Food Drug Administration talk about illegal vaccines: survey will be the first time in the official announcement-Food Drug Administration talk about illegal vaccines, vaccine-IT information

Shandong vaccine cases of illegal business concern, Deputy Director of China's State food and drug supervision administration Wu Zhen said 23rd food drug administration in conjunction with the Ministry of public security, health and planning commissions cooperate closely, handle the event that "was doing four things".

In interviews during the Boao Forum, Wu Zhen said that, overall, China's vaccine during the fairly standard, especially a class of vaccine management is very strict. "Illegal vaccines" belongs to the normal production, but there was a problem in the circulation.

Premier Li keqiang 22nd series case instruction to the illegal operation of vaccine, and requested a full investigation into the problem of vaccine flow and usage, crack down on illegal and criminal activities according to law, accountability to the related acts of malfeasance seriously and will not tolerate.

Wu Zhen said, at present, the food and drug administration, Ministry of public security, health and Planning Commission and other departments are doing four things:

First is to thoroughly investigate the case. Food and Drug Administration was announced involved 20th and accordingly combined Ministry of public security and health planning Commission went into its downstream operations involved.

Second is severely punished in the vaccine during the illegal or irregular and criminals. "Coverage may include both individual units, as well as other institutions. ”

Third is information made public. Verified anything, official website of the food and Drug Administration will be the first time in public.

Finally, fill holes, from the institutional, normative and regulatory aspects to compensate.

Wu Zhen said illegal vaccine event last April, Shandong case. Products identified as the formal production of the product, but the core problem was unlicensed, vaccines out of the cold chain for some time, resulting in reduced vaccine effectiveness.

For "lower, preventive drugs fail to prevent the effects of disease, it is harmful. But after the failure of vaccination harm to human body, scientists need to answer and demonstrate scientific data. "Wu Zhen said.

Representative Office of the World Health Organization vaccine event 22nd to post reported that vaccine should be properly stored and managed, otherwise it will lose effectiveness or reduce effectiveness, it is important to note is that incorrect storage or expired vaccine does not cause toxicity. "In this case, vaccine safety risk is very low."

Shandong police had earlier uncovered involving 570 million yuan in illegal vaccine, these vaccines were found without strict cold chain storage transport are sold to 24 provinces and municipalities. As of 22nd at 15 o'clock, 37 illegal vaccine involved has to be controlled. Shandong involved a wholesale Enterprise qualification certificates revoked drugs.

食药监谈非法疫苗：调查情况将第一时间在官网公布 - 食药监谈非法疫苗,疫苗 - IT资讯

针对备受关注的山东非法经营疫苗案件，中国国家食品药品监管总局副局长吴浈23日表示，食药监总局会同公安部、卫计委密切配合，把该事件处理好，目前“正在做四件事”。

在博鳌论坛期间接受采访时，吴浈说，总体来讲，中国的疫苗流通过程比较规范，特别是一类疫苗的管理非常严格。“非法疫苗”属于正规企业生产，但在流通过程中确实存在问题。

国务院总理李克强22日对非法经营疫苗系列案件作出批示，要求彻查问题疫苗的流向和使用情况，依法严厉打击违法犯罪行为，对相关失职渎职行为严肃问责，绝不姑息。

吴浈透露，目前，食药监总局、公安部、卫计委等部门正在做四件事：

第一是彻查案件。食药监总局已于20日将涉事名单公布，并将据此联合公安部和卫计委对涉事上下游进行深入调查。

第二是严厉处罚在疫苗经营过程中的违法、违规及犯罪分子。“涉及范围可能既包括个人也包括单位，既有企业也有其它机构。”

第三是信息公开。凡是查实的任何事情，食药监总局将第一时间在官方网站公布。

第四是补漏洞，从制度、规范、监管等多层面进行弥补。

吴浈称，山东非法经营疫苗事件去年4月立案。产品基本确认是正规企业生产的产品，但核心问题是无证经营，一段时间疫苗脱离冷链，造成疫苗效力减低。

“药效降低，预防性的药物达不到预防疾病的效力，那是有害。但至于失效疫苗注射后对人体的伤害，需要科学家的回答和科学数据的论证。”吴浈说。

世界卫生组织驻华代表处22日就疫苗事件发布通报称，疫苗应该正确储存和管理，否则将失去效力或降低效力，但必须注意的是，不正确储存或过期的疫苗几乎不会引起毒性反应。“在本事件中，疫苗安全风险非常低”。

山东警方在稍早前破获案值5.7亿元人民币的非法疫苗案，这些疫苗被发现未经严格冷链存储运输销往24个省区市。截至22日15时，37名非法疫苗涉案人员已被控制。山东一涉案批发企业被撤销经营药品资格证书。