Filenews 16 September 2021
The World Health Organization has suspended the approval process of the Russian Sputnik-V vaccine because quality standards were not met in one of the factories in which the vaccine is produced, Pan-American Health Organization (PAHO) Vice-President Jarbas Barbosa said today.
"This process was suspended because during an inspection at one of the factories in which the Russian Sputnik-V vaccine is produced, it was found that good manufacturing practices are not followed there," he said.
Good manufacturing practice (GMP) is a system that guarantees the preparation of the product based on quality standards. For the WHO to approve the coronavirus vaccine for emergency use, the manufacturer must confirm that these specifications are being met at the factory.
Therefore, the manufacturer of Sputnik-V must inform the WHO that the omissions have been eliminated and after this manufacturing plant will be re-checked.
In mid-June, WHO experts carried out an inspection at a unit of "Farmastandart-UfaVita" where the Sputnik-V vaccine is produced.
