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日本疫苗接种进展缓慢,是因为几十年前的一桩丑闻?

日本疫苗接种进展缓慢,是因为几十年前的一桩丑闻?

Grady McGregor 2021年04月28日
当年的教训让日本政府把所有鸡蛋都放到了“治疗药物”篮子里。

距离东京奥运会还有不到90天。

原定于去年夏天举办的2020年奥运会被推迟之后,又经过了接近一年的准备,然而日本疫苗接种工作毫无起色,导致绝大多数国民面对再次大幅增加的新冠肺炎感染病例,得不到充分保护。

4月23日,日本经济大臣西村康稔宣布,东京和大阪以及另外两个县从4月25日开始进入紧急状态。日本每日新增病例突破5,000例,仅次于今年1月的首轮疫情高峰。

西村康稔于4月23日宣布的措施是日本自疫情爆发以来执行的最严格的防疫措施。防疫措施要求大型酒吧和餐厅停业,并且在5月11日之前禁止观众现场观看体育比赛。

面对确诊病例激增,日本首相菅义伟所在的自民党干事长二阶俊博上周对东京能否举办奥运会提出了质疑。

但在宣布最新紧急措施之前,菅义伟还曾经在4月20日强调,防疫政策不会影响夏季奥运会。

他在4月20日对记者表示:“奥运会不会受到影响。政府将继续全力以赴安全成功地举办奥运会。”

日本已经禁止外国观众参加奥运会,并且发布了一系列规定,以避免运动员、官员和媒体工作人员在东京期间感染和传播新冠病毒。

这届奥运会对于参与人员没有接种疫苗的要求,但运动员在抵达东京时需要接受检测,并且在东京停留期间还要定期检测。运动员不得聚餐或聚集,必须避免身体接触,例如拍手庆祝和握手等。

不过依旧有专家担心,有来自93个国家数以万计的运动员、教练员和代表团成员计划前往东京停留13周,面对这种局面,这些措施可能不足以避免发生超级传播者事件的威胁。

对于奥运会的各种担忧,以及最近感染人数的大幅增加,使日本进展缓慢的疫苗接种工作备受关注。日本大部分国民没有接种疫苗,疫苗接种工作远远落后于其他主要经济体。

作为全球第三大经济体,日本并不缺乏采购、分配甚至生产新冠疫苗的资源或能力。但尽管面临要在疫情期间举办奥运会的额外压力,日本依旧选择了缓慢稳定地推进疫苗接种,导致新冠病毒给日本带来的风险并没有明显减少。

疫苗接种

日本在批准美国制药业巨头辉瑞(Pfizer)和德国疫苗制造商BioNTech开发的新冠疫苗几天之后,于2月17日正式启动疫苗接种。这比美国等国家已经落后了几个月,但政府官员依旧乐观地认为日本能够迎头赶上。

日本最初计划在3月为370万医护人员接种疫苗,而且菅义伟承诺在今年上半年,为日本1.26亿人口保证足够的疫苗供应。

但截至4月21日,日本仅施打了200多万剂疫苗,相当于只有1%的人口接种了疫苗。

相比之下,中国、美国、欧盟、印度和巴西等其他大型经济体的疫苗接种工作已经遥遥领先于日本。

日本表示,疫苗供应问题延误了初期的接种工作,并指责欧洲的出口限制导致日本无法确定疫苗分配计划。《财富》杂志曾经咨询日本政府到目前为止已经取得了多少剂疫苗,但并未得到回应。

但有人认为日本至少应该承担一定的责任。

到目前为止,日本严格的疫苗监管制度仅批准了辉瑞疫苗,它们要求疫苗生产商在日本完成安全性试验之后才可以获得批准。

日本也从英国阿斯利康和美国Moderna采购了疫苗,但卫生部门尚未批准这两款疫苗。

仙台白百合女子大学的日本政治专家塞巴斯蒂安·马斯洛指出,复杂的政府官僚政治可能让情况变得更加复杂。马斯洛表示,今年1月,日本任命行政改革担当大臣河野太郎主持疫苗分配工作,这一决定可能使疫苗接种工作出现混乱。

马斯洛称:“特别任命一位内阁大臣负责协调疫苗分配让情况变得更复杂”,因为“疫苗接种的具体工作”实际上是由卫生部门负责。

马斯洛说:“菅义伟政府的响应速度极其缓慢。”

但疫苗接种进展缓慢有一部分原因是有意为之。

日本当局之所以比美国晚几个月批准辉瑞疫苗,按照政府的说法是因为日本希望在全世界对是否接种疫苗最犹豫不决的时候,尽可能让公众树立对疫苗的信心。

医学期刊《柳叶刀》在2020年9月发表的一项调查发现,认为疫苗安全有效的日本受访者不足30%,而美国受访者的比例超过50%。

最近几个月,公众似乎认可了新冠疫苗,并开始对政府的行动迟缓日益不满。

东京大学在3月调查发现,62%的日本受访者愿意接种新冠疫苗。4月12日,日本共同社公布了对1,000名日本民众的调查结果,其中60%的受访者表示“不满意”政府的疫苗接种工作,表示满意的只有37%。

日本的疫苗生产

日本对外国疫苗的依赖引发了另外一个问题:日本作为全球第三大医药市场,有武田制药、安斯泰来制药和第一三共等行业巨头,为什么国内没有开发出有效的新冠疫苗?

世界卫生组织的报告称,截至4月20日,全世界已经有91款新冠疫苗开始进行人体试验。其中有四款是日本疫苗,但日本企业都没有完成三期临床试验,而三期临床试验是获得监管审批之前的最后一步。

诞生于大阪大学的初创制药公司AnGes Inc.在日本新冠疫苗开发方面进展最快。该公司在去年12月启动了基于DNA的候选疫苗的二期和三期临床试验。

日本药企第一三共正在开发一款mRNA疫苗。该公司表示其疫苗最早要在2022年4月才能够上市。《日本时报报道称,日本制药行业业内人士同样预计,最早要到明年4月才会有日本国产疫苗上市。

疫苗产能似乎并不是日本疫苗开发面临的主要障碍,因为日本药企与外国药企达成了大规模生产疫苗的协议。

日本药企第一三共、KM Biologics和JCR Pharmaceuticals每年将合作生产1.2亿剂阿斯利康的疫苗。武田制药则与美国药企Novavax合作,每年在日本生产2.5亿剂新冠疫苗。

马斯洛表示,由于缺乏政府支持,日本的疫苗开发系统不能与美国等国家的同行一样帮助推动创新。

马斯洛称:“多年来,日本始终没有为科研和疫苗开发提供足够的财政支持。”

日本确实向疫苗生产商拨款近30亿美元,以促进新冠疫苗的开发。但这笔投资显然远远低于诸如投入180亿的“曲速行动”等旨在加快新冠疫苗开发的项目。

日本政府对疫苗开发工作的支持不足,部分原因可以追溯到几十年前的疫苗丑闻。

20世纪80年代末和90年代初,麻疹、腮腺炎、风疹三联疫苗在日本被曝出可能与类似于流感的少量无菌性脑膜炎病例有关,尽管这种疫苗在全世界已经使用了数十年,其安全性和疗效也得到了证明。

90年代初,因为孩子接种疫苗后出现严重副作用而提起诉讼的三个家庭胜诉,其中有两名儿童死亡。法院裁定日本政府因为推荐接种这款疫苗,需要对此负责。

事后,日本停止接种MMR疫苗,直到今天,它依旧是少数不使用这款疫苗的主要经济体之一。

威尔逊中心的地理经济学副主任藤志保子表示,MMR疫苗以及其他疫苗争议的影响妨碍了日本疫苗开发行业的发展,让政府在选择支持疫苗制造商时变得更加谨慎。

面对新冠疫情,日本对待疫苗小心谨慎的态度导致政府和制药商将重心放到开发治疗药物而不是疫苗,例如富士胶片的流感药物Avigan。这款药物在减少新冠肺炎症状方面的结果好坏参半。

藤志保子称:“日本的应对方式并不是开发疫苗,而是宁可小心谨慎,也不愿意冒风险。”相反,她表示:“日本政府把所有鸡蛋都放到了‘治疗药物’这个篮子里,但事情的发展却并不像他们所想象的那样。”

从根本上来说,日本应对新冠病毒的表现,要好于美国和欧洲国家。但其在研发和接种疫苗方面进展缓慢,可能成为三个月后举办奥运会面临的致命弱点。(yabo88ios)

翻译:刘进龙

审校:汪皓

距离东京奥运会还有不到90天。

原定于去年夏天举办的2020年奥运会被推迟之后,又经过了接近一年的准备,然而日本疫苗接种工作毫无起色,导致绝大多数国民面对再次大幅增加的新冠肺炎感染病例,得不到充分保护。

4月23日,日本经济大臣西村康稔宣布,东京和大阪以及另外两个县从4月25日开始进入紧急状态。日本每日新增病例突破5,000例,仅次于今年1月的首轮疫情高峰。

西村康稔于4月23日宣布的措施是日本自疫情爆发以来执行的最严格的防疫措施。防疫措施要求大型酒吧和餐厅停业,并且在5月11日之前禁止观众现场观看体育比赛。

面对确诊病例激增,日本首相菅义伟所在的自民党干事长二阶俊博上周对东京能否举办奥运会提出了质疑。

但在宣布最新紧急措施之前,菅义伟还曾经在4月20日强调,防疫政策不会影响夏季奥运会。

他在4月20日对记者表示:“奥运会不会受到影响。政府将继续全力以赴安全成功地举办奥运会。”

日本已经禁止外国观众参加奥运会,并且发布了一系列规定,以避免运动员、官员和媒体工作人员在东京期间感染和传播新冠病毒。

这届奥运会对于参与人员没有接种疫苗的要求,但运动员在抵达东京时需要接受检测,并且在东京停留期间还要定期检测。运动员不得聚餐或聚集,必须避免身体接触,例如拍手庆祝和握手等。

不过依旧有专家担心,有来自93个国家数以万计的运动员、教练员和代表团成员计划前往东京停留13周,面对这种局面,这些措施可能不足以避免发生超级传播者事件的威胁。

对于奥运会的各种担忧,以及最近感染人数的大幅增加,使日本进展缓慢的疫苗接种工作备受关注。日本大部分国民没有接种疫苗,疫苗接种工作远远落后于其他主要经济体。

作为全球第三大经济体,日本并不缺乏采购、分配甚至生产新冠疫苗的资源或能力。但尽管面临要在疫情期间举办奥运会的额外压力,日本依旧选择了缓慢稳定地推进疫苗接种,导致新冠病毒给日本带来的风险并没有明显减少。

疫苗接种

日本在批准美国制药业巨头辉瑞(Pfizer)和德国疫苗制造商BioNTech开发的新冠疫苗几天之后,于2月17日正式启动疫苗接种。这比美国等国家已经落后了几个月,但政府官员依旧乐观地认为日本能够迎头赶上。

日本最初计划在3月为370万医护人员接种疫苗,而且菅义伟承诺在今年上半年,为日本1.26亿人口保证足够的疫苗供应。

但截至4月21日,日本仅施打了200多万剂疫苗,相当于只有1%的人口接种了疫苗。

相比之下,中国、美国、欧盟、印度和巴西等其他大型经济体的疫苗接种工作已经遥遥领先于日本。

日本表示,疫苗供应问题延误了初期的接种工作,并指责欧洲的出口限制导致日本无法确定疫苗分配计划。《财富》杂志曾经咨询日本政府到目前为止已经取得了多少剂疫苗,但并未得到回应。

但有人认为日本至少应该承担一定的责任。

到目前为止,日本严格的疫苗监管制度仅批准了辉瑞疫苗,它们要求疫苗生产商在日本完成安全性试验之后才可以获得批准。

日本也从英国阿斯利康和美国Moderna采购了疫苗,但卫生部门尚未批准这两款疫苗。

仙台白百合女子大学的日本政治专家塞巴斯蒂安·马斯洛指出,复杂的政府官僚政治可能让情况变得更加复杂。马斯洛表示,今年1月,日本任命行政改革担当大臣河野太郎主持疫苗分配工作,这一决定可能使疫苗接种工作出现混乱。

马斯洛称:“特别任命一位内阁大臣负责协调疫苗分配让情况变得更复杂”,因为“疫苗接种的具体工作”实际上是由卫生部门负责。

马斯洛说:“菅义伟政府的响应速度极其缓慢。”

但疫苗接种进展缓慢有一部分原因是有意为之。

日本当局之所以比美国晚几个月批准辉瑞疫苗,按照政府的说法是因为日本希望在全世界对是否接种疫苗最犹豫不决的时候,尽可能让公众树立对疫苗的信心。

医学期刊《柳叶刀》在2020年9月发表的一项调查发现,认为疫苗安全有效的日本受访者不足30%,而美国受访者的比例超过50%。

最近几个月,公众似乎认可了新冠疫苗,并开始对政府的行动迟缓日益不满。

东京大学在3月调查发现,62%的日本受访者愿意接种新冠疫苗。4月12日,日本共同社公布了对1,000名日本民众的调查结果,其中60%的受访者表示“不满意”政府的疫苗接种工作,表示满意的只有37%。

日本的疫苗生产

日本对外国疫苗的依赖引发了另外一个问题:日本作为全球第三大医药市场,有武田制药、安斯泰来制药和第一三共等行业巨头,为什么国内没有开发出有效的新冠疫苗?

世界卫生组织的报告称,截至4月20日,全世界已经有91款新冠疫苗开始进行人体试验。其中有四款是日本疫苗,但日本企业都没有完成三期临床试验,而三期临床试验是获得监管审批之前的最后一步。

诞生于大阪大学的初创制药公司AnGes Inc.在日本新冠疫苗开发方面进展最快。该公司在去年12月启动了基于DNA的候选疫苗的二期和三期临床试验。

日本药企第一三共正在开发一款mRNA疫苗。该公司表示其疫苗最早要在2022年4月才能够上市。《日本时报报道称,日本制药行业业内人士同样预计,最早要到明年4月才会有日本国产疫苗上市。

疫苗产能似乎并不是日本疫苗开发面临的主要障碍,因为日本药企与外国药企达成了大规模生产疫苗的协议。

日本药企第一三共、KM Biologics和JCR Pharmaceuticals每年将合作生产1.2亿剂阿斯利康的疫苗。武田制药则与美国药企Novavax合作,每年在日本生产2.5亿剂新冠疫苗。

马斯洛表示,由于缺乏政府支持,日本的疫苗开发系统不能与美国等国家的同行一样帮助推动创新。

马斯洛称:“多年来,日本始终没有为科研和疫苗开发提供足够的财政支持。”

日本确实向疫苗生产商拨款近30亿美元,以促进新冠疫苗的开发。但这笔投资显然远远低于诸如投入180亿的“曲速行动”等旨在加快新冠疫苗开发的项目。

日本政府对疫苗开发工作的支持不足,部分原因可以追溯到几十年前的疫苗丑闻。

20世纪80年代末和90年代初,麻疹、腮腺炎、风疹三联疫苗在日本被曝出可能与类似于流感的少量无菌性脑膜炎病例有关,尽管这种疫苗在全世界已经使用了数十年,其安全性和疗效也得到了证明。

90年代初,因为孩子接种疫苗后出现严重副作用而提起诉讼的三个家庭胜诉,其中有两名儿童死亡。法院裁定日本政府因为推荐接种这款疫苗,需要对此负责。

事后,日本停止接种MMR疫苗,直到今天,它依旧是少数不使用这款疫苗的主要经济体之一。

威尔逊中心的地理经济学副主任藤志保子表示,MMR疫苗以及其他疫苗争议的影响妨碍了日本疫苗开发行业的发展,让政府在选择支持疫苗制造商时变得更加谨慎。

面对新冠疫情,日本对待疫苗小心谨慎的态度导致政府和制药商将重心放到开发治疗药物而不是疫苗,例如富士胶片的流感药物Avigan。这款药物在减少新冠肺炎症状方面的结果好坏参半。

藤志保子称:“日本的应对方式并不是开发疫苗,而是宁可小心谨慎,也不愿意冒风险。”相反,她表示:“日本政府把所有鸡蛋都放到了‘治疗药物’这个篮子里,但事情的发展却并不像他们所想象的那样。”

从根本上来说,日本应对新冠病毒的表现,要好于美国和欧洲国家。但其在研发和接种疫苗方面进展缓慢,可能成为三个月后举办奥运会面临的致命弱点。(yabo88ios)

翻译:刘进龙

审校:汪皓

The Tokyo Olympic Games are less 90 days away.

But after nearly a year of preparation for the suspended 2020 Olympics, which were supposed to take place last summer, Japan’s sluggish vaccine rollout has left the vast majority of its citizens unprotected from COVID-19 as the country battles a new surge of infections.

On April 23, Japan’s Economy Minister, Yasutoshi Nishimura, announced that Tokyo, Osaka, and two prefectures will enter a state of emergency starting on April 25. The country is now recording over 5,000 new cases per day, marking its second-biggest wave of infections after its previous peak in January of this year.

The measures Nishimura announced on April 23 will be among the most stringent Japan has imposed since the beginning of the pandemic. They will call on large bars and restaurants to close and ban spectators from attending sporting events until May 11.

The surge in cases prompted Toshihiro Nikai, secretary-general of Prime Minister Yoshihide Suga’s Liberal Democratic Party, last week to question Tokyo’s ability to host the Olympics.

But before the emergency measures were announced, Suga on April 20 stressed that the policy would not have a bearing on the Summer Games.

“There will be no impact on the Olympics,” he told reporters on April 20. “The government will do its best to host the Games in safety.”

Japan has banned foreign fans from attending the Games, and has released a series of rules that aim to prevent athletes, officials, and media members from catching and spreading the virus once they are in Tokyo.

No one attending that Games is required to be vaccinated, but athletes, for example, will be tested for COVID when they arrive and then periodically throughout their stay. They are not allowed to eat or congregate with one another and must avoid physical interactions like high fives and handshakes. Still, experts fear that the measures may not be enough to curb the threat of a superspreader event with tens of thousands of athletes, coaches, and delegates from 93 countries planning to descend on Tokyo in 13 weeks’ time.

The concerns over the Olympics and the recent surge in infections have put a spotlight on the country’s lagging vaccine campaign, which has failed to provide access to vaccines to most Japanese citizens and trails that of other major economies.

Japan, the world’s third-largest economy, does not lack the resources or capacity to purchase, distribute, or even manufacture COVID-19 vaccines. But even with the added pressure of hosting the Olympics during a pandemic, Japan has opted for a slow and steady approach to COVID-19 vaccines that has left the country only marginally less exposed to a virus that forced Tokyo to suspend the Olympics nearly one year ago.

The rollout

Japan officially launched its COVID-19 vaccination drive on Feb. 17, days after approving the COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and German vaccine maker BioNTech. It started months after rollouts in countries like the U.S., but officials were optimistic that Japan could catch up.

Japan aimed to vaccinate its 3.7 million health care workers in March, and Suga pledged to secure enough doses for Japan’s 126 million people in the first half of the year.

But as of April 21, Japan has administered just over 2 million vaccine shots to its citizens, which translates to at least one vaccine dose for 1% of its population.

The U.S., by comparison, has administered 216 million shots, enough for 40.5% of Americans to get one dose. Other large economies like the European Union, China, India, and Brazil have also surged ahead of Japan in their own campaigns.

Japan says that supply issues slowed the initial rollout, and it accused European export curbs of delaying Japan’s ability to finalize its distribution plan. The Japanese government did not respond to Fortune’s request for comment on how many doses it has secured thus far.

But others say that Japan deserves at least some of the blame.

Japan’s stringent vaccine regulatory system has approved only Pfizer’s vaccine so far. Japan requires vaccine makers to conduct safety trials in the country before approval. Japan has purchased additional vaccines from the U.K.’s AstraZeneca and the U.S.’s Moderna, but the country’s health ministry has not yet approved either vaccine.

Complicated government bureaucracy may be adding to the problem, says Sebastian Maslow, a Japanese politics expert at Sendai Shirayuri Women’s College in Japan. In January of this year, Japan appointed Reform and Regulatory Minister Taro Kono to handle vaccine distribution, which may have muddled inoculation efforts, says Maslow.

“The creation of a specially appointed minister in charge for coordinating vaccine distribution has complicated the process,” he notes, given that the health ministry is “actually in charge of putting the vaccines into people’s arms.”

“The Suga government’s response has been extremely slow,” says Maslow.

But some of the sluggishness was intentional.

Japanese authorities approved the Pfizer vaccine months after counterparts in the U.S., in part, because Japanese authorities said they wanted to instill as much confidence as possible in a public that is among the most vaccine-hesitant in the world.

A survey published in September 2020 by the Lancet medical journal found that fewer than 30% of Japanese respondents agreed that vaccines were safe and effective, as opposed to over 50% of American respondents.

In recent months, the public appears to have warmed up to COVID-19 vaccines and has grown frustrated by the government’s slow administration of them.

Tokyo University found in a March survey that 62% of Japanese respondents were willing to get a COVID-19 jab. On April 12, Japan’s Kyodo News published a poll of 1,000 Japanese citizens, 60% of whom said they were “dissatisfied” with the government’s vaccine drive, compared with 37% who said they were satisfied with the effort.

Japan vaccine manufacturing

Japan’s reliance on foreign-made vaccines raises the question of why the world’s third-largest pharmaceutical market, which boasts domestic giants like Takeda Pharmaceutical, Astellas Pharma, and Daiichi Sankyo, has not developed its own proven COVID-19 vaccine.

The World Health Organization reports that as of April 20, 91 COVID-19 vaccines have reached human trials around the world. Japanese vaccines account for four of the vaccines on the list, but none of the Japanese firms have completed Phase III clinical trials, the final step before regulatory approval.

AnGes Inc., a pharmaceutical startup that emerged from Osaka University, is the farthest along of any Japanese firm in developing a COVID-19 vaccine. The firm launched Phase II and III trials with its DNA-based candidate in December.

Japanese drugmaker Daiichi Sankyo, which is developing a mRNA vaccine, says that its vaccine will not be ready until April 2022 at the earliest. The Japan Times reports that pharmaceutical industry insiders in Japan similarly do not expect any Japan-made vaccine to be ready until at least April of next year.

Vaccine manufacturing capacity does not appear to be a major hurdle in drug development since Japanese firms have struck large manufacturing deals with foreign drugmakers.

Japanese pharmaceutical firms Daiichi Sankyo, KM Biologics, and JCR Pharmaceuticals are partnering to produce 120 million doses of AstraZeneca’s vaccine annually. The pharmaceutical firm Takeda, meanwhile, is partnering with U.S. drugmaker Novavax to make 250 million COVID-19 vaccine shots in Japan each year.

Maslow says that Japan’s vaccine development system may not be as conducive to driving innovation as those in places like the U.S. owing to a lack of government support.

“Japan has over many years failed to provide sufficient financial support for research and vaccination development,” Maslow says.

To be sure, Japan has granted vaccine makers nearly $3 billion to promote the development of COVID-19 vaccines. But that investment is small compared with the U.S.’s Operation Warp Speed, the program to develop COVID-19 vaccines that received at least $18 billion in government funding.

Japan’s lack of governmental vaccine support can be traced, in part, to a vaccine scandal from decades ago.

In the late 1980s and early 1990s, Japan linked a small number of cases of aseptic meningitis, a flu-like illness, to people vaccinated with a measles, mumps, and rubella (MMR) vaccine, even though the vaccine had proved safe and effective in decades of use around the world. In the early 1990s, three families of children who had severe side effects after receiving the vaccine, including two children who died, won lawsuits that held the government responsible, since it recommended the vaccine. Afterward, Japan discontinued the use of MMR, and it remains one of the only major economies not to use the vaccine today.

The fallout of the MMR and other vaccine controversies stifled Japan’s vaccine development industry and made the government more cautious in its approach to supporting vaccine makers, says Shihoko Goto, deputy director for geoeconomics at the Wilson Center.

When it came to COVID-19, Japan’s wary approach to vaccines led the government and drugmakers to focus on treatment options like Fujifilm’s Avigan flu-fighting drug, which has demonstrated mixed results in reducing COVID-19 symptoms, instead of vaccines.

“Japan’s approach has not been to develop vaccines…and to err on the side of caution,” says Goto. Instead, she says, “they put all their eggs in the cure basket, and that has not really panned out the way they want it to.”

Ultimately, Japan has performed better in battling the virus than many of its peers in the U.S. and Europe. But its lack of speed on developing and rolling out vaccines may prove an Achilles’ heel as it prepares to host the Olympic Games three months from now.

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