WHO ‘identifies concerns’ at Sputnik V vaccine manufacturing plant in Moscow
- WHO inspectors also identified issues with traceability and identification of new batches of the Sputnik V vaccine
The World Health Organization (WHO) said it has unearthed some problems at a Sputnik V vaccine filling site in Moscow related to the monitoring and control of aseptic operation and filling of the vaccine, reported news agency PTI.
“Identified concerns with the implementation of an appropriate Environmental Monitoring Program to monitor and control the aseptic operation and filling of Gam-COVID-Vac," WHO said in its interim report.
The public health agency released a summary report of its preliminary findings, detailing around six issues found during its visit to the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia, starting from May 31 to June 4.
The Sputnik V vaccine, which is being manufactured by the Gamaleya Institute and the Russian Direct Investment Fund (RDIF), is waiting for approval from WHO. Kirill Dmitriev, who heads RDIF, told reporters on June 4 that a WHO approval for the vaccine is expected to come within two months.
WHO inspectors also identified issues with traceability and identification of new batches of the vaccine. AFP reported that concerns with the “data integrity and testing results from monitoring during manufacturing and quality control” were also highlighted in the report, the contents of which have been communicated to the manufacturer.
"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," the UN body told AFP.
If Sputnik V is approved by WHO and included in its emergency use listing along with jabs Pfizer, AstraZeneca, Sinovac, Sinopharm, Moderna, and Johnson and Johnson, it will be able to import vaccines quickly without waiting for country-wise approval, and become a part of the global vaccine alliance COVAX.