Russia’s Sputnik V vaccine is 92% effective in protecting people from Covid-19 based on interim test results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with drug makers. Westerners in the rush for an injection.
The results from Russia are just the second in a late-stage human trial, quickly following data released Monday by Pfizer Inc and BioNTech, which said their injection was also more than 90% effective.
While experts said the Russian data was encouraging and reinforced the idea that vaccines could stop the pandemic, they cautioned that the results were only based on a small number of trial volunteers who had contracted Covid-19.
The analysis was performed after 20 participants developed the virus and examined how many had received the vaccine versus a placebo. That’s significantly lower than the 94 infections in the vaccine trial being developed by Pfizer and BioNTech.
“I suppose there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now level their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the University of Mainz. “What is missing for now is an analysis of statistical significance.”
To confirm the efficacy rate of its vaccine, Pfizer said it would continue its trial until there were 164 cases of Covid-19.
The Russian Direct Investment Fund (RDIF), which has been backing the development of Sputnik V, said the Russian test would continue for six months.
Alexander Gintsburg, director of the Gamaleya Institute that developed the vaccine, said interim results showed that Sputnik V was effective and that mass vaccines would be rolled out in Russia in the coming weeks.
European stocks and US equity futures extended their gains slightly after Russia’s announcement, although the reaction was much more subdued than after Pfizer’s results.
China’s Sinopharm, which is conducting large-scale advanced-stage clinical trials for two Covid-19 vaccine candidates, said Wednesday that its data was better than expected, though it did not elaborate.
‘IT’S NOT A COMPETITION’
Vaccine success is seen as critical to restoring everyday life around the world by helping to end the pandemic that has killed more than 1.26 million people, closed businesses and put people out of work. millions.
However, experts said that knowledge about the Russian trial design was poor, making the data difficult to interpret.
Scientists have raised concerns about the speed at which Moscow has worked, giving regulatory go-ahead for injection and launching mass vaccines before full trials were completed to prove their safety and efficacy.
“This is not a competition. We need all trials to be conducted to the highest possible standards and it is particularly important that pre-set criteria are met to remove blinding of trial data to avoid selecting data,” Eleanor said Riley, professor of immunology and infectious diseases. at the University of Edinburgh.
“Anything less than this risks the public losing 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 injections of the two-dose vaccine.
“Based on the data, we are showing that we have a very effective vaccine,” RDIF director Kirill Dmitriev said, adding that it was the kind of news that the vaccine developers would one day talk about with their grandchildren.
The so-called phase III trial of the injection is being carried out in 29 Moscow clinics and will involve 40,000 volunteers in total, with a quarter receiving a placebo injection.
The chances of contracting Covid-19 were 92% lower among people vaccinated with Sputnik V than among those who received the placebo, the RDIF said.
That’s well above the 50% effectiveness threshold for Covid-19 vaccines set by the US Food and Drug Administration.
The RDIF said the study data will be published in a leading medical journal after peer review. The results of the early-stage Russian trials were peer-reviewed and published in September in the medical journal The Lancet.
Experts said that, as with the Pfizer results, it was not yet clear how long immunity would last after receiving the Russian vaccine, or how efficient it would be for different age groups.
“We certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for the numbers for Pfizer and BioNTech, ”Plachter said in Mainz.
As Moscow looks for overseas partners to boost production, China’s Tibet Rhodiola Pharmaceutical Holding announced an agreement shortly after results were released to manufacture, sell and test the injection in China.
SPUTNIK V
The Russian drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance to Russian President Vladimir Putin.
Russia registered the vaccine for public use in August, the first country to do so, before the start of the large-scale trial in September.
So far, it has inoculated 10,000 members of the public considered to be at high risk of contracting Covid-19, such as doctors and teachers, outside the trial.
The vaccine is designed to elicit a response from two injections given 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.
Russia is also testing a different vaccine, produced by the Institute of Vectors in Siberia, and is about to register a third, Putin said Tuesday, adding that all of the country’s vaccines were effective.
RDIF said that as of Nov. 11, no serious side effects had been reported during the phase III trial of Sputnik V.
Some volunteers had minor short-term adverse events, such as injection site pain, flu-like syndrome including fever, weakness, fatigue and headache, he said.
At the end of October, the vaccination of new volunteers was temporarily stopped due to high demand and a shortage of doses.
Russia’s deputy prime minister said Wednesday that the Vector Institute vaccine was expected to begin post-registration testing on November 15.
He also said Russia would produce 500,000 doses of Sputnik V in November, down from a previous forecast of 800,000 doses given by Trade and Industry Minister Denis Manturov.
Russia reported 19,851 new coronavirus infections in the past 24 hours and a record 432 deaths. At 1,836,960, its overall case count is the fifth-largest in the world, behind the United States, India, Brazil, and France.
(Information from Polina Ivanova; additional information from Kate Kelland, Ludwig Burger, Josephine Mason and Thyagaraju Adinarayan; edited by David Clarke)
.
