ajpek / Getty
Russia’s state-run Direct Investment Fund said it would cost foreign countries less than $ 20 to buy the two-dose injection © Andrey Rudakov / Bloomberg
As infections in Russia, the fifth worst-hit country in the world by the pandemic, reached more than 2 million in total, and 25,173 on Tuesday alone, the Kremlin admitted that Russia’s healthcare system was “under great pressure. “.
However, while Russia claims its vaccine is “safe,” Putin has yet to decide whether to get vaccinated, his spokesman Dmitry Peskov told reporters on Tuesday.
“The president cannot use an uncertified vaccine,” Peskov said, according to Interfax. “All the procedures will be completed and if you consider it necessary you will inform us.”
Russia’s state-run Direct Investment Fund, which is funding the vaccine, said it would cost foreign countries less than $ 20 to buy the two-dose jab, which it said was significantly cheaper than its Western counterparts.
The researchers claim they found no “unexpected adverse events” among the volunteers during the tests. Denis Logunov, deputy director of the institute, said that “between 30 and 40 percent” of the volunteers showed minor side effects, such as temperature, 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 publish the full clinical trial report at the conclusion of phase 3 trials.
The World Health Organization said Tuesday it welcomed any efforts to find a way out of the pandemic and 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”.
