WHO wants to review Russian vaccine safety data

The World Health Organization (WHO) said any WHO stamp of approval on a COVID-19 vaccine applicant would require a severe safety data review after Russia declared Tuesday it had approved a vaccine.

President Vladimir Putin announced Russia had become the first country to approve a vaccine offering “sustainable immunity” against the COVID-19.

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“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 United Nations (UN) health agency’s spokesman Tarik Jasarevic told reporters in Geneva at an online press briefing.

“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 defense ministry.

A total of 165 candidate vaccines are being worked on around the world, according to the latest WHO overview produced on July 31.

Of those, 139 are still in pre-clinical evaluation, while the other 26 are in the various phases of being tested on humans, of which six are the furthest ahead, having reached Phase 3 of clinical evaluation.

The Gamaleya candidate being produced in Russia, which is among the 26 being tested on humans, is listed as being in Phase 1.

Kirill Dmitriev, the head of the Russian Direct Investment Fund which finances the vaccine project, said Phase 3 trials would start on Wednesday, industrial production was expected from September and that 20 countries had pre-ordered more than a billion doses.

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