Russia’s Health Ministry is halting the enrollment of new volunteers for the main trial of the pioneering Sputnik V coronavirus vaccine, saying that the current number is sufficient to study its long-term effects and benefits.
The ministry’s press service made the announcement on Wednesday, adding that the decision was in accordance with “existing regulatory practices”.
The contingent of Sputnik V trial participants amounts to just over 31 thousand people. All of them, including the group given a placebo, will be kept under observation for at least six more months.
“There will be no recruitment of new participants for the study. The existing group of research participants allows to fully examine the safety and efficacy of the vaccine over a longer period of time,” the ministry announced.
Officials were quick to reassure that such decisions are nothing of an extraordinary.
Also on rt.com Deal with AstraZeneca shames ‘unethical’ attackers of Sputnik V & should inspire cooperation – funder of Russian vaccine tells RTMeanwhile, Kirill Dmitriev, CEO of The Russian Direct Investment Fund (RDIF), which bankrolled Sputnik V’s development, welcomed the move. He says it makes sense “after the vaccine showed high efficacy exceeding 90 percent.”
According to Dmitriev, more than 23,000 volunteers received the vaccine rather than a placebo, compared to 15,000 volunteers during Moderna’s trials and 22,000 volunteers at Pfizer.
“Data from successful clinical trials in Russia has been presented to global organizations and national regulators, who will shortly start the approval processes in their respective countries,” Dmitriev said.
According to RDIF’s earlier claims, the Sputnik V vaccine can be also effective against the new strain of the coronavirus, that was discovered in the UK earlier.
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