WHO Has Resumed the Approval Procedure for the Sputnik V Vaccine

The Russian Direct Investment Fund, which promotes Sputnik V abroad, expects approval from WHO in the coming months. In Europe, a permit can be obtained in May-June 2022. The World Health Organization (WHO) has resumed the approval procedure for the emergency use of the Sputnik V coronavirus vaccine developed in Russia. This follows from an update in the vaccine registry maintained by WHO. “As with other candidate vaccines, WHO continues to evaluate Sputnik V from different production sites and will publish a decision on its EUL (Emergency Use List) status when all data are available and the procedure is completed”, the organization said in its response to a question from Reuters on Thursday, October 21. WHO interrupted the inspection in July, when its experts revealed violations at one of the Russian enterprises where the vaccine is produced. Since then, the manufacturer has notified the organization that it was able to fix the problems detected by experts. The Russian Direct Investment Fund (RDIF), which promotes Sputnik V abroad, said that a group of WHO inspectors should visit Russia in the near future to conduct “all necessary checks and obtaining all document on the vaccine. The head of the RDIF Kirill Dmitriev said in an interview with CNN that he expects Sputnik V to be approved by WHO in the coming months. The decision on Sputnik V in the EU will be made next year The European Medicines Agency (EMA) will decide on the approval of Sputnik V no sooner than early next year. As a source familiar with the situation told Reuters, it is impossible to complete the verification by the end of this year, since all the necessary data is still missing. If they are filed by the end of November, the EMA will be able to complete the audit in the first quarter of 2022. Accordingly, a decision can be made as early as May or June. The first in the world The Sputnik V vaccine, a combined vector vaccine for the prevention of coronavirus infection, was developed by the Russian Gamaleya National Research Center of Epidemiology and Microbiology. It was registered on August 11, 2020 by the Ministry of Health of the Russian Federation on the basis of the results of the first and second phase of clinical trials, becoming the first officially accepted coronavirus vaccine in the world. According to Russian data, Sputnik V is approved for use in 70 countries, in 13 countries the vaccine is produced using Russian technologies. DW