Inspection on Sputnik V to be scheduled after review of Russian data, WHO says

Society & Culture December 14, 2021, 16:58

Russian counterparts committed to sharing all the relevant data by end of this year, the press service clarified

GENEVA, December 14. /TASS/. The World Health Organization (WHO) has not yet set a date of its experts’ visit to Russia within the framework of the application process to include the Sputnik V vaccine in the Emergency Use Listing (EUL). Inspections will be scheduled after its Russian partners submit the necessary information, a representative at the WHO headquarters in Geneva told TASS on Tuesday.

"No date has been set yet," a representative of the organization’s press service said in response to a question by a TASS correspondent on the matter. "Russian counterparts committed to sharing all the relevant data by end of this year, once the data has been reviewed, the EUL team will set up inspections," the press service stressed.

Earlier in December, WHO Spokesperson Christian Lindmeier told TASS that in October, the Russian Direct Investment Fund (RDIF) signed all legal agreements necessary for the review of Sputnik V’s application for inclusion in the EUL. At a meeting at the end of November, the WHO and the RDIF discussed the necessity to provide additional data on the quality, safety and efficacy of the vaccine and the RDIF committed to submit a detailed roadmap of providing data for the WHO to accelerate its assessment of this vaccine. The applicant and the vaccine’s producers will have to submit to the WHO, among others, updated information on measures undertaken after receiving inspectors’ comments. This year, the WHO conducted inspections of four Russian production sites within the framework of the procedure of Sputnik V’s preliminary qualification and made critical remarks about the operations of one of them.

Moscow has not yet submitted some information for the certification of the Russian Sputnik V vaccine against coronavirus to the WHO due to its differing understanding of standards but the process is underway, Kremlin Spokesman Dmitry Peskov told journalists on Tuesday, adding that Moscow hopes for a positive resolution of this issue.

Earlier in December, Dmitry Birichevsky, Director of Russia’s Foreign Ministry’s Economic Cooperation Department, said that his ministry expected that the World Health Organization (WHO) would approve the Sputnik V vaccine in the first half of the next year, adding that there was only technical paperwork left to approve the vaccine.

The Sputnik V jab that was certified in Russia on August 11, 2020, became the first officially certified vaccine against coronavirus worldwide. To date, it has been approved in 71 countries.

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