China has been investigating 17 deaths following inoculation with a hepatitis B vaccine, made by Shenzhen-based BioKangtai, on 13 December and again last Tuesday.
Public confidence in Chinese health authorities and the country’s drug safety regime is shaky at best, though improvements have been made in recent years since government agencies withheld information about the spread of the Sars virus and bird flu.
State news agency Xinhua reported that Yu Jingjin, director of the disease control bureau of the National Health and Family Planning Commission, insisted that nine of the deaths were unrelated to the injections, while a preliminary analysis of the eight other cases have also found no link between the deaths and the vaccines.
Meanwhile, China’s national product safety watchdog said three pharmaceutical companies – one of whom was scrutinised over the recent deaths – had suspended production because they failed to meet new manufacturing standards.
The causes of the first nine deaths were acute pneumonia, suffocation, kidney failure, severe diarrhoea, death of intestinal tissue, sudden infant death and congenital heart disease, the National Health and Family Planning Commission said.
The children were all younger than five and lived in nine provinces across China.
The cause of death of the remaining eight children, would only be confirmed after autopsies are completed, Mr Yu said.
Late last month after the first few deaths were reported, Chinese authorities sent health experts to investigate the manufacturer of most of the hepatitis B vaccines, BioKangtai, which produces 80 per cent of the hepatitis B vaccines in China.
Li Guoqing, of the China Food and Drug Administration, said at a press conference that no problems had been found with BioKangtai vaccines in production practices or product quality.
BioKangtai insisted in a statement in December that it rigorously followed safety rules but said it was carrying out tests on the batches suspected of causing the deaths.
The China Food and Drug Administration announced yesterday that BioKangtai and two other manufacturers of hepatitis B vaccines had to suspend production because they failed to meet new safety and quality standards for manufacturing.
However, it said the companies could resume production after obtaining the new certification.
BioKangtai said on its website that it is assisting investigators.
China has been beset by product safety scandals over the past few years.
At least six children died in 2008 after drinking milk contaminated by the industrial chemical melamine.
Meanwhile, there have also been previous reports of children dying or becoming seriously ill from encephalitis, hepatitis B and rabies vaccines.
In those cases, the health ministry said the vaccines had been improperly stored but were unrelated to subsequent illnesses that were reported.