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October 28, 2020

Russia seeks registration, prequalification from WHO for Sputnik V vaccine

The Russian Direct Investment Fund (RDIF) has submitted applications for accelerated registration under emergency use listing (EUL) and prequalification of its Sputnik V vaccine against Covid-19, to the World Health Organization (WHO).

The Russian Direct Investment Fund (RDIF) has submitted applications for accelerated registration under emergency use listing (EUL) and prequalification of its Sputnik V vaccine against Covid-19 to the World Health Organization (WHO).

The world’s first registered vaccine has two serotypes of a human adenovirus with an S-antigen of the Sars-Cov 2 to trigger an immune response in the body.

In August, Russia awarded regulatory approval to Sputnik V vaccine, becoming the first country in the world to register a coronavirus vaccine for use.

With the latest move, the Russian Federation became one of the first countries to submit an application to WHO for prequalification of Covid-19 vaccine.

Managed by WHO, the Prequalification of Medicines Programme is a United Nations programme that helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.

Accelerated registration will make the vaccine available globally in a shorter period of time that can back global efforts to prevent the Covid-19 infection. 

On obtaining prequalification, Sputnik V will be included in the list of medicines used by international procurement agencies and countries to guide the bulk purchasing of medicines.

The Russian Direct Investment Fund CEO Kirill Dmitriev said: “The Russian Federation was the first in the world to register a vaccine against the coronavirus, Sputnik V, which was created on a safe, effective and well-studied platform of human adenoviral vectors. 

“We have submitted an application for Emergency Use Listing and prequalification of the vaccine by the World Health Organization, which will allow Sputnik V to be included in the list of medical products that meet leading quality, safety and efficacy standards.”

Earlier, Russian health authorities granted approval to a second Covid-19 vaccine developed by the Vector State Virology and Biotechnology Center in Siberia.

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