WHO wants to review Russian vaccine safety data

GENEVA - 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 defense 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 6 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 that 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.

Agence France-Presse

Russia ready to supply Philippines with ‘effective,’ ‘safe’ coronavirus vaccine

MANILA —Russia is ready to supply the Philippines in what could be the world’s first vaccine against COVID-19, its diplomat to Manila said Friday.

In a virtual press briefing, Russian Ambassador to the Philippines Igor Khovaev said proposals to conduct clinical trials and the possible local production of the vaccine have been submitted to local authorities.

"We have 3 options for cooperation. First, clinical trials, if our Philippine partner considers it necessary. The second option [is] we are ready to supply vaccine to the Philippines. And third, the most promoted option, is local production of vaccine here on the Philippine soil,” Khovaev said.

“It means we are ready to combine our efforts, we are ready to make the investments together with our Philippines partners and we are ready to share our technologies, simply because we want to build a robust partnership between our 2 nations.”

Saying Russia already has an "effective" and "safe" COVID-19 vaccine, Khovaev said his government was ready to share it with interested international partners, including the Philippines.

He added that he expected the vaccine to get regulatory approval in Russia by mid-August before launching production.

Khovaev said Russian citizens would be vaccinated for free.

In response to Moscow’s offer, Foreign Affairs Secretary Teodoro Locsin Jr. said he had sent a note verbale or a diplomatic note to the Russian envoy on the proposals “with profound gratitude for Russia's offer and your warm friendship.”

In a separate tweet, Locsin hinted that the proposal would still go around different local departments.

In a statement, the Department of Foreign Affairs (DFA) welcomed Russia's willingness to assist the Philippines in fighting the virus.

"The DFA conveys its appreciation for Russia’s willingness to assist the Philippines in its fight against COVID-19, as well as its offer to supply the SARS-COV-2 vaccine developed by N.F. Gamaleya of the Ministry of Health of the Russian Federation," the agency said.

The DFA added that Russia's offer will be evaluated by other relevant government agencies.

To date, the number of coronavirus cases in the Philippines has reached 122,754, with 3,379 new infections reported Friday.

The nationwide caseload includes 2,168 fatalities, 66,852 recoveries and 53,734 active cases

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