Russia applies to WHO for emergency listing of Sputnik V Covid-19 vaccine, approval would speed up formula's global distribution

As global coronavirus cases surge, Russia has applied to the World Health Organization (WHO) for the early pre-qualification and registration of its pioneering Sputnik V vaccine, which would make it available globally sooner.

The Russian Direct Investment Fund (RDIF) has filed the application to include the Sputnik V formula in the WHO's Emergency Use Listing program allowing for its accelerated approval for use, 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's CEO Kirill Dmitriev said, expressing his hope that the hoped for WHO approval would allow it to “be included in the list of medical products that meet leading quality, safety and efficacy standards.”

Dmitriev also thanked the UN health body for “its active cooperation.” Pre-qualification is a “quality assurance” program run by the WHO designed to ensure new vaccines meet international standards.The WHO screens vaccines before greenlighting their use by various 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 has 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 pre-qualification on October 1. It is not clear though exactly how long it will take for a formula to go through all the WHO assessment stages and receive approval once it gets into the program.

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 Russian officials 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, this week announced his plans to order the vaccine from Russia once it is ready for sale.

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