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HEALTH-VIRUS-VACCINE
WHO wants to review Russian vaccine safety data
GENEVA, Aug 11, 2020 (BSS/AFP) – The World Health Organization said
any WHO stamp of approval on a COVID-19 vaccine candidate would
require a rigorous safety data review, after Russia announced Tuesday
it had approved a vaccine.
President Vladimir Putin said Russia had become the first country to
approve a vaccine offering “sustainable immunity” against the new
coronavirus.
“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 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 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 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.
– ‘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.”
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,” said
Jasarevic.
“Accelerating progress does not mean compromising on safety,” he said.
BSS/AFP/MRU/1843hrs