Outrage grows as CDC reportedly poised to fund "unethical" vaccine trial

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Outrage has erupted among health experts over news that the Centers for Disease Control and Prevention is still eager to fund a widely condemned vaccine trial that would expose newborns in Guinea-Bissau to hepatitis B, putting them at high risk of a lifelong infection, which can lead to liver cirrhosis, liver cancer, and premature death.

由于有消息称美国疾病控制与预防中心（CDC）仍急于资助一项广受谴责的疫苗试验，卫生专家中爆发了愤怒。该试验将使几内亚比绍的新生儿暴露于乙型肝炎风险中，使他们面临终身感染的高风险，而这种感染可能导致肝硬化、肝癌和过早死亡。

The trial was suspended in January after its unethical design came to light and drew international outcry. Although the trial is still halted, staff of the CDC director’s office told the agency’s budget office in late September to set aside $1.6 million to fund the trial, according to a report by Rolling Stone.

该试验因其不道德的设计被曝光并引发国际抗议后，于一月份被暂停。据《滚石》杂志报道，尽管试验目前仍处于停滞状态，但CDC主任办公室的工作人员在9月下旬告知该机构预算办公室，预留160万美元用于资助该试验。

The money was to be pulled from funding for the CDC’s global health security programs, which might otherwise go toward efforts like combating the Ebola outbreak currently raging in the Democratic Republic of the Congo. The Department of Health and Human Services, which oversees the CDC, did not respond to a request for comment from Ars Technica.

这笔资金将从CDC的全球卫生安全项目经费中拨出，而这些资金本可用于抗击目前在刚果民主共和国肆虐的埃博拉疫情等工作。负责监管CDC的美国卫生与公众服务部未回应Ars Technica的置评请求。

If the trial moves forward, it would be funded by the US but run by Danish researchers, who have separately been accused of misconduct. In December, the CDC announced the award of an unsolicited grant for $1.6 million to a research group at the University of Southern Denmark, led by married couple Christine Stabell Benn and Peter Aaby.

如果试验继续进行，它将由美国资助，但由丹麦研究人员负责执行，而这些研究人员此前曾被指控存在不当行为。去年12月，CDC宣布向南丹麦大学的一个研究小组授予一笔160万美元的非应邀拨款，该小组由克里斯汀·斯塔贝尔·本（Christine Stabell Benn）和彼得·阿比（Peter Aaby）这对夫妇领导。

The pair have produced numerous studies that have been promoted by anti-vaccine advocates, drawing concern and criticism from researchers. Stabell Benn and Aaby are currently under investigation by Danish authorities over allegations of “falsification” and “scientific misconduct” related to previous vaccine research.

这对夫妇发表了大量研究成果，并受到反疫苗倡导者的推崇，这引起了研究人员的担忧和批评。斯塔贝尔·本和阿比目前正因涉及先前疫苗研究的“伪造”和“科学不端行为”指控而受到丹麦当局的调查。

In January, amid criticism of the trial, officials in Guinea-Bissau said they had suspended the research, saying ethical and technical reviews of the trial’s design were ongoing. “There has been no sufficient coordination in order to take a final decision regarding the study,” Quinhin Nantote, the minister of public health for Guinea-Bissau, said at the time. “Faced with this situation, we decided to suspend it.”

一月份，在对该试验的批评声中，几内亚比绍官员表示他们已暂停了这项研究，称对试验设计的伦理和技术审查仍在进行中。几内亚比绍公共卫生部长昆欣·南托特（Quinhin Nantote）当时表示：“目前还没有足够的协调来对这项研究做出最终决定。面对这种情况，我们决定将其暂停。”

The trial intends to enroll 14,000 newborns in Guinea-Bissau, half of which would get a newborn dose of hepatitis B vaccine, while the other half would not. The aim is to try to find alleged vaccine harms from the newborn dose—despite the fact that the newborn dose has been proven safe and effective after decades of global use and is the current standard of care.

该试验计划在几内亚比绍招募14,000名新生儿，其中一半将接种新生儿剂量的乙肝疫苗，而另一半则不接种。其目的是试图寻找所谓的新生儿剂量疫苗危害——尽管事实证明，经过全球数十年的使用，新生儿剂量疫苗已被证明是安全有效的，并且是目前的护理标准。

Guinea-Bissau has a high burden of hepatitis B in its population, and newborns who are not vaccinated at birth are at risk of acquiring a chronic, life-threatening infection. Authorities in Guinea-Bissau want newborns to be vaccinated and intend to begin universally administering birth doses in 2028.

几内亚比绍的人口乙肝负担沉重，出生时未接种疫苗的新生儿面临感染慢性、危及生命的疾病的风险。几内亚比绍当局希望新生儿接种疫苗，并打算在2028年开始普遍实施出生剂量接种。

Stabell Benn and Aaby have argued that the trial is not unethical because newborns in Guinea-Bissau are currently not routinely given a dose of hepatitis B vaccine at birth. But outside experts point to ethical guidelines, such as the Declaration of Helsinki, which requires trials to provide the “best proven intervention”—which is a birth dose of hepatitis B vaccine—regardless of whatever the current standard is in the country hosting the trial.

斯塔贝尔·本和阿比辩称该试验并非不道德，因为几内亚比绍的新生儿目前并未常规接种出生剂量乙肝疫苗。但外部专家指出，根据《赫尔辛基宣言》等伦理准则，试验必须提供“最佳已证实的干预措施”（即出生剂量乙肝疫苗），无论试验所在国的当前标准如何。

In a scathing rebuke in February, the World Health Organization laid out a bullet-point list of “why withholding the vaccine is unethical.” The WHO notes that the entire premise of the trial is based on “hypothetical safety outcomes without sufficient credible evidence,” which don’t justify putting newborns at risk.

在二月份的一份严厉谴责中，世界卫生组织列出了一份要点清单，说明“为何不提供疫苗是不道德的”。世卫组织指出，该试验的整个前提是基于“没有足够可信证据的假设性安全结果”，这不足以证明让新生儿承担风险是合理的。

According to the Rolling Stone report, the trial’s design has been revised to now ask mothers if they are infected with hepatitis B—which can pass from mother to infant during birth—and test a small fraction of them for the infection. But the changes have not eased concerns that having an unvaccinated group as part of the trial is fundamentally unethical.

据《滚石》杂志报道，该试验的设计已进行修订，现在会询问母亲是否感染了乙肝（乙肝可在分娩时从母体传给婴儿），并对其中一小部分人进行感染检测。但这些改变并未缓解人们的担忧，即在试验中设置未接种疫苗组在根本上是不道德的。

For now, the trial is still on hold, pending final authorization from Guinea-Bissau officials. But the CDC, under anti-vaccine Health Secretary Robert F. Kennedy Jr., appears eager to move forward with it once it is approved.

目前，该试验仍处于暂停状态，等待几内亚比绍官员的最终授权。但在反疫苗倾向的卫生部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）领导下，CDC似乎急于在获得批准后推进该试验。

Nonprofit advocacy group Stand Up for Science vowed to block the trial. “We stopped this unethical study the first time and we’ll do it again,” Colette Delawalla, the group’s CEO and founder, said in a statement. “This is a gross violation of human rights and the use of bad science against some of the most vulnerable people in the world.”

非营利倡导组织“为科学挺身而出”（Stand Up for Science）誓言要阻止这项试验。该组织的首席执行官兼创始人科莱特·德拉瓦拉（Colette Delawalla）在一份声明中表示：“我们第一次阻止了这项不道德的研究，我们还会再次这样做。这是对人权的严重侵犯，也是利用糟糕的科学手段针对世界上最脆弱的人群。”