MOSCOW (Reuters) – Massive testing of Russia’s first prospective COVID-19 vaccine to discharge national regulatory approval will involve more than 40,000 people and be monitored through a foreign study organization when it launches next week, the allocation advocates said Thursday.
These are the first main points on the form and duration of the next complex trial of the vaccine administered through its developers, which aim to dispel the considerations of some scientists about the lack of knowledge provided through Russia so far.
The vaccine, called “Sputnik V” in homage to the world’s first satellite introduced through the Soviet Union, has been acclaimed and effective by the Russian government and scientists after two months of small-scale human trials, the effects of which have not yet been seen. made public.
But Western experts were more skeptical, caution opposed its use until the approved evidence and regulatory measures were taken around the world and successful.
“Several countries are waging a war opposed to the Russian vaccine,” said Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF), which supports the vaccine, in a briefing.
Knowledge of vaccines will be in a university magazine e late this month, he said.
Russia has won up to one billion doses of vaccines internationally and has the capacity to produce 500 million doses in line with annual production associations, he said.
A director of the Gamaleya Institute in Moscow, which developed the vaccine, said 40,000 others would be interested in mass testing at more than forty-five medical centers in Russia.
Knowledge is being provided to the World Health Organization (WHO), Dmitriev said, and to several countries participating in the complex trial, adding the United Arab Emirates, India, Brazil, Saudi Arabia and the Philippines.
Sputnik V has already obtained approval from national regulators, which led President Vladimir Putin and other officials to designate Russia as the first country to allow a COVID-19 vaccine.
However, the registration took place before the start of the large-scale trial, commonly known as the Phase III trial, which was considered through many to be a mandatory precursor to registration. At least 4 other possible vaccines opposed to COVID-19 are recently undergoing Phase III trials worldwide, according to WHO records.
TWO-PLANE INOCULATION
But Russia’s early approval of the vaccine will allow it to begin to be given to others in high-risk groups, such as fitness workers, in parallel with the complex trial, which will begin in October, Dmitriev said.
He said the procedure would be carried out on a voluntary basis and that participants would have normal controls.
The trial itself will be overseen through a foreign clinical studies organization, Dmitriev said, ensuring that the knowledge collection fully complies with foreign standards. He gave the main points of the organization of the studies.
The Sputnik V vaccine will involve a two-dose vaccine, another two vectors of human adenovirus. Because this vector had a significant history of use in past vaccines, it had older knowledge to support its protection than some other prospective vaccines opposed to COVID-19, Dmitriev said.
This has been addressed through researchers outside Russia. Ian Jones, virologist at the British University of Reading, said of the Russian vaccine: “I think there is enough general knowledge about recombinant adenovirus vaccines to assume that the vaccine itself will be at the same previous doses.”
Russian researchers said initial trials showed that the vaccine has a significant immune response, but the duration of coverage remains uncertain.
“Everyone can react differently,” Vladimir Chulanov, an infectious disease specialist at the Russian Ministry of Health, said Thursday in an interview with Gazeta.Ru.
“Some would possibly expand very strong protective immunity, others possibly wouldn’t. In such cases, an infection (coronavirus) might be possible, but the disease should, in theory, provide mild symptoms. And, in general, the percentage of these others people will be very small “.
Reporting through Polina Ivanova; Additional reports through Kate Kelland; Editing via Nick Macfie
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