Russia applies to WHO for Sputnik V vaccine prequalification

Oct 28: Russian Direct Investment Fund, (RDIF) had submitted applications to the World Health Organization (WHO) for accelerated registration and prequalification of the Sputnik V vaccine.

The Prequalification of Medicines Programme is a United Nations program managed by WHO. It is the only global medicines quality assurance program. 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 the 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 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 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”.