WHO to Subject Russia’s COVID-19 Vaccine to ‘Rigorous’ Review


By Martins Ifijeh

The World Health Organisation (WHO) has said it will subject Russia’s COVID-19 vaccine to rigorous review before approving it for human use.

Russia’s President, Vladimir Putin had earlier Tuesday said the country had become the first country in the world to approve a COVID-19 vaccine, offering ‘sustainable immunity’ against the virus.

But at a press briefing in Geneva Tuesday, the Spokesman, WHO, Tarik Jasarevic, said the United Nations body will only put its stamp of approval on any COVID-19 vaccine after subjecting it to a rigorous safety data review.

He said: “We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine. Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data,” he said.

According to him, every country has national regulatory agencies that approve the use of vaccines or medicines on its territory, adding that “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.”

The pandemic has seen an unprecedented mobilisation 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. Accelerating progress does not mean compromising on safety,” he said.

Russia’s Sputnik V vaccine has been developed by the Gamaleya Research Institute in coordination with the country’s defence 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 three 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 one.

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