– The agency interlocutor said that a decision by the EMA is absolutely out of the question until the end of this year. He added that if the necessary information on the vaccine is provided by the end of November, “the regulator will be able to make a decision in the first quarter of 2022.”
The EMA began the official Russian vaccine evaluation process in March of this year. Under the original assumptions, the EU regulator’s decision was due to take place in May or June. The approval procedure for Sputnik V is being delayed due to Russia’s delay in providing the required information about the readiness, Reuters reports.
On Thursday, the Russian Information Agency reported that the Russian side commented on the delays in the submitted documents, and informed that it was already finishing their completion. The agency also said that Russia’s Health Minister, Mikhail Murashko, has informed that EMA experts will visit the country by the end of the year.
The first information about the effect of the preparation Sputnik V, published in the prestigious scientific journal “The Lancet”, reported an effectiveness of 92 percent. against COVID-19. Later, the Russian side said that the vaccine showed 83 percent protection against the highly contagious Delta type of coronavirus.
The World Health Organization said on Wednesday it was still searching for the Russian drug. The Russian Direct Investment Fund (RDIF), which promotes the vaccine outside Russia, said the WHO inspectors were due to travel to Russia soon, “to complete the latest required inspections and read the new documents on Sputnik V.”
The Russian vaccine is widely used in the country of origin and in more than 70 countries around the world. In Europe, the vaccine is used, among other things, by Hungary, Serbia and San Marino.
Reuters concluded that the EU’s decision to allow people vaccinated with Sputnik V would be a huge relief to travelers from Russia, as the EU only recognizes Covid-19 preparations approved by the EMA and the World Health Organization.
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