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China Probes Hepatitis B Vaccine’s Role in Death of Six Babies

China is investigating links between the deaths of six babies and hepatitis B vaccines that they were given as part of a national campaign to immunize against the liver disease.

The babies, who were from the provinces of Hunan, Guangdong and Sichuan, died shortly after receiving inoculations, the People’s Daily reported on its website today. A seventh death was found to be unrelated to the vaccine, according to the newspaper that’s published by China’s Communist Party.

The deaths are the latest test of China’s ability to ensure safe food and medicine after cases of tainted baby formula, fox meat sold as mutton and thousands of dead pigs found floating in Shanghai’s main river sparked public outrage. Authorities in March elevated the China Food and Drug Administration to a ministry-level agency to strengthen supervision.

“In general, hepatitis B vaccine is known to be safe and effective,” Helen Yu, a Beijing-based communications officer for the World Health Organization in China, which provides technical support for the hepatitis B vaccination program, said in an e-mailed response to questions. “We are confident in the ability of CFDA to conduct a thorough investigation.”

Hepatitis B vaccinations were added to China’s national immunization program in 2002 and have been free for all children since 2005, according to the Atlanta-based Centers for Disease Control and Prevention. The first dose of the vaccine needs to be administered the day a baby is born to be most effective, according to the WHO’s Yu.

Vaccines Suspended

China’s food and drug regulator on Dec. 20 suspended the use of all batches of a hepatitis B vaccine made by Shenzhen Kangtai Biological Products Co. pending the results of a probe into its connection with the death of four infants. It had earlier on Dec. 13 halted use of two batches of the vaccine.

Kangtai Biological is “actively” assisting in the investigation and conducting its own tests, according to a statement on its website dated Dec. 16. The company said it’s not yet clear if there are links between its vaccine and the deaths. A woman who answered the company’s general line, who declined to identify herself, said no one was immediately available to comment.

Shenzhen Kangtai was the sole provider of hepatitis B vaccines for Shenzhen’s free vaccination program, the China Daily reported, citing the city’s health authorities.

Safety Issues

Food and drug safety has been a persistent problem in China. At least six children died in 2008 after consuming baby formula tainted with the chemical melamine. In May, police busted a ring selling fox and mink meat as mutton in Shanghai and the neighboring province of Jiangsu, two months after the city pulled more than 10,000 dead pigs from the Huangpu river.

In 2007, former chief drug regulator Zheng Xiaoyu was executed for taking bribes amid a clamp down on fake medicine. A former deputy director of the same agency was fired for serious violations of discipline and law in 2011, the same year a Shanghai court handed a suspended death sentence to a former chief executive of Shanghai Pharmaceutical Group for corruption that enabled him to amass more than 50 million yuan ($8.2 million).

After the suspension of Kangtai Biological’s product, Guangdong purchased three types of hepatitis B vaccine, including one type from Beijing Tiantan Biological Products Corp., to ensure sufficient supplies, financial data and news provider Great Wisdom reported today, citing an unidentified person from the local disease control and prevention center.

Tiantan Biological shares rose by the 10% daily limit today in Shanghai trading following the report.

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