WHO To Review Russia’s COVID-19 Vaccine
World Health Organization has said stamp of approval on a COVID-19 vaccine candidate would require a rigorous safety data review.
This is in reaction to Russia’s announcement on Tuesday about approving a COVID-19 vaccine.
President Vladimir Putin said Russia had become the first country to approve a vaccine offering “sustainable immunity” against the new coronavirus.
Speaking in Geneva, Switzerland on Tuesday, United Nations health agency’s spokesman Tarik Jasarevic 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.
Russia’s vaccine, which has been named Sputnik V, was developed by the Gamaleya research institute in collaboration with the country’s defence ministry.
The vaccine’s name is same as the world’s first satellite to be launched into orbit, Sputnik, during the cold war space race by Soviet Union.
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 vaccines, 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 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.
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.
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.