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英国“秒过”疫苗惹美欧不满,福奇批完又道歉
英国“秒过”疫苗惹美欧不满,福奇批完又道歉

 

12月2日,英国率先给美国药企辉瑞(Pfizer)和德国公司BioNTech研发的新冠肺炎疫苗开了绿灯,批准了这款新冠疫苗的使用,并计划在下周进行大规模接种。

The UK is to begin a mass-vaccination program next week after becoming the first country in the world to approve a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech.

作为第一个批准该疫苗的西方国家,英国多名官员都对此次“抢跑”表现出十足的自信。

英国商务大臣夏尔马就将此次授权形容为一项“成就”,并宣称这一刻是“英国领导全人类抗击这一疾病的日子。”

英国“秒过”疫苗惹美欧不满,福奇批完又道歉

 

英国教育大臣威廉森则猛夸了一通英国制度的优越性,他强调,正是英国拥有最好的人才和医疗法规,疫苗才能如此快速的通过审批,更特意点名法国、比利时和美国,宣称英国“比他们任何一个国家都强得多,不是吗?”

英国“秒过”疫苗惹美欧不满,福奇批完又道歉

 

这番言论一下惹恼了美国和欧盟。

要知道,这款疫苗是美国和德国联合研发的,但美国食品和药物管理局(FDA)仍在审查数据,预计将在12月10日开会作出决定。欧洲医药监管局(EMA)也表示要到12月29日才会做出是否批准疫苗上市的决定。

英国“秒过”疫苗惹美欧不满,福奇批完又道歉

 

而英国的药品和医疗产品监管署(MHRA)直到10月30日才开启审批流程,就已经抢先宣布批准接种,这种半路“截胡”的行为,杀了美国和欧洲一个措手不及。

对此,EMA专门发表了一份声明,批评英国将速度置于赢得公众信任之前,所以才能第一个批准疫苗。

EMA还称,欧盟成员国也可以选择采取同样的紧急授权途径,但欧盟的程序给予更详细的检测,是“在当前疫情大流行的紧急情况下最合适的监管机制。”

The European Union’s drug regulator said on Wednesday that its longer approval process for COVID-19 vaccines was safer, after Britain granted an emergency authorisation to the experimental shot being developed by Pfizer and BioNTech.

Asked about the UK approval of the Pfizer vaccine, the European Medicines Agency said: "EMA considers that the conditional marketing authorisation is the most appropriate regulatory mechanism for use in the current pandemic emergency." It said that procedure was based on more evidence and more checks than the emergency procedure chosen by Britain.

EMA said on Tuesday it will decide by Dec. 29 whether to authorise Pfizer’s vaccine.

话里话外,不仅强调欧盟对疫苗的严谨态度,也暗示英国审批的不严谨。

美国也提出了质疑。连一贯低调谦逊的美国首席传染病专家福奇也站了出来,称英国就像在马拉松附近兜圈,突然在最后一公里加入了比赛。此外,他认为MHRA没有像FDA那样谨慎地审查数据、做临床试验,并补充说FDA才是药品监管的黄金规则……

面对各方质疑,MHRA信誓旦旦表示,审查没有走捷径,对“疫苗质量、安全性和有效性均进行了严格的科学评估”,并不存在偷工减料的情况。

英商务大臣夏尔马则强调,MHRA在整个审批过程中非常谨慎,同时他向媒体表示,如果不能保证疫苗安全性,国家就不会批准接种。英国首相发言人也对该国快速授权疫苗进行了辩护,称MHRA在药物监管领域全球领先。

最新消息称,福奇为自己的言行道歉了。

他表示自己的本意并非是批评英方草率,并宣称“无论从科学角度还是监管角度来看,都对英国的作为有极大的信心。”

Top infectious diseases expert in the U.S., Anthony Fauci, previously described MHRA as having run “around the corner of the marathon and joined it in the last mile” and “rushed through that approval”. However, he recently apologized for his comments about the speed at which the UK has approved the Pfizer vaccine.

On Thursday, he said: "The UK has decided to do it a little bit differently. They've gone over it very quickly and I can say, and this is not a criticism, they've done it in a way that is less deep than is being done by the FDA (Food and Drug Administration) in the United States."

Fauci now says he has a great deal of confidence in the UK's regulatory process.

英国“秒过”疫苗惹美欧不满,福奇批完又道歉

 

目前英国已预先订购了4000万剂疫苗,英国官员表示,将在下周初开始推广这种疫苗,医护人员和疗养院居民将是第一批接种疫苗的人。

英国首相约翰逊也敦促民众不要“过分乐观”,疫苗获批不意味着与新冠疫情的“斗争已经结束”,仍然存在巨大的后勤挑战。

那英国的民众对疫苗有信心吗?

美国约翰斯·霍普金斯大学统计数据显示,截至北京时间12月5日下午15时,英国累计新冠确诊病例已接近170万例,死亡病例超6万例。

然而,英国调研机构YouGov最近的一项民调显示,仅27%的民众对疫苗的安全性非常有信心,大部分受访者表示,英国卫生大臣汉考克应该率先接种疫苗并在电视上直播,才能打消顾虑。

The UK has bought 40 million doses of the jab, enough to vaccinate 20 million people. The first 800,000 doses are expected to arrive over the coming days.

People should not get "carried away with over optimism" after the UK approved its first coronavirus vaccine, Boris Johnson has warned. The PM said it did not mean "our struggle is over", saying parts of the economy still faced tough restrictions.