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Watchdog fines vaccine producer for 'accidental' substandard vaccines

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2018-07-31 15:54:45Global Times Editor : Li Yan ECNS App Download

China's drug watchdog said on Tuesday that the substandard vaccines provided by a company in Wuhan, Central China's Hubei Province was accidental, and that the company has recalled all unopened products amid public outrage.

Apart from Changsheng Biotechnology, another vaccine company, the Wuhan Institute of Biological Product Company, also came into the spotlight as the public questioned the whereabouts and effectiveness of the 400,000 substandard DPT vaccines for diphtheria, pertussis or whooping cough, and tetanus sold in Chongqing and Hebei Province.

A statement published by the China Food and Drug Administration (CFDA) said the vaccines were substandard because the suspension was uneven due to equipment malfunction, and therefore accidental.  

CFDA said the company had recalled all unopened vaccines and destroyed them in May under the supervision of the Wuhan Food and Drug Administration. The company corrected the situation based on the CFDA's requirements, improved the maintenance of its equipment and training, and sense of quality. 

The company resumed production after the National Institutes for Food and Drug Control tested 30 batches of its DPT vaccines, which passed the test. 

CFDA said it had fined the company for substandard vaccines, and confiscated revenue from the sales, but did not disclose the amount of the fine.

China Judgments Online said the company had bribed disease control centers officials. For example, an employee surnamed Wang bribed Li Chuantao, former director of the disease control center in Lixin county, Anhui Province in the amount of 40,000 yuan ($5,897). 

The website also showed that the company was sued several times after vaccine injections. A decision on October 11, 2017 shows that a child surnamed Wang, born in December 2012, appeared to have a fever after being injected with the DPT vaccines produced by the company. 

Wang was diagnosed with an upper respiratory infection by Wuhan's Third Hospital the following day. In October 2013, Wang was diagnosed with epilepsy. Experts in Wuhan called it an abnormal reaction to the vaccine injection. 

  

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