Sunday, 22 December 2013

Shenzhen Kangtai Hepatitis B vaccine withdrawn after four infant deaths

by Michael Woodhead
The China Food and Drug Administration (SFDA) has suspended the use of recombinant hepatitis B vaccine for children manufactured by Shenzhen Kangtai Biological Products (Shenzen Kangtai Shengwu Zhipin, 深圳康泰生物制品股份有限公司) after the four deaths were reported among children who received the vaccine. According to an announcement by the SFDA on 20 Dec, the four deaths were reported following vacination with batches of the company's vaccine in Hunan, Guangdong and Sichuan. The SFDA says an investigation into the cause of death is still underway and until the results of this investigation are available, the use of all batches of the vaccine is being suspended immediately, in the interests of child safety and safety of the infant vaccination program.

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