Russia says its Sputnik V coronavirus vaccine is 92 per cent effective at protecting people from COVID-19 according to interim trial results, as the global race for a vaccine accelerates to help end the pandemic that has claimed more 1.26 million lives worldwide.
An analysis was conducted after 20 participants developed the novel coronavirus and examined how many had received the vaccine versus a placebo, the Russian Direct Investment Fund (RDIF), which has been backing the vaccine development, said on Wednesday.
The results were based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine.
“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.
The so-called Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.
The chances of contracting COVID-19 were 92 per cent lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said. The Russian trial would continue for six months, it added.
That’s well above the 50 per cent effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.
The RDIF said data from the study would be published in a leading medical journal following a peer review. The results of the early-stage Russian trials were peer reviewed and published in September in The Lancet medical journal.
Moscow’s announcement comes two days after data was released on Monday by U.S. drugmaker Pfizer Inc and Germany’s BioNTech, which said their shot was more than 90 per cent effective.
To confirm the efficacy rate of its vaccine, Pfizer said it would continue its trial until there were 164 COVID-19 cases.
“I assume there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the Mainz University, told Reuters news agency. “What is missing for now is an analysis of statistical significance.”
While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19.
Scientists have also raised concerns about the speed at which Moscow has worked, giving the regulatory go-ahead for the shot and launching mass vaccinations before full trials to test its safety and efficacy had been completed.
“This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for unblinding the trial data are adhered to avoid cherry picking the data,” Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh, told the Reuters news agency.
“Anything less than this risks a public loss of trust in all vaccines, which would be a disaster.”
Alexander Gintsburg, director of the Gamaleya Institute which developed the Sputnik V vaccine, said mass vaccinations would be rolled out in the country in the coming weeks.View link »