MOSCOW, (Reuters) – Russia is expecting a specialist team from the World Health Organization (WHO) to visit in December to work on a review of its Sputnik V vaccine for possible WHO emergency use listing, the head of the RDIF fund that markets the vaccine said on Wednesday.
The listing would mark a significant breakthrough for Sputnik V, matching the approval the WHO has already granted to eight other vaccines.
The process for Sputnik has dragged on all year with multiple WHO requests for submission of data and various inspections of manufacturing sites. The RDIF has said it hopes for WHO approval by the end of the year.
Asked for comment, a WHO spokesperson said the organization met with the RDIF in late November “to discuss the need for additional data on the quality, safety and efficacy of the vaccine”.
The spokesperson said the company had committed to present a “detailed road map for data submission” so the WHO could expedite its assessment.