Russian application of Sputnik V vaccine for WHO vaccine prequalification among the first applications submitted
Moscow, October 27, 2020 – The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world’s first registered vaccine against the coronavirus Sputnik V, which is based on a well-studied platform of human adenoviral vectors. The Russian Federation has become one of the first countries to apply to WHO for prequalification of its vaccine against the novel coronavirus infection.
The Prequalification of Medicines Programme is a United Nations programme managed by WHO. It is the only global medicines quality assurance programme. 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 WHO.
In the face of the ongoing pandemic, accelerated vaccine registration under the 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. Successful prequalification will enable Sputnik V to be included in the list of medicines used by international procurement agencies and countries to guide bulk purchasing of medicines.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented:
“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. We express our gratitude to WHO for its active cooperation and look forward to the successful completion of the prequalification process at all major stages”.