The WHO has suspended the Sputnik-V vaccine approval process

The World Health Organization (WHO) has suspended the approval of the Russian Sputnik-V vaccine because quality standards were not met at one of the factories where the vaccine is manufactured, Jarbas Barbosa, vice-president of the World Health Organization (PAHO), said today.

"This process was suspended because during an inspection at one of the factories where the Russian Sputnik-V vaccine is produced, it was found that it does not follow good manufacturing practices," he said.

Good manufacturing practice (GMP) is a system that guarantees the manufacture of the product based on quality standards. In order for the WHO to approve the coronavirus vaccine for emergency use, the manufacturer must confirm that these specifications are met at the factory.

Therefore, the manufacturer of Sputnik-V must inform the WHO that the omissions have been eliminated and that the manufacturer will be inspected again.

In mid-June, WHO experts inspected a Farmastandart-UfaVita plant producing the Sputnik-V vaccine.

Source: RES-EAP

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