An official at the World Health Organization (WHO) says the group has suspended its approval process for Russia’s Sputnik V coronavirus vaccine, after a number of manufacturing infringements were uncovered during an inspection in Russia earlier this year.
Jarbas Barbosa, assistant director at the Pan American Health Organization, the regional office of WHO for the Americas, suggested on September 15 that new inspections at one of the plants where the vaccine is being manufactured would be required before the vaccine is granted approval for emergency use.
The plant “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.
In a report published in June, the WHO reported it had found multiple infringements at a factory owned by Russia’s pharmaceutical company Pharmstandard in the city of Ufa, including regarding the “implementation of adequate measures to mitigate the risks of cross contamination.”
The plant later said it had addressed these concerns.
Russia submitted its applications for approval by both the WHO and European Medicines Agency (EMA) in February, after peer-reviewed results published in the medical journal The Lancet showed it to be safe and 91.6 percent effective against COVID-19.
Despite a lack of approval, Sputnik V is being used in a number of countries across the world.
