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这是新冠疫苗竞赛不可逾越的6个问题

这是新冠疫苗竞赛不可逾越的6个问题

Bill George 2020年09月17日
在推进新冠疫苗开发的过程中,为了应对风险隐患,有6个问题必须要解决好。

2020年8月13日,位于佛罗里达州好莱坞的美国研究中心(RCA)在进行新冠疫苗研究。图片来源:CHANDAN KHANNA—AFP/GETTY IMAGES

新冠肺炎疫情仍然在美国肆虐,已经导致将近20万美国人死亡,全球死亡人数也达到100万人。因此亟需安全有效的疫苗来阻止疫情持续蔓延,并全面重启经济。

全世界的目光都聚焦在医药行业,领头企业都以前所未见的速度推进疫苗的发现、测试和生产工作。众多全球顶尖的科学家都在专注于实现疫苗开发目标。为了在最短的时间内加快疫苗的推出,特朗普政府启动了“空间机战行动”(Operation Warp Speed),资助多个候选疫苗加速开发流程,并承诺采购数亿剂获批准的疫苗。

但试图加快推进科学研究会带来许多风险,对像新冠病毒这样的新型病毒的科学研究尤甚。这种病毒不好理解,也不容易定性。科学发现不能像即将到来的美国总统选举那样被时间表牵着走。

为了应对这些风险,必须得解决好以下的六个问题:

1. 会不会出现早期临床试验中未发现的安全问题?

2. 这些疫苗是否足以有效阻止新冠病毒的传播?

3. 美国人们会足够放心去接种疫苗吗?

4. 是否会有充足的疫苗供应?谁能优先接种?

5. 如果多种疫苗获得批准,人们如何知道应该接种哪一种?

6.疫苗审批流程会受阻吗?

安全性

由于完成试验的时间非常紧迫,人们担心疫苗安全问题可能在数百万人接种后才会出现。“空间机战行动”疫苗研发部门的主管蒙塞夫•斯拉维称,疫苗在选举日之前获批的可能性“非常非常低”,如果他迫于压力而批准了不安全的疫苗,他会主动辞职。

9月9日,阿斯利康(AstraZeneca)主要候选疫苗的临床试验在一名患者出现神经系统症状后叫停,这说明新疫苗测试必须要小心谨慎。(经过仔细的临床审查,那些试验后来恢复进行。)要是数百万健康的人接种疫苗后安全问题才被知晓,整个国家的卫生健康和公众信心无疑都会受到毁灭性的打击。

有效性

美国食品与药品管理局(FDA)已经将新冠疫苗有效性的最低门槛设定为50%,基本上与流感疫苗相同,但流感的死亡风险要远远低于新冠病毒。如果疫苗的有效性是50%,公众会足够放心去恢复正常生活——在拥挤的空间工作,现场观看音乐会或体育赛事,去人头攒动的酒吧和餐厅,或乘坐长途飞机?但愿制药公司能够开发出有效性远远高于50%的疫苗吧。

公众信心

凯撒家庭基金会(Kaiser Family Foundation)在9月10日的一项民意调查发现,54%的美国人不想接种在11月3日选举日之前获得批准的疫苗。与此同时,反疫苗活动人士正在利用疫情来挑起人们对所有疫苗安全性的担忧。因此,建立公众对疫苗安全性和有效性的信心至关重要,这样才会有更多的人自愿接种疫苗。

可获得性

获得批准以后,疫苗不太可能会在几个月内一直广泛供应。医护人员应该优先获得疫苗。在此之后,如何确定获得疫苗的优先次序呢?应该根据风险分级来确定优先次序,老年人、糖尿病患者、肥胖症患者、高危职业人群等脆弱人群要优先获得疫苗。

该接种哪个疫苗

各大制药公司斥资数十亿美元来开发有效的疫苗,最终将有几种候选疫苗获得FDA的批准,每一种都将有各自的科学方法和有效性。最早面世的疫苗将引起广泛的关注,但它会是最有效的吗?消费者将需要有足够的信息来决定该接种哪种疫苗,他们应当从医生那里获得这些信息,而不是从电视上的医药广告或口口相传获知。

对于审批的担忧

人们越来越担心政治因素会影响FDA的决定,尤其是11月3日总统大选前的批准或紧急使用授权决定。上述的凯撒家庭基金会民意调查发现,61%的美国人担心FDA会因为政治压力而仓促批准疫苗。

FDA上个春天就曾经在测试前过早给予羟氯喹紧急使用授权,但后来撤销授权,此事加剧了公众的担忧。此外,美国国立卫生研究院(National Institutes of Health)的一个专家小组最近也批评FDA给予没有进行随机测试的恢复期血浆疗法紧急使用授权。对于如此重要的医疗卫生决策,疫苗审批过程不应该有任何的政治干预。

如何确保安全有效

在我们拥有一种或多种安全有效且可广泛获得的疫苗之前,新冠疫情危机不会结束。监管者和卫生保健领导者必须要带头建立公众对整个疫苗开发和分发过程的完整性的信心。

医药行业和公共卫生官员必须强调安全第一。9月8日,9家领先的制药公司签署了一份承诺书,保证:“只有在经过设计和实施均符合FDA要求的三期临床研究证明疫苗的安全性及有效性之后,才提交批准或紧急使用授权申请。”这份承诺书的签署者包括阿斯利康、BioNTech、葛兰素史克、强生、默沙东、Moderna、Novavax、辉瑞、赛诺菲等公司的首席执行官。

安全有效的疫苗是阻止疫苗蔓延以及全面重启经济的关键所在。当有疫苗最终获得批准时,公众必须能够仰仗仔细审查过临床试验数据的公共卫生官员和医生提供接种指引。为了建立公众信心,独立于政客的医疗卫生领导者必须迎接挑战,确保新冠病毒疫苗安全有效,并首先提供给最需要的人。(财富中文网)

作者比尔•乔治是哈佛商学院高级研究员,曾经担任美敦力公司(Medtronic)的董事长兼首席执行官。他著有《真北》(Discover Your True North)一书。

译者:万志文

2020年8月13日,位于佛罗里达州好莱坞的美国研究中心(RCA)在进行新冠疫苗研究。

新冠肺炎疫情仍然在美国肆虐,已经导致将近20万美国人死亡,全球死亡人数也达到100万人。因此亟需安全有效的疫苗来阻止疫情持续蔓延,并全面重启经济。

全世界的目光都聚焦在医药行业,领头企业都以前所未见的速度推进疫苗的发现、测试和生产工作。众多全球顶尖的科学家都在专注于实现疫苗开发目标。为了在最短的时间内加快疫苗的推出,特朗普政府启动了“空间机战行动”(Operation Warp Speed),资助多个候选疫苗加速开发流程,并承诺采购数亿剂获批准的疫苗。

但试图加快推进科学研究会带来许多风险,对像新冠病毒这样的新型病毒的科学研究尤甚。这种病毒不好理解,也不容易定性。科学发现不能像即将到来的美国总统选举那样被时间表牵着走。

为了应对这些风险,必须得解决好以下的六个问题:

1. 会不会出现早期临床试验中未发现的安全问题?

2. 这些疫苗是否足以有效阻止新冠病毒的传播?

3. 美国人们会足够放心去接种疫苗吗?

4. 是否会有充足的疫苗供应?谁能优先接种?

5. 如果多种疫苗获得批准,人们如何知道应该接种哪一种?

6.疫苗审批流程会受阻吗?

安全性

由于完成试验的时间非常紧迫,人们担心疫苗安全问题可能在数百万人接种后才会出现。“空间机战行动”疫苗研发部门的主管蒙塞夫•斯拉维称,疫苗在选举日之前获批的可能性“非常非常低”,如果他迫于压力而批准了不安全的疫苗,他会主动辞职。

9月9日,阿斯利康(AstraZeneca)主要候选疫苗的临床试验在一名患者出现神经系统症状后叫停,这说明新疫苗测试必须要小心谨慎。(经过仔细的临床审查,那些试验后来恢复进行。)要是数百万健康的人接种疫苗后安全问题才被知晓,整个国家的卫生健康和公众信心无疑都会受到毁灭性的打击。

有效性

美国食品与药品管理局(FDA)已经将新冠疫苗有效性的最低门槛设定为50%,基本上与流感疫苗相同,但流感的死亡风险要远远低于新冠病毒。如果疫苗的有效性是50%,公众会足够放心去恢复正常生活——在拥挤的空间工作,现场观看音乐会或体育赛事,去人头攒动的酒吧和餐厅,或乘坐长途飞机?但愿制药公司能够开发出有效性远远高于50%的疫苗吧。

公众信心

凯撒家庭基金会(Kaiser Family Foundation)在9月10日的一项民意调查发现,54%的美国人不想接种在11月3日选举日之前获得批准的疫苗。与此同时,反疫苗活动人士正在利用疫情来挑起人们对所有疫苗安全性的担忧。因此,建立公众对疫苗安全性和有效性的信心至关重要,这样才会有更多的人自愿接种疫苗。

可获得性

获得批准以后,疫苗不太可能会在几个月内一直广泛供应。医护人员应该优先获得疫苗。在此之后,如何确定获得疫苗的优先次序呢?应该根据风险分级来确定优先次序,老年人、糖尿病患者、肥胖症患者、高危职业人群等脆弱人群要优先获得疫苗。

该接种哪个疫苗

各大制药公司斥资数十亿美元来开发有效的疫苗,最终将有几种候选疫苗获得FDA的批准,每一种都将有各自的科学方法和有效性。最早面世的疫苗将引起广泛的关注,但它会是最有效的吗?消费者将需要有足够的信息来决定该接种哪种疫苗,他们应当从医生那里获得这些信息,而不是从电视上的医药广告或口口相传获知。

对于审批的担忧

人们越来越担心政治因素会影响FDA的决定,尤其是11月3日总统大选前的批准或紧急使用授权决定。上述的凯撒家庭基金会民意调查发现,61%的美国人担心FDA会因为政治压力而仓促批准疫苗。

FDA上个春天就曾经在测试前过早给予羟氯喹紧急使用授权,但后来撤销授权,此事加剧了公众的担忧。此外,美国国立卫生研究院(National Institutes of Health)的一个专家小组最近也批评FDA给予没有进行随机测试的恢复期血浆疗法紧急使用授权。对于如此重要的医疗卫生决策,疫苗审批过程不应该有任何的政治干预。

如何确保安全有效

在我们拥有一种或多种安全有效且可广泛获得的疫苗之前,新冠疫情危机不会结束。监管者和卫生保健领导者必须要带头建立公众对整个疫苗开发和分发过程的完整性的信心。

医药行业和公共卫生官员必须强调安全第一。9月8日,9家领先的制药公司签署了一份承诺书,保证:“只有在经过设计和实施均符合FDA要求的三期临床研究证明疫苗的安全性及有效性之后,才提交批准或紧急使用授权申请。”这份承诺书的签署者包括阿斯利康、BioNTech、葛兰素史克、强生、默沙东、Moderna、Novavax、辉瑞、赛诺菲等公司的首席执行官。

安全有效的疫苗是阻止疫苗蔓延以及全面重启经济的关键所在。当有疫苗最终获得批准时,公众必须能够仰仗仔细审查过临床试验数据的公共卫生官员和医生提供接种指引。为了建立公众信心,独立于政客的医疗卫生领导者必须迎接挑战,确保新冠病毒疫苗安全有效,并首先提供给最需要的人。(财富中文网)

作者比尔•乔治是哈佛商学院高级研究员,曾经担任美敦力公司(Medtronic)的董事长兼首席执行官。他著有《真北》(Discover Your True North)一书。

译者:万志文

With COVID-19 still raging in the U.S. and the death toll approaching 200,000 Americans and 1 million people worldwide, a safe and effective vaccine is required to stop the spread of the disease and restart the economy.

All eyes are on the pharmaceutical industry, as leading companies have moved ahead to discover, test, and manufacture a vaccine faster than ever before. Many of the world’s best scientists are focused on this goal. To accelerate the availability of a vaccine in record time, the Trump administration launched Operation Warp Speed, funding multiple vaccine candidates through an accelerated development process and committing to purchase hundreds of millions of doses of approved vaccines.

Trying to speed up science carries many risks, especially for a novel virus like this one, which is not well understood nor easily characterized. Scientific discoveries cannot be driven by timetables like the upcoming Presidentialelection is.

To address these risks, the following questions must be answered:

1. Will there be safety issues not revealed in early clinical trials?

2. Will the vaccines be sufficiently effective to stop COVID-19’s spread?

3. Will the American people have enough confidence to get vaccinated?

4. Will there be sufficient quantities of vaccines available, and who gets priority?

5. If multiple vaccines are approved, how will people know which one to get?

6. Will political pressure influence the approval process?

Safety

Time pressure to complete the trials raises concerns that safety issues may appear only after millions of people have been vaccinated. Moncef Slaoui, head of Operation Warp Speed’s vaccine development arm, has said there is a “very, very low chance” of a vaccine being approved by election day, and that he will resign if he feels pressure to approve an unsafe vaccine.

On Sept. 9, clinical trials for AstraZeneca’s leading vaccine candidate were halted after a patient developed neurological symptoms, illustrating the care that must be taken in testing new vaccines. (Those trials have since resumed after a careful clinical review.) Learning of safety issues after millions of healthy people have been vaccinated would be devastating to the nation’s health and public confidence.

Effectiveness

The Food and Drug Administration (FDA) has set the minimum threshold for a vaccine’s effectiveness at 50%, essentially the same bar as flu vaccines, but influenza has a far lower risk of death than COVID-19 does. With 50% effectiveness, will the public feel sufficiently confident to resume their normal lives—working in crowded spaces, attending concerts or sporting events, going into crowded bars and restaurants, or taking long airplane flights? Hopefully, pharmaceutical makers will be able to develop a vaccine with substantially more than 50% effectiveness.

Public confidence

A Sept. 10 Kaiser Family Foundation poll found that 54% of Americans would not want to receive a vaccine approved prior to election day on Nov. 3. Meanwhile, anti-vaccine activists are using COVID-19 to stoke fears about the safety of all vaccines. Thus, it is essential to build public confidence in the vaccine’s safety and effectiveness, so more people will volunteer to get vaccinated.

Availability

Once approved, a vaccine is unlikely to be widely available for several months. Health care workers should have priority access. After that, how will priorities be established to determine who gets the vaccine? Priorities should be based on risk stratification, with more immediate access given to vulnerable populations such as the elderly, people with diabetes and obesity, or people in high-risk occupations.

Determining which one to get

With major pharmaceutical companies spending billions of dollars to create an effective vaccine, several candidates will eventually be approved by the FDA, each with its own scientific approach and level of effectiveness. The first vaccine will get the publicity, but will it be the most effective? Consumers will need sufficient information to decide which vaccine to receive, and they should get that information from their physicians, not pharmaceutical ads on television or word of mouth.

Political intervention

There are growing concerns about politics entering into FDA decisions, especially if approval or an emergency use authorization (EUA) is granted prior to the Nov. 3 election. The aforementioned Kaiser poll found that 61% of Americans are worried the FDA will rush to approve a vaccine due to political pressure.

These concerns are heightened by the FDA’s premature EUA of hydroxychloroquine prior to testing last spring, an approval the FDA later withdrew. Additionally, a recent National Institutes of Health panel criticized the FDA for its EUA of convalescent plasma without having performed randomized tests. For such an important health care decision, political pressure has no place in the vaccine approval process.

A plan to win the public’s confidence

The COVID-19 crisis will not end until we have one or more safe, effective, and widely available vaccines. Regulators and health care leaders, backed up by political leaders, must take the lead in building public confidence in the integrity of the entire vaccine development and distribution process.

The pharmaceutical industry and public health officials must emphasize safety first. On Sept. 8, nine leading pharmaceutical companies signed a pledge to “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of … the FDA.” This pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.

A safe and effective vaccine holds the key to stopping the spread of COVID-19 and fully restarting the economy. When a vaccine is ultimately approved, the public must be able to rely on public health officials and physicians who have carefully reviewed clinical trial data. In order to build public confidence, health care leaders—independent from politicians—must step up to the challenge of ensuring COVID-19 vaccines are safe, effective, and available to those most in need first.

Bill George is senior fellow at Harvard Business School and former chair and CEO of Medtronic. He is the author of Discover Your True North.

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