"No Sufficient Data to Prove Safety, Oppose Approval"
Russia "Must Publicly Apologize for Negative Remarks"

[Image source=AP Yonhap News]

[Image source=AP Yonhap News]

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[Asia Economy Reporter Hyunwoo Lee] The chairperson of the European Medicines Agency (EMA) board, which reviews vaccine approvals for the European Union (EU), opposed the approval of the Russian Sputnik V vaccine and compared the Russian vaccine to "Russian Roulette," a life-risking gamble. Russian authorities have demanded a public apology, stating that the remarks undermine the credibility of the vaccine approval process and constitute political interference, escalating into a diplomatic dispute between the EU and Russia.


According to Russia's TASS news agency on the 8th (local time), researchers from the Gamaleya Institute, which developed the Russian Sputnik V vaccine, and officials from the Russian Direct Investment Fund (RDIF) issued a statement demanding a public apology for the negative remarks made by EMA board chairperson Christa Wirthumer-Hoche regarding the Sputnik V vaccine. They strongly criticized, saying, "It is highly inappropriate for the EMA chairperson to compare the Sputnik V vaccine to Russian Roulette, and it undermines the credibility of EMA's approval review. There should be no political interference in vaccine approval."


Earlier, on the previous day, Chairperson Wirthumer-Hoche appeared on Austria's ORF broadcast and said, "Approving the Russian Sputnik V vaccine like Hungary did is akin to Russian Roulette," emphasizing, "I strongly advise against emergency use approval of Sputnik V because there is insufficient data proving its safety." Russian Roulette here refers to a life-risking gambling game from 19th-century Russia, where a revolver is loaded with a single bullet, pointed at one's head, and the trigger is pulled.


EMA had previously announced on the 4th that it had begun the review process for the Sputnik V vaccine. Last month, the Sputnik V vaccine published Phase 3 clinical trial results in the medical journal The Lancet, showing 91.6% efficacy, but EMA has maintained concerns about safety and stated that Russia must submit definitive data for approval.



So far, among EU member states, health authorities in Hungary and Slovakia have independently approved and are administering the Sputnik V vaccine prior to EMA approval. According to Russian authorities, 46 countries have approved the use of the Sputnik V vaccine to date.


This content was produced with the assistance of AI translation services.

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