13 Aug
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 mobilization 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.
Pre-orders of COVID-19 vaccine
Although none of the coronavirus vaccines under development has proved its efficacy yet in clinical trials, at least 5.7 billion doses have been pre-ordered around the world.
First shipments of a COVID-19 vaccine created by Western laboratories have often been snapped up by the United States.
Five vaccines -- three Western and two Chinese -- are in Phase 3 efficacy trials involving thousands of people.
In a surprise announcement, Russian President Vladimir Putin claimed Tuesday that a vaccine dubbed “Sputnik V” -- after the Soviet satellite -- conferred “sustainable immunity” against the novel coronavirus.
As research laboratories around the world race to develop a vaccine, manufacturers have received financing to help them prepare to have millions of doses ready to administer in 2021 or even before the end of the year.
Oxford University, working with the Swedish-British pharmaceutical group AstraZeneca, hopes to have results by September while the US biotech company Moderna, partnering with the US National Institutes of Health (NIH), is aiming for the end of the year, possibly November.
US: 700 million doses
President Donald Trump has launched “Operation Warp Speed” in a bid to develop, manufacture and distribute a COVID-19 vaccine to all Americans by January 2021.
Hundreds of millions of dollars have been directed to vaccine developers including nearly $500 million to Johnson & Johnson at the end of March.
The United States has allocated funding to more companies than other nation in the hope that one of them will come up with the vaccine to counter the highly contagious virus.
So far, Washington has handed out at a total of least 9.4 billion dollars to seven vaccine developers and signed manufacturing contracts with five of them to provide 700 million doses.
The companies involved are: Johnson & Johnson, Moderna, Oxford/AztraZeneca, Novavax, Pfizer/BioNTech, Sanofi/GSK, Merck Sharp and Dohme.
Europe: 700 million doses
Two vaccine developers -- Oxford/AztraZeneca and Sanofi/GSK -- have signed or are in advanced negotiations with the European Commission to provide a combined 700 million vaccine doses.
Britain, Japan, Brazil
Britain, because of Brexit, is negotiating a separate pre-order of 250 million doses from four developers. Japan is counting on 490 million doses from three suppliers including 250 million from Novavax of the United States.
Japanese pharmaceutical giant Takeda bought the rights to a Novavax vaccine for Japan, which has funded the research. It would be produced locally.
Brazil chose a similar model, ordering 100 million doses from AstraZeneca, and partnering with China’s Sinovac to produce 120 millions of “CoronaVac,” which is already undergoing testing with Brazilians.
SOURCE: AFP
