- World Health Organization suspends emergency approval of Russian-made Sputnik V COVID-19 vaccine.
- HO had found multiple manufacturing infringements at the production plant in Ufa, Russia.
- New inspection of the facility will be needed before emergency approval is granted, says WHO.
Assistant Director of the World Health Organization (WHO) Jarbas Barbosa announced that Russia’s bid for emergency authorization of its Sputnik V COVID-19 vaccine had been suspended by the organization after a number of production violations were uncovered during a WHO inspection in Russia.
During a press briefing of the Pan American Health Organization, a regional branch of the WHO, Barbosa said that the emergency approval process had been put on hold pending a fresh inspection of at least one Russian factory manufacturing the vaccine.
“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.
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, according to independent scientists and industry insiders, the manufacturing breaches could compromise the vaccine’s quality.
The World Health Organization said it was still awaiting an update from Pharmstandard and suggested new inspections of the facilities would be required before WHO 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.
Russia submitted its applications for approval by both the WHO and European Medicines Agency (EMA) in February.
But the bid has run into multiple problems.
Both the European Medicines Agency (EMA) and the WHO said last week they were still awaiting a “complete set of data” from the developers of Sputnik V.
Gaining approval from either organization is extremely important for Russia, which has launched an aggressive vaccine diplomacy drive and sold millions of doses to dozens of countries. It would also pave the way for possible mutual recognition of vaccines, simplifying post-pandemic travel for Russians vaccinated with Sputnik V.