Russia vaccine: Russia to begin testing Kovid-19 vaccine on 40,000 people next week | world News

Russia vaccine: Russia to begin testing Kovid-19 vaccine on 40,000 people next week | world News

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MOSCOW: Russia’s first potential Kovid-19 vaccine to receive domestic regulatory approval will involve more than 40,000 people in a large trial and will be overseen by a foreign research body when it starts next week, project backers said on Thursday .
These were the first details on the size and shape of the upcoming late-stage trial of the vaccine given by its developers, which is a concern among some scientists about the lack of data provided by Russia so far.
The vaccine, called “Sputnik V” in tribute to the world’s first satellite launched by the Soviet Union, has been safely and effectively prepared by Russian authorities and scientists after two months of small-scale human trials, with no results. Have come Yet to be made public.
But Western experts have been more skeptical, warning against its use until all internationally approved testing and regulatory steps were taken and proved successful.
“There is an information war going on against the Russian vaccine to the extent that countries supporting the vaccine,” said Kirill Dimitrik, head of the Russian Direct Investment Fund (RDIF).
He said the vaccine data would be published later this month in an academic journal.
He said that Russia has received requests for one billion doses of the vaccine from around the world and has the capacity to produce 500 million doses per year through a manufacturing partnership.
A director at the Gamale Institute in Moscow, which developed the vaccine, said 40,000 people would be involved in a mass test at more than 45 medical centers around Russia.
The data is being provided to the World Health Organization (WHO), Dimitri said, and in several countries that are considering participating in late-stage trials, including the United Arab Emirates, India, Brazil, Saudi Arabia and the Philippines.
Sputnik V has already received approval from domestic regulators, with leading Vladimir Putin and other officials named Russia the first country to license the Kovid-19 vaccine.
Registration, however, occurred before the start of the large-scale trial, commonly known as a Phase III trial, which many considered to be the necessary precursor to registration. According to WHO records, at least four other potential Kovid-19 vaccines are currently in Phase III trials globally.
Two-tablet vaccine
Since October, Dukeries said Russia’s early registration of the vaccine would allow it to be administered to people in high-risk groups, such as with health workers, during late-stage trials.
He said that the process would be conducted on a voluntary basis and the participants would undergo regular medical checkups.
The test will be supervised by a foreign clinical research organization, Dimitri said, ensuring that the data collection fully conforms to international standards. He did not provide details of the research organization.
The Sputnik V vaccine will include a two-shot jab, using two different vectors of human adenovirus. As this vector had a significant track record of use in previous vaccines, it had more historical data supporting its safety than some other potential Kovid-19 vaccines, Dimitri said.
It is echoed by researchers outside Russia. Ian Jones, a virologist at Reading University in Britain, said of the Russian vaccine, “I think there is enough general background data on recombinant adenovirus-based vaccines to assume the vaccine would be safe at normal doses.”
Russian researchers have said that initial tests showed the vaccine to have a significant immune response, but how long the safety remains unclear.
“Everyone can react differently,” the leading expert on infectious diseases at the Russian Ministry of Health, Vladimir Chulanov, was said in an interview on Thursday.
“Some people can develop very strong protective immunity, while others cannot. In such cases, (coronavirus) infection may be possible, but the disease should theoretically have mild symptoms. And in general, such people share Will be very small. ”


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