China pushes emergency use of vaccine despite concerns

Eufemia Didonato

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 on 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 new 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, 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.

Another candidate being jointly developed by the military and Cansino, a biopharmaceutical company, has been approved for emergency use in military personnel.

31 PHOTOS

States reopen, relax guidelines to prevent coronavirus spread

See Gallery

NEW YORK, NEW YORK – MAY 06: An employee wearing a mask cleans the inside of the restaurant, Blue Stripes Cacao Shop as it prepares to reopen for takeaway and delivery orders after being closed for over a month amid the coronavirus pandemic on May 6, 2020 in New York City. Governor Andrew Cuomo made the announcement that all bars and restaurants must close by on March 16th unless it was takeout or delivery. COVID-19 has spread to most countries around the world, claiming over 263,000 lives with over 3.8 million cases. (Photo by Alexi Rosenfeld/Getty Images)

NEW YORK, NEW YORK – MAY 06: An employee wearing a mask cleans the inside of the restaurant, Blue Stripes Cacao Shop as it prepares to reopen for takeaway and delivery orders after being closed for over a month amid the coronavirus pandemic on May 6, 2020 in New York City. Governor Andrew Cuomo made the announcement that all bars and restaurants must close by on March 16th unless it was takeout or delivery. COVID-19 has spread to most countries around the world, claiming over 263,000 lives with over 3.8 million cases. (Photo by Alexi Rosenfeld/Getty Images)

THOUSAND OAKS, CA – MAY 06: A Cadillac Dealership displays a sign stating its reopened during the Coronavirus Pandemic on May 06, 2020 in Thousand Oaks, California. The coronavirus pandemic worldwide has claimed over 263,000 lives and infected over 3.7 million people. (Photo by Josh Lefkowitz/Getty Images)

HOUSTON, May 5, 2020 — Customers shop at a shopping mall in Frisco, on the outskirts of Dallas, Texas, the United States, May 5, 2020. After closed for several weeks due to the outbreak of COVID-19 pandemic, the shopping mall reopened with shortened business hours on Tuesday. (Photo by Dan Tian/Xinhua via Getty) (Xinhua/ via Getty Images)

HOUSTON, May 5, 2020 — Cars are parked in front of a shopping mall in Frisco, on the outskirts of Dallas, Texas, the United States, May 5, 2020. After closed for several weeks due to the outbreak of COVID-19 pandemic, the shopping mall reopened with shortened business hours on Tuesday. (Photo by Dan Tian/Xinhua via Getty) (Xinhua/ via Getty Images)

Dawson Padilla (L), owner of a protein shakes store, works behind the bar on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

A worker of the Aspen Cafe wears a mask as she makes coffee on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

Kelly Lyda, owner of the Aspen Cafe, stands in his Cafe on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

Computer specialist Toby Angel drinks his coffee on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

WESTPORT, CONNECTICUT – MAY 05: A cafe along a shopping street in the affluent community remains mostly empty of pedestrians and open stores on May 05, 2020 in Westport, Connecticut. A growing number of states have begun reopening parts of the economy amid demonstrations like the one yesterday that targeted the Connecticut state capital and the governor’s mansion in Hartford. (Photo by Spencer Platt/Getty Images)

WESTPORT, CONNECTICUT – MAY 05: A cafe along a shopping street in the affluent community remains mostly empty of pedestrians and open stores on May 05, 2020 in Westport, Connecticut. A growing number of states have begun reopening parts of the economy amid demonstrations like the one yesterday that targeted the Connecticut state capital and the governor’s mansion in Hartford. (Photo by Spencer Platt/Getty Images)

LAGUNA HILLS, CA – MAY 05: Customers maintain safety protocols at The BarberHood in Laguna Hills, CA, on Tuesday, May 5, 2020. The shop is one of the first to re-open and defy the state”u2019s stay-at-home order during the COVID-19 (coronavirus) lockdown. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

SAN CLEMENTE, CA – MAY 05: Visitors walk on the beach south of the pier in San Clemente, CA on Tuesday, May 5, 2020. The city opened its beaches for daily active use after coordinating with Gov. Gavin Newsom”u2019s office to maintain social distancing during the COVID-19 (coronavirus) lockdown. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

SAN CLEMENTE, CA – MAY 05: Surfers were back on the waves at T Street in San Clemente, CA on Tuesday, May 5, 2020. The city opened its beaches for daily active use after coordinating with Gov. Gavin Newsom”u2019s office to maintain social distancing during the COVID-19 (coronavirus) lockdown. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

KENMORE, WA – MAY 05: Lynette Fisher-Charles and her dog Gracie, a two-year-old springer spaniel, go for a hike in Saint Edward State Park on May 5, 2020 in Kenmore, Washington. The first phase to reopen the state begins today easing some restrictions including opening some parks, that were put in place during Governor Jay Inslees Stay Home, Stay Healthy order last March to help reduce the spread of COVID-19. Kenmore, WA is located northeast of Seattle. (Photo by Karen Ducey/Getty Images)

KENMORE, WA – MAY 05: Daryl Kline, a park ranger at Saint Edward State Park removes a sign saying the park is closed on May 5, 2020 in Kenmore, Washington. The first phase to reopen the state begins today easing some restrictions that were put in place during Governor Jay Inslees Stay Home, Stay Healthy order last March to help reduce the spread of COVID-19. Kenmore, WA is located northeast of Seattle. (Photo by Karen Ducey/Getty Images)

LAGUNA BEACH, CA – MAY 05: Lifeguards keep a lookout at Laguna Beach, CA after officials reopened access to the sand on Tuesday, May 5, 2020. The beach has been closed since March 23, 2020 due to the COVID-19 (coronavirus) outbreak. City parks along the beach are still closed and people cannot sit or linger on the sand. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

NEW YORK, May 4, 2020 — Photo taken on May 4, 2020 shows Times Square in New York, the United States.
Amid the ongoing COVID-19 pandemic, New York Governnor Andrew Cuomo on Monday outlined additional guidelines regarding when regions can reopen.
According to the Governor’s Press Office, the state will monitor four core factors to determine if a region can reopen: number of new infections, health care capacity, diagnostic testing capacity and contact tracing capacity. (Photo by Wang Ying/Xinhua via Getty) (Xinhua/Wang Ying via Getty Images)

NEW YORK, May 4, 2020 — A worker cleans a cafe’s signboard at Times Square in New York, the United States, May 4, 2020.
Amid the ongoing COVID-19 pandemic, New York Governnor Andrew Cuomo on Monday outlined additional guidelines regarding when regions can reopen.
According to the Governor’s Press Office, the state will monitor four core factors to determine if a region can reopen: number of new infections, health care capacity, diagnostic testing capacity and contact tracing capacity. (Photo by Wang Ying/Xinhua via Getty) (Xinhua/Wang Ying via Getty Images)

ASBURY PARK, NJ – MAY 4: People walk near the closed boardwalk due to the outbreak of COVID-19 in the state on May 4, 2020 in the Jersey Shore in New Jersey. Some towns at Jersey Shore expect the reopening of beaches soon. (Photo by Eduardo MunozAlvarez/VIEWpress/Corbis via Getty Images)

NORTH ANDOVER, MA – MAY 4: Although all golf courses in Massachusetts are still ordered to stay closed by governor Charlie Baker, workers at the North Andover Country Club in North Andover, MA work on the grass on May 4, 2020, getting the course ready for when they eventually are allowed to re-open. (Photo by Jim Davis/The Boston Globe via Getty Images)

LOS ANGELES, CA – MAY 04: Gov. Gavin Newsom announced select retail businesses will be allowed to reopen starting Friday in California during the coronavirus pandemic on Monday, May 4, 2020 in Los Angeles, CA. (Jason Armond / Los Angeles Times via Getty Images)

SANFORD, UNITED STATES – MAY 04, 2020: Customers enjoy a meal at Racks Billiards Sports Bar and Grill on the first day that retail stores and restaurants in all Florida counties except Palm Beach, Broward, and Miami Dade were permitted to reopen as COVID-19 restrictions are eased. Under phase one of the plan to reopen the state, stores and restaurants are limited to 25 percent of their indoor capacity.- PHOTOGRAPH BY Paul Hennessy / Echoes Wire/ Barcroft Studios / Future Publishing (Photo credit should read Paul Hennessy / Echoes Wire/Barcroft Media via Getty Images)

SANFORD, UNITED STATES – MAY 04, 2020: A customer leaves a Books-A-Million store on the first day that retail stores and restaurants in all Florida counties except Palm Beach, Broward, and Miami Dade were permitted to reopen as COVID-19 restrictions are eased. Under phase one of the plan to reopen the state, stores and restaurants are limited to 25 percent of their indoor capacity.- PHOTOGRAPH BY Paul Hennessy / Echoes Wire/ Barcroft Studios / Future Publishing (Photo credit should read Paul Hennessy / Echoes Wire/Barcroft Media via Getty Images)

BOZEMAN, MT – MAY 04: Sales staff wear masks at the reopened Schnee’s Boots, Shoes and Outdoors on Main Street on May 4, 2020 in Bozeman, Montana. Wyoming health officials today reported that the state’s confirmed coronavirus cases grew by nine to a total of 444. (Photo by William Campbell/Getty Images)

BOZEMAN, MT – MAY 04: Signs for restaurants and stores announce their reopenings on Main Street on May 4, 2020 in Bozeman, Montana. Wyoming health officials today reported that the state’s confirmed coronavirus cases grew by nine to a total of 444. (Photo by William Campbell/Getty Images)

JENSEN BEACH, FLORIDA – MAY 04: Cole Hunter carries Harper Hunter, 1, as Holly Hunter,4, follows along as they arrive at the beach on May 04, 2020 in Jensen Beach, Florida. Restaurants, retailers, as well as beaches and some state parks reopened today with caveats, as the state continues to ease restrictions put in place to contain COVID-19. The counties of Palm Beach, Broward and Miami Dade continue to maintain restrictions. (Photo by Joe Raedle/Getty Images)

JACKSONVILLE BEACH, FLORIDA – MAY 04: People are seen dining outside at Cruisers Grill as the state of Florida enters phase one of the plan to reopen the state on May 04, 2020 in Jacksonville Beach, Florida. Restaurants, retailers, beaches and some state parks reopen today with caveats, as the state continues to ease restrictions put in place to contain the coronavirus (COVID-19). (Photo by Sam Greenwood/Getty Images)

JACKSONVILLE BEACH, FLORIDA – MAY 04: People are seen at a department store as the state of Florida enters phase one of the plan to reopen the state on May 04, 2020 in Jacksonville Beach, Florida. Restaurants, retailers, beaches and some state parks reopen today with caveats, as the state continues to ease restrictions put in place to contain the coronavirus (COVID-19). (Photo by Sam Greenwood/Getty Images)

SAINT AUGUSTINE, FLORIDA – MAY 04: A mask is seen on the statue of Henry M. Flagler as the state of Florida enters phase one of the plan to reopen the state on May 04, 2020 in Saint Augustine, Florida. Restaurants, retailers, beaches and some state parks reopen today with caveats, as the state continues to ease restrictions put in place to contain the coronavirus (COVID-19). (Photo by Sam Greenwood/Getty Images)

A man works on power lines in Los Angeles, California on May 4, 2020, amid the coronavirus pandemic. – California governor Gavin Newsom earlier today announced the gradual reopening of the state later this week as dismal US employment figures are expected with the release of figures Friday May 8 for April’s US jobs report, as 30 million Americans filed for unemployment in the last six weeks. (Photo by Frederic J. BROWN / AFP) (Photo by FREDERIC J. BROWN/AFP via Getty Images)




HIDE CAPTION

SHOW CAPTION

“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 organization.

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 Sydneym, 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 the U.K.

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 isn’t authorized to speak with 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.

___

Wu reported from Taipei, Taiwan. Associated Press producer Olivia Zhang and video journalist Dake Kang contributed to this report.

Source Article

Next Post

Weeks into school year, groups pushing for more transparent coronavirus data

For several weeks, the Florida Education Association has been calling on state officials to release more information on COVID-19 in public schools. There isn’t a statewide dashboard, and only about half of Florida’s 67 school districts publicly report cases, the state’s largest teachers union said. “You can’t make choices and […]