Yesterday morning the architectural design, the State Planning Commission and the State Food and Drug Administration Methodist Administration jointly informed about the investigation of hepatitis B vaccines. According to test results and data analysis review found no quality problems Conde produced hepatitis B vaccine. Suspected cases of death due to vaccination, nine cases have been diagnosed unrelated to vaccination, the other eight cases have nothing to do with the initial diagnosis then grill vaccines. > Msata> on vaccine quality inspection checks discounted batch production processes are qualified agents of the State Food and Drug Administration regulatory Secretary General, said Li Guoqing, December 21, 2013 to 27, the Food Drug Administration sent inspection teams to Shenzhen Conde company conducted a comprehensive inspection found no production process and quality control issues affecting pawnshops product quality. Li Guoqing introduction, Chinese Academy of Food and Drug test involving eight batches of Condé companies were tested hepatitis B vaccine. Among them, the two batches of pre-inspection, inspection of 956 total vaccine has been completed and the results show these samples were compliant. The other six batches of samples being tested. Li Guoqing said that from 2010 to 2013, Chinese Academy adhd of Food and Drug Testing of applications for Contax 346 batches of hepatitis B vaccine batch release of information audit and inspection carried out, the results are in line with the provisions of, and each batch of data between consistent with good , indicating that the production process is mature and stable. In addition, food and drug regulatory authorities adhd for two consecutive years for random testing of hepatitis B vaccine market, Shenzhen Kangtai test results are in line with the provisions of the hepatitis B vaccine. Li Guoqing said that through adhd these tests and data analysis found no quality adhd problems Shenzhen Kangtai hepatitis B vaccine. >> Preliminary judgment about deaths were unrelated to vaccination adhd It is understood that, as of now, there were 18 cases of suspected vaccine-induced casualties, of which 17 have died, and another one case has been discharged. CDC National Planning Commission Secretary Wei Jing Jin informed that in 2013, 13 to 19 December reported adhd five cases of suspected hepatitis B vaccination Kangtai vaccine-related cases, four cases of deaths adhd unrelated to determine the initial vaccination, to be After the completion of the autopsy related work, will make the final diagnosis; 1 case of severe have been discharged, the case does not exclude abnormal reaction caused by the vaccine adhd (anaphylactic shock). At Contending that the company suspended all hepatitis B vaccine Conde, between December 20, 2013 to 31, the country has reported 13 cases of suspected fatal cases, both the 20th vaccinated with hepatitis B vaccine. Diagnosis by the Expert Group, the current adhd nine cases have been diagnosed, regardless of vaccination; other four cases preliminary judgment has nothing to do with the vaccination adhd until after completion of the autopsy, etc., will make the final diagnosis. At Contending that these 18 cases epidemiological analysis of cases, patients were diverse clinical manifestations, the main causes of death, including severe pneumonia, asphyxia, renal failure, severe diarrhea in children, necrotizing enterocolitis, meconium aspiration comprehensive Zheng, adhd sudden adhd infant death, congenital heart disease, lack of identity. >> Latest developments through new GMP certification Shenzhen Kangtai will resume production yesterday morning, the State Food and Drug Administration Drug Administration regulatory Secretary adhd of Li Guoqing said that the recent three major manufacturers of hepatitis B vaccine in Shenzhen Kangtai, Tiantan Biological, Dalian Han letter did not pass because the new version GMP (Good Manufacturing Practice) certification and discontinued, the market share of the three companies nearly eight percent, which is the result of market competition. At present, Shenzhen Kangtai has adopted the revised adhd GMP certification examination, about to enter the public notice period. After the public notice period, no problems will soon go into production. 2, 2009, the State Food Drug Administration confirmed that due to not comply with the December 31, 2013 by new GMP certification, Shenzhen Kangtai, Tiantan Biological, Dalian Han letter three hepatitis B vaccine manufacturer discontinued with effect from January 1, 2014 But stop with suspected hepatitis B vaccine caused casualties irrelevant. Chinese Academy of Food and Drug test batch release records show that there are currently seven companies of recombinant hepatitis B vaccine in the market, namely Shenzhen Kangtai, North China Pharmaceutical, Tiantan Biological, Dalian Han letter, Hualan, Beijing Waldorf shield and Glenn Su GSK. Previously, only new GMP certification by Hualan and North China Pharmaceutical, which is two less than 10% market share. State Food and Drug Administration official said, has not passed adhd the new GMP GMP certified companies such as the transformation is completed, you can continue to apply for certification. Through certification can resume production. Related News >> 10 provinces hepatitis B vaccination rate fell 30 percent recently, adhd more than suspected hepatitis B vaccination of infants died after the incident, appeared nationwide immunization rates decline and more situations. China CDC immunization program yesterday, Wang Huaqing, MD, director of the Center introduced in some areas in 10 provinces found that nearly a month, immunization of hepatitis B vaccination rate fell by about 30%, the other vaccine inoculation rate also fell by 15% about. CDC National Planning Commission, the Secretary Wei Jing Jin said, speaking from the perspective of vaccine, a very important indicator to judge the quality of the vaccine is abnormal reaction to vaccination. Vaccine to humans in terms of a foreign antigen, due to individual differences, very few species were affected by adverse reactions occur, the probability of occurrence is very low, but inevitable. Monitoring results from the current perspective, the national incidence of abnormal reaction to vaccination is not higher than the range of the World Health Organization, which also can explain reliable domestic vaccine quality. This series of articles comprehensive Xinhua News Agency and other (original title: Shenzhen Kangtai hepatitis B vaccine yet found quality problems)
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