WHO to Assess Russia's Coronavirus Vaccine for Approval

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.

Stamp of quality

"Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory," 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."

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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.

"Accelerating progress does not mean compromising on safety," he said. 

(Writers & Editors: RJM/JG/BP, Agence France-Presse)

Source: http://u.afp.com/32Pn