Malaysia takes ‘wait and see’ stand on Russian-made C19 vaccine


KUALA LUMPUR: Malaysia is not quite ready to stand in line to embrace the “Sputnik V”  Russian developed Covid-19 vaccine yet.  

Senior Minister Datuk Seri Ismail Sabri Yaakob (pix) said the government will monitor Moscow’s progress closely following Russia’s announcement recently that it had granted regulatory approval to a Covid-19 vaccine in less than two months of human testing.

“The Ministry of Health will definitely study the development first because there are many countries that have claimed to have found the vaccine,” the defence minister told a press conference held in Parliament.

“How effective is this vaccine? I believe the Ministry of Health will conduct its own study. It’s still too early to decide on it,” he added.

Russian President Vladimir Putin said recently that his country had become the first to approve a vaccine for the novel coronavirus after international media.

Putin had likened the move to its success in the Cold War-era space race. The vaccine will be called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union.

Experts, however, suggested Moscow was rushing through the approval since it has yet to complete its final trials, the newswire reported.

Only about 10 per cent of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.

Meanwhile, 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 announcement of its newly minted vaccine.

 “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 the United Nations health agency’s spokesman Tarik Jasarevic.

“Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data,” he told reporters in Geneva at an online press briefing.

Russia’s Sputnik V vaccine has been developed by the Gamaleya research institute in coordination 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 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 three of clinical trials.

The Gamaleya candidate, which is among the 28 in clinical evaluation, is listed as only being in phase one.

Kirill Dmitriev, the head of the Russian Direct Investment Fund which finances the vaccine project, said phase three trials would start on Wednesday, industrial production was expected from September and that 20 countries had pre-ordered more than a billion doses.

Benchmark on 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 medicine. 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,” said Jasarevic.

“Accelerating progress does not mean compromising on safety,” he said.