The approval process for the Russian Sputnik V coronavirus vaccine by the World Health Organization (WHO) has been suspended, Deputy Head of the Pan American Health Organization (PAHO) Jarbas Barbosa told reporters.
“Vaccine manufacturers must confirm that the locations where vaccines are produced agree with good manufacturing practice standards. With regard to the approval process for Sputnik V’s emergency vaccine, this process has been suspended because an inspection of one of the factories that forms part of Sputnik V’s production did not find that the factory was in agreement with good manufacturing practices. ” , – he said (quoted by RIA Novosti).
Barbosa clarified that the necessary changes must be made to resume the approval process. After that, a new inspection will take place.
At the end of June, the Ministry of Industry and Trade reported that a WHO delegation had inspected four of the seven sites where Sputnik V is being produced and expressed comments on the work of one of them. The department noted that even before the publication, WHO initiated unscheduled inspections of Pharmstandard-UfaVITA and now the company is eliminating the comments.
The ministry stressed that the results of the WHO inspection do not call into question the quality of Sputnik V. Each of its lots undergoes a triple test: production control, as well as control of the center. Gamaleya and Roszdravnadzor, which allows you to guarantee confidence in the quality of the drug. In general, the drug is produced by the Medgamal branch of the center. Gamalei, Binnopharm, R-Pharm, Biocad, Generium, Lecco and Pharmstandard-UfaVITA.
“Sputnik V”, developed by the Center. Gamalea, was registered the first in the world among such drugs – on August 11, 2020. The effectiveness of the vaccine is estimated at 97.6%. At the moment “Sputnik V” is approved in 70 countries of the world with a total population of 4 billion people.
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