WHO suspends Sputnik V approval process

WHO suspends Sputnik V approval process

PanARMENIAN.Net - The World Health Organization (WHO) has suspended its approval process for Russia’s Sputnik V coronavirus vaccine, pending a fresh inspection of at least one Russian factory manufacturing the shot, The Moscow Times reports.

Speaking at a press briefing of the Pan American Health Organization, a regional branch of the WHO, Assistant Director Jarbas Barbosa said Russia’s bid for emergency authorization had been put on hold after a number of manufacturing infringements were uncovered during a WHO inspection in Russia in May.

“The process for Sputnik V’s emergency use listing (EUL) was suspended because while inspecting one of the plants where the vaccine is being manufactured, they found the plant was not in agreement with best manufacturing practices,” Barbosa said Wednesday.

The WHO previously reported it had found multiple infringements and had concerns related to the “implementation of adequate measures to mitigate the risks of cross contamination” at a Pharmstandard factory in the Russian city of Ufa.

Following the publication of the WHO’s findings, the plant said it had already addressed their concerns and that the inspectors had not questioned the safety or efficacy of the vaccine. But independent scientists and industry figures told The Moscow Times the manufacturing breaches could compromise the vaccine’s quality.

The WHO said Wednesday it was still awaiting an update from Pharmstandard and suggested new inspections of the facilities would be required before the body would grant Sputnik V approval.

“The producer needs to take this under advisement, make the necessary changes, and be ready for new inspections. The WHO is waiting for the manufacturer to send news that their plant is up to code,” Barbosa said.

 Top stories
The earthquake caused a temporary blackout, damaged many buildings and closed a number of rural roads.
The Prosecutor’s Office has released surveillance footage and said that one of the detainees in the case, Iveri Melashvili.
Destinations welcomed 900m fewer international tourists in January–October when compared with the same period of 2019.
Austrian authorities said at least one gunman remained on the run at 1am Vienna time on November 3.
Partner news