Panic grows over vaccine safety in China after producer fakes records

Henrietta Strickland
July 24, 2018

According to the China Food and Drug Administration, Changsheng fabricated production records as well as product inspection records, and arbitrarily changed process parameters and equipment, in "serious violations" of the law.

Following the outcry, Premier Li Keqiang in a statement on Sunday said the vaccine case has crossed a moral line, and the nation deserves a clear explanation. Changsheng, whose company name means "long life", is the country's second-largest maker of rabies vaccines.

China is hit regularly by quality-control scandals, fuelling fear over the safety of food and medicines and anger at regulatory lapses.

Chinese authorities have launched an investigation into a vaccination scandal that is sending shockwaves through the country.

"All my friends are freaking out with this vaccine case, everyone is scared".

Substandard vaccines from Changchun Changsheng have been administered to more than 210,000 children in eight cities in Shandong, including the provincial capital of Jinan, and in Zibo, according to the Shandong Center for Disease Control and Prevention.

Changsheng shares, which resumed trading on Monday afternoon session after being suspended in the morning, were down 10 percent. They have slumped 47 percent since mid July.

The China Securities News also weighed in, saying that listed companies - like Changsheng Biotechnology - have a duty to the public and to conduct business with integrity. The wider CSI 300 healthcare index was down about 5 percent. The disclosure was the company's second major scandal in a week: just days earlier, a probe by state food and drug regulators announced that Changsheng had distributed more than 250,000 doses of a "substandard" DPT (diphtheria, pertussis, and tetanus) vaccine, which was discovered a year ago.

Separately, authorities in Hebei province near Beijing announced on Monday that almost 150,000 people had received a substandard diphtheria, tetanus and pertussis vaccine made by another firm, Wuhan Institute of Biological Products.

The Changsheng case is the latest in a slew of scandals that has plagued China's pharmaceutical industry in recent years.

Last week European regulators found that a common blood pressure and heart drug manufactured in bulk by Chinese firm Zhejiang Huahai Pharmaceutical may have contained an impurity linked to cancer since 2012.

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. But investigators said the vaccine could have led to "abnormal reactions" among recipients. "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.

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 state-run Global Times newspaper questioned in an editorial Monday how suspect vaccines were still being produced following the harsh lessons of the past.

Other reports by Click Lancashire

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