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China: Changsheng Biotechnology reportedly sold 250,000 faulty vaccines, ordered to stop production after outrage

"Regulators last week ordered the Jilin-based Changsheng Biotechnology to stop production of a rabies vaccine, after investigators found fabricated production and inspection records during an inspection...Changsheng said in a stock market filing later in the week that authorities were punishing the company over a “substandard” DPT vaccine for diphtheria, pertussis, and tetanus…Chinese state media reported that 250,000 doses of the DPT vaccine in question had been sold to the province of Shandong"

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Article
8 July 2019

China: Tougher law on vaccine administration will go into effect in December 2019

Author: Xinhua Net (China)

“China Focus: China adopts tough law to ensure vaccine safety”, 29 June 2019

China's top legislature… passed a law on vaccine administration, which stipulates the "strictest" management by requiring a whole-process supervision system and toughening penalties on producing and selling fake or substandard vaccines. The law was adopted after the third reading at a bimonthly session of the Standing Committee of the National People's Congress… As the country's first legislation dedicated to vaccine management, the new law will go into effect on Dec. 1, 2019.

According to the law, supervision of vaccines will cover the whole process, from vaccine development, production and distribution, to vaccination. Specialized inspection teams of pharmaceutical professionals will be established at the central and provincial levels to conduct the supervision work. An electronic information system will be set up to make all information of vaccines trackable… The records must be retained for at least five years after the expiry of the vaccine, according to the law. To increase the transparency of the industry, vaccine license holders are required to publish vaccine information on their websites in a timely manner…

Aside from strengthening the whole-process supervision, the new law also toughens penalties on the production and sale of fake or substandard vaccines. It stipulates that people whose violations constitute a crime shall bear heavier criminal responsibility in accordance with the law. Meanwhile, the law imposes heavier fines on producers and sellers of defective vaccines. Those producing or selling fake vaccines shall face a fine of 15 to 50 times the value of the illicit products, while substandard vaccine makers or sellers face a fine of 10 to 30 times the value… Production and business operation will be suspended for rectification, and drug registration certificates or even pharmaceutical production licenses can be revoked, it said.

The tough punishments will exert positive impacts on the whole-process supervision of vaccines, said Jiao Hong, head of the National Medical Products Administration. It will further enhance the quality of the country's vaccines and boost the public's confidence on vaccine safety, Jiao said at a press conference held after the five-day legislative session closed…

The law introduces a compensation system for people who suffer adverse events linked to vaccinations. It stipulates that compensation shall be provided in cases of adverse events leading to death, serious disability or organ damage during or after vaccination, or when the possibility of an adverse event cannot be excluded. For mandatory vaccination, the compensation must be paid through local fiscal budgets, while for voluntary vaccination, the vaccine license-holder must shoulder the responsibility…

 

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Article
24 September 2018

China: Parents of faulty vaccine victims reportedly detained or "disappeared" after seeking accountability and help

Author: Yang Fan, Radio Free Asia

"China Detains, 'Disappears' Parents of Faulty Vaccine Victims", 20 Sep 2018

…Dong Junhua, the parent of a child affected by substandard vaccines from Dancheng county in the central province of Henan, is being held under criminal detention on suspicion of "picking quarrels and stirring up trouble," his wife said in a recent interview…Meanwhile, Shanghai-based vaccine campaigner Tan Hua "disappeared" in Beijing on Sept. 3 after going to the capital to campaign for compensation for disability, which she says is linked to a rabies vaccine several years ago. Police also detained Hu Changjie…for nine days under administrative detention for "disrupting public order," while Jiang Peng of Henan's Hebi city was held for six days on the same charge, and Zou Wanli from Guangshan county was held for 10 days' administrative detention, CHRD [Chinese Human Rights Defenders] said.

"Protesters against government mishandling of scandals over faulty vaccines faced [a] swift police response after trying to demonstrate on Tiananmen Square…" [CHRD] said in a statement on its website. "The protesters were ... victims of faulty vaccinations, which were believed to have caused permanent health damage, as well as their parents and supporters," it said…

He Fangmei became a vocal advocate for families hit by substandard vaccines after the couple's daughter developed gray matter spondylitis from a substandard diptheria tetanus-whooping cough vaccine made by Wuhan Biotechnology at the age of three months. The couple has also been banned from overseas travel, on grounds that they may "endanger state security," the group said. "The couple had hoped to take their sick child overseas for treatment," it said…Parents are calling for a vaccine law, and more timely public information about vaccine safety, as well as help with mounting medical bills for their children, some of whom are severely disabled after receiving substandard vaccines.

China fired senior provincial food and drug administration official Jin Yuhui last week, and is investigating a former top drug regulator after a safety scandal at vaccine maker Changchun Changsheng Biotechnology in the northeastern province of Jilin. More than 40 government officials…have been held sanctioned over the scandal by various administrative punishments…

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Article
23 July 2018

News programme documents numerous cases of children suffering from various medical conditions after receiving faulty vaccines

Author: I-cable (Hong Kong)

[Hong Kong news programme documents numerous cases of children suffering from various medical conditions, including limb and eye defects, suspected to be due to faulty vaccines produced by Changsheng Biotechnology. An earlier article on Caixin quoted source as saying the faulty vaccines did not go through mandatory animal tests. The report was later deleted.]

【問題疫苗】長春長生生物科技公司違法違規生產凍乾人用瘋狗症疫苗,公安帶走公司董事長高俊芳及四名公司管理人員調查。內地《財新網》引述知情人士指,涉案疫苗未進行動物實驗檢測。 【屢次出事】有線中國組的記者前往多個省市,訪問多個懷疑注射長春長生公司疫苗後,身體出現問題的受害者。記者發現早於兩年前,已經有在山東和廣東的小朋友,注射該公司的疫苗出事。 【疫苗之王】長生生物疫苗問題,在過去一個周末迅速發酵,演變成轟動全國的疫苗事件,其中一個觸發點,是一篇題為《疫苗之王》的文章,披露該公司不少黑幕。

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Article
22 July 2018

China: Outcry over sale of 250,000 faulty vaccines prompts investigation

Author: Lily Kuo, Guardian (UK)

…Regulators last week ordered the Jilin-based Changsheng Biotechnology to stop production of a rabies vaccine, after investigators found fabricated production and inspection records during an inspection...Changsheng said in a stock market filing later in the week that authorities were punishing the company over a “substandard” DPT vaccine for diphtheria, pertussis, and tetanus…China’s food and drug administration said it was investigating Changsheng…and that all production had been halted. The company issued a statement expressing its “deepest apology.”

There have been no reports of injuries or side effects from the vaccines and Chinese officials and state media have released statements promising accountability. But a lack of public trust continues…Censors, which at first deleted critical Wechat articles, seemed to allow the deluge of public discussion. The hashtag #Changsheng vaccine case# had been viewed over 470 million times as of Monday…

Chinese state media reported that 250,000 doses of the DPT vaccine in question had been sold to the province of Shandong. The company recalled 186 doses that were still in stock at the regional disease centre. Changsheng said other regional disease control agencies have suspended use of some of the company’s other vaccines…

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