‘Not so fast on COVID-19 vaccine’, WHO tells Russia

The WHO has warned any stamp of approval on a COVID-19 ­vaccine candidate would require a rigorous safety data review, after Russia announced it had approved a vaccine.

Russian President Vladimir Putin. Picture: AFP

The World Health ­Organisation has warned any stamp of approval on a COVID-19 ­vaccine candidate would require a rigorous safety data review, after Russia announced it had approved a vaccine.

President Vladimir Putin said on Tuesday that 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 UN health agency’s spokesman Tarik Jasarevic said.

“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 co-ordination with the country’s defence ministry.

A total of 168 candidate vaccines are being worked on around the world, according to a WHO overview published on Tuesday.

Of those, 28 have progressed to the various phases of being tested on humans, of which six are the furthest ahead, having reached phase 3 of clinical trials. The Gamaleya candidate, which is among the 28 in clinical evaluation, is listed as only being in phase 1.

Kirill Dmitriev, the head of the Russian Direct Investment Fund that finances the vaccine project, said phase 3 trials were to 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,” Mr Jasarevic said. “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,” Mr Jasarevic said.

One of the vaccine candidates being tested at phase 3 is from US biotech firm Moderna, which on Tuesday was granted a $US1.5bn ($2.1bn) contract by the Trump ­administration to deliver 100 million doses of an eventual vaccine. It was the sixth such deal reached since May. “The federal government will own these vaccine doses, we’re buying them,” US President ­Donald Trump said.

“We’re on track to rapidly produce 100 million doses as soon as the vaccine is approved, and up to 500 million shortly thereafter, so we’ll have 600 million doses.”

Moderna, in partnership with the US National Institutes of Health, is conducting phase 3 clinical trials, and manufacturing of vaccine doses will take place while the trials are under way.

The vaccine is being co-developed by Moderna and the NIH’s National Institute of Allergy and Infectious Diseases, led by ­Anthony Fauci, who has said ­researchers are unlikely to know the efficacy of the vaccine before the end of the year at the earliest. But Mr Trump has said he hopes to have a vaccine before the November 3 presidential election.

The latest contract brings the US government’s total commitments to Moderna to $US2.48bn.

The company, founded less than 10 years ago, has not previously developed a vaccine of any kind but preliminary results of the its experimental COVID-19 vaccine have reportedly produced promising results.

The Trump administration has allocated at least $US10.9bn for the development and manufacturing of a vaccine, and has already ordered 100 million vaccine doses from Johnson & Johnson, Novavax, Pfizer and Sanofi and 300 million from AstraZeneca.

AFP