Russia did not submit additional documents for the approval of Sputnik V and the recognition of covid certificates
“The situation remains unchanged. Authorization work continues,” he said.
According to Ederer, two EMA inspections took place in Russia in the first half of last year, after which the European regulator requested additional documents on Sputnik, but, according to data, they have not yet been received.
“The situation with the WHO is different, as we understand it, they received the necessary documents. We expect that and we will see the discovery of documentation in the EMA, I think everyone is interested in having as many vaccines as possible available in the world, ”Ederer said.
He added that the situation has not changed with the foreign origin of vaccination certificates. According to rumors, in October between Russia and the EU he held an online technical meeting on this issue.
“It was a positive meeting, which, according to experts, discussed how it is done, Russia reported that at the political level, interest corresponds to equivalence,” Ederer said. He noted that Russia should send a letter with the receipt of mutual recognition of certificates, but so far the EU has not received it.
The European regulator began the registration process for Sputnik V in March 2021. Over the summer, Reuters reported that approval of the vaccine was being delayed because its developer, the Gamaleya Center, did not report to the European Freight Agency (EMA) about vaccine trials.
In October, the agency reported that the Russian vaccine could be approved in Europe before the first quarter of 2022. According to the deputy head of the Gamaleya Center Denis Logunov, EMA gave a positive conclusion on the study of Sputnik V.
In mid-December, the representative of the World Health Organization in Russia, Melita Vujnovic, announced that WHO had received all the necessary documents for the registration of Sputnik V from the Russian Direct Investment Fund. The WHO vaccine approval process has been suspended several times in the past.
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