The WHO has raised few concerns including possible cross-contamination and insufficient sterilisation checks at a Sputnik V COVID-19 vaccine manufacturing plant in Russia’s Ufa.
Moscow-based Gamaleya Research Institute had applied for WHO’s Emergency Use Listing (EUL) approval for Sputnik V vaccine, following which the WHO team inspected four manufacturing sites of the vaccine and found six manufacturing shortcomings at a manufacturing site in Ufa city in western Russia.
In preliminary inspection findings, the WHO outlined production infringements at Pharmstandard Ufa Vitamin Plant. The organisation also identified concerns with the full traceability, identification and history of batches.
There were also concerns over the filling lines, sterility assurance, sterile filtration validation and the risks of cross-contamination.
“Communications have been initiated with the relevant manufacturer, the applicant and the respective national regulatory authority with the view that the preliminary findings outlined in this report are investigated and addressed as quickly as possible,” WHO told the media.