Three Chinese drug producers that make about 80 percent of the nation’s hepatitis B vaccines halted output because they don’t meet new production quality requirements, Xinhua News Agency said on its microblog.
Beijing Tiantan Biological Products Corp. (600161), Shenzhen Kangtai Biological Products Co. and Dalian Hissen Bio-Pharm stopped production on Jan. 1, the official Xinhua agency’s Weibo microblog reported, citing the China Food and Drug Administration. The nation will ensure hepatitis B vaccine products meet market demand, according to Xinhua Weibo.
At least a dozen newborn babies have died nationwide after receiving hepatitis B shots, fueling concern about the safety of vaccines in China, Xinhua reported Dec. 31. China is investigating links between the deaths and hepatitis B vaccines that they were given as part of a national campaign to immunize against the liver disease, the People’s Daily reported Dec. 23.
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.
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 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 Dec. 16 statement on its website. The company said it’s not yet clear if there are links between its vaccine and the deaths.
Two calls each to Kangtai Biological and Dalian Hissen’s general lines went unanswered after hours. A woman who answered Tiantan Biological’s general line and declined to identify herself, said no one was immediately available to comment.
The three companies accounted for about 80 percent of China’s hepatitis B vaccine output in January through November last year, Xinhua Weibo reported.
The 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.
To contact Bloomberg News staff for this story: Sarah Chen in Beijing at firstname.lastname@example.org