China clears hep B vaccine makers in child deaths

Chinese regulators do not possess a sterling reputation in their home country, having been caught unprepared as one health scare after another has panicked the population. So when reports began surfacing that children were dying from hepatitis B vaccinations, drug and health regulators sprang into action, launching a probe and putting a hold on millions of doses from the leading hep B vaccine maker.

Today, they assured the country that there is no connection between children getting shots through the country's national vaccination program and at least 9 of the 17 deaths they are investigating, Reuters reports, citing China's state news agency Xinhua. They are awaiting autopsies on the other 8, but no link has been found thus far, Yu Jingjin, a director with the National Health and Family Planning Commission, said during a press conference. According to the Associated Press, the deaths were attributed to conditions ranging from pneumonia to suffocation. The children, all under the age of 5, came from 9 provinces across China, the commission said.

Reuters reported that BioKangtai, which made most of the suspect doses, was cleared of any lapses in vaccine quality or production problems related to the deaths, acccording to Li Guoqing, an official with the China Food and Drug Administration. The AP reports the agency said BioKangtai and two other hep B vaccines, however, were suspended from producing products until they are certified under new safety and quality standards for manufacturing.

BioKangtai, which according to some accounts produces up to 60% of the hep B vaccines in China, was started in 1992 with government support, as well as a big helping hand from Merck ($MRK), which provided manufacturing expertise and donated the technology to make the vaccine. At the time, about 2 million children a year were being diagnosed with the condition, leading China to institute an early childhood vaccination program for the disease.

China has struggled to keep up with oversight on health and food issues even as the public has become increasingly vocal about its concerns. In 2003, the country was found to be covering up the spread of SARS and bird flu. Counterfeit medicines are a problem in many rural areas, not to mention often peddled globally on the Internet. But Chinese authorities say they are stepping up efforts to improve the quality of drug and food production. The new program was announced last week by Zhang Yong, who heads China's FDA, although no details were provided about how the agency intends to do it.

- here's the Reuters story
more from the Associated Press

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