A Chinese health official said on Friday that China, which has largely eliminated the disease, needs to take steps to prevent its return. But one outside expert questioned the need for emergency use when the virus was not spreading in the country in which it was first detected.
It’s unclear exactly who and how many people have been injected yet, but Chinese vaccine makers have provided some clues. A senior CNBG executive recently said that state-owned Sinopharm’s CNBG has given the vaccine to 350,000 people outside of its clinical trials, in which about 40,000 people have participated.
CEO Yin Weidong said another company, Sinovac Biotech, has injected 90 percent of its employees and family members, or about 3,000 people, most of them under the emergency use clause. It has also provided tens of thousands of CoronaVac tours to the Beijing city government.
Separately, the Chinese military has approved the use of a vaccine it developed with CanSino Biologics, a biopharmaceutical company, in military personnel.
“The first people to have priority in emergency use are the vaccine researchers and vaccine manufacturers because when an epidemic comes, if these people are infected, there is no way to produce the vaccine,” Yin said.
Now, big Chinese companies, including telecom giant Huawei and Phoenix TV, have announced that they are working with Sinopharm to get the vaccine for their employees.
Several people who said they work for “front line” organizations said on social media that their workplaces offered vaccinations for around 1,000 yuan (US $ 209). They declined to comment, saying they would need permission from their organization.
If the virus is in the United States where it is still rampant that is a bit different, but in a country like China that does not make sense to me.
Dr. Diego Silva, University of Sydney
In a well-established but limited practice, experimental drugs have historically been approved for use when they are still in the third and final stage of human trials. Chinese companies have four vaccines in Phase 3 – two from Sinopharm and one each from Sinovac and CanSino.
National Health Commission official Cheng Zhongwei, at a press conference on Friday, said the Chinese government had indicated the WHO principles for using emergencies to create its own principles through a rigorous process. He said there were no serious side effects in the clinical trials.
“We have shown that the COVID-19 vaccine we used in emergency situations is safe,” said Cheng. “Their safety can be guaranteed, but their effectiveness has not yet been determined.”
Under the emergency law, he said, priority is given to high-risk employees such as medical workers, customs and those who have to work abroad. He declined to provide accurate numbers.
“In the case of China, the pressure is still tremendous in preventing imported infections and domestic returns,” said Cheng.
But Diego Silva, a lecturer in bioethics at the University of Sydney, said giving vaccines to hundreds of thousands outside clinical trials has no “scientific merit” in China, where there are currently very few locally transmitted cases and arrivals have been centrally isolated.
He said: “If the virus is in the United States where it is still rampant, then this is somewhat different, but in a country like China that does not make sense to me.” “Since there isn’t enough virus in China locally to infer anything, you are introducing a whole host of other factors” by injecting people outside of the trials.
All those who have been injected in emergency situations are being closely monitored for any adverse health effects, Cheng said.
“I’m ready to be a little white mouse”
Columnist Kan Chai wrote in an article posted online in September that despite initial hesitation, he decided to sign up after hearing that a state-owned company was looking for volunteers.
He did not say if it was an emergency use, but the timing of the vaccination indicated that. He took the first dose in late July, when the emergency vaccinations began and trials ended.
“I am ready to be a little white mouse, and the biggest reason is that I trust vaccination technology in our country,” he said.
His real name is Li Yong, but his 1.65 million followers on the Twitter-like social platform Weibo know him better by his nickname, which means “10 years of chopping wood,” which turned down the interview request.
He described taking the vaccine at a public webinar hosted by 8am HealthInsight, a popular health media outlet. It is unclear why he qualifies for it.
Little information is available to the public about the program’s scope, size, and academic merit. CNBG and Sinopharm parent declined to comment. Cheng, an official with the National Health Commission, was not aware of Kan Chai’s case.
While use in emergencies may be the right path, Chinese companies are not being transparent about issues such as informed consent, said Joy Zhang, a professor who researches the ethical management of emerging sciences at the University of Kent in the UK.
Zhang said she was unable to find any relevant information on the Sinopharm website, and aside from the reports published in international medical journals, nothing else has been announced.
She said relatively more information is available to the public about other experiments such as those conducted by the University of Oxford and AstraZeneca. The trial was stopped after one participant developed severe neurological side effects, and only resumed after clinical data was submitted to an independent review board.
A history of vaccine scandals
China has a tumultuous past with vaccines, with many scandals over the past two decades.
The most recent case was in 2018, when Changsheng Biotechnology came under investigation for falsifying records and making ineffective rabies vaccines for children.
In 2017, the Wuhan Institute of Biological Products, a subsidiary of CNBG behind one of the vaccines in their Phase 3 trials, was found to have manufactured defective diphtheria vaccines that were not effective.
Public outrage over the case led to a reform of the Vaccine Punishment Law in 2019. The state tightened control over the vaccine development and distribution process, and increased penalties for fabricating data.
These fears appear to be in the past. Guizhen Wu, a chief biosafety expert at the Chinese Center for Disease Control, said the vaccine may be ready for the general public in China as early as November. She said she took an experimental vaccine in April.
A foreign employee at a Chinese state-owned company, who spoke on condition of anonymity because she was not authorized to speak to the media, said that she decided to register last week.
She said she is not concerned that the vaccine is a government priority, so authorities will monitor the process closely.
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