The Russian Sputnik V vaccine complies with medical requirements, but the European Medicines Agency (EMA) refuses to approve it due to political and economic reasons. This opinion was expressed by a member of the Bundestag Committee on International Affairs from the “Alternative for Germany” Petr Bystron during interview “Izvestia”.
“[EMA] protects the market so that large Western pharmaceutical companies can sell their drugs without competition. In addition, it does not want to ensure the inflow of foreign currency into Russia,” he said.
WHO spokeswoman explains delay in recognition of Sputnik V
Sputnik V became the world’s first registered coronavirus vaccine; it was approved in Russia in mid-August 2020. In October of the same year, the Russian Direct Investment Fund (RDIF) filed an application for accelerated registration of the drug with the WHO; in January last year, a similar application was sent to the EMA.
Reuters in July 2021, citing sources, he named as the reason for the delay in registration of the drug the developer’s failure to provide the necessary documentation on the compliance of the Master Cell Bank with one of the European regulations. The reviewers noted the lack of clarity in tracking results for placebo recipients in a vaccine trial. RDIF responded that the article contained unverified data and errors. The fund also concluded that Sputnik V is under pressure “from the international pharmaceutical lobby.”
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