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World Health Organization to Review Russian Vaccine Safety Data

The WHO 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 President Vladimir Putin, Russia had become the first country to approve a vaccine offering “sustainable immunity” against the novel coronavirus.

“We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine,” said the United Nations Health Agency’s Spokesman Tarik Jasarevic.

“Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data,” he added.

The Sputnik V vaccine of Russia 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 31 July.

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, which is among the 28 in clinical evaluation, is listed as only being in Phase 1.

The Head of the Russian Direct Investment Fund, Kirill Dmitriev which finances the vaccine project, the 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.

Jasarevic explained, “Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory. 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,” he said.

The pandemic has seen an unprecedented mobilization of funding and research to rush through a vaccine that can protect billions of people worldwide.

“We are encouraged by the speed by which several candidate vaccines have been developing and as we have been always saying, we hope some of these vaccines will prove to be safe and efficient,” said Jasarevic.

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