Major drug producer accused of embezzlement, causing death of newborns
Three major vaccine producers in China that occupy over half of the total market share are guilty of swallowing up national assets and bribing regulators to acquire production license. The article also suggested close connections between the three and multiple vaccine scandals over the years, one of which even caused the death of eight newborns.
In December 2013, Shenzhen Kangtai and its boss Du Weimin risked being wiped out after eight newborns died within 10 days after being given their hepatitis B inoculation shots.
One month later, Chinese regulators announced that all deaths were accidental, and Kangtai got back its license to produce.
The NY Times, reporting on the China scandal, and relying on the World Health Organization (a PR front for the vaccine industry) took an assuring tone:
“Despite such fears, the tainted vaccines are more likely to be ineffective than harmful…The World Health Organization has said that outdated or poorly stored vaccines rarely if ever trigger illness or toxic reactions. Chinese government investigators said last week that they had not found any cases of adverse reactions or spikes in infections linked to ineffective vaccines.”
Perhaps editors at the NY Times and the World Health Organization would like to prove their faith and confidence by taking shots in the arm of those spoiled vaccines.
“Most Americans do not understand that many pharmaceutical products, including vaccines, are not made in the United States and foreign pharmaceutical companies are not subject to U.S. Food and Drug Administration (FDA) quality control regulations.”
“It is unclear what percentage of the vaccines currently used in the United States are made by Chinese pharmaceutical companies in China or by Western companies with manufacturing facilities in China. We do know that major U.S. and European vaccine makers such as Merck & Co., GlaxoSmithKline plc, and Sanofi Pasteur SA maintain vaccine manufacturing operations in China, that this activity is on the rise, and that Western vaccine makers are also establishing joint venture partnerships with Chinese vaccine companies.”
In late May of 2010, a human rabies vaccine maker, Wuhan Institute of Biological Products in central China, voluntarily recalled its vaccine. The batch number was 200905007-3, and involved 10,902 doses, of which 8,376 had been used. That vaccine was found to contain an excessive amount of the bacteria endotoxin, which causes fever.
"Defective vaccines are like child abuse and trafficking — it touches on the most sensitive, vulnerable part of the public's hearts," wrote Xi Po, a columnist for The Paper, a popular online news outlet backed by the Shanghai government. "But unlike in cases of child abuse, the vaccine scandals involve layers and layers of broken regulators and interest groups."
How did all this happen?
On 15 July, China's State Drug Administration (SDA) announced that Changchun Changsheng had falsified production data during the production of its freeze-dried human rabies vaccine.
According to a report by Xinhua, an official said the company had "fabricated production records and product inspection records", as well as "arbitrarily changed process parameters and equipment" during production.
The China Food and Drug Administration (CFDA) said the rabies vaccine had been recalled and that the company would be put under investigation.
Days later, Jilin province authorities announced a 2017 batch of the firm's diptheria, tetanus and pertussis (whooping cough) vaccine - or DTaP - was also substandard.
Censors jump into action as China’s latest vaccine scandal ignites
The company said in a stock exchange filing yesterday 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.
China’s Serious & Breaking Vaccine Scandal: Are Your Vaccines Made In China?
The question all administering physicians, healthcare workers who administer vaccines, parents and intended vaccinees should be asking before submitting to receiving a Diphtheria, Tetanus and Pertussis vaccine is: “Was the DTP vaccine made in China, and may I please see the vaccine package insert describing the vaccine?”
Chinese citizens have been protesting the above DTP vaccine while Chinese health officials have been sanitizing the web of any information about the problems with Chinese vaccines.
"Yesterday it was milk powder, today vaccines. What will it be tomorrow?" another wrote, referring to a major scandal in 2008 when several infants died after industrial chemical melamine was added to milk powder to raise protein levels.
China has been exporting vaccines for diphtheria, hepatitis B, measles, pertussis, polio, tetanus and yellow fever to poor countries for decades through bilateral aid programmes, says Xu, but “WHO prequalification of the Japanese encephalitis vaccine is a game changer.”
“As more Chinese companies obtain WHO prequalification, this will open the door to the export of Chinese vaccines,” Xu says.
The CFDA’s role is vital to this process, as it looks at whether the clinical trials needed for licensing a vaccine are conducted ethically and meet international standards. The CFDA only licenses vaccine once it is satisfied with all the required data, including from clinical trials and technical reviews of production facilities and processes, provided by the manufacturer.
The dominant player in China’s vaccine industry is state-owned Sinopharm’s subsidiary China National Biotechnology Group, comprising seven manufacturers – one of which is the Chengdu Institute of Biological Products, the producer of the Japanese encephalitis vaccine that was prequalified last year.
The government’s Vaccine for Children Program (a CDC organization) purchases vaccines for about 50 percent of children in the U.S.” (The Atlantic, February 10, 2015)
If you wanted to buy a product…
And the main safety-researcher of the product was the company selling it to you…
Would you automatically assume the product was safe and effective?
But you see, that’s the just the beginning of the problem. Suppose the company’s research was cited thousands of times in the press, as the authoritative standard of proof—and anyone who disputed that research was labeled a conspiracy theorist and a quack and a danger to the community and an anti-science lunatic.
Would you begin to suspect the company had awesome media connections? Would you suspect some very powerful people were backing the company?
This is exactly the situation with the US Centers for Disease Control (CDC). Read these two quotes:
Reminder: CLINTON Health Access Initiative allowed Tainted Chinese Vaccines to Enter the World Market
The Clinton Health Access Initiative (CHAI) has been working with Chinese suppliers to support their applications for WHO prequalification for several vaccine candidates for the last two years, says Joshua Chu, CHAI’s Director, Vaccines Markets.
This “Preapproved” also defined in the article
The “prequalified” stamp of approval means that these vaccines are consistently safe, effective and of high quality, and thus recommended for bulk purchase by the United Nations Children’s Fund (UNICEF) in 152 low and middle-income countries, the GAVI Alliance – which funds vaccines in 73 of these countries – and other agencies.
Hillary Clinton PERSONALLY Arranged For Chinese Vaccine Manufacturers to Avoid US Government Scrutiny…
Chinese Made Vaccines are “Pre-Approved” by the World Health Organization (WHO). They Completely Bypass Any US Agency Inspections…
Why the federal government broke vaccine law for 30 years
The human vaccine industry presented the following main characteristics in 2016 in China:
Affected by the illegal vaccine case in Mar 2016 in Shandong, the country’s lot release volume of human vaccines came to 553.6 million doses through the year 2016, down 3.8% over the previous year. The lot release volume of ten vaccines (Hepatitis B vaccine, Diphtheria, Tetanus and acellular Pertussis combined vaccine (adsorbed), rabies vaccine, Japanese encephalitis vaccine, poliomyelitis vaccine, meningococcal vaccine, measles and rubella combined attenuated live vaccine, MMR combined attenuated live vaccine, influenza vaccine, and Hepatitis A Vaccine) was relatively higher, totaling 467.2 million doses, 84.4% of the country’s total, a year-on-year 1.4% drop.
Where are Australia’s Vaccines Made?
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Vaccines today, like most pharmaceutical products, are no longer being produced or regulated in the countries in which they are used. There is an extensive international network of production and most Australian vaccines are made in other countries and licensed in the USA where vaccine manufacturers are free from liability for any harm that vaccines cause in humans.
Many vaccines today are being made in China and India and the Australian government does not provide information on its Immunise Australia Program (IAP) website describing where Australia’s vaccines are made.
The only vaccines that are made in Australia are some influenza vaccines and Q Fever vaccine that are made by Seqiris – a CSL company. All other Australian vaccines are made in other countries and licensed in the US before being approved for the Australian market under a different name without further testing
We were pleased to discover today that RUC News Workshop (RUC新闻坊), the official WeChat account of Renmin University of China’s School of Journalism and Communication, has posted a helpful timeline and summary of the development of the ongoing vaccine scandal in China. We share a translation of the timeline below.
This is obviously a story with potentially huge implications for China’s leadership. Under Xi Jinping, the Party has managed quite effectively to keep scandal out of the headlines. This story, with its clear indication of deeper institutional problems, will be surely be aggressively curtailed by censors in coming days. But its development is in many ways eerily familiar — not unlike the bursts of coverage, and often decent reporting, that we grew accustomed to seeing in the heyday of the commercial press in China, up through the Hu Jintao era.RUC News Workshop notes that the incident, which is being referred to in Chinese as the “Changsheng Bio-Tech Problem Vaccine Incident” (长生生物问题疫苗事件), first unfolded on July 15, but was slow to gain public attention — finally culminating yesterday with an official response from Premier Li Keqiang.RUC News Workshop divides the scandal so far into three phases.
Our translation of the RUC News Workshop timeline follows, with some edits and cuts for clarity — and a few notes and links here and there.
July 15, 2018
A notice issued by the China Food and Drug Administration says that fabricated productions records had been discovered for rabies vaccines produced by Changchun Changsheng Life Sciences Limited (长春长生生物科技有限责任公司), known for short as Changchun Changsheng (长春长生). According to the notice, the company had been ordered to stop production, and its Good Manufacturing Practice (GMP) certification (生产质量管理规范证书) had been revoked. According to a news report by the Shanghai-based outlet Jiemian, the investigation had been prompted by an older staff member working inside a production facility who had come forward.
July 16, 2018
Changchun Changsheng’s share price sinks and several large shareholders dump their holdings.
July 17, 2018
Changchun Changsheng issues a public response to the situation, assuring customers there are no problems. Changchun Changsheng’s parent company, “Changsheng Bio-Technology Company” (长生生物科技股份有限公司), known for short as Changchun Bio-Tech (长生生物), issues a statement saying that all rabies vaccines that have entered the market comply with quality regulations and there is no cause for concern.
July 19, 2018
The incident is further fueled as Changchun Bio-Tech issues a statement saying that its subsidiary, Changchun Changcheng, had previously received a penalty notice (处罚书) from health authorities in Jilin province notifying them that a batch of their DPT vaccines did not comply with safety regulations. The notice [which dated the start of the investigation to October 2017] said that the company’s DPT vaccines had been deemed “inferior medicines” not meeting standards. The company had been fined 3.44 million yuan, and some of its vaccine stocks were seized.
The first page of the notice issued by authorities in Jilin province to Changchun Changsheng. July 20, 2018
The news, based on the previously mentioned notice, that problems with the vaccines had apparently been discovered, prompting an investigation, by October 27, 2017, drew anger from many Chinese. According to the timestamp accompanying the notice as it was made public on the official website of the Jilin Food and Drug Administration, it had not been posted until July 18. The gap between now and the start of the investigation by the Jilin Food and Drug Administration into the sale of these 250,000 doses of vaccine in Shandong was already close to 9 months. But Changchun Changsheng had made no mentioned whatsoever of the notice from health authorities in its 2017 annual report. It is worth noting that in November 2017 another batch of DPT vaccines had shown problems, this time from Wuhan Institute of Biological Products Co. Ltd. (武汉生物制品研究所有限责任公司) — [whose website is now taken down]. And in 2016, another batch of DPT vaccines from Changchun Changsheng had failed to pass inspection. July 22, 2018
Responses come from official media. CCTV Finance runs a report saying the vaccine problem must be thoroughly investigated, and that “comprehensive oversight mechanisms” (完善的监管机制) and emergency response systems must be put in place. The official Xinhua News Agency points out that mishaps cannot happen when it comes to vaccines, and that “loss of confidence” [in vaccines] is even more terrible than “loss of efficacy.” The Food and Drug Administration issues a notice on the case, saying it has already ordered vaccine manufacturers across the country to inspect their processes, ensuring production is strictly compliant with GMP production standards.The Food and Drug Administration says it will also carry out unannounced inspections across the country, dealing strictly with lawbreakers.
At 11PM on July 22, an article appears on the website of China’s central government: “Li Keqiang Issues Official Comment on the Vaccine Incident: We Must Give the People of the Country a Clear Explanation” (李克强就疫苗事件作出批示：必须给全国人民一个明明白白的交代). The article says: “Premier Li Keqiang has issued official comments on the vaccine incident: This vaccine scandal has crossed a moral red line for the people, and we must give the people of the country a clear explanation.”In his official comments, Li Keqiang demands that the State Council immediately dispatch an inspection team, conducting a thorough investigation of the entire chain of vaccine manufacture and distribution. The full facts must be ascertained, he says, and those companies and people responsible be “resolutely punished and in no way appeased.”
If not so far for pharma supply chain tracking, blockchain has at least been used once again as a means to bypass China’s “Great Firewall” and permanently store censored articles.
On Saturday, an investigative article – called “The Vaccine King” and published on WeChat – listed the wrongdoings of Changsheng Biotechnology over the decades. Within a day of publication, the piece was blocked across social media and the internet in China due to sensitive information it included that the authorities believed had the potential to cause panic.
To counter the censorship, coders to have now hashed the entire article into a transaction on the ethereum blockchain, so that the original text is still available to readers in China.
Although currently opening that ethereum address on WeChat is also censored, access through blockchain exploring websites such as etherscan.io is still available.
The vaccine exposé marks the latest case in which controversial information that was blocked in China has been permanently recorded on the public blockchain to fight internet censorship.
Previously, an article detailing a Chinese version of the #metoo movement was also widely blocked in China, but was later encoded to the ethereum blockchain as a permanent, visible record.
Vaccine image via Shutterstock
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Samoa Seizes All MMR Vaccines After Two Toddlers Die
Prime Minister Malielegaoi revealed that his grandson went “under similar circumstances” and “will never be the same, as he has lost the ability to speak.”
“And if so, rest assured those processes will be implemented to the letter – to ensure that such a tragedy will not be repeated and those responsible will be made to answer,” he said.
Of course, this negative publicity has brought out the vaccine program frontrunners to try and coax more people into vaccination. New Zealand Ministry of Health wants to know how it can help the investigation and one doctor said:
The last thing you want is for people to be fearful of something that we know is actually incredibly safe.
He emphasized that the incident is rare and that the vaccines were either administered incorrectly (i.e. wrong substance injected) or were contaminated somehow. But perhaps there is more than meets the eye.
Needless to say, our friends from down under have been rocked by the news, and they have some of the most draconian vaccine mandates currently in the world. SEE: Australia Now Issuing Fines To Citizens Who Refuse Vaccines For The...