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The World Health Organization (WHO) has suspended its approval process for the Russian vaccine against the Sputnik V coronavirus, pending further inspection of at least one Russian factory making the vaccine.
Speaking during a press conference of the Pan American Health Organization, a regional arm of the WHO, Deputy Director Jarbas Barbosa said Russia’s emergency clearance request was suspended after a number of manufacturing violations were discovered during a WHO inspection in Russia in May.
“Sputnik V’s Emergency Use List (EUL) process was put on hold because during an inspection of one of the factories where the vaccine is being made, they discovered that the factory was not in operation. accord with best manufacturing practices, ”Barbosa said Wednesday.
WHO before reported he had found multiple violations and had concerns about the “implementation of adequate measures to mitigate the risk of cross-contamination” at a Pharmstandard factory in the Russian city of Ufa.
Following the publication of the WHO findings, the factory said it had already addressed their concerns and inspectors had not questioned the safety or effectiveness of the vaccine. But independent scientists and industry figures told the Moscow Times the manufacturing violations could compromise the quality of the vaccine.
The WHO said on Wednesday it was still awaiting an update from Pharmstandard and suggested that further facility inspections would be needed before the agency grants approval to Sputnik V.
“The grower needs to take this into consideration, make the necessary changes and be ready for further inspections. WHO is waiting for the manufacturer to send information indicating that their factory is in compliance with the code, ”said Barbosa.
Russia submitted its requests for approval to both the WHO and the European Medicines Agency (EMA) in February, following the publication of research in leading medical journal The Lancet that showed that the vaccine was 91.6% effective.
But the offer ran into multiple problems and was beset by delays.
EMA and WHO said last week that they are still waiting a “full data set” from the developers of Sputnik V. The EMA declined to say what kind of information was missing. The body is Vaccine strategy manager Marco Cavaleri said the timing of final approval was “uncertain” amid the lockdowns.
Getting approval from either organization would be a major victory for Russia, which has launched an aggressive vaccine diplomacy campaign and sold millions of doses to dozens of countries. It would also pave the way for eventual mutual recognition of vaccines, simplifying post-pandemic travel for Russians vaccinated with Sputnik V.
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