Vaccines ‘not to blame’ for deaths of 17 children
Print Edition
Vaccines did not cause the deaths of nine children shortly after they were inoculated for hepatitis in a Chinese government program and no links have been found in eight cases still being investigated, health officials said yesterday.
At the same time, it was revealed that three drug makers — one of which was scrutinized over the recent deaths — had suspended production because they failed to meet new manufacturing standards.
Eighteen infants were reported ill in the wake of vaccinations between December 13 and 31. Only one survived.
Nine of the deaths were clearly unrelated to the vaccines, the National Health and Family Planning Commission said at a press conference yesterday, while a preliminary investigation found no links in the remaining cases.
The cause of those eight deaths would only be confirmed after autopsies are completed, said Yu Jingjin, director of the commission’s disease control bureau.
Instead, the deaths were from acute pneumonia, suffocation, kidney failure, severe diarrhea, death of intestinal tissue, sudden infant death, congenital heart disease and other conditions, the commission said. The children were all younger than 5 and lived in nine provinces across China.
Late last month, after the first few deaths were reported, Chinese authorities sent health experts to investigate Shenzhen-based BioKangtai, manufacturer of most of the hepatitis B vaccines.
The China Food and Drug Administration said 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. It said the companies could resume production after obtaining the new certification.
At the press conference, officials confirmed no problems or contamination had been found with BioKangtai vaccines in production practices, product quality or transportation.
The company has sent 2,271 samples from eight batches to authorities. Two batches had tested safe and the results for other six batches would be published soon, China Central TV reported.
China has seven hepatitis B vaccine manufacturers. The three biggest — BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharm — make up nearly 75 percent of the domestic market.
Li Guoqing, director of the food administration’s drug regulatory department, said at the press conference that the three companies had suspended production after failing to meet a 2010 manufacturing code by the end of 2013. They may resume production after certification.
In fact, BioKangtai has passed the certification and should resume production after an unspecified notice period.
Tiantan was found to have its factory in a downtown area — an “improper location” — while Hissen had some problems in workshops. Both have started to rectify the problems.
Li said the suspensions wouldn’t cause a shortage of vaccines as those made before the end of last year could still be used if they were within their valid period.
Shanghai uses hepatitis B vaccines produced by Hissen. The city’s disease control and prevention center said the city still had 600,000 hepatitis B vaccines in store, an amount estimated to last for six months.
China launched the hepatitis B vaccination program in 2002.
Previously, nearly one in 10 Chinese people tested positive for hepatitis B — nearly 10 times the current rate, Li said.
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