China police probe vaccine maker Changsheng Bio

Pearl Mccarthy
July 26, 2018

The CFDA has asked the provincial food and drug administration of Jilin, where the company is based, to revoke Changchun Changsheng's Good Manufacturing Practice (GMP) certificate, an worldwide recognized license for drug production.

There has been no evidence of harm from the vaccine, but the scandal has sparked a huge outcry in China.

Changsheng's Shenzhen-listed shares plunged by their daily limit of 10 percent on Tuesday, extending falls that have seen it lose US$1.8 billion (1.4 billion pounds) or more than half their value since mid-July.

Chinese Premier Li Keqiang has vowed stern action over the latest safety scare to hit the country's pharmaceutical industry, as a mounting scandal over a rabies vaccine sent drug stocks tumbling.

In the statement Sunday, Li promised to "resolutely crack down" on violations that endanger public safety.

The China Food and Drug Administration said last week the problematic rabies vaccine had not left Changsheng's factory, but the company admitted it had shipped a separate sub-standard vaccine.

How did all this happen?

Regulators 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, according to the report.

Chinese police have launched an investigation into Changsheng Biotechnology Co, its chairwoman and four senior executives over suspected criminal behavior, the official Xinhua news agency said late on Monday.

The company behind the rabies vaccine, Changchun Changsheng Biotechnology, has faced criticism after the China Food and Drug Administration (CFDA) revealed that the company had violated good manufacturing practice (GMP).

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And the president has already put tariffs on $34 billion in Chinese imports in a separate dispute over Beijing's high-tech industrial policies.

A regulator in the northeastern province of Jilin, where Changsheng is based, revealed on Friday that the company had past year sold 252,600 substandard DPT vaccines to inoculate children against diphtheria, whooping cough and tetanus.

According to state media outlet CGTN, more than 250,000 doses of DTaP in the batch had already been sold to disease control and prevention centres in eastern China. The company was fined 2.58 million yuan ($282,000), and assets worth 859,000 yuan from the sales of the vaccine were confiscated.

How will this affect people?

According to the latest announcement, Jilin FDA began its investigation into Changchun Changsheng's DTap vaccine about 10 months ago, on October 21, 2017.

Concern has now shifted to the safety of the DTaP vaccine.

The Chinese biologics manufacturer at the centre of a vaccine scandal said its chairman was taken away by the police, signalling the government is intensifying its crackdown on wrongdoing in the industry. The 252,600 doses were sold to the Shandong public health authority and although no cases of ill-health have been reported, the incidents have further eroded trust in a sector that has regularly been shaken by scandals.

What has the reaction been?

Another concerned parent wrote on China's micro-blogging website Wiebo, "Thousands of mothers around the country are anxious".

Large numbers of Chinese netizens have since taken to Weibo to express their frustration and anger at the authorities and Changchun Changsheng, while consoling the affected children and their families. "What kind of society am I living in?" A woman who gave her name as Mrs Yin, from Shenzhen in southern mainland China, said she had brought her two-year-old son to the clinic for three different types of vaccinations.

At the moment the authorities say that the vaccines are only ineffective; it is still unknown if they are harmful to health. A widely circulated article pointing out murky practices in the vaccine industry in China was deleted.

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