The WHO said it would require a rigorous safety data review before giving its stamp of approval to a COVID-19 vaccine candidate, after Russia on Tuesday announced that it had approved a vaccine.
Russian President Vladimir Putin said that his country had become the first 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,” WHO spokesman Tarik Jasarevic said.
Photo: AFP / Russian Direct Investment Fund
“Prequalification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data,” he told reporters in Geneva, Switzerland, at an online press briefing.
Russia’s Sputnik V vaccine has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology in coordination with the country’s Ministry of Defense.
A total of 168 candidate vaccines are being worked on worldwide, a WHO overview published on Tuesday showed.
Of those, 28 have progressed to the various phases of being tested on humans, of which six are the furthest ahead, having reached phase III clinical trials.
The Gamaleya candidate, which is among the 28 in clinical evaluation, is listed as only being in phase I.
Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, which is financing the vaccine project, said phase III trials were to start yesterday, industrial production was expected from next month and that 20 countries had ordered more than 1 billion doses.
“Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory,” Jasarevic said. “WHO has in place a process of prequalification for vaccines, but also for medicines. Manufacturers ask to have the WHO prequalification 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.
“Accelerating progress does not mean compromising on safety,” Jasarevic added.
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