Merkel: "Russia's Sputnik V Vaccine Has Good Efficacy... Any Vaccine Is Welcome"
Indication of Introducing Chinese Vaccines Following Russian Ones
Desperate Measures Due to Vaccine Supply Shortage... EMA's Difficult Position
[Asia Economy Reporter Hyunwoo Lee] German Chancellor Angela Merkel directly praised the Phase 3 clinical trial results of Russia's COVID-19 vaccine, Sputnik V, strongly suggesting the introduction of the Russian vaccine. As Germany is expected to introduce not only the Russian vaccine but also Chinese vaccines to overcome vaccine supply shortages, the position of the European Medicines Agency (EMA), which oversees vaccine approval in the European Union (EU), is expected to become even more difficult. So far, Hungary has independently approved Russian and Chinese vaccines, but the EMA has criticized this as inappropriate.
According to foreign media including the Associated Press on the 2nd (local time), Chancellor Merkel appeared on Germany's public ARD broadcast and praised, "The Russian Sputnik V vaccine has shown good data," adding, "The European Union (EU) welcomes all vaccines." She further urged, "We will vaccinate 10 million people by the end of March, so please wait a little longer," strongly implying the possibility of introducing the Russian Sputnik V vaccine.
Earlier that day, Russia's state news agency RIA Novosti reported that the Phase 3 clinical trial data of the Sputnik V vaccine was published in the international medical journal 'The Lancet.' According to the data, the Sputnik V vaccine showed an immune efficacy of 91.6% based on the analysis of Phase 3 clinical trial data from 19,866 participants who completed both the first and second doses. The Russian side added that the immune efficacy was 91.8% in clinical trials involving 2,144 people aged 60 and over, and safety was also confirmed to be excellent.
Kiril Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), which supported the development of Sputnik V, emphasized in an interview with RIA Novosti, "Among the three vaccines worldwide that show over 90% efficacy, including Sputnik V, Sputnik V surpasses other vaccines in safety, transportability, and price accessibility."
However, safety controversies surrounding the Sputnik V vaccine continue. The Sputnik V vaccine was developed by the Gamaleya National Research Center of Epidemiology and Microbiology under the Russian Ministry of Health and was the first vaccine in the world to receive emergency use authorization from its government in August last year. However, it has been criticized for skipping the basic vaccine development process by combining Phase 1 and 2 clinical trials and immediately receiving government approval, then conducting Phase 3 clinical trials on 40,000 Moscow residents starting in September in a so-called 'post-registration trial,' effectively experimenting on its own citizens.
Despite these controversies, as Europe's vaccine shortage worsens, the German government is indicating the possibility of introducing not only Russian but also Chinese vaccines. Earlier, German Health Minister Jens Spahn stated on the 31st of last month, "Regardless of the manufacturing country, if the vaccine is safe and effective, it can help in pandemic response." However, Chinese vaccines have also faced ongoing safety and efficacy controversies, with varying reports of immune efficacy from countries that have approved them, leading to strong opposition to their introduction.
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Conscious of these controversies, the EMA, which has so far not considered introducing Russian or Chinese vaccines, finds its position more difficult. Previously, the Hungarian government approved Sputnik V and China's Sinopharm vaccine due to vaccine supply shortages, and the EMA criticized this decision as inappropriate in a statement, saying, "While we do not have the authority to overturn Hungary's decision, it is inappropriate." In principle, EU member states can only introduce vaccines after EMA approval, which oversees vaccine authorization. However, if Germany, a key EU country, independently approves vaccines, the EMA's position is expected to become even more constrained.
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