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Russia announced Thursday the start next week of clinical trials involving more than 40,000 people for its coronavirus vaccine, announced on August 11 and viewed with skepticism by the international community.
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“Next week (…), a clinical study on the effectiveness (…) and safety of the Sputnik V vaccine will begin in Russia,” said the Russian sovereign wealth fund, associated with the development of the vaccine, specifying that “more than 40,000 people will participate in the study in more than 45 medical centers ”.
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The official website dedicated to the vaccine had announced that “phase 3 of clinical trials involving more than 2,000 people” in several countries had started on August 12.
Asked by AFP on these tests, the press service of the sovereign fund specified that “there is no phase 3 in Russian law”.
“From a legal point of view, these are studies taking place after the vaccine is registered” on August 11, the fund said, adding that they can be considered a “equivalent of phase 3” .
Sovereign wealth fund boss Kirill Dmitriev told an online briefing Thursday that vaccination of “risk groups,” including medical staff, would also begin next week on a voluntary basis.
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More than 20 countries have applied for the purchase of one billion doses of the vaccine, he added. He noted that Russia has agreed to produce vaccines in five countries. Dmitriev also indicated that he planned the start of “massive vaccinations in Russia in October”, the start of vaccine deliveries abroad being scheduled for November or December. A delegation from the Saudi Ministry of Health is expected to visit Moscow next week, he added.
The Sputnik V, name given in reference to the first artificial satellite in history, was viewed with skepticism around the world, in particular because of the lack of a final phase of testing at the time of its announcement.
“We have seen a significant change in tone from the WHO. Initially, indeed, they did not have enough information about the Russian vaccine, now official information has been sent and they will evaluate it, ”said Dmitriev.
“We see no obstacle to individual regulators approving the Russian vaccine without WHO approval,” he added.
