Covid-19: Russia submits application to WHO for Sputnik V vaccine prequalification

Russia has submitted applications to the World Health Organisation (WHO) for accelerated registration and prequalification of its Covid-19 vaccine Sputnik V to make it available globally in a shorter time frame than usual procedures, according to an official statement on Wednesday.

The WHO prequalification of medicines assesses the quality, safety, and efficacy of medicines. A medicinal product is included in the list of prequalified medicinal products subject to compliance with established requirements and standards of the WHO.

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The Russian Direct Investment Fund (RDIF) submitted applications to the WHO for accelerated registration and prequalification of the Sputnik V vaccine, an official statement released by the Russian embassy in New Delhi said.

In the face of the ongoing pandemic, accelerated vaccine registration under the Emergency Use Listing EUL procedure will make the Russian vaccine available globally in a shorter time frame than usual procedures and will support global efforts to prevent the coronavirus infection, it said.

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

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Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “The Russian Federation was the first in the world to register a vaccine against the Covid-19 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 Organisation, which will allow Sputnik V to be included in the list of medical products that meet leading quality, safety and efficacy standards," Dmitriev said.

"We express our gratitude to the WHO for its active cooperation and look forward to the successful completion of the prequalification process at all major stages”.

The RDIF and Dr Reddy's Laboratories Ltd. (Dr. Reddy's), a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India.