WHO raises concerns over Sputnik V manufacturing plant, company says all issues addressed
Jun 24, 2021
Moscow [Russia], June 24 : The World Health Organization (WHO) has raised concerns over a manufacturing plant responsible for filling the vials with the Sputnik V COVID-19 vaccine.
In a statement, Pharmstandard-UfaVITA, a leading pharmaceutical company in Russia, said that the WHO inspectors' attention was focused on only four technical issues mostly related to one of the filling lines, which have all been subsequently fully addressed.
The company said that the WHO did not raise any questions about the safety and efficacy of the produced and finished vaccine as the "Sputnik V" vaccine undergoes strictest double quality output control.
"Moreover, 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.
The pharmaceutical company said that it remained fully transparent and will continue with the WHO pre-qualification process, while inviting the global health body for another inspection.
It also said that UfaVITA responded to all the questions and concerns raised within 48 hours and both the Russian Ministry of Industry and the Health Ministry confirmed the highest quality of the UfaVITA filling process, the quality of the vaccines and of a double quality output control system in place.
"UfaVITA thanks WHO for recognizing the outstanding quality of "Sputnik V" by raising only a very narrow set of technical questions that have been fully addressed in our response," it said.
Pharmstandard-UfaVITA currently runs only four out of 20 filling lines for the Sputnik V vaccine.
