World Health Organization (WHO) Wednesday said that it found problems at a Sputnik V production plant in Russia. The organization said it noticed issues in monitoring and control of aseptic operation and filling of the vaccine.
"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 according to Hindustan Times.
The public health organization inspected four Sputnik V manufacturing sites in Russia. The concern was raised in a report filed after the visit to the Pharmstandard Ufa Vitamin Plant in Ufa, from May 31 to June 4.
Company Says Issues Fixed
Pharmstandard Ufa said that WHO officials only raised concerns over four technical issues related to problems in one of the filling lines, Livemint reported. All the issues, the company said, have been addressed.
"WHO interim inspection did not identify any critical issues with the actual vaccine's production, quality, clinical studies, possible side effects, nor with the double quality output control by both the Gamaleya Institute and the Russian health regulator," said Pharmstandard-UfaVITA.
According to AFP, WHO also identified concerns in data integrity and testing results from monitoring during manufacturing and quality control.
Sputnik V Is Seeking WHO's Emergency Use Listing
The vaccine produced by the Gamaleya Institute and the Russian Direct Investment Fund is seeking WHO's approval for Emergency Use Listing (EUL). At present, WHO has approved six vaccines for global Emergency use. These are AstraZeneca, Pfizer-BioNTech, Moderna, Johnson & Johnson, Sinopharm and Sinovac.
EUL inclusion would mean Sputnik V becomes a part of the global vaccine alliance COVAX.
Sputnik V and India's Dr Reddy's laboratories deal
The Russian vaccine has been given a nod for emergency use in India. Dr Reddy's Laboratories has signed a pact with the Russian Direct Investment Fund that allows the company to sell 250 million doses of the vaccine in the country.
Dr Reddy's has received three million doses of Sputnik V so far, according to Business Standard.