China is doubling down in the global push for a coronavirus vaccine

And while the successful development of a vaccine wouldn’t prevent other countries from continuing their own research, China has placed particular emphasis on being the first.

By October, four of the 10 Covid-19 vaccine candidates that have entered Phase 3 clinical trials worldwide – the final and most important test step before regulatory approval is sought – were being developed by Chinese companies.

Two come from the China National Biotec Group (CNBG), a unit of the state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm). Another candidate, CoronaVac, was developed by drug maker Sinovac Biotech. The remaining candidate was jointly developed by the Chinese military-affiliated Beijing Institute of Biotechnology and vaccine company CanSino Biologics.

CNBG chairman Yang Xiaoming said last month that his vaccine progress is “faster than expected”. The company has conducted phase 3 studies in countries such as the United Arab Emirates, Bahrain, Peru, Morocco and Argentina with a total of 42,000 participants.

“We are only one last mile away from later success,” he said recently at a bio-industry conference in the Chinese city of Wuhan, where the coronavirus was first discovered last December.

Wu Guizhen, Chief Biosafety Expert at the Chinese Center for Disease Control and Prevention, told state broadcaster CCTV last month that the country’s coronavirus vaccines could be ready for general public use as early as November.

“I think it is very likely that they will be the first to announce the successful development of a vaccine,” said Yanzhong Huang, senior fellow on global health with the Washington-based Council on Foreign Relations.

“The key question, however, is how well international society, especially the scientific community, will recognize this.”

“Spirit of Sacrifice”

A vaccine usually takes years to develop. To stop a virus that has killed more than a million people worldwide, scientists are developing Covid-19 vaccines at an unprecedented rate. In China, efforts to move this process forward included the controversial testing of hundreds of thousands of people outside of the normal regulatory approval process.

Since July, Chinese drug manufacturers have been giving experimental vaccines to people working in “high-risk” professions – including medical workers and border guards – under a government-approved emergency program that allows vaccine candidates to be used on a limited scale before their safety and effectiveness reach clinical Studies have been fully proven.

The vaccine candidates approved for emergency use are still in phase 3 studies. Some experts fear that swiftly following the normal regulatory process could expose participants to potentially unknown side effects, and Chinese drug manufacturers are taking risks that violate international ethical and safety standards.

“Despite official claims that the vaccines are safe and effective, it may not be a wise decision to vaccinate so many people on such a large scale before systematic data from phase 3 clinical trials become available,” said Huang, the global health expert.

However, Chinese pharmaceutical companies were already taking controversial and risky steps months before the emergency program was launched.

Yang, the chairman of CNBG, said at a conference in Wuhan last month that more than 100 people received the company’s early-stage coronavirus vaccine candidate before it was approved for human testing on April 12 – including himself.

“I’m not wearing a mask today because I injected this vaccine on March 22nd,” said Yang. “We’re known as pioneers. Before clinical trials were approved, we had four people in the first batch, 38 people in the second batch, and a total of 138 people in the third batch to test safety and efficacy.”

At the end of May, Sinopharm announced in an online statement that its employees, including top executives, had received experimental recordings as a “pretest” prior to clinical trials.

“It’s like the legendary Shennong tasting hundreds of herbs themselves,” the statement read, referring to the mythological father of traditional Chinese medicine who eventually died after ingesting a poisonous plant.

“It has been a tradition for CNBG employees to test drugs themselves for more than a hundred years. In addition, it is a spirit of sacrifice that is passed on from generation to generation.”

Huang said sacrificing individual wellbeing for the benefit of the collective – or the state – has long been promoted by the government and goes way back in Chinese history.

Emergency use

The sense of self-sacrifice can also partly explain the large number of people willing to take the risk and get vaccinated as part of the emergency program.

Yang, the chairman of CNBG, said about 350,000 people took experimental recordings of his company.

CNBG’s two coronavirus vaccine candidates were approved for emergency use and offered to medical professionals, diplomats deployed in high-risk countries and employees of state-owned companies working overseas as part of the Chinese Belt and Road Initiative. This is evident from a statement posted on Sinopharm’s website this month. The vaccine candidate developed by Sinovac is also included in the emergency program, according to Reuters.Within the company at the forefront of China's quest to develop a coronavirus vaccine

The company injected 90% of its employees and family members – roughly 2,000 to 3,000 people – with its experimental vaccine.

Separately, the Chinese government also approved the use of CanSino Biologics’ coronavirus vaccine for the country’s military in June.

Chinese health officials say the emergency program has its legal basis in the country’s vaccination law and participation is completely voluntary.

Given that many of the attendees are civil servants or officials and government employees, some may have felt politically pressured to sign up, Huang said – especially if their bosses and colleagues did.

“I always have the feeling that I am not sure to what extent they should be considered ‘volunteers’ in the Western sense,” he said of the participants.

National pride

There is also a question of the need for emergency testing in China as the country has not reported any locally transmitted symptomatic coronavirus cases in more than a month.

For some observers, there might be other factors underlying China’s pursuit of the vaccine race.

“The government’s efforts to aggressively develop and promote the vaccines are increasingly driven by political and foreign policy concerns,” Huang said.

In addition to scientific prestige and national pride, a safe and effective Covid-19 vaccine could have geopolitical implications.

The Chinese government was sharply criticized – especially from the US – for dealing with the coronavirus outbreak for the first time. The subsequent “mask diplomacy” – an attempt to deliver medical care to countries struggling with Covid-19 – also raised suspicions of changing the coronavirus narrative.Chinese President Xi Jinping learns of the progress of a candidate for a coronavirus vaccine during his visit to the Academy of Military Medical Sciences in Beijing in March.

As the first to provide the world with a vaccine, China would have the opportunity to build its global reputation by positioning itself as a leader in the fight against the pandemic, filling the void the US has left and cementing its position as a true superpower.

It would also provide some degree of diplomatic leverage. China has promised priority access to a Chinese vaccine if it is found to be safe and effective to a growing list of countries – mostly developing countries that have helped Chinese companies conduct Phase 3 trials, including Beijing’s strategic allies .

However, China’s vaccine industry has a troubled safety record. A number of vaccine scandals have ravaged China over the past decade.

In 2018, Changsheng Biotechnology Co. was fined for producing data to manufacture and inspect vaccines. Back in 2017, the same company was discovered to be making ineffective vaccines against diphtheria, pertussis and tetanus (DPT) for children. The Wuhan Institute of Biological Products, a CNBG subsidiary behind one of the vaccines in Phase 3 trials, was also found to have made faulty DPT vaccines.

“Recipe for a Disaster”

In the US, any move that undermines the safety and effectiveness of a future vaccine is likely to be heavily pushed back by experts, regulators and drug makers, no matter how much Trump wants to speed up the development process.

FDA is considering regulatory rules that could drive coronavirus vaccine forward after Election Day

Amid growing concerns that a vaccine could be pushed for emergency use authorization (EEA) before Election Day without political safety checks through political pressure, the US Food and Drug Administration released new guidelines this week and wished for it two months of safety data after volunteers received their second dose of vaccine before companies can apply for EEA – something that would make it impossible to obtain an EEA before November 3rd.

In the first presidential debate, Trump said he had spoken to the major vaccine manufacturers, including Moderna, and they had told him that a vaccine might be available soon.

Moderna CEO Stéphane Bancel said at a Financial Times conference last week that he had received no political pressure in either direction.

“Since we started this race against the virus in early January, no party, branch of government, or country has asked us to go faster or slower,” he said.

CNN’s Elizabeth Cohen, John Bonifield, Jeremy Diamond and Lauren Mascaren contributed to this story.