The country’s sovereign wealth fund said on Wednesday that Russia’s Sputnik V vaccine was 92 percent effective in protecting people from COVID-19, based on the results of mid-stage trials, as Moscow struggled to keep up. of Western drug manufacturers.
The Russian results are only the second from late-stage human trials, and come after data released Monday by Pfizer and BioNTech that said their vaccines were also more than 90 percent effective.
While experts said the Russian data was encouraging and bolstered the idea that a vaccine could stop the pandemic, they cautioned that the results were based on only a small number of test volunteers infected with COVID-19.
The analysis was done after 20 participants contracted the virus and looked at how many received the vaccine and a placebo. That’s significantly lower than the 94 infections in vaccine trials being developed by Pfizer and BioNTech.
“I think there was political pressure after the press releases from Pfizer and BioNTech earlier this week, which are now on par with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the University of Mainz. .”
To confirm the effectiveness of its vaccine, Pfizer said it will continue trials until 164 cases of COVID-19 emerge.
The Russian Direct Investment Fund (RDIF), which has been supporting the development of Sputnik V, said the Russian test will last six months.
Alexander Ginzburg, director of the Gammaria Institute that developed the vaccine, said interim results showed Sputnik V was effective and mass vaccines would be rolled out in Russia in the coming weeks.
In subsequent comments broadcast by the state-run Rossiya-24 television channel, he said at least 1.5 million people in Russia are expected to be injected by the end of the year. Between 40,000 and 45,000 Russians have been vaccinated, he added.
European stocks and US stock futures extended gains slightly after the Russian statement, but the reaction was much weaker than Pfizer’s results.
Sinopharm, which is conducting large-scale, late-stage clinical trials of two COVID-19 vaccine candidates, said on Wednesday that its data was better than expected, but gave no further details.
A successful vaccine is seen as key to restoring daily life around the world by helping end a pandemic that has killed more than 1.26 million people, shuttered businesses and lost millions of jobs.
However, experts say little is known about the design of the Russian trial, making interpretation of the data difficult.
Scientists have raised concerns about the speed at which Moscow is working, with regulators approving the vaccine and launching mass vaccinations before full trials to test its safety and efficacy are completed.
“This is not a race. We need to perform all trials to the highest possible standard, and it’s especially important to adhere to preset criteria for unlocking trial data to avoid being picky,” said Eleanor Riley, professor of immunology and disease. infectious. , University of Edinburgh.
“Anything lower than that would result in a loss of 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 two doses of the vaccine.
“According to the data, we show that we have a very effective vaccine,” said RDIF chief Kirill Dmitriev, adding that vaccine developers will one day share the news the granddaughter is talking about with their grandchildren.
The so-called injectable phase III trial is underway in 29 Moscow clinics and will involve a total of 40,000 volunteers, a quarter of whom will receive a placebo injection.
People who received the Sputnik V vaccine had a 92 percent lower chance of contracting COVID-19 than those who received a placebo, RDIF said.
That’s well above the 50 percent effectiveness threshold for a COVID-19 vaccine set by the US Food and Drug Administration.
The study data will be published in a leading medical journal after peer review, RDIF said. The results of the first Russian trial were peer-reviewed and published in the Lancet medical journal in September.
Like the Pfizer results, experts say it’s not clear how long immunity lasts after Russia’s vaccine, or how well it works in all age groups.
“We certainly need longer-term observations to draw valid conclusions about efficacy and side effects.
The same thing happens with the data from Pfizer and BioNTech,” said Plachter from Mainz.
As Moscow seeks partners abroad to boost production, China’s Tibet Rhodiola Pharmaceutical Holdings announced a deal to make, sell and test the vaccine in China shortly after the results.
Russian drug named Sputnik V after the Soviet-era satellite that ignited 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 large-scale trials began in September.
So far, it has vaccinated 10,000 members of the public, such as doctors and teachers, who are considered to be at high risk of contracting COVID-19 outside of the trial.
The vaccine is designed to trigger a response with two injections 21 days apart, each based on a different viral vector that normally causes the common cold: the human adenovirus Ad5 and Ad26.
Pfizer and BioNTech’s vaccines use messenger RNA (mRNA) technology designed to trigger an immune response without the use of pathogens such as actual viral particles.
Russia is also testing another vaccine produced by the Siberian Vector Institute and is about to register a third, Putin said on Tuesday, adding that all vaccines in the country are effective.
As of November 11, no serious side effects had been reported during the phase III trial of Sputnik V, RDIF said.
He said some volunteers had mild short-term adverse events, such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue and headache.
Vaccines for new volunteers were suspended at the end of October due to high demand and a shortage of doses.
Russia’s deputy prime minister said on Wednesday that post-registration trials of the Vector Institute’s vaccine are expected to start on November 15.
He also said Russia would produce 500,000 doses of Sputnik V in November, down from the 800,000 doses previously forecast by Trade and Industry Minister Denis Manturov.
Russia has reported 19,851 new coronavirus infections and a record 432 deaths in the last 24 hours. Its total number of cases, 1,836,960, ranks fifth in the world after the United States, India, Brazil and France.
