Health Planning Commission Director micro signal: the advent of vaccines and no clear rules

On March 18, the State food and Drug Administration rushed to "Shandong vaccine" to respond.

In recent days, "Shandong vaccine" vigorous, even medium tear each other vs. The case involving more than 500 million Yuan, covering provinces covering more than half of China, the amount and impact of staggering; in various media attention forward and reporting process, or even a "vaccine" and "vaccine" such a statement, and got to the point of panic, particularly the mothers of those children need to be vaccinated.

Exactly which vaccines might be at risk? After vaccination may bring harm? Small new reign promised after visiting it again, but also with the official "involved" was contacted, and objectively respond to these social concerns.

　　Problem is not known specific flow and quantity of vaccine

Police in Jinan has issued letters of investigation to 20 cities nationwide to verify the flow and use of vaccines, but Pang a few years outside books record vaccine sold by quantity and flow have been difficult to verify. After fermentation, the drug regulators frequently.

On March 18, the State food and Drug Administration rushed to respond. State food and Drug Administration spokesman, said the Council has instructed the food and drug administration, Shandong province together with public security and health and family planning sectors, immediately identified sources and flows of related products such as vaccines, for the first time to the public relevant information. The Council requested, according to the public security organ to provide clues products into the provincial food and drug supervision departments involved to identify immediately into vaccine product purchased, used and inventory, unused immediately seized; on vaccination has been used for the human body, health and family planning departments to quickly identify specific situations, and to evaluate the effectiveness of vaccination. Suspect products for sale to illegal business vaccine production and operation of enterprises, and buy products from the operation, use, immediately to initiate an investigation by the provincial food and drug supervision departments, seriously dealt with according to law.

On March 19, according to the State food and drug administration requirements and Shandong province, Pang and other illegal operations, food and drug supervision Bureau on vaccine case leads to society announcements, Pang were combing a provide vaccine and biological product line leads 107, purchased from the Pang a vaccine and biological product line leads 193.

Early on March 20, State food and Drug Administration directed two notification asked suspects in the March 23 to the food and drug supervision departments or police initiative to report illegal vaccines, fails to report will be severely punished according to law. And requested the local food and drug supervision departments at all levels pay close attention to this area of Shandong province, announced in connection with the suspected member of the list and an investigation leads, set up a task force, the timely identification of illegal purchase and sale of vaccines.

Morning on the same day, according to information released in Shandong province, little reign promised, respectively called Beijing a "line officer" and a "line officer" on the phone.

The "line officer" told new reign promised, his staff is a vaccine manufacturer, "I don′t know why my phone number will be released, without much explanation, the whole thing was handed over to the law." Addition one "line personnel" in verified has small reign promised of identity Hou said, himself "with she (Pang a) just awareness, annual are will participate in vaccine related of Conference, everyone for a card on awareness has, things no so serious", "while drug prison Council of led to to, estimated is verification this things", does not told reporter he of work units, the "line personnel" on hurried hanging broken has phone.

　　May increase the risk of adverse reactions

First reported case of media said, II class vaccine can by disease control sector, and vaccination units independent procurement, vaccine sales Enterprise for Chase interests, will through various relationship as to "go volume", will vaccine sales to disease control sector, and vaccination units, disease control sector, and vaccination units part personnel will profiting from them, but "last vaccination can′t so more vaccine, vaccine sales personnel will trying to, and find channel, put is due of vaccine again find place sales out", Pang a is grasp live has this layer relationship, Build relationships, matchmaking illegal low wholesale prices from vaccine companies, purchased by the personnel department temporary phase II vaccine through "CPB" fare sale to dealers or disease control Department of the vaccine, immunization unit, hands down to grab interest.

To that end, small circulation in the new reign promised also interviewed a vaccine in China, he said, has many vaccine vaccine dealers affiliated to qualified wholesale business name, while avoiding regulatory do his "business", "an individual unit officers tainted is not impossible." But the industry says no more published cases on the merits in this case, impairments on Pang′s marketing methods and marketing chains do more evaluation.

So here′s the thing, do not use but near the validity of vaccines to deal with, is there a requirement? Experts and practitioners, "said General with the CDC, vaccination unit, after consultation by the vaccines business recovery", but how to deal with States and not explicitly stated.

After the incident, Shanghai, Guangdong, Jiangsu, Beijing, and other relevant departments of the province have responded, said to the vaccine supply procurement, distribution to centers for disease control and prevention′s vaccines at all levels within the province, are not in cases involving the illegal business of vaccines.

Deputy Director of the Guangdong provincial CDC introduced Lin Jinyan, vaccines are in the province to the provincial food and Drug Administration issued the relevant permit of vaccine Enterprise procurement or production enterprise, provincial disease control Department cold chain system specifications storage, distribution to the vaccination unit, daily temperature monitoring, ensure that the storage specification. Small new reign promised learned, Beijing established a vaccine inventory system, real-time online check the number of vaccination, community health center of a vaccine and two types of vaccines are made by the Beijing Municipal Center for disease control integrated cold chain distribution company distribution, individual and only seedlings from disease control Department lead.

A community health service center in Beijing said a preventive health doctors, urban and rural with very large amount of preventive health care for children vaccination, vaccination daily outpatient capacity of more than hundred people. Two such vaccines are in informed consent on the basis of voluntary self-inoculation, including chicken pox vaccine, seven-Valent Pneumococcal conjugate vaccine, rotavirus vaccine, part of community health service centers of the second vaccination accounted for about 30% of the total.

The health care doctors, vaccine is not valid generally refers to a vaccine to accept loss of high temperature activity, no adverse reaction in most cases, but in the long run save the high temperatures may result in decreased activity or deteriorate, produce harmful substances, and the increased risk of adverse reactions after vaccination. But the doctor also admitted that there is no data to support how big is the risk of adverse reactions. Experts again, II vaccine inoculation, should select qualified guarantee regular vaccination units.

(Editors: Pan Yi burn UN657)
2016-03-20 19:47:47
Surging

卫计委主管报微信号：处理临期疫苗并无明确规定

　　3月18日，国家食品药品监督管理总局连夜对“山东疫苗案”作出回应。

　　近几日，“山东疫苗案”轰轰烈烈，甚至引发了自媒体的互撕大战。该案案值超过5亿元，涉及省域覆盖大半个中国，数额和影响之大令人咋舌；在各路媒体竞相转发和报道的过程中，甚至出现了“假疫苗”“毒疫苗”这样的表述，一时间闹得人心惶惶，特别是那些孩子需要接种疫苗的妈妈们。

　　到底有哪些疫苗可能存在风险？接种以后可能带来怎样的危害？小新君再次追访此事，也与官方公布的“涉案人员”取得了联系，以期客观回应上述社会关切。

　　尚不知问题疫苗的具体流向和数量

　　济南警方已向全国20个地级市发出协查函，核实疫苗流向和使用单位，但庞某账本记录以外几年所售疫苗数量和流向已很难查证。事件发酵后，药品监管部门动作频频。

　　3月18日，国家食品药品监督管理总局连夜对此作出回应。国家食药总局新闻发言人表示，该局已责成山东省食品药品监管局会同公安和卫生计生部门，立即查清疫苗等相关产品的来源和流向，第一时间向社会公开相关信息。该局要求，根据公安机关提供的线索，涉案产品流入地省级食药监管部门要立即查明流入的疫苗产品购进、使用和库存情况，对尚未使用的立即查扣；对已用于人体接种的，会同卫生计生部门迅速查清具体情况，并对接种效果进行评估。对向非法经营疫苗嫌犯销售产品的生产经营企业，以及从其购入产品的经营、使用单位，由所在地省级食品药品监管部门立即立案调查，依法严肃处理。

　　3月19日，根据国家食药总局要求，山东省食药监管局就庞某等非法经营疫苗案有关线索向社会发布公告，共梳理出向庞某等提供疫苗及生物制品的上线线索107条，从庞某等处购进疫苗及生物制品的下线线索193条。

　　3月20日一早，国家食药总局连发两条通知，要求涉案嫌疑人员在3月23日前向食药监管部门或公安机关主动报告违法经营疫苗情况，逾期不报告将依法从严惩处。并要求地方各级食药监管部门密切关注山东省公布的本地区涉案嫌疑人员名单和协查线索，成立专案组，及时查明疫苗非法购销情况。

　　同日早晨，根据山东省公布的信息，小新君分别拨通了北京市一名“上线人员”和一名“下线人员”的电话。

　　该“上线人员”告诉小新君，他是一家疫苗生产企业的工作人员，“不知道为什么自己的电话号码会被公布出来，没有过多的解释，整个事情都交给法律解决吧”。另外一名“下线人员”在核实了小新君的身份后表示，自己“跟她（庞某）只是认识，每年都会参加疫苗相关的会议，大家换个名片就认识了，事情没有那么严重”，“一会儿药监局的领导要来，估计也是核查这个事情”，并未告诉记者他的工作单位，该“下线人员”就匆匆挂断了电话。

　　可能会增加不良反应风险

　　最早报道此案的媒体表示，二类疫苗可由疾控部门、接种单位自主采购，疫苗销售企业为追逐利益，会通过各种关系尽可能地“走量”，将疫苗销售给疾控部门、接种单位，疾控部门、接种单位部分人员会从中渔利，但“最后接种不了那么多疫苗，疫苗销售人员就要想办法、找渠道，把即将到期的疫苗再找地方销售出去”，庞某正是把握住了这层关系，利用自己构建的人脉关系，牵线搭桥违法低价从疫苗批发企业、人员处购进临期二类疫苗，通过“体外循环”加价销售给疫苗贩子或疾控部门、接种单位，倒手攫取利益。

　　为此，小新君也采访了一位疫苗流通领域的从业人员，他表示，确实有不少疫苗贩子会挂靠在有资质的疫苗批发企业名下，在规避相关监管的同时做自己的“小买卖”，“出现个别单位人员不干不净的情况也不是没有可能”。但这位业内人士同时表示，在此案没有更多案情公布的情况下，不便对庞某的营销手段和营销链条做出更多评价。

　　那么问题来了，对于未使用但临近有效期的疫苗如何处理，是否有相关规定呢？专家和业内人士均表示，“一般情况下经与疾控部门、接种单位协商后，由疫苗经营企业回收”，但最终如何处理国家并无明确规定。

　　事件发生后，上海、广东、江苏、北京等省份有关部门均做出了回应，表示向各疫苗供应单位采购、配送到省内各级疾病预防控制中心的疫苗，均不涉及该案件中非法经营的疫苗。

　　广东省疾控中心副主任林锦炎介绍，该省的疫苗都是向持有省级食药监管理部门颁发的相关许可证的疫苗经营企业或生产企业进行采购，经全省疾控部门冷链系统规范储存、配送至各接种单位，每日开展温度监测，确保储存规范。小新君了解到，北京市建立了疫苗进销存系统，可实时在线核对疫苗接种数量，各社区卫生服务中心的一类疫苗和二类疫苗均由北京市疾控中心统一的冷链配送公司配送，仅个别临时加苗需从区疾控部门请领。

　　北京市某社区卫生服务中心一位预防保健医生表示，北京市城乡结合部的儿童预防保健接种量非常大，预防接种日均门诊量达到百人次以上。二类疫苗是在知情同意的基础上自愿、自费接种的，主要包括水痘疫苗、七价肺炎球菌结合疫苗、轮状病毒疫苗等，部分社区卫生服务中心的二类疫苗接种量占到总量的30%左右。

　　这位保健医生介绍，疫苗无效一般是指疫苗接受高温失去活性，多数情况下不会产生不良反应，但长期高温保存可能会导致活性降低或者变质，产生有害物质，使接种后不良反应的几率增加。但这位保健医生同时坦言，目前并没有数据支撑产生不良反应的几率有多大。专家再次提醒，接种二类疫苗，应选择有资质保证的正规接种单位。

(责任编辑：潘奕燃 UN657)
2016-03-20 19:47:47
澎湃