The effects of Russia are only the moment in a complex human trial, after the knowledge published Monday through Pfizer Inc and BioNTech, which said that its injection is also more than 90% effective.
While experts said Russian knowledge was encouraging and reinforced the concept that the pandemic could be stopped by vaccines, they warned that the effects were based on only a small number of test volunteers who had COVID-19.
Research conducted after 20 participants developed the virus and analyzed how many had won the vaccine compared to a placebo. That’s particularly less than the 94 infections in the vaccine trial that evolved through Pfizer and BioNTech.
“I guess there’s political tension after Pfizer and BioNTech’s press release earlier in the week to get close to their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the University of Mainz. “What is missing at the moment is an investigation of statistical importance. “
To verify the effectiveness rate of its vaccine, Pfizer stated that it would continue its test until there were 164 instances of COVID-19.
The Russian Direct Investment Fund (DRIF), which supports Sputnik V, said the Russian test would continue for six months.
Alexander Gintsburg, director of the Gamaleya Institute that developed the vaccine, said the interim effects showed that Sputnik V was effective and that mass vaccines would be deployed in Russia in the coming weeks.
European equities and US equity futures slightly extended their gains after Russia’s announcement, the reaction was much more subdued than after Pfizer’s results.
‘It’s not a competition’
Effective vaccines are considered essential to restore life around the world by helping to end the pandemic that has killed more than 1. 26 million people, closed businesses and left millions of others out of work.
However, experts said that wisdom about the design of the Russian check is scarce, making it difficult to interpret the data.
Scientists have expressed fear of the speed Moscow has worked at, giving the regulatory approval to shoot and launch mass vaccines before the complete tests for their protection and effectiveness are completed.
“This is not a concheck. We want all trials to be conducted with the highest criteria imaginable and it is essential that the predefined criteria for cancelling knowledge of blind verification are met to avoid selectively deciding on knowledge,” said Eleanor Riley, Professor of Immunology and Infectious Diseases at the University of Edinburgh.
“Nothing less than a loss of public confidence in all vaccines, which would be a disaster. “
The effects are based on the knowledge of the first 16,000 trial participants to obtain two-dose vaccine injections.
“We showed, based on the data, that we have a very effective vaccine,” RDIF director Kirill Dmitriev said, adding that this is the kind of news vaccine developers would one day talk about with their grandchildren.
The so-called phase III trial of the vaccine is being conducted in 29 moscow clinics and will have a total of 40,000 volunteers, and a quarter will receive a position.
The chances of getting COVID-19 decreased by 92% in other people vaccinated with Sputnik V than in those who gained placebo, RDIF said.
This is above the 50% efficacy threshold for COVID-19 vaccines established by the US Food and Drug Administration. But it’s not the first time
RDIF stated that knowledge would be published in a leading medical journal after peer review. The effects of initial Russian trials were peer reviewed and published in September in the medical journal The Lancet.
Experts said that, as with Pfizer’s results, it is not yet transparent how long immunity will last after taking the Russian vaccine, or how effective it would be for other age groups.
“We want longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer and BioNTech figures,” Plachter said in Mainz.
Sputnik V
Russian drugs are called Sputnik V in honor of the Soviet-era satellite that runs through the area, a nod to the geopolitical importance of the project 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 under the highest threat of coVID-19, as doctors and teachers, outdoors during the trial.
The vaccine is designed to cause a reaction from two injections given 21 days apart, each based on other viral vectors that cause the unusual cold: the human adenovirus Ad5 and Ad26.
The Pfizer vaccine and BioNTech uses messenger RNA generation (mRNA) and is designed to cause an immune reaction without pathogens, such as real viral particles.
Russia is also another vaccine, produced through the Vector Institute in Siberia, and is about to sign a third vaccine, Putin said Tuesday, adding that all vaccines in the country were effective.
RDIF stated that, as of November 11, no serious side effects had been reported from the phase III Sputnik V trial.
Some volunteers had minor short-term adverse occasions, such as at the injection site, a flu syndrome that included fever, weakness, fatigue and headaches, he said.
At the end of October, vaccination of new volunteers was temporarily discontinued due to high demand and dose shortages.
Russia’s deputy prime minister said Wednesday that the Vector Institute vaccine will be tested after registration on November 15.
Russia has reported 19851 new coronavirus infections in the last 24 hours and a record 432 deaths. At 1,836,960, its general instances are the 5th largest in the world, the United States, India, Brazil and France.
(REUTERS)