The World Health Organization (WHO) plans to complete inspections of manufacturing processes used in Russia for the Sputnik V vaccine against the coronavirus infection in the first week of June, Mariangela Simao, WHO Assistant-Director General for Access to Health Products, told a briefing in Geneva on Friday.
The inspections are conducted in light of a possible listing of Sputnik V for emergency use by the WHO.
“We did have a team doing inspections in Russia during April for the good clinical practices together with the European Medicines Agency. And on the 10th of May, we have a team again in Russia inspecting the good manufacturing practices for four manufacturers [of the Sputnik V vaccine],” she said.
Currently, the WHO is “still analyzing the data, receiving additional information on the dossier and doing the inspections on site.” “We expect that the inspections will end the first week of June and if we have the full dossier and all the information that’s needed, we will be able to convene the TAG, the technical advisory group,” she explained.
Currently, the WHO Emergency Use Listing includes six preparations: a vaccine by China’s Sinopharm, the Comirnaty vaccine developed jointly by US Pfizer and German BioNTech, a vaccine by Janssen, a subsidiary of US Johnson & Johnson, a vaccine by US Moderna as well as two versions of a vaccine developed by British-Swedish AstraZeneca and the University of Oxford.
On August 11, 2020, Russia became the first country in the world to register a vaccine against the coronavirus infection – dubbed Sputnik V. It was developed by the Gamaleya National Research Center for Epidemiology and Microbiology.
The jab has already been certified for use in many countries.
