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December 17, 2021
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Russia has not yet submitted data for Sputnik V approval to the WHO

Russia has not yet submitted data for Sputnik V approval to the WHO

The spokesman for the Russian Direct Investment Fund (RDIF), Dmitri Peskov, admitted this Tuesday, December 14, that they have not yet delivered the information requested by the World Health Organization (WHO) to continue with the approval process of the vaccine. Sputnik V, confirmed the Reuters agency.

“We have not yet provided the necessary information because we had a different vision of the data to be transmitted and how it had to be provided (…) We have different standards and Russia is progressively adapting to these requirements,” he said.

Last September, the WHO temporarily suspended the approval process for the Sputnik V vaccine after one of the factories where it is produced failed a quality inspection. However, in October, Russian Health Minister Mikhail Murashko announced that they had already overcome all obstacles to registering the Sputnik V vaccine and that only minor administrative procedures remain.

Following these factory improvements, on October 21, the WHO resumed the vaccine approval process. And as announced, the team of specialists was expected to visit the factories again in December to finalize the authorization.

As reported by Reuters, last November, the WHO met with Russia to discuss additional data on the quality, safety and efficacy of the vaccine. ” And at that meeting, the company that created the vaccine promised to present a “detailed roadmap for data submission” so that WHO could accelerate its evaluation.

EMA has not received any documents either.

Despite the fact that Sputnik V was the first vaccine against covid-19, it has not managed to be approved by international organizations such as the WHO, the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) of the United States . This has triggered travel limitations for citizens who received these doses, as several countries have imposed “covid passports” that only admit approved vaccines.

In October, the European Medicines Agency told Reuters that Russia had not provided the necessary data for the review scheduled for the end of November, so it will not be approved by the European Union until the first quarter of 2022.

Last week, the president of Russia, Vladimir Putin, asked the World Health Organization (WHO) to include Sputnik V “as soon as possible” in its catalog of recognized vaccines against covid-19, so that those who have used it can move with maximum freedom to any part of the world.

In Nicaragua, the Russian vaccines Sputnik V and Sputnik Light are the ones that are being applied the most because the Ortega government acquired 4.4 million of them. The latter is also being applied as a booster dose.

Russia claims Sputnik is highly effective against mortality

An observational study carried out in Hungary ensures that the Russian Sputnik V vaccine is 98% effective in preventing covid-19-related mortality and 85.7% against coronavirus infection.

“Sputnik V has shown the best results among five vaccines administered in the European Union member state, Hungary as part of an independent study based on data from 3.7 million people,” said Dmitriev.

This study included 3.7 million people vaccinated in Hungary, between January 22, 2021 and June 10, 2021, with five types of vaccines Sputnik V, Moderna, Pfizer-BioNTech, Sinopharm and AstraZeneca.



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