CNR network in Guangzhou on January 3 news (reporter Feng Huiling), according to Voice of China

CNR network in Guangzhou on January 3 news (reporter Feng Huiling), according to Voice of China "CNR News" reported this morning, strokes the State Food and Drug Administration, the National Health and Family Planning Commission held a joint hepatitis B vaccine latest progress briefing. The first is the drug of the State Food and Drug Administration regulatory Secretary General Francis Chan speaking about the situation to everyone's health check Conde. The inspection team is composed of four long been engaged in inspection and quality control of vaccines certified international pharmaceutical GMP's Procuratorate and the experts. Among on-site inspection, the inspection team focus is on the production process is not the existence of contamination and cross-contamination, is not there a change strokes that may affect the quality of products and exceptions. In short, they are likely to affect all aspects of product quality have carried out intensive checks and collect the relevant raw data. Inspection team also focus on checking the batch production records involving suspected abnormal reaction strokes to vaccination eight batches of the product and batch inspection records, this test deviation change materials, etc., and all situations. After that inspection, the inspection team that says Conde hepatitis B vaccine companies produce only one variety, there is no other product line production of cross-contamination. In addition, they produce inspection and quality control procedures and quality measurement is consistent with the approved manufacturers, it's liquid, semi-finished products after quality review strokes found that the quarantine strokes of eight batches of results, process strokes parameters and enterprise Other batches of product produced as compared to its quarantine results are within the acceptable range and stable. Critical supply parameters within strokes the set range, production quality management is in line with Good Manufacturing Practice requirements. Overall, the inspection found no Conde in the process of production and quality control issues affecting the quality of products. In addition, strokes on December 17, China Certification and Inspection Institute for Food and Drug Food and Drug Administration, Hunan Province, Shenzhen Kangtai company focused strokes on two batches of hepatitis B vaccine have been tested. The results show that these two batches of samples strokes and standards are in line with national drug registration standards of the enterprise, in addition, they are also products of the same batch lot release results were compared and found no significant change in the indicators, test results and batch release of the results are consistent, which concluded strokes that the product quality is stable. But last December 13 to the 19th five cases have been reported strokes incidents of suspected hepatitis B vaccine inoculation Conde's relevant. The Secretary of Health and Family Planning Commission of disease control strokes bureau in competition into the definition of the five made a note, saying that the deaths of four cases preliminary judgment is not related to vaccination, but have to wait after the completion of the autopsy strokes do related work a final judgment has been discharged severe case, this does not rule out the disease or vaccine-induced abnormal reaction, that anaphylactic shock. Conde company suspended all of the hepatitis B vaccine after, between December 20 to 31, the country has reported 13 cases of suspected hepatitis B vaccine inoculation Kangtai deaths, are also before 20 December vaccinated. At least now know the result, eight cases the cause of death has entered the clinical diagnosis, parents see media reports after vaccination with suspicion about, strokes then asked again for diagnosis, diagnosis after experts found that the current nine cases have been diagnosed strokes with this vaccines does not matter, the other four cases have nothing to do with the initial judgment vaccination, but after the completion of the autopsy related work have to wait until then to make a final judgment. Judging from the survey results across units and personnel are qualified to meet the requirements of vaccination, strokes vaccine storage and transportation requirements are met, vaccinated links are also in line with practices. Now we get the latest news is that Conde Shenzhen, Dalian and Beijing Tiantan Biological Han letter did not get GMP, pharmaceutical production and management practices is certified in 14 years on January 1 all discontinued, which accounted for three of the hepatitis B vaccine 80% of the market, we are very concerned that if 80% of the vaccine supply is not on, the other children vaccinated how to do? (Original title: Health Planning: early deaths and four cases of hepatitis B vaccine inoculation is no direct relationship)
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