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WHO says continues to assess Russia’s Sputnik V vaccine

The World Health Organization (WHO) continues to assess the Russian Sputnik V coronavirus vaccine under the Emergency Use Listing (EUL) procedure, the WHO Geneva office told TASS on Tuesday, making it clear that the organization’s position on this matter has not changed in the recent days.

"As with other candidate vaccines, WHO continues to assess Sputnik V vaccines from different manufacturing sites and will publish decisions on their EUL status when all the data are available and the review is concluded," the WHO said. "Any vaccine that is proven to be safe, efficacious and quality assured, and otherwise meets the requirements set forth in the EUL procedure, will be granted an EUL recommendation."

According to the WHO, the EUL assessment process is geared "to speed up equitable access to vaccines in order to save lives."

Speaking about Sputnik’s prospects to be adopted for the EUL, the WHO cited Mariangela Simao, WHO Assistant Director-General for Access to Medicines, who told a news conference on October 7 that "the process is about to be restarted." "There still will be issues around complete information on the dossier that has to be provided by the applicant, the Russian Direct Investment Fund, and there are also issues regarding the finalization of the inspections in the different manufacturers in Russia," she said.

After talks with Director General of the World Health Organization Dr Tedros Adhanom Ghebreyesus in Geneva on October 1, Russian Health Minister Mikhail Murashko said that all barriers hampering the registration of Sputnik V with the WHO had been removed.

The WHO press service told TASS on September 27 that it was waiting for additional information about Sputnik V from Moscow. It said that only after this data was considered it would be possible to organize an inspection trip to Russia by international experts.

Earlier this year, the WHO inspected four production facilities in Russia as part of the preliminary assessment of Sputnik V and issued recommendations to one of them.

Today, seven coronavirus vaccines have been recommended for emergency use by the WHO, and applications for 13 more vaccines, including Russia’s Sputnik V and EpiVacCorona, are at various stages of assessment.

[Source: Tass, Geneva, 12Oct21]

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