WHO did not rule out inspections of the Sputnik V vaccine in January

An inspection by World HEALTH Organization (WHO) experts to RUSSIA to evaluate the Sputnik V vaccine against covid-19 will take place no earlier than January 2022. About this, as reported by "RIA Novosti", said the press service of the organization.

In November, the WHO met with representatives of the Russian Direct Investment Fund. “The company has committed to provide a detailed roadmap for data submission so that WHO can expedite vaccine evaluation. Data submission is expected by the end of December 2021. An inspection cannot be expected before the data is presented and evaluated,” the WHO said.

RDIF submitted an application for accelerated registration and re-qualification of Sputnik V with WHO at the end of October 2020. Based on the results of the inspection in June, WHO revealed violations at one of the four enterprises where the vaccine is produced - JSC Pharmstandard - Ufa Vitamin Plant. Experts expressed concerns about the implementation of "measures to reduce the risk of cross-contamination of the vaccine" and "control of aseptic conditions on the filling lines."

On September 15, the organization suspended the approval process for Sputnik V due to the results of the inspection. The WHO has started reviewing the RDIF application again. The manufacturer of the vaccine reported that the procedure for requalifying the drug was in its final stages, and noted that the inspectors of the organization had to come to Russia again in order to check and complete the documents.