No Link with Hepatitis B and Newborn Deaths Say Chinese Authorities


On Friday, Chinese Health Authorities ruled out the Hepatitis B vaccine in the deaths of nine infants.  Eight other deaths are still under investigation. According to Li Guoqing, Secretary of the Chinese Food and Drug Administration (CFDA), an investigation showed no productions issues that would affect the quality of the vaccine.

Investigation in to the deaths of 17 newborns nationwide was conducted after suspected abnormal adverse reactions to a Hepatitis B vaccination.  The deaths occurred between Dec. 13 and Dec. 31 after the newborns were vaccinated for Hepatitis B under a government vaccination program. All infants born in the country receive the first dose of the hepatitis B vaccine within 24 hours of birth.

According to Guoqing, after Dec. 13, the CFDA learned of three cases of suspected abnormal reactions to the vaccine in the province of Hunan.  The CFDA immediately began an investigation identifying Shenzhen Kangtai Biological Products Co., Ltd. as the vaccine source.  The CFDA as well as the Guangdong Province Food and Drug Administration organized a site inspection and vaccine sampling.  The CFDA also assembled teams of experts to further the in-depth investigation of the company’s production line for inspection, a comprehensive inspection of raw materials, quality management and quality control.  The investigation showed no issues affecting the quality of the vaccine.

On Dec. 25, The Shenzhen Kangtai Biological Products Company issued a statement on their website informing the public that the company was working in cooperation with government departments on vaccine quality and production management checks.  Although the investigation showed no link between the vaccine and the deaths of nine infants, the company was ordered to halt production because it did not pass the CFDA’s new good-manufacturing practice certification for 2013.

According to Lei Zhenglong of the National Health and Family Planning Commission (NHFPC), the commission had received the reports on the Shenzhen Kangtai Biological Products used in the production of recombinant Hepatitis B vaccine and continues to work with food and drug regulatory authorities on the suspected abnormal reactions.  The NHFPC plans to facilitate vaccination monitoring and continue to collect supplementary information.  The commission is also using combined clinical and epidemiological investigation and autopsy results on the cause of deaths to reach a comprehensive judgment in the remaining cases.

The NHFPC plans to coordinate with other vaccine manufacturers to swap hepatitis B vaccine supplies to enable the effected provinces to carry out routine immunization of hepatitis B vaccine.  According to the NHFPC, over 16 million babies were born in China last year. Of these children, 90 percent were covered by China’s immunization program that offers free hepatitis B inoculations. The hepatitis B vaccine program began in 2002 in China and has reduced of the prevalence of hepatitis B in the country to less than one percent among children under five.

According to the World Health Organization, China’s vaccines are produced and regulated in accordance with international standards.

Hepatitis B is a virus which can cause a life-threatening liver infection. It can lead to chronic liver disease and chronic infection. The virus increases the risk of death from cirrhosis of the liver and liver cancer. According to the Centers for Disease Control, 90 percent of infants who contract Hepatitis B will develop chronic infection.


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