MOSCOW — Russia has made no secret of its intention to win the global race for a COVID-19 vaccine, claiming to have a viable and effective vaccine ready to launch into production in the coming weeks.

But if Russia succeeds in being first to market with a vaccine, it will be a sign of the country’s appetite for risk as much as its scientific prowess.

“Russia traditionally has been very strong in vaccines,” said Kirill Dmitriev, head of the Russian Direct Investment Fund, which is financing the vaccine trials, in an interview with NBC News. “The vaccine we have is actually sort of a copycat of an Ebola vaccine that was developed five years ago by the Gamaleya Institute in Moscow.”

Download the NBC News app for the latest news on the coronavirus

According to Dmitriev, who took part in the vaccine’s early clinical trials, Russia’s vaccine was able to race ahead because it is a tweaked version of an earlier vaccine against the Middle East respiratory syndrome virus, which first appeared in Saudi Arabia in 2012 and is closely related to COVID-19. The MERS vaccine itself was created by using the Ebola virus as its foundation.

Russia’s trade minister, Denis Manturov, said Monday that vaccine production “should begin as soon as September,” with three Russian companies already tapped to handle mass production with “a production volume of several hundred thousands of vaccine doses per month with a subsequent increase to several million by the beginning of next year.”

Image: Russia coronavirus vaccine (Sechenov Medical University Press office / TASS via Getty Images file)

In shooting for such an ambitious schedule, Russia’s vaccine is jumping ahead of established pharmaceutical practice. Similar vaccines, such as one being developed by the University of Oxford and AstraZeneca, are still undergoing so-called phase three clinical trials and are not expected to be widely available until early 2021.

Russia is moving forward before completing similar trials, a move Dmitriev says is made possible by the fact that Russia’s vaccine — despite being similar to Oxford’s — is based on vaccine technologies already tested in Russia. Both use a so-called adenoviral vector, Dmitriev said. But where Oxford uses a monkey adenovirus, Russia’s vaccine uses a human adenovirus.

Story continues

Health experts worry that such rapid progress comes with inherent risks.

“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering it to anyone,” U.S. disease expert Dr. Anthony Fauci said of Russia and China’s race to field a vaccine. “Claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best.”

Image: Russia coronavirus vaccine (Olga Maltseva / AFP via Getty Images file)

The Russian vaccine, developed in cooperation between the Gamaleya Institute in Moscow and a Russian Defense Ministry laboratory, has completed phase one and two clinical trials with several small groups of volunteers. A larger trial, involving up to 1,600 people, will only begin this month after initial batches of the virus go into circulation.

Russian Health Minister Mikhail Murashko told reporters over the weekend the vaccine had completed its clinical trials and was being prepared for approval by state regulators on a conditional basis. The first groups of people to be vaccinated — doctors, teachers and high-risk individuals — will be under some kind of observation.

In effect, Russia is conducting its phase three trials live, treating them more like a demonstrator group than a control group meant to ensure there’s nothing dangerous awaiting the larger population. Russia’s pharma industry is preparing to launch into mass production in September. If all goes well, Murashko said, mass vaccination awaits in October.

“The benefit [of our vaccine] versus other vaccine platforms is that while they’re using technology that has never, ever received regulatory approval, Russia is using technology that has previously received regulatory approval,” Dmitriev said, pointing again to Russia’s work with Ebola and MERS human-adenovirus-based vaccines.

Despite the risks associated with cutting corners in testing a new vaccine, pushing forward with an apparently effective candidate may be Russia’s best way out of the coronavirus crisis.

“They are accelerating the vaccine approval process, but it seems to me that the situation requires this,” says Tom Adshead, director of research at Macro-Advisory, a Moscow-based consulting firm.

Almost two months after exiting one of the world’s strictest lockdowns, the decline in daily COVID-19 case growth in Russia has slowed to a glacial pace, although Moscow in the past few weeks has seen signs of a gradual increase in cases. Moscow authorities have begun to reinforce a widely ignored mask regime, but Muskovites for weeks now have lived generally without precaution.

“If you want an immune population, you either need to expose lots of people to the virus and let natural selection take its course or you need a vaccine,” Adshead said. “The alternative is a Taiwan or New Zealand-style lockdown, which requires far more social cohesion than is available in Russia or most other countries.”



Source link

Topics #chooses #COVID19 #faster #production #race #Russia #testing #vaccine #win