Russia becomes one of first nations to apply to WHO for registration of Sputnik V Covid-19 vaccine

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Russia becomes one of first nations to apply to WHO for registration of Sputnik V Covid-19 vaccine
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Fecha de publicación: 
27 October 2020
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Russia has applied to the World Health Organization (WHO) for the early prequalification and registration of its Sputnik V coronavirus vaccine, which would make it available globally sooner.

Russia’s Direct Investment Fund (RDIF) has filed the application with the WHO to include the Sputnik V vaccine in its Emergency Use Listing program allowing for its accelerated prequalification, the sovereign wealth fund said in a statement.

“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,” the RDIF CEO Kirill Dmitriev said, expressing his hope that the WHO approval would allow it to “be included in the list of medical products that meet leading quality, safety and efficacy standards.”

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Dmitriev also thanked the UN health body for “its active cooperation.” Prequalification is a “quality assurance” program run by the WHO designed to ensure new vaccines are up to the international standards.The WHO prequalifies vaccines before greenlighting their use by various UN agencies such as the UN Children’s Fund (UNICEF) and other international organizations. It is also used to support “specific needs” of national immunization programs.

In the wake of the coronavirus pandemic, the WHO also included vaccines in its Emergency Use Listing (EUL) procedure designed to accelerate the assessment of unlicensed medicines, therapeutics and diagnostics in an emergency situation.

The UN health body issued its first invitation to Covid-19 vaccine manufacturers around the world to apply for the EUL program and prequalification on October 1. It is not clear though exactly how long it will take for a vaccine to go through all the WHO assessment stages and receive approval once it gets into the program.

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Russia was the first country to officially register a Covid-19 vaccine. The developers of Sputnik V, which is currently undergoing its third and final stage of clinical trials, say more than 40 countries have expressed their interest in it.

Brazil, Venezuela, Azerbaijan, Kazakhstan, Belarus and India were specifically named by the Russian authorities as nations that could receive the Sputnik V vaccine as well as take part in its development and production. Bolivia’s newly elected president, Luis Arce, has recently announced his plans to order the vaccine from Russia once it is ready for sale.

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