Russia’s Sputnik V vaccine is 92% effective in protecting people from COVID-19 according to interim court results, the country’s sovereign wealth fund said on Wednesday as Moscow rushes to keep pace with Western drugmakers in the fight for a shot.
Russia’s results are just the second from a late-stage human trial, which quickly follows data released on Monday by Pfizer Inc and BioNTech, which said their shots were also more than 90% effective.
While experts said the Russian data was encouraging and reinforced the idea that the pandemic could be stopped by vaccines, they warned that the results were based only on a small number of trial volunteers who had received COVID-19.
The analysis was carried out after 20 participants developed the virus and examined how many had received the vaccine against placebo. This is significantly lower than the 94 infections in the study of the vaccine developed by Pfizer and BioNTech.
“I guess there was political pressure after the press release from Pfizer and BioNTech earlier this week to reach the level of their own data,” said Bodo Plachter, deputy director of the Institute of Virology at Mainz University. “What is missing at the moment is an analysis of statistical significance.”
To confirm the effectiveness of its vaccine, Pfizer said it would continue testing until there were 164 COVID-19 cases.
The Russian Direct Investment Fund (RDIF), which has supported Sputnik V’s development, said the Russian trial would continue for six months.
Alexander Gintsburg, director of the Gamaleya Institute, which developed the vaccine, said the interim results showed that Sputnik V was effective and that mass vaccinations would be rolled out in Russia in the coming weeks.
European equities and US equities extended their gains slightly after Russia’s announcement, but the reaction was much more subdued than after Pfizer’s results.
‘Not a competition’
Successful vaccines are seen as crucial to restoring daily life around the world by helping to stop the pandemic that has killed more than 1.26 million people, closed businesses and left millions unemployed.
But experts said that knowledge of the design of the Russian trial was sparse, making it difficult to interpret the data.
Researchers have raised concerns about the speed with which Moscow has been operating, giving the regulatory status of the shot and launching mass vaccinations before complete attempts to test its safety and effectiveness were completed.
“This is not a competition. We need all trials to be conducted to the highest possible standard and it is especially important that the preset criteria for blinding trial data are followed to avoid cherry picking data,” said Eleanor Riley, professor of immunology and infectious disease at the University. of Edinburgh.
“Anything less than this risks public confidence in all vaccines, which would be a disaster.”
The results are based on data from the first 16,000 trial participants who received both shots of the two-dose vaccine.
“We show, based on the data, that we have a very effective vaccine,” said RDIF chief Kirill Dmitriev, adding that this was the kind of news that vaccine developers would talk about one day with their grandchildren.
The so-called phase III trial of the shot takes place in 29 clinics across Moscow and will involve a total of 40,000 volunteers, a quarter of whom will receive a placebo shot.
The chance of getting COVID-19 was 92% lower among people who were vaccinated with Sputnik V than those who received placebo, RDIF said.
This is well above the 50% efficacy limit for COVID-19 vaccines set by the US Food and Drug Administration.
RDIF said that data from the study would be published in a leading medical journal after a peer review. The results of the Russian trials at an early stage were reviewed and published in September in the medical journal The Lancet.
Experts said that as with the Pfizer results, it was not clear how long the immunity would take after taking the Russian vaccine, nor how effective it would be for different age groups.
“We really need long-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer’s and BioNTech’s figures,” says Plachter in Mainz.
The Russian drug is named Sputnik V after the satellite from the Soviet era that triggered the space race, a nod to the project’s geopolitical significance for Russian President Vladimir Putin.
Russia registered the vaccine for general use in August, the first country to do so, before the start of the large-scale trial in September.
To date, it has inoculated 10,000 public figures who are at high risk of receiving COVID-19 as doctors and teachers outside the trial.
The vaccine is designed to elicit a response from two shots administered at 21-day intervals, each based on different viral vectors that normally cause colds: human adenovirus Ad5 and Ad26.
The Pfizer and BioNTech vaccines use messenger RNA (mRNA) technology and are designed to elicit an immune response without the use of pathogens, such as actual virus particles.
Russia is also testing another vaccine, produced by the Vector Institute in Siberia, and is about to register a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.
As of November 11, RDIF said that no serious side effects have been reported during the Sputnik V phase III study.
Some volunteers had short-term minor side effects such as injection site pain, flu-like syndromes including fever, weakness, fatigue and headaches, it said.
At the end of October, the vaccination of new volunteers was temporarily suspended due to high demand and lack of doses.
Russia’s deputy prime minister said on Wednesday that the Vector Institute vaccine was expected to be tested after registration on November 15.
Russia reported 19,851 new coronavirus infections in the last 24 hours and a record high of 432 deaths. At 1,836,960, its total fall is the fifth largest in the world, behind the United States, India, Brazil and France.