李克強就疫苗事件作出批示：必須給全國人民一個明明白白的交代

近日，長春長生生物科技有限公司(下稱“長春長生”)“狂犬病疫苗生產(chǎn)記錄造假”及“百白破疫苗效價不符合規(guī)定”兩起事件備受關(guān)注。

李克強總理就疫苗事件作出批示：

The vaccine case has crossed a moral line, and the nation deserves a clear explanation.

此次疫苗事件突破人的道德底線，必須給全國人民一個明明白白的交代。

李克強在批示中要求，

The State Council should immediately send a group to thoroughly investigate the production and selling chain of vaccine, to uncover the truth as soon as possible, and any wrongdoing will be severely punished regardless of who is involved.

國務(wù)院要立刻派出調(diào)查組，對所有疫苗生產(chǎn)、銷售等全流程全鏈條進行徹查，盡快查清事實真相，不論涉及到哪些企業(yè)、哪些人都堅決嚴懲不貸、絕不姑息。

Any illegal acts that could harm the people's lives should be severely cracked down and people behind it punished in accordance with law. Any dereliction of duty in the supervision authority should be held accountable, and we should give the people a living environment that is safe, trustworthy and credible.

對一切危害人民生命安全的違法犯罪行為堅決重拳打擊，對不法分子堅決依法嚴懲，對監(jiān)管失職瀆職行為堅決嚴厲問責(zé)。盡早還人民群眾一個安全、放心、可信任的生活環(huán)境。

針對“狂犬病疫苗生產(chǎn)記錄造假”事件，昨日，國家藥監(jiān)局在官網(wǎng)通報最新調(diào)查進展。

A child is vaccinated in hospital in Southwest China's Guizhou province on April 25, 2018. [Photo/VCG]

According to the investigation, the company counterfeited the vaccine’s production and inspection data, and changed the parameters for equipment and processing the vaccine.

通報說，現(xiàn)已查明，企業(yè)編造生產(chǎn)記錄和產(chǎn)品檢驗記錄，隨意變更工藝參數(shù)和設(shè)備。

目前，已責(zé)令企業(yè)停止生產(chǎn)(terminate the production)，收回藥品生產(chǎn)質(zhì)量管理規(guī)范(Good Manufacturing Practices，GMP)證書，同時會同吉林省局已對企業(yè)立案調(diào)查，涉嫌犯罪的移送公安機關(guān)追究刑事責(zé)任(the cases of those suspected of violating laws will be transferred to public security departments)。

GMP(Good Manufacturing Practices)，中文含義是“生產(chǎn)質(zhì)量管理規(guī)范”或“良好作業(yè)規(guī)范”、“優(yōu)良制造標(biāo)準”。

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

“良好作業(yè)規(guī)范”是監(jiān)管部門審批和發(fā)放食品飲料、化妝品、藥品、膳食補充劑以及醫(yī)療設(shè)備時要遵照的規(guī)范要求。

These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.

這些規(guī)范是生產(chǎn)方確保所有批次產(chǎn)品保證高質(zhì)量并且有效的基本要求，每個行業(yè)的具體規(guī)范或有不同，但GMP的核心目標(biāo)是防止產(chǎn)品對終端用戶產(chǎn)生有害影響。

國家藥監(jiān)局表示，已部署全國疫苗生產(chǎn)企業(yè)進行自查，確保企業(yè)按批準的工藝組織生產(chǎn)，嚴格遵守GMP生產(chǎn)規(guī)范，所有生產(chǎn)檢驗過程數(shù)據(jù)要真實、完整、可靠，可以追溯。

國家藥監(jiān)局將組織對所有疫苗生產(chǎn)企業(yè)進行飛行檢查(unannounced inspections)，對違反法律法規(guī)規(guī)定的行為要嚴肅查處。

【起因】

事情的起因是7月15日，國家藥監(jiān)局宣布發(fā)現(xiàn)長春長生生物科技有限責(zé)任公司生產(chǎn)的狂犬病疫苗造假。

The State Drug Administration has launched an investigation of Changchun Chang­sheng Bio-tech Co, which was found to have fabricated production records for freeze-dried rabies vaccines for human use.

國家藥品監(jiān)督管理局組織對長春長生生物科技有限責(zé)任公司開展檢查，發(fā)現(xiàn)長春長生“凍干人用狂犬病疫苗”生產(chǎn)存在記錄造假等嚴重違反《藥品生產(chǎn)質(zhì)量管理規(guī)范》的行為。

據(jù)《中國證券報》報道，接近長生生物的一位疫苗業(yè)資深人士說，此次事發(fā)是因為長生生物內(nèi)部生產(chǎn)車間的老員工實名舉報。

一波未平，一波又起。

7月20日，吉林省食藥監(jiān)局又宣布對去年11月份發(fā)現(xiàn)的長生生物子公司長春長生的疫苗造假事件進行處罰，公告稱，長春長生生產(chǎn)的一批約25萬支百白破疫苗效價指標(biāo)不合格。

It was also revealed that Changsheng Bio-tech was linked to a substandard adsorbed diphtheria-pertussis-tetanus, or ADPT, vaccine for infants.

隨后又發(fā)現(xiàn)，長春長生生產(chǎn)的“吸附無細胞百白破聯(lián)合疫苗”效價指標(biāo)不合格。

吉林省藥監(jiān)局對長春長生給予行政處罰：

沒收庫存的剩余“吸附無細胞百白破聯(lián)合疫苗”186支、沒收違法所得85.88萬元。同時，處違法生產(chǎn)藥品貨值金額三倍罰款258.4萬元，罰沒款總計344.29萬元。

根據(jù)長生生物的公告，在被查之前該批次約25萬支疫苗幾乎已全部銷售到山東省疾病預(yù)防控制中心。

Changsheng Bio-tech Co, parent company of Changchun Changsheng Bio-tech Co, revealed in November that 252,600 doses of the substandard ADPT vaccine that couldn't meet the standard of immunity results were all sold to Shandong province.

長生生物去年11月稱，25.26萬支效價指標(biāo)不合格的百白破疫苗已全部銷售往山東省。

現(xiàn)在網(wǎng)友們最關(guān)心的是，這批疫苗有多少流入市場，是否有孩子因為問題疫苗患病、健康受損。

據(jù)山東《大眾日報》報道，7月22日，記者從山東省疾控中心獲悉，長春長生公司生產(chǎn)的流入山東的不合格百白破疫苗流向已全部查明，流向濟南、淄博、煙臺、濟寧、泰安、威海、日照、萊蕪等8個市。

這批疫苗已接種247359支，涉及兒童215184人，后續(xù)補種工作陸續(xù)開展

報道稱，監(jiān)測顯示，山東省接種該批次疫苗的兒童未發(fā)現(xiàn)疑似預(yù)防接種異常反應(yīng)發(fā)生率增高。

山東省衛(wèi)生計生委要求各級疾控機構(gòu)和預(yù)防接種單位密切關(guān)注，及時發(fā)現(xiàn)問題，妥善處置，確保每一名接種過不合格百白破疫苗的兒童獲得補種。

中國疾病預(yù)防控制中心有關(guān)專家也稱：

The substandard ADPT vaccine may reduce the expected immune effects, but won’t post safety threats to people’s health.

不合格的百白破疫苗可能影響免疫保護效果，但接種安全性風(fēng)險沒有增加。

另外，國家藥監(jiān)局22日稱：

The state drug administration confirmed on Sunday that it was discovered in October that one batch of Changsheng’s ADPT vaccine was substandard, and its production of ADPT has been suspended since then.

去年10月，原食藥監(jiān)總局抽樣檢驗中發(fā)現(xiàn)該企業(yè)生產(chǎn)的1批次百白破疫苗效價不合格，該產(chǎn)品目前仍在停產(chǎn)中。

A plan for reinoculation of those affected was worked out in February.

有關(guān)補種工作原國家衛(wèi)計委會同原食藥監(jiān)總局已于今年2月進行了部署。

疫苗事關(guān)生命健康，質(zhì)量安全容不得半點瑕疵，不能有一絲僥幸。

《中國日報》昨日發(fā)表中英文社論，其中提到：

唯有公開透明的處理方式，才能有效化解“問題疫苗”引發(fā)的公共衛(wèi)生危機。

這次“問題疫苗”事件，不僅引起公眾恐慌，更因為涉事公司已有過生產(chǎn)不合格疫苗的劣跡而可能引發(fā)公眾對于監(jiān)管體系的質(zhì)疑。

The government should launch an investigation into the case, not only about how the company tampered with the vaccines but also about how the loopholes in supervision have allowed problematic vaccines into the market.

面對洶洶輿論，監(jiān)管部門有必要不僅嚴查涉事企業(yè)，更反思整個監(jiān)管體系，亡羊補牢，防止“問題疫苗”流入市場的悲劇重現(xiàn)。

Given social media’s power in spreading rumors and alarm about anything, transparency and the truth are the most effective way to keep people’s worries at bay.

更重要的，新媒體時代輿情傳播以秒計算，有關(guān)部門切不可做鴕鳥，而應(yīng)與時間和謠言賽跑，知無不言、言無不盡，防止謠言的出現(xiàn)，讓公眾看到自己保護公共衛(wèi)生安全的決心。

The authorities need to release whatever information they know about the incident to the public as soon as possible.

事已至此，唯有公開透明的處理方式，才能有效化解“問題疫苗”引發(fā)的公共衛(wèi)生危機。

It is not just to pacify the public in the wake of this particular incident. It is also for a thorough overhaul of the industry as vaccines are directly related to people’s health, particularly children.

這不僅是為了平息輿論，更是為了整頓整個疫苗行業(yè)。畢竟這一行業(yè)關(guān)系著全國人民的生命健康，尤其牽涉著少年兒童，牽涉著祖國的未來。

【相關(guān)詞匯】

fabricate：偽造

freeze-dried： 經(jīng)過冷凍干燥的

rabies ['re?bi?z]：狂犬病

vaccine [væk'sin]：疫苗

diphtheria [d?p'θ??r?r]：白喉

pertussis [p?'t?s?s]：百日咳

tetanus ['t?t?n?s]：破傷風(fēng)