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Rabies vaccine license revoked
Source: Xinhua |
March 12, 2009, Thursday
|
Print Edition
Print Edition
CHINA'S drug watchdog has revoked the production license of a pharmaceutical company that produced flawed rabies vaccine and banned the firm's principals from any involvement in the industry for 10 years.
The State Food and Drug Administration also canceled the approval certificate for the vaccine produced for human use by Dalian Jingang-Andi Bio-products Co Ltd.
An SFDA official said yesterday that General Manager Wang Quanfeng and Deputy General Manager Luo Huosheng had been found responsible for the faulty vaccine, according to an investigation by the government of Liaoning Province, where the company is based.
However, officials were still investigating how many others could be culpable.
Police detained the pair and Yu Jingqing, a purchasing agent, on February 7 after the company was found to have deliberately added nucleic acid in the production of the vaccine from February to June last year.
Nucleic acid acts as an adjuvant, or a substance used to enhance the effectiveness of anti-viral drugs. However, China has yet to approve it for use in rabies vaccines as it has still to undergo clinical trials before it can be used on humans.
According to the SFDA, of the 360,200 doses produced and sold by the company last year, 326,400 had been recalled as of February 22, and most of the rest might already have been used.
No problems related to the company's vaccine have been reported so far.
The SFDA said the administration was closely monitoring any vaccine-related illness and working with health authorities.
The State Food and Drug Administration also canceled the approval certificate for the vaccine produced for human use by Dalian Jingang-Andi Bio-products Co Ltd.
An SFDA official said yesterday that General Manager Wang Quanfeng and Deputy General Manager Luo Huosheng had been found responsible for the faulty vaccine, according to an investigation by the government of Liaoning Province, where the company is based.
However, officials were still investigating how many others could be culpable.
Police detained the pair and Yu Jingqing, a purchasing agent, on February 7 after the company was found to have deliberately added nucleic acid in the production of the vaccine from February to June last year.
Nucleic acid acts as an adjuvant, or a substance used to enhance the effectiveness of anti-viral drugs. However, China has yet to approve it for use in rabies vaccines as it has still to undergo clinical trials before it can be used on humans.
According to the SFDA, of the 360,200 doses produced and sold by the company last year, 326,400 had been recalled as of February 22, and most of the rest might already have been used.
No problems related to the company's vaccine have been reported so far.
The SFDA said the administration was closely monitoring any vaccine-related illness and working with health authorities.
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