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China Pushes Emergency Use of Vaccine  09/26 08:44

   Chinese companies earlier drew attention for giving the vaccine to their top 
executives and leading researchers before human trials to test their safety and 
efficacy had even begun. In recent months, they have injected a far larger 
number under an emergency use designation approved in June, and that number 
appears poised to rise.

   BEIJING (AP) -- After the first shot, he had no reaction. But Kan Chai felt 
woozy following the second dose of a COVID-19 vaccine approved for emergency 
use in China.

   "When I was driving on the road, I suddenly felt a bit dizzy, as if I was 
driving drunk," the popular writer and columnist recounted in a webinar earlier 
this month. "So I specially found a place to stop the car, rest a bit and then 
I felt better."

   His is a rare account from the hundreds of thousands of people who have been 
given Chinese vaccines, before final regulatory approval for general use. It's 
an unusual move that raises ethical and safety questions, as companies and 
governments worldwide race to develop a vaccine that will stop the spread of 
the coronavirus.

   Chinese companies earlier drew attention for giving the vaccine to their top 
executives and leading researchers before human trials to test their safety and 
efficacy had even begun. In recent months, they have injected a far larger 
number under an emergency use designation approved in June, and that number 
appears poised to rise.

   A Chinese health official said Friday that China, which has largely 
eradicated the disease, needs to take steps to prevent it from coming back. But 
one outside expert questioned the need for emergency use when the virus is no 
longer spreading in the country where it was first detected.

   It's unclear exactly who and how many people have been injected so far, but 
Chinese vaccine makers have offered some clues. State-owned Sinopharm 
subsidiary CNBG has given the vaccine to 350,000 people outside its clinical 
trials, which have about 40,000 people enrolled, a top CNBG executive said 

   Another company, Sinovac Biotech Ltd., has injected 90% of its employees and 
family members, or about 3,000 people, most under the emergency-use provision, 
CEO Yin Weidong said. It has also provided tens of thousands of rounds of its 
CoronaVac to the Beijing city government.

   Separately, the Chinese military has approved the use of a vaccine it 
developed with CanSino Biologics Inc., a biopharmaceutical company, in military 

   "The first people to have priority in emergency use are the vaccine 
researchers and the vaccine manufacturers because when the pandemic comes, if 
these people are infected then there's no way to produce the vaccine," Yin said.

   Now, large Chinese firms including telecom giant Huawei and broadcaster 
Phoenix TV have announced they're working with Sinopharm to get the vaccine for 
their employees.

   Several people who say they work in "front-line" organizations have said on 
social media that their workplaces have offered vaccinations for about 1,000 
yuan ($150). They declined to comment, saying they would need permission from 
their organizations.

   In an established but limited practice, experimental medications have been 
approved historically for use when they are still in the third and last phase 
of human trials. Chinese companies have four vaccines in phase 3 --- two from 
Sinopharm, and one each from Sinovac and CanSino.

   The Chinese government referenced the World Health Organization's 
emergency-use principles to create its own through a strict process, National 
Health Commission official Zheng Zhongwei said at a news conference Friday.

   He said there have been no serious side effects in the clinical trials.

   "We've made it very clear that the COVID-19 vaccine we put into emergency 
use are safe," Zheng said. "Their safety can be ensured but their efficacy is 
yet to be determined."

   Under the emergency rule, high-risk personnel such as medical and customs 
workers and those who have to work overseas are given priority access, he said. 
He declined to provide exact numbers.

   "In China's case, the pressure in preventing imported infections and 
domestic resurgence is still huge," Zheng said.

   But Diego Silva, a lecturer in bioethics at the University of Sydney, said 
that giving vaccines to hundreds of thousands outside of clinical trials 
doesn't have "scientific merit" in China, where there are currently very few 
locally transmitted cases, and incoming arrivals are quarantined centrally.

   "If it's in the U.S. where the virus is still raging that's a bit different, 
but in a country like China it doesn't seem to make sense to me," he said. 
"Because there's not enough of the virus in China locally to deduce anything, 
you're introducing a whole host of others factors" by injecting people outside 
of trials.

   Zheng said that all those injected under emergency use are being closely 
tracked for any adverse health effects.

   Kan Chai, the columnist, wrote in an article posted online in September that 
despite initial hesitation, he decided to sign up after he heard a state-owned 
company was looking for volunteers.

   He didn't say whether his was an emergency-use case, but the timing of his 
vaccination suggests it was. He took the first dose in late July, when the 
emergency inoculations were getting started and the trials were all but over.

   "I'm willing to be a little white mouse, and the biggest reason is because I 
have trust in our country's vaccination technology," 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 pen name, which means "10 years of 
chopping wood." He declined an interview request.

   He described taking the vaccine in a public webinar hosted by 8am 
HealthInsight, a popular health media outlet. It's unclear why he qualified to 
receive it.

   Scant information is publicly available about the program's scope, size, and 
scientific merit. CNBG and parent Sinopharm declined to comment. Zheng, the 
National Health Commission official, did not know about the Kan Chai case.

   While emergency use 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 governance of emerging science at University of Kent 
in Britain.

   Zhang said that she could not find any relevant information on the Sinopharm 
website, and aside from reports published in international medical journals, 
there is little else made public.

   She said relatively more information is publicly available about other 
trials such as one run by Oxford University and AstraZeneca. The trial was 
halted after a participant developed severe neurological side effects, and only 
resumed after clinical data was submitted to an independent review board.

   China has a troubled past with vaccines, with various scandals over the past 
two decades.

   The most recent case was in 2018, when Changsheng Biotechnology Co. came 
under investigation for falsifying records and making ineffective rabies 
vaccines for children.

   In 2017, Wuhan Institute of Biological Products Co., a CNBG subsidiary 
behind one of the vaccines in phase 3 trials, was found to have made defective 
diphtheria vaccines that were ineffective.

   Public anger over the case prompted an overhaul of a vaccine punishment law 
in 2019. The country tightened supervision over the vaccine development and 
distribution process, and increased penalties for fabricating data.

   Those concerns seem to be of the past. Guizhen Wu, the chief biosafety 
expert for China's Center for Disease Control, said a vaccine could be ready 
for the general public in China as early as November. She said she took an 
experimental vaccine back in April.

   An overseas employee at a Chinese state-owned company, who spoke on 
condition of anonymity because she wasn't authorized to speak with the media, 
said she decided to sign up last week.

   She said she isn't worried because a vaccine is a government priority, so 
authorities will keep a close watch on the process.

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