How drug firm at centre of China’s latest vaccine scandal cut corners and forged data
Investigators say Changchun Changsheng Bio-technology used expired materials to make rabies vaccine, carried out experiments at the wrong stage in the process and falsified records
Chinese authorities have released further details of how Changchun Changsheng Bio-technology, the vaccine producer at the centre of the China’s worst public health crisis in years, had made substandard products saying it had used expired materials and conducted experiments on mice at the wrong time.
The company, which state drug authorities found had made substandard vaccines for rabies and DPT (diphtheria, whooping cough and tetanus), also forged production data and records concerning the mice, Xinhua news agency quoted an investigation team as saying on Friday.
Central government investigators were ordered to start examining the case at the beginning of the week in an attempt to assuage widespread public anger.
“The company failed to organise production in accordance with prescribed production procedures in order to cut costs and improve the success rate of making rabies vaccines,” the Xinhua report said.
It is an industry norm that one batch of vaccine should be made in a continuous process, but the drug firm was found to have breached this.
The investigation, which focused on rabies vaccine, found that Changsheng had blended active ingredients produced at different times to make the final product.
Some of the batches used had expired, and some were mixed with each other and then re-extracted and purified.
Experiments on mice, which should be made after the production process has finished, were conducted during the manufacturing of the active ingredients instead, it added.
To cover up these violations, the firm made up production and testing records, and issued receipts that contained false information about when the lab mice had been bought.
However, the report said only 0.002 per cent of the people who had received a rabies vaccine produced by the company had experienced any untoward effects, and none of them had serious symptoms, citing China’s top disease control authority.
The company has said it had produced around 3.5 million rabies vaccines last year.
Last year, there were 516 cases of people being infected with rabies, a fall from the previous year, the report added.
The health authorities have already said that the vaccines involved in the scandal were of limited effectiveness, but not harmful.
Shanghai-based vaccine expert Tao Lina said it was “crazy” that the company had cut corners to save money, but the vaccines might still have some effect.
“To receive such vaccines is like eating food cooked by gutter oil – it might not cause obvious harm to health, but it’s disgusting and creates ill feeling,” he added.
Changsheng’s illegal production of rabies vaccines emerged after an unannounced inspection earlier this month by state drug authorities.
Mainland media later found that a sample check by authorities last November also found Changsheng and Wuhan Institute of Biological Products (WIBP) had altogether produced over 650,000 inferior DPT vaccines, most of which had been administered to children as young as three months old in Chongqing, Hebei and Shandong provinces, triggering widespread public panic.
It is still unclear how the other firm, WIBP, a state enterprise, has been punished.
A statement from the website of Wuhan Municipal Food and Drug Administration said the company had been fined and all its revenues made from the problematic vaccines had been confiscated, without disclosing the amount.
Police have detained 15 executives and staff from Jilin-based Changsheng, including its chairwoman Gao Junfang.
Listed in Shenzhen, the company faces an increasing risks of being delisted after the Chinese securities authorities changed the mainland stock market’s delisting rules recently.
According to a directive that took effect on Friday, violating public health regulations could be grounds to delist a limited company.
The company could not be reached for comment.