Fond called the statement of the head of the European Commission Ursula von der Leyen about the lack of sufficient data on the safety of the Russian vaccine politicized. The process of approval of Sputnik V by the European regulator in the RDIF was evaluated positively
Statements by representatives of the European Commission about the lack of sufficient data for the approval of the Russian vaccine against the coronavirus “Sputnik V” are politicized and cause regret. This is stated in the comments of the representative of the Russian Direct Investment Fund (RDIF), published in the Telegram channel of the vaccine.
“Earlier, some EU representatives have already stated that there is no need for the vaccine “Sputnik V” in the EU, and also spread false information about the Russian vaccine, ” the fund noted, adding that the RDIF and the Gamalei Center, which developed the drug, have repeatedly refuted this information.
The Foundation positively assessed the approval process of the drug at the European Medicines Agency (EMA). All data on clinical trials were transferred as part of the GCP (good clinical practice) inspection, according to the results of which the European regulator left a positive review, the RDIF added.
On August 4, the President of the European Commission, Ursula von der Leyen, said in an interview with the German agency RND that the situation around the V Satellite had calmed down. According to her, so far the manufacturer has not provided sufficient data that would confirm the safety of the vaccine.
In response, the RDIF indicated that the safety and effectiveness of the V Satellite were confirmed by the regulators of 69 countries in which the drug was registered. Mass vaccination in Russia, Argentina, Hungary, the United Arab Emirates and other countries showed that the Russian vaccine did not cause serious side effects, such as brain vein thrombosis or myocarditis, the representative of the fund said.
In July, Reuters, citing sources, wrote that the developer did not provide the necessary data on the compliance of the main cell bank (Master Cell Bank) with one of the EU regulations. According to the agency, the inspectors had questions about the reporting forms about the negative consequences after vaccination during the trials.It is unclear how the scientists tracked the results in people who received a placebo. Due to insufficient data, the approval process for the V Satellite has reached an impasse, the agency reported.
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The RDIF stated that the Reuters material contains gross errors and incorrect facts, and the agency’s employees “spread deliberately false and incorrect information”. The Fund also believes that the Russian drug has faced “pressure from the international pharmaceutical lobby”.
The head of the RDIF, Kirill Dmitriev, said that Russia is waiting for the approval of the V Satellite by the European regulator and the World Health Organization (WHO) in the autumn.
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