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WHO wants a safety data review on Russian COVID-19 vaccine

The World Health Organisation said any WHO stamp of approval on a COVID-19 vaccine candidate would require a rigorous safety data review, after Russia announced it had approved a vaccine. According to a Mail & Guardian report, President Vladimir Putin said Russia had become the first country to approve a vaccine offering “sustainable immunity” against the new coronavirus.

“We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine,” the UN’s health agency’s spokesman Tarik Jasarevic is quoted in the report as saying. “Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data.”

Russia’s Sputnik V vaccine has been developed by the Gamaleya Research Institute in coordination with the country’s defence ministry and, the report says, the Gamaleya candidate being produced in Russia, which is among the 26 being tested on humans, is listed as being in Phase I.

Kirill Dmitriev, the head of the Russian Direct Investment Fund which finances the vaccine project, said Phase III trials would start on Wednesday, industrial production was expected from September and that 20 countries had pre-ordered more than a billion doses.

“Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory,” the report says Jasarevic explained. “WHO has in place a process of pre-qualification for vaccines but also for medicines. Manufacturers ask to have the WHO pre-qualification because it is a sort of stamp of quality.

“To get this, there is a review and assessment of all required safety and efficacy data that are gathered through the clinical trials. WHO will do this for any candidate vaccine.”

[link url="https://mg.co.za/coronavirus-essentials/2020-08-11-who-wants-to-review-russian-vaccine-safety-data/"]Full Mail & Guardian report[/link]

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