China, Russia roll out vaccines for mass distribution

SPUTNIK: A handout photo shows an employee demonstrating vials with "Gam-COVID-Vac" vaccine against the coronavirus disease (COVID-19), developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF), during its production at Binnopharm pharmaceutical company in Zelenograd near Moscow, Russia Aug. 7. The Russian Direct Investment Fund (RDIF)/Andrey Rudakov/Handout via Reuters

SEOUL - China and Russia have begun a mass rollout of their coronavirus vaccines before clinical tests are complete, in what is emerging as an unexpectedly complex geopolitical challenge for the United States.

China's Sinopharm announced this week that it would provide emergency doses of one of its two trial vaccines to the United Arab Emirates, prioritizing the U.S. ally over the vast majority of Chinese. China is now the sole supplier of coronavirus vaccine to the Middle East.

Meanwhile, Russia's sovereign wealth fund signed a deal this week to supply India with 100 million doses of the Sputnik V vaccine.

These moves have thrown Western policymakers off balance. American health-care experts say the United States should not rush out its own vaccine in response. But that leaves China and Russia as the only countries wielding this valuable diplomatic tool for potentially months to come.

The upshot is that by next year, China and Russia may have purchased significant geopolitical power by having bent the rules and rushed out their vaccines. It's also possible their vaccines may fail, at enormous human cost.

"It's really insane and a terrible idea," said Arthur Caplan, head of the division of medical ethics at New York University's Grossman School of Medicine, of China and Russia not waiting for the results of Phase 3 trials. "It's staggeringly hard to comprehend."

Kirill Dmitriev, head of the Russian Direct Investment Fund, which bankrolled Russia's vaccine efforts, said Russia's decision to roll out Sputnik V before the completion of Phase 3 trials has been validated by other countries now doing the same.

"The criticism was that you cannot register a vaccine before Phase 3," Dmitriev said. "But after this, China registered a vaccine, the UAE registered a vaccine before completion of Phase 3, and both Britain and the U.S. said publicly they're considering registering a vaccine before Phase 3. So this part of the criticism is gone."

In recent days, President Donald Trump has pressed for faster release of an American vaccine, while U.S. pharmaceutical companies have resisted the idea of taking a shortcut around long-established safety protocols.

Hundreds of thousands of people in China, including diplomats, the military, front-line health workers and employees of state-owned enterprises, have received Sinopharm's vaccines under urgent-use stipulations, according to state media reports last week. But even as the rest of the country awaits access, Beijing has begun deploying vaccines abroad to regions where it is seeking to expand its influence.

Aside from the UAE collaboration, Sinopharm is also running Phase 3 trials in Jordan and Bahrain.

Egypt announced on Sept. 11 it will also begin trials with Sinopharm, three days after the British-Swedish drugmaker AstraZeneca paused its clinical trial due to a "potentially unexplained illness." The trial has since resumed, although not in the United States. Egypt signed a deal with AstraZeneca in July to purchase 30 million doses of its vaccine.

Caplan said of these geopolitical dynamics, "Yeah, it's a problem."

Officials in Moscow said this week that initial doses of the Sputnik V vaccine have been delivered to all regions of Russia, with health-care workers and teachers the first to receive access.

India, Brazil, Mexico and Kazakhstan have agreed to purchase Sputnik V.

For China, the moves represent an enormous gamble. As the country where the novel coronavirus originated, it has sought to make amends and blunt international fury. But some of its earlier efforts backfired, such as when batches of face masks and other personal protective equipment exported from China were found to be defective.

The stakes are far higher with vaccines. Physicians say there's a risk of rare but severe side effects that don't present in small-scale trials, which is why large-scale Phase 3 trials are usually conducted for months before a vaccine is approved for sale. Safety issues could also emerge due to rushed manufacturing.

But if China's bet pays off - if its vaccines prove to be safe and effective - it could cement its lead over the West in economic recovery in 2021, while also using the vaccine as a powerful diplomatic tool.

Even as China and Russia speed ahead with vaccine deployment, there will not be enough doses for everyone, necessitating decisions about who gets priority. Both countries estimate they can produce enough vaccine in the first year for a fraction of their populations.

Last week, Zhou Song, a Sinopharm executive, told state radio that the company expected an initial output of 300 million doses a year. At two doses per person, that would cover a tenth of China's population. The vaccines will be more broadly available in December, he said.

China has a total of four covid-19 vaccine candidates in Phase 3 testing, and their makers have scattered across the world to run trials. Executives have explained that China has so few covid-19 cases that it is hard to run the trials at home.

But this overseas testing has also been diplomatically expedient for Beijing, as it's essentially an early access pass to vaccines that China can offer developing nations. Countries that have signed up to run Phase 3 trials of Chinese covid-19 vaccines include Argentina, Bahrain, Brazil, Bangladesh, Egypt, Indonesia, Jordan, Morocco, Peru, Russia, Saudi Arabia and the UAE.

The Russian Direct Investment Fund said it expects to have 30 million doses produced in Russia by the end of the year - enough for roughly 20 percent of the population.

But while the domestically produced doses of Sputnik V will be reserved for Russians, the investment fund plans to manufacture larger quantities of the vaccine abroad for international sale.

Russian Health Minister Mikhail Murashko told the state-run Tass news agency this week that of the announced 40,000 volunteers for Phase 3 trials, more than 300 have been vaccinated so far. That doesn't include the health-care workers or teachers who volunteered for vaccination, and it's unclear how many have done so.

Murashko added that the vaccine will be more widely available to the general population in late November or December. Russia's Health Ministry did not respond to a requests for comment.

Officials in Beijing and Moscow stress that all recipients of the vaccines have been volunteers and that the vaccines are safe.

Russian President Vladimir Putin said his daughter has taken Sputnik V. In China, Sinopharm's Zhou told state media, without providing substantiating data, that of the hundreds of thousands of vaccine doses that have been administered, there has not been "a single case of obvious adverse reaction or a single case of infection."

But both countries have heavy controls over speech. Many of the expressions of concern have been oblique, unlike in the United States, where debate has raged over the safety of the vaccines.

Speaking to state media last week, Sinopharm's Zhou acknowledged there were public worries about vaccine safety. The vaccine is not yet indicated for use by pregnant or breastfeeding women, he added, given the lack of research for those demographics.

Vaccine safety scandals are prevalent in China. Surveys have shown high levels of public skepticism, with one 2019 study reporting 70% of respondents did not have vaccine confidence.

In Russia, an August poll revealed that 54% of the more-than 1,600 respondents said they're not ready to volunteer for vaccination, according to the independent Levada Center.

Semyon Galperin, head of the rights group Doctors' Defense League, said some doctors are concerned they could be pressured into vaccination. Russia's Medvestnik medical news website reported this week on a proposal by the Health Ministry to withhold from health-care workers long-promised bonuses for treating coronavirus patients if they decline vaccination.

Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics, said that the rushed rollouts in both countries and top-down emergency-use plans raised questions about informed consent by the early recipients.

"When you have reports, for example, that members of the military are being administered something, to me that can raise questions of: Are these individuals really able to refuse?" he said.

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