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BEIJING, Sept. 26 (AP): After the first shot, he had no reaction. But Kan Chai felt dizzy after the second dose of a Covid-19 vaccine approved for emergency use in China.
“When I was driving on the highway, I suddenly felt a little dizzy, like I was driving drunk,” the popular writer and columnist recounted in a webinar earlier this month. “So I especially found a place to stop the car, get some rest and then I felt better.”
His is a rare account of the hundreds of thousands of people who have received Chinese vaccines, before final regulatory approval for general use. It is an unusual move that raises ethical and safety questions as companies and governments around the world compete to develop a vaccine that will stop the spread of the coronavirus.
Chinese companies previously drew attention for administering the vaccine to their top executives and leading researchers before human trials began to test its safety and efficacy.
In recent months, they’ve injected a much larger number under an emergency use designation approved in June, and that number appears set to rise.
A Chinese health official said on Friday that China, which has largely eradicated the disease, must take steps to prevent it from returning. But an outside expert questioned the need for emergency use when the virus is no longer spreading in the country where it was first detected.
It is not clear exactly who and how many people have injected so far, but Chinese vaccine manufacturers have offered some clues.
Sinopharm’s state subsidiary, CNBG, has administered the vaccine to 350,000 people outside of its clinical trials, which have about 40,000 people enrolled, a senior CNBG executive said recently.
Another company, Sinovac Biotech Ltd., has injected 90% of its employees and family members, or around 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.
Furthermore, the Chinese military approved the use of a vaccine it developed with CanSino Biologics Inc., a biopharmaceutical company, in military personnel.
“The first people who have priority for emergency use are vaccine researchers and vaccine manufacturers because when the pandemic hits, if these people are infected, there is no way to make the vaccine,” Yin said.
Now large Chinese companies, including telecommunications giant Huawei and broadcaster Phoenix TV, have announced that they are working with Sinopharm to obtain 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 vaccines for around 1,000 yuan ($ 150). They declined to comment, saying they would need permission from their organizations.
In established but limited practice, experimental drugs have historically been approved for use while they are still in the third and final phase of human trials. Chinese companies have four vaccines in phase 3: two from Sinopharm and one from Sinovac and one from 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 conference on Friday. press.
He said there have been no serious side effects in clinical trials.
“We have made it very clear that the COVID-19 vaccine that we put into emergency use is safe,” Zheng said. “Its safety can be guaranteed, but its efficacy has yet to be determined.”
Under the emergency rule, high-risk personnel, such as medical and customs workers and those who have to work abroad, have priority access, he said. He declined to provide exact numbers.
“In the case of China, the pressure to prevent imported infections and domestic resurgence remains enormous,” Zheng said.
But Diego Silva, a professor of bioethics at the University of Sydney, said giving vaccines to hundreds of thousands outside of clinical trials has “no scientific merit” in China, where there are currently very few cases of local transmission and inbound arrivals. they are centrally quarantined.
“If it’s in the US, where the virus is still raging, that’s a little different, but in a country like China it doesn’t seem to make sense to me,” he said. “Because there is not enough virus in China locally to deduce anything, it is introducing a lot of other factors” by injecting people outside of the trials.
Zheng said that all those injected under emergency use are being closely monitored 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 learning that a state-owned company was looking for volunteers.
He did not say if his was an emergency use case, but the timing of the vaccination suggests that it was. He took the first dose in late July, when the emergency shots were starting and the tests were over.
“I am willing to be a white mouse, and the main reason is that I trust the vaccination technology of 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 best by his pseudonym, which means “10 years chopping wood.” He declined an interview request.
He described vaccination in a public webinar hosted by 8am HealthInsight, a popular health media outlet. It is not clear why he qualified to receive it.
Little information is publicly available on the scope, size, and scientific merit of the program. CNBG and parent company Sinopharm declined to comment. Zheng, the official of the National Health Commission, did not know about the Kan Chai case.
While emergency use may be the right way to go, Chinese companies are not being transparent about issues like informed consent, said Joy Zhang, a professor researching the ethical governance of emerging science at the University of Kent in Britain.
Zhang said he was unable to find any relevant information on the Sinopharm website and, apart from reports published in international medical journals, little else was made public.
He said there is relatively more information publicly available on other trials, such as one conducted by the University of Oxford and AstraZeneca. The trial was stopped after a participant developed serious neurological side effects and was only resumed after the clinical data was sent to an independent review board.
China has a troubled past with vaccines, with several scandals in the past two decades.
The most recent case was in 2018, when Changsheng Biotechnology Co. was investigated for falsifying records and making ineffective rabies vaccines for children.
In 2017, the Wuhan Institute of Biological Products Co, a CNBG subsidiary behind one of the vaccines in phase 3 trials, was found to have produced faulty diphtheria vaccines that were ineffective.
Public anger over the case prompted a review of a vaccine punishment law in 2019. The country tightened oversight over the vaccine development and distribution process and increased penalties for fabricating data.
Those concerns seem to be from the past. Guizhen Wu, the chief biosafety expert at the China Center for Disease Control, said that a vaccine could be ready for the general public in China from November. She said she took an experimental vaccine in April.
An overseas employee of a Chinese state-owned company, who spoke on condition of anonymity because she was not authorized to speak to the media, said she decided to sign up last week.
She said she is not concerned because a vaccine is a government priority, so authorities will closely monitor the process. – AP
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