Fresh scandal erupts over vaccine safety in China

[Akasa]

Fresh scandal erupts over vaccine safety in China
Dominique Patton

BEIJING (Reuters) - A scandal over faulty vaccines in China has sparked anger on social media, underscoring the difficulties regulators face in rebuilding trust after years of food and drug safety scares.

The incident is a major blow for Beijing’s efforts to push domestically made vaccines and for China’s drug regulator, which has been struggling to clean up the world’s second-biggest drug industry.

Worried parents trying to ascertain if their children had been administered faulty vaccines led to the topic becoming the second most watched at the weekend on the Weibo social media site, with details widely shared on the WeChat messaging app.

“If the state does not protect its citizens, how can we love our country?” asked one Weibo user, while another lamented, “Looking at the news, I don’t dare to have an injection.”

The scandal erupted a week ago, after major vaccine maker Changsheng Biotechnology Co was found to have violated standards in making rabies vaccine for humans.


The regulator ordered it to halt production and recall all its vaccines, the company said in a statement.

On Thursday, however, it told the stock exchange that authorities in its base in northeastern Jilin province were fining it over substandard production, uncovered in 2017, of a DPT vaccine to combat diphtheria, pertussis and tetanus (DPT).

The defective vaccine might not confer immunity but would not affect human safety, provincial authorities had said in November, implicating another company, Wuhan Institute of Biological Products, in substandard DPT vaccines.

Reuters’ calls to Changsheng’s headquarters on Sunday went unanswered.

The Food and Drug Administration said in a statement on Sunday evening that its investigation had found that Changsheng fabricates production records and product inspection records, and arbitrarily changes process parameters and equipment, “serious violations” of the law.

It said the agency was investigating the company and suspected crimes would be handled by the public security department, adding that all vaccine producers would be inspected and any violations would be dealt with seriously.

In a stock exchange statement on Sunday, the company said its suspension of rabies vaccine production would have a significant impact on its finances and that some regional disease control agencies had suspended some of its other vaccines.

The latest problems come a little more than two years after police in northern Shandong province said they had uncovered the illegal sale of vaccines worth nearly $90 million.

Last week China’s Zhejiang Huaihai Pharmaceutical said it was recalling a heart drug sold in the United States after the European Medicines Agency found that it was tainted with an impurity linked to cancer.

The Changsheng scandal will hit confidence in domestic vaccines by rekindling safety concerns over products for children, a challenge state media highlighted.

“Vaccines directly concern the health of children and are related to life,” the state-run Global Times said in a commentary. “Every negative news item in this area will make all of society look at it.”

Changsheng’s shares fell the maximum limit of 10 percent on Friday, to stand at 14.5 yuan ($2.14). They have lost 40 percent of their value since July 13.


($1=6.7659 Chinese yuan renminbi)

Reporting by Dominique Patton; Additional reporting by Zhou Jianfeng; Editing by Clarence Fernandez and David Goodman

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Another report is now confirming that Chinese censors are deleting news regarding this vaccine scandal: https://www.channelnewsasia.com/new...ina-s-latest-vaccine-scandal-ignites-10553062

BEIJING: Chinese censors on Sunday (Jul 22) deleted articles and postings about the vaccine industry as an online outcry over the country's latest vaccine scandal intensified.

Regulators said last week that they had halted production of a rabies vaccine at a large pharmaceutical company in the northeast after finding fabricated records and other problems during an inspection.

It was just the latest in a series of health and safety scandals which have fuelled fear over the safety of basic food and medicine and anger at regulators asleep on the job.

China's censors and regulators struggled to stay abreast of the public's response, deleting posts on WeChat as state media tried to take control of the narrative.

On Sunday night China's Food and Drug Administration (CFDA) announced it had ordered all production stopped at the vaccine maker and launched an investigation.

Changchun Changsheng Biotechnology is China's second largest maker of the rabies vaccine and a subsidiary of a large publicly-traded vaccine maker.

Anxiety grew over the weekend as an essay alleging corruption and murky practices in the vaccine industry spread across WeChat. Netizens reposted the self-published essay as censors swooped in to delete the content.

The CFDA said last week that the problematic rabies vaccine had not left Changsheng's factory.

The company said in a stock exchange filing Sunday that it had already halted production of another vaccine - for diphtheria, tetanus and pertussis - which regulators found last year to be sub-standard and which had also become the focus of public attention.

Still the action aroused concern that other problematic vaccines had already been administered to children.

In Beijing, an unnamed official at the Center for Disease Control and Prevention told local website The Paper that parents in China's capital need not worry: "Beijing does not have either of these two vaccines in question, the public can be at ease."

Regulators in Guangdong and Sichuan, cited by state broadcaster CCTV, told residents that Changsheng's problematic vaccines had not been made available in their provinces.

But CCTV acknowledged that 250,000 doses of the problematic vaccine had been sold to the eastern province of Shandong.

Communist Party mouthpiece the People's Daily said on Sunday that local regulators must "rapidly take action, do a complete investigation and announce authoritative information in a timely manner to pacify public anxiety".

CCTV listed questions the public needed answering and noted that the local regulator overseeing Changsheng had hung up on journalists' calls or declined to answer the phone.

A similar scandal erupted in Shandong in 2016, involving the improper storage, transport and sale of tens of millions of dollars' worth of vaccines - many of them expired.

For parents it also has parallels to China's most notorious incident of recent years. Some 300,000 children fell ill, six of them dying, in a 2008 case involving milk powder contaminated with melamine.

Source: AFP/ng

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I know that some PDF members are reluctant to post this news due to fear of prosecution, prison time, or even more serious punishment in China, but this needs to get out. The Chinese government does not care one bit for its citizens and is willing to give slack to such companies in order to push for "domestic vaccines".

There needs to be a revolution, civil war, or foreign intervention to stop the oppression, totalitarianism, and egregious human rights violations by the worst regime in the history of mankind.

 

[Akasa]

Equally important, if any PDF members have family members in China, this is very important information to share with them. Do not let government censorship or empty promises negatively impact their health. It would be even better if they can move out of the dystopian rogue regime called "China".

 

[JSCh]

China's vaccine maker ordered to stop production, subject to investigation
Source: Xinhua| 2018-07-23 01:11:32|Editor: Mu Xuequan


BEIJING, July 22 (Xinhua) -- China's drug regulator said on Sunday that it has ordered Changchun Changsheng Life Sciences Limited to stop production and launched an investigation into the company over illegal production of rabies vaccines for human use.

An official with China Food and Drug Administration (CFDA) said it found that the company had fabricated production records and product inspection records, arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines.

The CFDA had revoked the company's drug GMP certificate following its serious violations of relevant law and regulations, and demanded a recall of unused vaccines, according to the official.

The administration and the food and drug bureau of northeast China's Jilin Province have launched an investigation into the company and those criminal suspects would be transfered to the public security department, said the official.

The CFDA and Jilin provincial food and drug bureau launched an unannounced inspection of the company on July 5 upon tip-off. On July 15, CFDA made an announcement on the company's illegal production of freeze-dried human rabies vaccines after a comprehensive investigation on the same day.

The administration has launched further tests on samples kept by the company to ascertain the effectiveness of its vaccines.

All vaccines shall be subject to safety checks and a certain proportion of them shall undergo examinations on their effectiveness by the National Institutes for Food and Drug Control before going on sale.

In October 2017, a batch of DPT vaccine produced by the company were found to be defective and the production of the vaccine was suspended since then.

The CFDA official said that all vaccine producers in China would be subject to unannounced inspection and any violations of law and regulations would be dealt with seriously.

China's rabies incidence rate has dropped gradually in recent years, data from the Chinese Center for Disease Control and Prevention showed.

 

[JSCh]

SDA to carry out surprise checks on vaccine makers
Xinhua Finance in www.cfbond.com
2018-07-23 10:13

The State Drug Administration will conduct unannounced inspections on all companies that produce vaccines.

Investigation starts on new vaccine scandal

The State Drug Administration has launched an investigation of Changchun Changsheng Bio-tech Co, which was found to have fabricated production records for freeze-dried rabies vaccines for human use.

The cases of those suspected of violating laws will be transferred to public security departments, the authority said on Sunday.

Premier Li Keqiang said in an instruction that the vaccine case has crossed a moral line, and the nation deserves a clear explanation, the State Council said on its website on Sunday.

The State Council should immediately send a group to investigate to uncover the truth as soon as possible, and any wrongdoing will be severely punished regardless of who is involved, Li said.

Xu Jinghe, deputy head of the drug administration, said the company was found to have fabricated production and inspection records.

Such activities are in violation of the country’s drug management law and related regulations on drug production, Xu said.

In a notification on July 15, the drug administration ordered the company to stop producing the human rabies vaccine. It said no products involved in the inspection were currently being sold and all the vaccine involved had been removed.

The administration has also revoked the company’s certificate that is needed for production and sales of the vaccine.

The administration confirmed that the company’s other vaccines now available on the market have been tested and no quality problems were found. The administration also launched further tests on the vaccine samples kept by the company.

Its remarks came amid public concerns about vaccine safety in China over the weekend, after it was also revealed that Changsheng Bio-tech was linked to a substandard adsorbed diphtheria-pertussis-tetanus, or ADPT, vaccine for infants.

On Friday, the Jilin Provincial Drug Administration announced a penalty regarding Changchun Changsheng Bio-tech Co’s substandard ADPT vaccine.

The company was fined 2.58 million yuan ($282,000), and 859,000 yuan in assets from sales of the vaccine were confiscated.

The case was under investigation last year.

Changsheng Bio-tech Co, parent company of Changchun Changsheng Bio-tech Co, revealed in November that 252,600 doses of the substandard ADPT vaccine that couldn't meet the standard of immunity results were all sold to Shandong province and had been recalled.

“The substandard ADPT vaccine won’t post safety threats to people’s health, but will reduce the expected immune effects,” Dingxiangyuan, a professional medical website, said in an online reply to public concerns about the vaccine’s safety.

The state drug administration confirmed on Sunday that it was discovered in October that one batch of Changsheng’s ADPT vaccine was substandard, and its production of ADPT has been suspended since then.

A plan for reinoculation of those affected was worked out in February.

Several state media called for severe punishment and stricter supervision of vaccines. People’s Daily released a commentary on Sunday saying that drugmakers should stick to moral principles and make life their priority rather than profits.

In a news report released on Sunday, the Procuratorate Daily, a publication of the Supreme People’s Procuratorate, called for stronger supervision of vaccine production and tougher penalties for violators.

The Shenzhen Stock Exchange announced that it sent letters to Changsheng Bio-tech Co on Sunday, calling for early disclosure of the two cases to the public.

“We will maintain strict supervision over the listed company’s information disclosure responsibility according to the law and guarantee legal rights of investors,” it said in the online announcement.

The Shenzhen Stock Exchange posted a reply from Changsheng Bio-tech Co later in the afternoon on its website. It says, “We feel very remorseful and guilty about what has happened, and we apologize to all those vaccinated and investors.”

The company added that it will learn a lesson.

 

[Jlaw]

Another black eye. Those people responsible will get off Scott free. Nobody will want to buy vaccines made in China.

The company added that it will learn a lesson.

That's it? Just as bad as Japan executive falsifying defective steel as good steel and bowing their head and apologize. nothing happened to them

 

[haidian]

Equally important, if any PDF members have family members in China, this is very important information to share with them. Do not let government censorship or empty promises negatively impact their health. It would be even better if they can move out of the dystopian rogue regime called "China".

LOL...A tyical brainwashed westerner, it's been talking about on TV , news paper and social media for days already, every day my Wechat moments is being flooded by this.

http://news.sina.com.cn/c/2018-07-22/doc-ihfqtahk0723030.shtml
Every city and provincial government public statements to the publc on wether there are "problem vaccines" exist in their cities or provinces.

 

[F-22Raptor]

China vaccine scandal ripples through domestic market, threatens global push


SHANGHAI (Reuters) - A vaccine scandal in China, which has hit a nerve in the country and prompted quick reactions from leaders in Beijing, is sending ripples across the wider domestic drug market while threatening to dent Chinese ambitions to play a larger global role.

Shares in Chinese vaccine makers and biotech firms fell across the board on Monday after Premier Li Keqiang slammed Changsheng Biotechnology Co for having crossed a moral red line and called for swift action.

The case erupted a week ago when Changsheng was found to have violated standards in making rabies vaccine.

While there have been no apparent reports of people being harmed by the vaccine or having contracted rabies after receiving it, the regulator has already ordered Changsheng to halt production and recall all its vaccines.

The case has gone viral in China, where sensitivity over food and drug safety is extremely high after a series of scandals over the last decade. Changsheng’s shares, which have lost 40 percent since mid July, were suspended on Monday.

The scandal has sparked anger on social media and dealt a blow to China’s drug regulator, which has been struggling to clean up the world’s second-biggest drug industry and promote domestically made vaccines.

It is also a setback for the country given it is looking to play a bigger role globally in the production and export of vaccines and other medicines.

In a statement posted on the government’s website late on Sunday, Premier Li called for an immediate investigation and urged severe punishment for the companies and people implicated. He added the public needed clear information.

“We will resolutely crack down on illegal and criminal acts that endanger the safety of peoples’ lives, resolutely punish lawbreakers according to the law, and resolutely and severely criticize dereliction of duty in supervision,” he said.

The China Food and Drug Administration said in a statement that its investigation had found that Changsheng fabricated production records and product inspection records, and arbitrarily changed process parameters and equipment, in “serious violations” of the law.

PUBLIC HEALTH CRISIS
Changsheng said in a regulatory filing that the suspension of its rabies vaccine production would have a significant impact on its finances and that some regional disease control agencies had suspended some of its other vaccines.

An editorial on Monday in the China Daily warned the case could become a public health crisis if it is not handled “in a reasonable and transparent manner”.

“The government needs to act as soon as possible to let the public know it is resolved to address the issue and will punish any wrongdoers without mercy,” it said.

Late on Sunday, the state news agency Xinhua ran an editorial calling for strict punishment for any violations, big or small, in the vaccine industry and for regulators to close loopholes and tighten oversight of the industry.

The China Securities News also weighed in, saying listed companies have a duty to the public and to conduct business with integrity.

“Cases like Changsheng Biotechnology, where laws and regulations are ignored and internal controls exist only in name bring a painful price,” it said.

State media have said Changsheng made a public apology and recalled all their rabies vaccine available on the market.

https://www.reuters.com/article/us-...ic-market-threatens-global-push-idUSKBN1KD01V

 

[haidian]

From this OP's article, we see first hand how people are brainwashed by western media, calling Chinese here to tell their relatives in China the news that everyone in China has been talking about for days and occupies the headline spot on all major media channel every day. SO HILLARIOUS...

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I know that some PDF members are reluctant to post this news due to fear of prosecution, prison time, or even more serious punishment in China, but this needs to get out. The Chinese government does not care one bit for its citizens and is willing to give slack to such companies in order to push for "domestic vaccines".

There needs to be a revolution, civil war, or foreign intervention to stop the oppression, totalitarianism, and egregious human rights violations by the worst regime in the history of mankind.

That's epic, should be reposted to our Chinese social media and let Chiense people have a good laugh...I will do it. lol..

 

[JSCh]

Authorities investigate vaccine maker as scandal enrages public
By Cao Siqi Source:Global Times Published: 2018/7/22 20:48:40

Parents consider imported vaccines

China launched a nationwide inspection over the safety of vaccines amid a huge public outcry after evidence showed one of the country's largest vaccine makers fabricated data and provided substandard vaccines to children.

Changsheng Biotechnology Corporation, the country's second-largest maker of rabies vaccines and a major producer of vaccines for children, apologized in a statement late Sunday, saying that the company has stopped its production of DPT vaccines and felt very "guilty" and "regretful" to inoculators and investors.

A notice published on the company's website on Thursday said its subsidiary, Changchun Changsheng, in Northeast China's Jilin Province, received an administrative penalty, which claimed that the diphtheria-pertussis-tetanus (DPT) vaccine produced by the company failed to meet drug standards.

The National Food and Drug Administration (NFDA) and Jilin drug authorities have turned over to the police those suspected of criminal liability in the case, the NFDA said on Sunday, China Central Television reported.

The NFDA said they did not find any quality issues in the vaccines on the market and will conduct laboratory tests on the company's sample products.

The Jilin provincial drug administration confiscated 186 doses of the DPT vaccine, 858,840 yuan ($126,936) in illegally acquired revenue, and levied an additional fine of 2.6 million yuan.

The penalty was in response to media reports in November, when drug authorities in East China's Shandong Province recalled 252,600 doses of DPT vaccine. Another 400,520 went to Southwest China's Chongqing Municipality and North China's Hebei Province.

Three days prior to the fine, the drug regulator withdrew a manufacturing permit for the company over data fraud.

The NFDA said Sunday that since February it has been making arrangements for a repeat dosage of those who bought the products from the company, without further elaboration.

Although the NFDA said the rabies vaccines were intercepted before they reached the market, the two scandals have quickly trended on China's social media as analysts pointed out that the scandals brought back painful memories of the powdered baby milk and gutter oil scandals.

Serious violations

A statement published by the NFDA last week said inspectors found serious violations in the company's protocol for drug production involving the Vero-cell rabies vaccine. It has revoked the company's certificate for medical products.

"The question is whether the falsified data will affect the medicine's effectiveness as rabies is a deadly virus," Peking University professor Zhang Yiwu told the Global Times.

The curative effect of vaccine determines the credibility of the domestic industry, Zhang added.

Meanwhile, parents wrote online that the fines imposed on the company were too light, and demanded that authorities offer remedial measures to children injected with the substandard vaccine.

Liang Xiaofeng, a deputy director of the Chinese Center for Disease Control and Prevention, previously told the Global Times that "the vaccines are safe, but their potency does not meet standards. So some children injected with a low dose of the problematic vaccine have to get additional injections."

Damage to vaccine industry

Officials at local centers for disease control, including those from Beijing and Sichuan, told media that they did not purchase the scandal-tainted vaccines, while some other cities said they have stopped using the company-made DPT vaccines.

Experts said they are concerned the scandal could damage the domestic vaccine industry.

Parents told the Global Times that they are considering imported vaccines, while others are questioning the use of the vaccine.

"There is no guarantee that imported vaccines are absolutely safe. The government should better supervise manufacturers of domestic vaccines and swiftly respond to outcries," Zhang said.

"It is not only about vaccines. The cases highlight the difficulties faced by ordinary people on health, child-rearing, corruption and the gap between the rich and poor," said Zhi Zhenfeng, an expert at the Chinese Academy of Social Sciences.

 

[Götterdämmerung]

People should watch the documentary Vaxxed before getting their children vaccinated. It's a big scam either way.

 

[JSCh]

Another black eye. Those people responsible will get off Scott free. Nobody will want to buy vaccines made in China.


That's it? Just as bad as Japan executive falsifying defective steel as good steel and bowing their head and apologize. nothing happened to them

Well, it is an administrative punishment according to the law.

From what I read, the issue is really not as serious as some made it out to be. There is no reason to panic.

That DPT vaccine simply failed standard test. It is not fake vaccine, it is just that particular batch is less potent than standard required. That batch of vaccine is therefore might not be strong enough to have trigger immune response from the recipient's immune system.

I am not a professional on this, so I don't know if this could be deliberate mistake or negligence from the manufacturer. But mistake do happen in manufacturing. And the system should be designed in the way that no harm would be caused even if that happen. So the system would need to be reviewed to make it better.

From reports from various media, it doesn't seem that anyone is physically harm by the mistake. But those 200+ thousand kids would probably need to be re-inoculate again.

 

[Jlaw]

Well, it is an administrative punishment according to the law.

From what I read, the issue is really not as serious as some made it out to be. There is no reason to panic.

That DPT vaccine simply failed standard test. It is not fake vaccine, it is just that particular batch is less potent than standard required. That batch of vaccine is therefore might not be strong enough to have trigger immune response from the recipient's immune system.

I am not a professional on this, so I don't know if this could be deliberate mistake or negligence from the manufacturer. But mistake do happen in manufacturing. And the system should be designed in the way that no harm would be caused even if that happen. So the system would need to be reviewed to make it better.

From reports from various media, it doesn't seem that anyone is physically harm by the mistake. But those 200+ thousand kids would probably need to be re-inoculate again.

I understand no one was killed but this kind of stuff gives a negative image on other Chinese pharma who make drugs and vaccine based on international standard. Best to put harsh punishment on this company as a warning for others.

 

[casual]

Well, it is an administrative punishment according to the law.

From what I read, the issue is really not as serious as some made it out to be. There is no reason to panic.

That DPT vaccine simply failed standard test. It is not fake vaccine, it is just that particular batch is less potent than standard required. That batch of vaccine is therefore might not be strong enough to have trigger immune response from the recipient's immune system.

I am not a professional on this, so I don't know if this could be deliberate mistake or negligence from the manufacturer. But mistake do happen in manufacturing. And the system should be designed in the way that no harm would be caused even if that happen. So the system would need to be reviewed to make it better.

From reports from various media, it doesn't seem that anyone is physically harm by the mistake. But those 200+ thousand kids would probably need to be re-inoculate again.

the company falsified it's vaccine test results. that's reason enough to shut it down.

 

[JSCh]

I understand no one was killed but this kind of stuff gives a negative image on other Chinese pharma who make drugs and vaccine based on international standard. Best to put harsh punishment on this company as a warning for others.

Well, I don't think manufacturer of other countries could prevent such sub-standard vaccine as well. According to what I read from the web, in 2017, Chinese custom has detected and barred imported sub-standard vaccine at a high rate than locally produce vaccine. What I think the main issue in this case is, the vaccine were detected only after used. And that is not ideal.

the company falsified it's vaccine test results. that's reason enough to shut it down.

This is what the CFDA said,

An official with China Food and Drug Administration (CFDA) said it found that the company had fabricated production records and product inspection records, arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines.

the company probably miss regulation and procedures that are strictly required. This was discovered because an employee/whistle blower reported the practice. Harsher punishment for offender would probably be required to make commercial company follow procedure strictly.
However, this does not mean the rabies vaccine is faulty or sub-standard. There has not been reported case of rabies vaccine that was detected to be sub-standard and the current batch of rabies vaccine were destroyed and never gone to public.
I think the company would most likely shut down.

 

[Place Of Space]

Hope the company go bankrupt soon and its administrator be into jail.