The European Medicines Agency (EMA) has recognized the production standards for the Russian Sputnik V coronavirus vaccine, issuing a corresponding positive conclusion. Denis Logunov, deputy head of the Gamaleya Center, spoke about this.
The conclusion also concerns the conduct of clinical trials of the Russian drug. Logunov stressed that EMA specialists had no critical remarks.
He also noted that production standards in Europe, China and Russia should be harmonized, indicating that work in this direction is already underway. The deputy head of the Gamaleya Center expressed hope that this work will be completed in the coming months.
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The RAS said that now there are no serious obstacles to Europe’s recognition of “Sputnik V”
The conclusion issued by the EMA specialists means that they examined the enterprises where the Russian vaccine is produced, and the experts recognized them as meeting European requirements. Vitaly Zverev, a virologist, academician of the Russian Academy of Sciences, spoke about this in an interview with Lenta.ru.
This is one of the main stages, after which only formalities will remain. Now there are no serious obstacles to the recognition of our vaccine
Vitaly Zverevvirologist, academician of the Russian Academy of Sciences
Also, according to him, if the issue of the recognition of foreign vaccines is raised in Russia, “then we will also have to send someone to foreign enterprises and check the production technology.”
Earlier, the Russian Foreign Ministry spoke about “encouraging signals” from the WHO
The fact that Russia sees some encouraging signals in the issue of recognition of “Sputnik V” by the World Health Organization (WHO), said in early January Russian Deputy Foreign Minister Alexander Pankin.
At the same time, he pointed out that such gestures are primarily intended only to calm Moscow down.
“I see something encouraging, but in this, in my opinion, there is clearly a certain politeness in relation to Russia – that just about, in the first quarter, in the first half of the year [“Спутник V” может получить одобрение]”, – said the diplomat.
The WHO attributed the delay in the recognition of “Sputnik V” to the verification of technological processes
WHO spokeswoman Margaret Harris said at the end of December that the delay in the organization’s recognition of the Russian vaccine was due precisely to the “verification of technological processes.”
To include the drug on the official list of emergency drugs, WHO is asking for safety and efficacy data, as well as manufacturing technology documentation, she said.
“Often the third thing – process checks – takes a lot of time to figure out all the details, conduct inspections and so on,” Harris said, noting that other regulators work in a similar way.
Russian President Vladimir Putin announced the registration of Sputnik V on August 11, 2020. The development of the Gamalea Center became the world’s first registered vaccine against COVID-19. In the fall of 2021, the head of state said that the Russian drug had been approved in 70 states “with a total population of over four billion people.”
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