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No link has been found to the vaccines given to nine of the children in China who died after receiving hepatitis B shots, health authorities claim.
There have been 17 deaths following BioKangtai vaccinations reported between Dec. 13 and 31. All have been investigated or are under investigation. Nine of the cases have nothing to do with the vaccines, director of the disease control bureau of the National Health and Family Planning Commission Yu Jingjin told a press conference.
Preliminary analysis of the eight other cases have also found no link between the deaths and the vaccines, but the cause of the deaths will be confirmed only after autopsies, Yu said.
Also at the press conference, Li Guoqing of the China Food and Drug Administration, said no problems had been found with BioKangtai vaccines in production practices or product quality.
China's big Hep.B vaccine makers stop production
China's three biggest hepatitis B vaccine manufacturers have suspended production, the food and drug administration announced late on Thursday.
BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharmfailed to meet the 2010 good manufacturing practice (GMP) code for all pharmaceutical manufacturers by the deadline at the end of 2013. Those who did not reach the new standards must suspend production in 2014.
Over the first 11 months last year, hepatitis B vaccines produced by the three suppliers accounted for about 80 percent of total output.
Hepatitis B vaccines sold in China are produced by seven companies, including British pharmaceutical company GlaxoSmithKline. Only two have passed the new GMP certification, responsible for no more than 10 percent of sales.
The statement by the China Food and Drug Administration (CDFA) says that companies may resume production after certification. Li Guoqing, a senior CFDA official, said vaccine supplies are sufficient to meet market demand.
The authority has clarified that vaccines produced before the deadline can still be sold. The five suspended manufacturers have inventories of qualified vaccines for about 25 inoculations, Li said.
The authority will organize increased production if necessary, the official said.
