WHO ‘identifies concerns’ at Sputnik V vaccine manufacturing plant in Moscow
WHO inspectors have also identified traceability and identification issues of new Sputnik V vaccine batches
The World Health Organization (WHO) stated that it had undertaken problems at a Sputnik V vaccine filling site in Moscow related to monitoring and controlling the aseptic operation and filling the vaccine, the PHI press agency.
“Concerns identified with the implementation of an appropriate environmental monitoring program aimed at monitoring and controlling the aseptic operation and the filling of Gam-Covid-Vac,” said who stated in his interim report.
The Public Health Agency has published a synthesis report of its preliminary findings, detailing about six questions found during its visit to the UFA Pharmatic Vitamin Factory UFA in the UFA, in southern Russia, from from May 31 to June 4.
The Sputnik V vaccine, which is manufactured by the Gamaleya Institute and the Russian Direct Placement Fund (GDIF) is waiting for WHO approval. Kirill Dmitriev, who runs the RDIF, told reporters on June 4 that WHO vaccine approval should arrive within two months.
WHO inspectors have also identified problems related to the traceability and identification of new lots of the vaccine. The AFP reported that “the integrity of the data and the results of the monitoring tests during the control of manufacturing and quality” was also highlighted in the report, the content of which was communicated to the manufacturer.
“Communications have been launched with the manufacturer concerned, the applicant and the respective national regulatory authority, in the opinion that the preliminary conclusions described in this report are examined and treated as quickly as possible,” said the AFP of UN.
If Sputnik V is approved by WHO and included in its emergency use with Jabs Pfizer, AstraZeneca, Sinovac, Sinophammarm, Moderna and Johnson and Johnson, it will be able to import vaccines quickly without waiting for the Country approval and become part of the Global Alliance Covax vaccine.
