Chinese regulators last week cleared the manufacturers of hepatitis B vaccines of any connection to the deaths of nearly 20 children around the country, but that did not keep them from having their operations suspended. It turns out 5 of the vaccine makers had yet to hit a Jan. 1 deadline to meet new manufacturing standards announced four years ago.
According to China's state news agency Xinhua, the country's three largest hep B vaccine makers, BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharm, are among those whose operations have been suspended until they show they are meeting the new standards. They are allowed to continue to sell product produced before the first of the year. Those three account for about 80% of the vaccine production in the country, Xinhua reported.
Drug and health regulators, often criticized for slow responses to health issues, sprang into action last month after reports surfaced that vaccinated children had died. They launched a probe and ordered a hold on millions of doses of hep B vaccines. But last week, they assured the country that there is no connection with children getting shots through China's national vaccination program and that they are investigating at least 9 of the 17 deaths, Reuters reported, citing Xinhua. They are awaiting autopsies on the other 8, but no link has been found thus far. 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.
Li Guoqing, an official with the China Food and Drug Administration, said that BioKangtai, which made most of the suspect doses, was cleared of any lapses in vaccine quality or production problems related to the deaths, Reuters reported. BioKangtai, which according to some accounts produces up to 60% of the hep B vaccines in China, launched 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 food safety and health 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.