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[Asia Economy Reporter Hyunwoo Lee] The Russian Clinical Trials Association has expressed opposition to the mass use of the domestically approved vaccine 'Sputnik V,' stating that the number of clinical trial participants is too small to confirm safety, making it dangerous, and that proving efficacy is also impossible. Previously, the organization had pointed out to the Russian Ministry of Health the day before the Russian government approved the Sputnik V vaccine on the 11th, urging a delay in vaccine registration, but it is reported that this was not accepted.
According to Russian TASS news agency on the 17th (local time), Svetlana Zavidova, head of the Russian Clinical Trials Association, criticized the Sputnik V vaccine, approved by the Russian government on the 11th, saying, "This vaccine was approved based only on clinical trials conducted on 38 patients, and in principle, its safety and efficacy cannot be proven," adding, "We should examine how vaccines that have not undergone proper testing throughout the history of vaccine development have led to serious immunobiological side effects."
It is also reported that the organization had urged the Ministry of Health to delay vaccine registration on the 10th, the day before the Ministry announced vaccine approval. Although Sputnik V was approved by the Russian government on the 11th, it has been embroiled in safety controversies as clinical trials were conducted on only 38 participants combined in phases 1 and 2.
Earlier, the Gamaleya National Research Center of Epidemiology and Microbiology under the Russian Ministry of Health announced that it would begin the final clinical trial of Sputnik V, which has already received government approval, causing further controversy. Alexander Gintsburg, director of the Gamaleya Institute, stated, "We are about to enter the research phase that can be called mass vaccination," adding, "We will first vaccinate 30,000 residents of Moscow and then distribute the vaccine to the public." This means entering the final phase 3 clinical trial targeting residents.
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However, both the Russian government and political circles maintain that the vaccine poses no major problems. On the same day, Tatiana Kusayko, Deputy Chairperson of the Russian Federal Assembly, said at a press conference, "Sputnik V is a vaccine based on a well-known platform and is sufficiently usable after just five months of research," adding, "We must trust the researchers at the Gamaleya Institute who have been developing this vaccine for 20 years. Their Ebola vaccine developed in 2016 was also very effective." She emphasized, "If I were at risk of contracting COVID-19, I would get vaccinated."
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