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美国新冠疫苗想成功,首先要凑够100万名志愿者

美国新冠疫苗想成功,首先要凑够100万名志愿者

黎克腾(Clifton Leaf) 2020年10月08日
他们需要的志愿者应该远远超过这个数量,这样才可以确保被试者相对公平地代表了美国社会的人口构成。

2020年6月24日,在南非索韦托市的巴拉瓜纳特医院里,首批南非志愿者正在参加牛津大学研发的新冠肺炎疫苗临床试验。图片来源:SIPHIWE SIBEKO—POOL/AFP/GETTY IMAGES

这个主意最初是好莱坞大帅哥阿什顿·库彻提出的。库彻是好莱坞知名演员和科技公司投资人,他在与南加州大学劳伦斯·埃里森变革医学研究所(Lawrence J. Ellison Institute for Transformative Medicine at USC)的首席执行官戴维斯·阿格斯谈话时指出,美国的抗疫工作要想取得成功,首先要解决一个艰巨的挑战——招募到足够多的志愿者来参与新冠疫苗和药物的试验工作。库彻建议,美国应该开展一项宣传活动,让那些已经报名的志愿者录制一段视频,向大家解释他们为什么要做这件事。“他们未经过滤的声音就是一个强大的佐证。”而这就是这次宣传活动需要传递的信息。阿格斯说:“疫苗无关政治,只关乎科学、公民责任,只关乎拯救你所爱的人和你的邻居的生命。已经报名的志愿者们理解这一点,而且他们能够比任何人更好地宣传这一点。”

库彻这个简单明了的想法可谓一呼百应,这样一项公益宣传活动已经在全美范围内展开了。最近,大卫·埃利森的Skydance Media公司与美国国家卫生研究院(National Institutes of Health)的防疫部门合拍了一则90秒的公益广告,这则广告由哈里森·福特担任解说,已于9月25日在CBS电视台播出,现已登陆美国其他主流电视台和有线电视网络。这则广告有好几个版本,里面有一些临床试验志愿者的真实声音,为了方便线上分享,它已同步登陆Facebook、YouTube和Instagram等社交平台。

这则广告引用了美国前总统肯尼迪的那句名言:“不要问国家能为你做什么,问问你能为国家做什么。”广告呼吁美国民众踊跃通过美国国家卫生研究院的新冠病毒预防网络平台进行报名,争当新冠疫苗和药物临床试验的志愿者。

阿格斯表示,到目前为止,大约已有50万名美国人注册成为了新冠肺炎相关临床试验的志愿者,但美国很有可能还需要100万名志愿者。阿格斯与国际上的很多新冠疫苗研发项目都保持着密切合作。目前有五支很有希望的疫苗已经进入了三期临床试验,研发者分别是辉瑞(与德国BioNTech公司合作)、阿斯利康(与牛津大学合作)、Moderna、强生和诺瓦瓦克斯(Novavax)。按程序来说,这五支疫苗的三期试验大约需要17.4万名志愿者。但实际上,考虑到接种对象的种族、年龄、健康状态和地区等影响因素,他们需要的志愿者应该远远超过这个数量,这样才可以确保被试者相对公平地代表了美国社会的人口构成。

Bio.org是生物制药行业的一个行业组织,它目前正在追踪188种候选疫苗、198种抗病毒药物,和351种正处于不同研究阶段的潜在疗法。要想知道任何一种疫苗或药物是否有效,至少在美国,相关疫苗和药物在获得美国食品与药品管理局的审批前,至少要经过两次严格受控的人体试验。而为了战胜新冠疫情,我们可能得需要好几种可用的疫苗和药物:一是要有可用的疫苗来防止病毒引发更多病例;二是对于疫苗防不住的那部分,还得有药物来治疗严重的感染。因此我们需要大量志愿者来测试它们。

为什么需要那么多志愿者呢?阿古斯表示,首先,新冠疫苗不仅面对那些有严重基础病的人群,而是要面对全球几十亿人。美国有3.3亿人口,要想控制疫情的大面积传播,这3.3亿人中的大部分都是要接种疫苗的。因此疫苗的安全性和有效性门槛是相当高的。

尽管疫苗总体上是非常安全的,但和任何药物一样,它对不同的人也会产生不同的影响。对于任何一支新冠肺炎疫苗,要想真正证明它适合在全球范围内使用,就必须在年轻人、老年人以及有各种基础病的人群中进行测试。而且这些人的人口基数并不是个小数目,根据美国医疗保险和医疗补助服务中心(Centers for Medicare & Medicaid Services)的数据,在美国,大约有5000万到1.29亿的非老年人都患有某种基础病。

其次,这些疫苗和药物还有必要针对不同种族和国籍的人进行测试。曾经有人对美国食品与药品管理局在2008年至2013年批准的167种新药进行过研究,结果发现,大约五分之一的新药在某些种族和民族的人身上有不同表现。这种差异在某些情况下表现在对药物的吸收和代谢上,也就是最终还有多少药量保持在人体之内;还有些时候则表现在对药物的反应上。甚至两者兼而有之的也有。

从目前的病情数据看,对新冠疫苗和药物来说,这种差异很可能造成更显著的影响。美国疾控中心今年8月公布的数据显示,患有新冠肺炎的黑人的住院率比非拉美裔的白人高出4.7倍,死亡率也比后者高出2.1倍。另外,拉美裔和美国印第安人也比白人更容易发展为重症甚至死亡。虽然这种风险有可能是由相关族群中的其他基础因素导致的,但说不定也受生理因素的影响。总而言之,相关临床试验有必要包含大量的黑人和拉美裔志愿者,这样才能够在疫苗大范围使用前,发现它可能造成的负作用。

然而有关报道表明,在目前正在进行的相关临床试验中,情况恰恰是相反的。据《华盛顿邮报》报道,截至8月底,在报名参加辉瑞和Moderna疫苗研究的志愿者中,黑人和拉美裔加起来只占了五分之一。在报名美国国家卫生研究院新冠病毒预防网络平台的志愿者中,黑人和拉美裔加起来还不到十分之一。(而在美国的总人口中,黑人占了13.4%,拉美裔占了18%。)虽然少数族裔在医学临床试验中的代表性不足已经是一个老问题了,但在疫情时代,这个问题的严重性又被上升到了一个新的水平。

有鉴于此,这则公益广告也希望能把信息传递给大量的黑人观众和拉美裔观众。为此,它也登上了黑人观众居多的BET和欧普拉电视网,以及以西语观众为主体的Telemundo和Univision电视网。

阿格斯指出,除了确保种族和民族的多样性以外,志愿者队伍中还应该包括来自全国各地的人(尤其是疫情比较严重的地区),并且还应包括处于不同健康状态的人。美国有100多家医院都在开展新冠疫苗和药物的临床试验,相关研究通常需要志愿者在一年或两年里到研究场所复查10次左右。

当然,在“双盲”试验中,受试者不会知道他们接种的是究竟是疫苗还是安慰剂。但他们应该知道,他们正在帮助世界终结这次疫情。(财富中文网)

译者:朴成奎

2020年6月24日,在南非索韦托市的巴拉瓜纳特医院里,首批南非志愿者正在参加牛津大学研发的新冠肺炎疫苗临床试验。图片来源:SIPHIWE SIBEKO—POOL/AFP/GETTY IMAGES

这个主意最初是好莱坞大帅哥阿什顿·库彻提出的。库彻是好莱坞知名演员和科技公司投资人,他在与南加州大学劳伦斯·埃里森变革医学研究所(Lawrence J. Ellison Institute for Transformative Medicine at USC)的首席执行官戴维斯·阿格斯谈话时指出,美国的抗疫工作要想取得成功,首先要解决一个艰巨的挑战——招募到足够多的志愿者来参与新冠疫苗和药物的试验工作。库彻建议,美国应该开展一项宣传活动,让那些已经报名的志愿者录制一段视频,向大家解释他们为什么要做这件事。“他们未经过滤的声音就是一个强大的佐证。”而这就是这次宣传活动需要传递的信息。阿格斯说:“疫苗无关政治,只关乎科学、公民责任,只关乎拯救你所爱的人和你的邻居的生命。已经报名的志愿者们理解这一点,而且他们能够比任何人更好地宣传这一点。”

库彻这个简单明了的想法可谓一呼百应,这样一项公益宣传活动已经在全美范围内展开了。最近,大卫·埃利森的Skydance Media公司与美国国家卫生研究院(National Institutes of Health)的防疫部门合拍了一则90秒的公益广告,这则广告由哈里森·福特担任解说,已于9月25日在CBS电视台播出,现已登陆美国其他主流电视台和有线电视网络。这则广告有好几个版本,里面有一些临床试验志愿者的真实声音,为了方便线上分享,它已同步登陆Facebook、YouTube和Instagram等社交平台。

这则广告引用了美国前总统肯尼迪的那句名言:“不要问国家能为你做什么,问问你能为国家做什么。”广告呼吁美国民众踊跃通过美国国家卫生研究院的新冠病毒预防网络平台进行报名,争当新冠疫苗和药物临床试验的志愿者。

阿格斯表示,到目前为止,大约已有50万名美国人注册成为了新冠肺炎相关临床试验的志愿者,但美国很有可能还需要100万名志愿者。阿格斯与国际上的很多新冠疫苗研发项目都保持着密切合作。目前有五支很有希望的疫苗已经进入了三期临床试验,研发者分别是辉瑞(与德国BioNTech公司合作)、阿斯利康(与牛津大学合作)、Moderna、强生和诺瓦瓦克斯(Novavax)。按程序来说,这五支疫苗的三期试验大约需要17.4万名志愿者。但实际上,考虑到接种对象的种族、年龄、健康状态和地区等影响因素,他们需要的志愿者应该远远超过这个数量,这样才可以确保被试者相对公平地代表了美国社会的人口构成。

Bio.org是生物制药行业的一个行业组织,它目前正在追踪188种候选疫苗、198种抗病毒药物,和351种正处于不同研究阶段的潜在疗法。要想知道任何一种疫苗或药物是否有效,至少在美国,相关疫苗和药物在获得美国食品与药品管理局的审批前,至少要经过两次严格受控的人体试验。而为了战胜新冠疫情,我们可能得需要好几种可用的疫苗和药物:一是要有可用的疫苗来防止病毒引发更多病例;二是对于疫苗防不住的那部分,还得有药物来治疗严重的感染。因此我们需要大量志愿者来测试它们。

为什么需要那么多志愿者呢?阿古斯表示,首先,新冠疫苗不仅面对那些有严重基础病的人群,而是要面对全球几十亿人。美国有3.3亿人口,要想控制疫情的大面积传播,这3.3亿人中的大部分都是要接种疫苗的。因此疫苗的安全性和有效性门槛是相当高的。

尽管疫苗总体上是非常安全的,但和任何药物一样,它对不同的人也会产生不同的影响。对于任何一支新冠肺炎疫苗,要想真正证明它适合在全球范围内使用,就必须在年轻人、老年人以及有各种基础病的人群中进行测试。而且这些人的人口基数并不是个小数目,根据美国医疗保险和医疗补助服务中心(Centers for Medicare & Medicaid Services)的数据,在美国,大约有5000万到1.29亿的非老年人都患有某种基础病。

其次,这些疫苗和药物还有必要针对不同种族和国籍的人进行测试。曾经有人对美国食品与药品管理局在2008年至2013年批准的167种新药进行过研究,结果发现,大约五分之一的新药在某些种族和民族的人身上有不同表现。这种差异在某些情况下表现在对药物的吸收和代谢上,也就是最终还有多少药量保持在人体之内;还有些时候则表现在对药物的反应上。甚至两者兼而有之的也有。

从目前的病情数据看,对新冠疫苗和药物来说,这种差异很可能造成更显著的影响。美国疾控中心今年8月公布的数据显示,患有新冠肺炎的黑人的住院率比非拉美裔的白人高出4.7倍,死亡率也比后者高出2.1倍。另外,拉美裔和美国印第安人也比白人更容易发展为重症甚至死亡。虽然这种风险有可能是由相关族群中的其他基础因素导致的,但说不定也受生理因素的影响。总而言之,相关临床试验有必要包含大量的黑人和拉美裔志愿者,这样才能够在疫苗大范围使用前,发现它可能造成的负作用。

然而有关报道表明,在目前正在进行的相关临床试验中,情况恰恰是相反的。据《华盛顿邮报》报道,截至8月底,在报名参加辉瑞和Moderna疫苗研究的志愿者中,黑人和拉美裔加起来只占了五分之一。在报名美国国家卫生研究院新冠病毒预防网络平台的志愿者中,黑人和拉美裔加起来还不到十分之一。(而在美国的总人口中,黑人占了13.4%,拉美裔占了18%。)虽然少数族裔在医学临床试验中的代表性不足已经是一个老问题了,但在疫情时代,这个问题的严重性又被上升到了一个新的水平。

有鉴于此,这则公益广告也希望能把信息传递给大量的黑人观众和拉美裔观众。为此,它也登上了黑人观众居多的BET和欧普拉电视网,以及以西语观众为主体的Telemundo和Univision电视网。

阿格斯指出,除了确保种族和民族的多样性以外,志愿者队伍中还应该包括来自全国各地的人(尤其是疫情比较严重的地区),并且还应包括处于不同健康状态的人。美国有100多家医院都在开展新冠疫苗和药物的临床试验,相关研究通常需要志愿者在一年或两年里到研究场所复查10次左右。

当然,在“双盲”试验中,受试者不会知道他们接种的是究竟是疫苗还是安慰剂。但他们应该知道,他们正在帮助世界终结这次疫情。(财富中文网)

译者:朴成奎

It was Ashton Kutcher’s idea, originally. The actor and technology company investor was talking recently with David Agus, M.D., CEO of the Lawrence J. Ellison Institute for Transformative Medicine at USC, about a formidable challenge in the battle against COVID-19: recruiting enough volunteers for the many clinical studies needed to test experimental vaccines and therapies. Kutcher suggested an awareness campaign in which Americans who had already volunteered for a study record a video explaining why they’d done it. “Their unfiltered voices will offer a powerful testimony,” Agus recalls Kutcher saying, and that’s what we need to get the message out. “The vaccine effort isn’t about politics,” says Agus. “It’s simply about good science and civic duty and saving the lives of your loved ones and neighbors. Those who have volunteered for trials understand that—and can communicate that better than anyone.”

This straightforward notion has now been transformed into a striking public service announcement that’s being rolled out nationally. The 90-second PSA, narrated by Harrison Ford and produced by David Ellison’s Skydance Media in partnership with the National Institutes of Health’s COVID-19 Prevention Network, launched September 25 on CBS, and is slated to air on other major television and cable networks as well. There are also shareable versions of the ad—which features a number of personal statements from clinical trials volunteers, designed for Facebook, YouTube, and Instagram.

Hearkening back to President John F. Kennedy’s stirring call to action—“Ask not what your country can do for you, ask what you can do for your country”—the new campaign urges Americans to volunteer for a clinical trial through COVID-19 Prevention Network’s registration platform, which is helping to find participants for all the major ongoing studies.

About 500,000 Americans have already registered to be potentially included in COVID clinical trials to date, but we’ll likely need a million more to sign up, says Agus, who is working closely with many of the international vaccine efforts. For context, the ongoing Phase 3 trials for just the five leading vaccine candidates—those being developed by Pfizer(with the German firm BioNTech), AstraZeneca (with Oxford University), Moderna, Johnson & Johnson, and Novavax—require 174,000 study participants, according to their protocols. But in truth, they require many more volunteers than that merely to get the needed compositions of race, age, health status, and location—distributions that are necessary to ensure that the trial populations fairly represent the makeup of society at large.

Bio.org, a trade group for the biopharma industry, is currently tracking188 vaccine candidates, 198 antiviral therapies, and 351 would-be treatments in various stages of development. Before any one of them can be proven safe and effective—and, in the United States at least, approved for use by the FDA—they would generally need to be vetted in human volunteers in two well-controlled studies. To defeat COVID, it’s likely that we’ll need several viable vaccines and therapies—the first, to prevent the SARS-CoV-2 virus from causing illness; the second, to treat the more serious infections that do occur. And that means we’ll need lots of volunteers to test them.

Why so many? For one reason, COVID vaccines will eventually be given not just to a confined group of patients with serious disease, but rather to billions of people around the world. In the U.S., most of the country’s 330 million people will need to be vaccinated in order to curtail the spread. That puts the bar for both safety and effectiveness incredibly high, says Agus.

While extremely safe overall, vaccines—as with any medicine—can affect different people in different ways. For any candidate COVID vaccine or therapy to truly demonstrate that it’s appropriate for global use, it will have to be tested in the very young and the very old, as well as in people with any number of pre-existing medical conditions. That’s no small number: According to the Centers for Medicare & Medicaid Services (CMS), between 50 million and 129 million non-elderly Americans have a pre-existing health condition of some form.

It’s equally important that vaccines and other drugs be tested on people of different races and national origin. One study that examined 167 new drugs approved by the FDA between 2008 and 2013 found that roughly one in five acted differently in some racial or ethnic groups versus others. In some of the cases, the difference lay in the way the drug was absorbed, metabolized, or eliminated, which ultimately left more or less drug exposed in the body, depending on who took it; in others, it produced a different response; in still others, it did both.

And in the case of COVID, such differences in vaccine or drug interactions could conceivably have far more impact, given the huge disparity in disease outcomes witnessed so far. According to data posted by the CDC in August, Black Americans with COVID have a rate of hospitalization that’s 4.7 times higher than that for non-Hispanic whites, and a rate of death 2.1 times higher. Hispanic Americans and American Indians are also far more likely to get extremely ill from COVID, or die from it, than their white counterparts. Though much of this increased risk may be due to other underlying conditions more prevalent in those groups, there may as yet be other biological factors at work. That is all the more reason to make sure clinical trials include substantial numbers of Black and Latino volunteers—so that potential complications can be unearthed before any vaccine or drug is given to many millions of people.

But reports suggest that the opposite is happening in the COVID-related clinical trials already underway. As of late August, just one-fifth of those enrolled in the Pfizer and Moderna vaccine studies, for instance, were Black or Hispanic, according to reporting by the Washington Post. And among those signing up for the COVID-19 Prevention Network’s Volunteer Screening Registry, the share of both groups combined was closer to 10%. (In the U.S. as a whole, for comparison, Blacks make up 13.4% of the population; Latinos, 18.%.) While the under-representation of minority groups in clinical trials is a longstanding problem, the scale of the challenge in the COVID era is at a whole new level.

Which is why the creators of the new PSA hope to bring their message to television networks with large numbers of Black viewers (including BET and the Oprah Winfrey Network) and to Spanish-speaking audiences (Telemundo, and Univision).

In addition to racial and ethnic diversity, says Agus, it’s important that the volunteer registry have people from all over the country (particularly in areas where the disease is spreading) and include those with a wide range of health conditions. Clinical trials are currently in progress at some 100 medical centers around the U.S., with studies typically asking volunteers to visit the research site 10 or times over one to two years.

In the case of the “blinded” vaccine trials, of course, participants will not know ahead of time whether they’ll get the experimental vaccine or a placebo. What they will know, however, is that they’re helping to bring this pandemic to an end.

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