Glava of the WHO European Bureau: “I hope the process of registration of the Satellite will soon be completed” The pandemic will end when 70% of the world’s population is vaccinated and medicines are developed to treat those who have fallen ill, said the head of the WHO European Bureau. According to him, Sputnik V will soon receive the registration of the organization
The process of registration of the Russian vaccine “Sputnik V” by the World Health Organization (WHO) will soon be completed, according to the head of the organization’s Regional Office for Europe, Hans Kluge.
In an interview with TASS, Kluge said that the Russian Direct Investment Fund (RDIF) in October concluded all the legal agreements necessary for inclusion in the list of drugs recommended for use in emergency situations (Emergency Use Listing, EUL), after which the WHO held a meeting with the RFPI, where it was discussed which names the organization lacks to complete the procedure.
“The company has committed to provide a detailed roadmap for the submission of data so that WHO can accelerate the evaluation of this vaccine. The submission of data is expected by the end of December 2021, and I hope that the process will be completed soon after,” said the head of the WHO European Bureau.
RBC sent a request to the RDIF.
According to Kluge, the approval of the Russian vaccine is a non-political process: now it is important to vaccinate as many people as possible around the world to stop the pandemic.
“The pandemic will end when we can reach 70% of the world’s population with vaccination. It will be completed when we will be able to develop effective and safe antiviral drugs for the treatment of people infected with COVID-19,” says the head of the WHO European Bureau.
It is also necessary to strengthen health systems, train future medical workers to work in the conditions of other pandemics and interact not as separate nation States, but as one family. “It [the pandemic] will end when everyone, without exception, will arm themselves with science and take responsibility for their actions,” Kluge said.
The RFPI submitted an application for accelerated registration and retraining of the V Satellite to the WHO at the end of October 2020.
In June, WHO published a report on the inspection of four Russian enterprises where the V Satellite is manufactured. It said that the organization had comments on the work of the company “Pharmstandard” Ufa Vitamin Plant, located in Bashkiria, regarding compliance with the standards of production of the drug.
On the same day, the press secretary of the President of Russia Dmitry Peskov said that all the shortcomings identified by WHO inspectors had been corrected. Nevertheless, in September it became known that because of this, the approval process for the V Satellite was suspended; it was resumed only in October. Before that, the head of the Ministry of Health Mikhail Murashko met with WHO Director General Tedros Ghebreyesus: they discussed, among other things, the procedure for approving the vaccine. According to the Minister, within the framework of this meeting, all issues related to the registration of the V Satellite were resolved.
PozdneeKluge said that WHO could approve the V Satellite in the first quarter of 2022. The organization also called the terms of inspection at Russian vaccine production plants. According to the director of the WHO Department of Retraining and Circulation of Medicines, Rogerio Gaspara, a re-inspection of enterprises may take place in February next year.
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