Official: detained 32 Shandong illegal cases of vaccine-related products 21 batches of vaccine expires

Beijing, April 25, according to the State food and Drug Administration's Web site, food and Drug Administration today issued a circular on April 28, 2015 in Jinan, Shandong province operating a vaccine series cases at the time of the scene seized a total of 32, including 21 batches of the vaccine, immunoglobulin 3 batches of the validity period.

April 28, 2015 in Jinan, Shandong province operating a vaccine series cases at the time of the scene seized a total of 32, including 12 kinds of vaccines (27), 2 kinds of immunoglobulins (4) dissolved and 1 species of bacteria (1). Among them, 6 within the validity period of vaccine batches 1, bacteria, dissolved 1 batch of immune globulin, 21 batches of the vaccine, immunoglobulin 3 batches of the validity period. Food and drug supervision Bureau in Jinan City, Shandong province, have seized 32 March 21, 2016, send these products in China's food and drug inspection Institute for examination.

China's food and drug inspection Institute of the 32 batches of product validation. As of April 25, 2016, the completed validation 29 tests comply with the standard 27, in which vaccine products 24; 2 batches of test results do not meet the standards provisions, namely hepatitis b human immune globulin and rabies immunoglobulin (not vaccine), valid for 3 months and 6 months. Another 2 AC meningococcal a conjugate vaccine and 1 recombinant hepatitis b vaccine (CHO cells) validity of the test is still underway.

China's food and drug inspection Institute of the 32 30 batches of products in the batch checked for abnormal toxicity (the check are important indicators to reflect product safety), the results are in line with the standards. In addition, there is 1 batch of rabies immunoglobulin and 1 Haemophilus influenzae type b conjugate vaccine samples do not meet inspection requirements, no abnormal toxicity tests.

(Editors: Pan Yi burn UN657)
2016-04-25 20:58:39
China News Network

官方：扣押32批涉山东非法疫苗案产品 21批疫苗过期

　　中新网4月25日电 据国家食药监总局网站消息，食药监总局今日发布通告，2015年4月28日山东济南非法经营疫苗系列案件案发时现场扣押产品共32批，其中，已过有效期的疫苗21批、免疫球蛋白3批。

　　2015年4月28日山东济南非法经营疫苗系列案件案发时现场扣押产品共32批，包括12种疫苗(27批)、2种免疫球蛋白(4批)和1种细菌溶解物(1批)。其中，在有效期内的疫苗6批、免疫球蛋白1批、细菌溶解物1批，已过有效期的疫苗21批、免疫球蛋白3批。山东省济南市食品药品监管局已将上述扣押的32批产品于2016年3月21日全部送中国食品药品检定研究院进行检验。

　　中国食品药品检定研究院对上述32批产品进行了有效性检验。截至2016年4月25日，已完成有效性检验29批，检验结果符合标准规定27批，其中疫苗产品24批；检验结果不符合标准规定2 批，分别为乙型肝炎人免疫球蛋白和狂犬病人免疫球蛋白(均不属于疫苗)，超过有效期3个月和6个月。另有2批AC群脑膜炎球菌结合疫苗和1批重组乙肝疫苗(CHO细胞)的有效性检验还在进行中。

　　中国食品药品检定研究院对上述32批产品中的30批产品进行了异常毒性检查(该检查是反映产品安全性的重要指标)，结果均符合标准规定。另外，有1批狂犬病人免疫球蛋白和1批b型流感嗜血杆菌结合疫苗因样品量不能满足检验需要，未做异常毒性检查。

(责任编辑：潘奕燃 UN657)
2016-04-25 20:58:39
中国新闻网