WHO Suspends Sputnik V Vaccine Approval Process Due to Manufacturing Concerns
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The World Health Organization (WHO) has halted the approval process for Russia's Sputnik V COVID-19 (search) vaccine following inspections.
Violations of best manufacturing practices were identified at a Pharmstandard (search) factory in Ufa, Russia, prompting the suspension.
The WHO is awaiting necessary changes and re-inspection readiness from the manufacturer before proceeding further with the approval.
The World Health Organization (WHO) has suspended the approval process for Russia's Sputnik V vaccine against COVID-19 (search), citing manufacturing violations discovered during a factory inspection. The decision follows concerns raised about Pharmstandard (search)'s facility in Ufa, Russia, where the vaccine is produced.
According to Jarbas Barbosa, assistant director at the Pan American Health Organization (PAHO), the suspension was initiated after the inspection revealed that the factory did not comply with best manufacturing practices. "The process for the use of Sputnik V was suspended because during the inspection of one of the factories where the vaccine is being produced, it was discovered that the factory was not in compliance with the best manufacturing practices," Barbosa stated.
The WHO had previously identified numerous violations and expressed concerns regarding the "implementation of adequate measures" at the Pharmstandard (search) facility. The manufacturer is now required to implement the necessary changes and prepare for subsequent inspections. The WHO is awaiting confirmation from the manufacturer that the factory is in compliance before resuming the approval process.
Russia had submitted requests for approval of Sputnik V to both the WHO and the European Medicines Agency (EMA). However, the requests have encountered several obstacles and delays. Both the EMA and WHO have indicated that they are still awaiting additional data from the vaccine's manufacturer.