WHO expects Russia to submit final data on Sputnik V in late January
While the process is ongoing, the details must remain confidential
GENEVA, January 18. /TASS/. The World Health Organization (WHO) expects final data on Russia’s Sputnik V vaccine necessary for the EUL (Emergency Use Listing) assessment in late January, the bulk of the necessary data was submitted in late December, a source in the WHO Geneva office told TASS on Tuesday.
The WHO recalled that it met with the Russian Direct Investment Fund (RDIF) in late November to discuss "the need for additional data on the quality, safety, and efficacy of the vaccine." "The submission of most of the data took place at the end of December 2021. Final data are expected at the end of January," the source noted. "The applicant and the manufacturers will need to submit updated corrective and preventive actions (CAPAs) to address the inspection observations."
"Once the EUL application and corresponding CAPA responses to the inspections conducted have been received and reviewed, a decision on the need to perform an onsite verification inspection will be communicated to the applicant," the WHO said. "While the process is ongoing, the details must remain confidential. A recommendation will be made public as soon as the full process is finalized."
Rogerio Gaspar, Director of the WHO Regulation and Prequalification (RPQ) Department, told a briefing in December 2021 that the WHO planned to organize an inspection in Russia in February 2022. WHO Representative to Russia, Melita Vujnovic, told Solovyov Live YouTube channel on January 15 that the RDIF had submitted necessary documents on Sputnik V to the organization.