Update (1145ET): The WHO has decided to review the COVID-19 vaccine candidate officially approved by Russian regulators on Tuesday, saying it would require “a rigorous safety data review”.
“We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine,” said Tarik Jasarevic, the United Nations health agency’s spokesman. He made the statement while answering questions during a digital press briefing on Tuesday.
“Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data.”
Russia’s Sputnik V vaccine was developed by Moscow’s Gamaleya research institute with help from the Russian defense ministry. It was tested at Moscow’s state medical university.
A total of 165 candidate vaccines are being tested around the world, according to a WHO tally. 139 of these are still in pre-clinical evaluation, while 26 have progressed to various phases of human testing. The 6 market leaders have already reached Phase 3.
The Gamaleya Institute candidate being produced in Russia (it’s far from the only vaccine project underway in the country) is among the 26 being tested on humans in the country. However, it’s still listed as ‘Phase 1’ for testing.
Kirill Dmitriev, the head of the Russian Direct Investment Fund, the project’s main financial backer, confirmed Tuesday that Phase 3 trials are ready to begin on Wednesday, while mass production likely won’t begin until September or October. More than 20 countries have already ordered doses, he added. Jasarevic added that the process being undertaken by the WHO to review the Russian vaccine would be the same undertaken for any other vaccine project.
“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.”
But even if things don’t work out with the Russian candidate, Jasarevic said, there are many other vaccine candidates in Phase 3, and beyond.
“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.
However, Dr. Ali Nouri, a molecular biologist and President of the Federation of American Scientists, slammed Russia’s decision as “reckless” and insisted that Russia’s vaccine is “well behind” the biggest western and Chinese competitors.