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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
recently.
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
personnel.
"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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