China, which has largely eradicated the disease, should take action to prevent it from recurring, a Chinese health official said on Friday. But an external expert questioned the need for emergency use when the virus was not spreading in the country where it was first detected.
So far it is not clear who or how many were vaccinated, but Chinese vaccine makers have provided some clues. CNPG, a state-owned Sinoform subsidiary, has given the vaccine to 350,000 people outside its clinical trials, of which about 40,000 have been registered, a senior CNPG executive recently said.
Another company, Sinovac Biotech, has injected 90 percent or about 3,000 of its employees and family members, most of them under emergency use arrangement, CEO Yin Weidong said. It has donated tens of thousands of rounds of its Coronavak to the Beijing city government.
Separately, the Chinese military has approved the use of the vaccine, developed by Cancino Biologics, a biopharmaceutical company, in military personnel.
“Vaccine researchers and vaccine manufacturers are the first priority in emergency use because when it comes to infection, there is no way to produce a vaccine if these people become infected,” Yin said.
Now, major Chinese companies, including telecommunications company Hawaii and broadcaster Phoenix TV, have announced that they will be working with Sinoform to get the vaccine for their employees.
Many who claim to work for “leading” companies claim on social media that their workplaces have vaccinated them for about 1000 yuan (9,209). They declined to comment, saying their company needed permission.
“If it’s in the United States, the virus is even worse, but it’s a little different, but in a country like China I do not understand it.”
Dr. Diego Silva, University of Sydney
In established but limited practice, test drugs have historically been recognized as being in the third and final stages of human testing. Chinese companies have four vaccines in Phase 3 – two from Sinoform and one each from Sinovac and Cancino.
National Health Authority official Zheng Zhangwei told a news conference on Friday that the Chinese government had instructed the World Health Organization to develop its own emergency use policies through a strict process. He said there were no serious side effects in the clinical trials.
“We have made it very clear that the COVID-19 vaccine we have for emergency use is safe,” Zheng said. “Their safety can be confirmed, but their effectiveness has not yet been determined.”
Under the emergency rule, priority is given to high-risk individuals, such as medical and customs workers, who have to work abroad, he said. He refused to give exact numbers.
“In the case of China, the pressure to curb imported infections and domestic uprisings is even greater,” Zheng said.
But Diego Silva, a lecturer in bioethics at the University of Sydney, says vaccinating hundreds of thousands of people outside of clinical trials is not “scientifically qualified” in China, and that cases are currently very low domestically, and isolated as an incoming visit center.
“If it’s in the United States, the virus is even worse, but it’s a little different, but in a country like China I do not understand it,” he said. “Because there is not enough virus to reduce anything domestically in China, you are introducing the whole factor to others” by injecting people out of the tests.
Zheng said all those paid for under emergency use are closely monitored for any ill health effects.
‘I’m ready to be a little white mouse’
In an article published online in September, columnist Khan Chai wrote that despite initial reluctance, he decided to sign up after hearing that the state-owned company was looking for volunteers.
He did not say it was an emergency use case, but his vaccination time says it was. By the end of July he had started emergency vaccinations and all the tests were over.
“I am ready to be a little white mouse, and the biggest reason is that I have confidence in our country’s vaccine technology,” he said.
His real name is Li Yong, but his 1.65 million followers on social media site Weibo like Twitter know him well by his pen name, which means “10 years of chopping wood”. He declined an interview request.
He described the vaccination at a public webinar hosted by Health Insight, a popular health media outlet, at 8 p.m. It is not clear why he qualified to receive it.
Less information is generally available about the purpose, size, and scientific merit of the project. CNPG and parents Synoform declined to comment. National Health Authority official Zheng was unaware of Khan Chai’s case.
Joy Zhang, a research professor of ethical management of emerging science at the University of Kent in the UK, said Chinese companies are not transparent about issues such as informed approval when emergency use is on the right track.
Zhang said he could not find any relevant information on the Sinoform website and that nothing had been made public other than reports in international medical journals.
He added that relatively additional information about Oxford University and other experiments conducted by Astrogeneka was publicly available. The experiment was discontinued after one participant developed severe neurological side effects, and resumed after clinical data were submitted to an independent review panel.
History of vaccine scandals
With various scandals over the past two decades, China has had a complicated past with vaccines.
The most recent case came to trial in 2018 for falsifying Changsheng biotechnology records and making ineffective rabies vaccines for children.
In 2017, the Wuhan Institute of Biological Products, a CNPG subsidiary, was found to have developed defective diphtheria vaccines that were ineffective behind one of the vaccines in Phase 3 trials.
Public outrage over the case prompted a change in the Vaccine Penal Code in 2019. The country tightened oversight of the vaccine development and distribution process, and increased penalties for preparing data.
Those concerns seem to be in the past. Guizhen Wu, chief life-saving expert at China’s Center for Public Control, said a vaccine could be ready for the general public in China by early November. He said he took a test vaccine again in April.
A foreign employee at a Chinese state-owned company, who spoke anonymously because he did not have the authority to speak to the media, said he decided to register last week.
He said he was not worried because a vaccine was a government priority, so officials would closely monitor the process.
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