美国支持的非洲新生儿乙肝疫苗试验因引发全球强烈反对而被叫停，首席研究人员周三表示。
The US-backed hepatitis B vaccine trial in African newborns that drew global backlash was halted, the lead researcher said on Wednesday.
丹麦研究人员弗雷德里克·沙尔茨-布赫霍尔泽在领英上写道，该研究“现在清楚”将“不会在几内亚比绍推进”，并补充说，“我们未获得必要的政府批准。”几内亚比绍卫生部长金欣·南托特此前曾否认该项目将推进。“这根本不是真的，”南托特上周用葡萄牙语告诉《卫报》。
It is “now clear” that the study “will not move forward in Guinea-Bissau”, Frederik Schaltz-Buchholzer, a Danish researcher, wrote on LinkedIn, adding, “we were not given the necessary governmental approval.”The minister of health in Guinea-Bissau, Quinhin Nantote, previously denied that the project would move forward. “This is not even remotely true,” Nantote told the Guardian in Portuguese last week.
该研究原计划由美国疾病控制与预防中心（CDC）提供160万美元资金，此外还有来自私人合作伙伴的160万美元，如比尔·阿克曼支持的潘兴广场基金会和蓝铃花基金会。
The study was to be funded with $1.6m from the US Centers for Disease Control and Prevention (CDC), along with another $1.6m from private partners like the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation.
“解决方案很明确：拿到钱，给尽可能多的孩子接种疫苗，”费城儿童医院疫苗专家保罗·奥菲特说，他严厉批评这项拟议研究不符合伦理。
“The solution is clear here: Take the money and vaccinate as many kids as you can,” said Paul Offit, a vaccines expert at the Children’s Hospital of Philadelphia, who sharply criticized the proposed study as unethical.
几内亚比绍政府现已控制研究人员的疫苗，这些疫苗是周一在搜查班迪姆健康项目办公室时扣押的。
The government of Guinea-Bissau now has control over the researchers’ vaccines, which they apprehended when they searched the offices of the Bandim Health Project on Monday.
奥菲特说，至关重要的是支持几内亚比绍尽快向所有新生儿推广免疫接种。几内亚比绍目前计划于2028年提供普遍的出生剂次接种。
It is vital to support Guinea-Bissau in rolling the immunizations out to all newborns as soon as possible, Offit said. Guinea-Bissau currently plans to offer the universal birth dose in 2028.
由沙尔茨-布赫霍尔泽、克里斯蒂娜·斯塔贝尔·本和彼得·阿比领导的丹麦研究人员假设，接种卡介苗（BCG）等活疫苗可能具有预防结核病等疾病之外的总体降低死亡率益处——但同时接种乙肝疫苗等其他疫苗可能会削弱这种效应。
The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby, hypothesized giving live vaccines, like the Bacillus Calmette-Guérin (BCG), may have an overall mortality benefit beyond simply preventing illnesses like tuberculosis – but giving another vaccine like hepatitis B alongside it could dampen that effect.
奥菲特说，这种假设是“异想天开”的，因为乙肝疫苗只是一种单一蛋白，而免疫系统每天会遇到数十亿种蛋白。
Such a hypothesis is “fanciful” because the hepatitis B vaccine is a single protein among billions encountered by the immune system each day, Offit said.
“没有证据支持这一点，这在生物学上也讲不通，”他接着说。他还补充说，尽早给婴儿接种疫苗有非常明显的好处，因为该国乙肝发病率高，感染后可能导致终身疾病甚至死亡。
“There’s no evidence for that, and it doesn’t make biological sense,” he continued. He also added that there was a very clear benefit to giving the vaccine to babies as soon as possible, because of high rates of hepatitis B in the country and the possibility of lifelong illness and death from infection.
截至截稿时，丹麦研究人员未就该研究或此批评作出回应。美国疾控中心（CDC）截至截稿时也未就资金问题作出回应——该资金是通过其全球卫生工作拨付的——即这笔资金现在是否会用于按照世界卫生组织（WHO）的建议，向几内亚比绍所有新生儿推广疫苗接种。
The Danish researchers did not respond by press time to questions about the study or to this criticism. The CDC did not respond by press time to questions about whether the funding, which was appropriated through its global health work, would now be used to roll out the vaccine to all newborns in Guinea-Bissau, as recommended by the World Health Organization (WHO).
“世卫组织建议所有婴儿在出生后尽快接种第一剂乙肝疫苗——最好在24小时内——随后至少再接种两剂，”世卫组织发言人塔里克·亚沙雷维奇（Tarik Jašarević）说。“世卫组织依然致力于与各国政府、研究人员和合作伙伴合作，确保所有新生儿——在几内亚比绍和全球范围内——都能及时获得基于证据的乙肝防护。”专家表示，拒绝参与研究的人本不会获得疫苗——这使得真正的知情同意成为不可能。
“WHO recommends that all infants receive a first dose of the hepatitis B vaccine as soon as possible after birth – preferably within 24 hours – followed by at least 2 additional doses,” said Tarik Jašarević, a WHO spokesperson. “WHO remains committed to working with national authorities, researchers, and partners to ensure that all newborns – in Guinea‑Bissau and worldwide – receive timely, evidence‑based protection against hepatitis B.” Those who declined participation in the study would not have received the vaccines – making true informed consent impossible, experts say.
“想象一下你是一位母亲。你想为孩子做最好的事，”丹麦研究人员亨里克·斯托夫林（Henrik Støvring）说，他曾合著研究，对班迪姆项目（Bandim project）之前的研究提出过质疑。
“Imagine you’re a mother. You want to do the best for your child,” said Henrik Støvring, a Danish researcher who has co-published research raising questions about previous research from the Bandim project.
“如果她们决定参加试验，孩子有50%的机会获得疫苗。但如果她们不参加，孩子获得疫苗的机会就是0%。那么，怎么能说这是非强迫性的知情同意呢？”斯托夫林问道。
“If they decide to participate in the trial, they have a 50% chance of getting the vaccine for their children. But if they stay out, they have a 0% chance of getting the vaccine. So how can you say that’s a non-coercive informed consent?”Støvring asked.
施尔茨-布赫霍尔策（Schaltz-Buchholzer）在其帖子中表示，拟议的试验导致比绍几内亚人产生不信任，他们怀疑这种拥有数十年安全有效记录的疫苗，是否因为危险才在非洲人身上进行测试。
The proposed trial led to distrust among Bissau-Guineans, who wondered if the vaccine – which has a decades-long record of being safe and effective – was being tested on Africans because it was dangerous, Schaltz-Buchholzer said in his post.
他写道，两种出生疫苗接种时间表——无论是否包含乙肝疫苗——都“不对任何人构成危险”，这“应该很清楚”。专家表示，出生时接种乙肝疫苗有明确的益处，不接种可能导致终身危险。
It “should be clear” that both birth vaccination schedules – with or without hepatitis B – are not “dangerous to anyone”, he wrote. There is a clear benefit to giving hepatitis B vaccines at birth, and not doing so can lead to lifelong danger, experts say.
奥菲特表示，进行这样的研究“意味着有值得研究的东西，而他们却没有证据”。
Conducting a study like this “makes the case that there’s something that’s worthy of study, for which they have no evidence,” Offit said.
奥菲特补充道：“全世界有数百万、可以说是数亿儿童在出生时接种了该疫苗，也有没接种的。如果有任何证据表明这有问题，你现在早就知道了。我们在美国启动该计划几年内，几乎就在儿童中消灭了乙肝，所以益处是显而易见的。” 沙尔茨-布赫霍尔泽也对出生时接种乙肝疫苗的有效性和安全性表示怀疑，并指出他认为该研究被取消是因为它挑战了“主流医学假设，例如HBV0没有非特异性效应”。
“We have millions and millions, arguably hundreds of millions, of children in this world who have gotten that vaccine as a birth dose or haven’t. If there was any evidence that this was problematic, you would know this by now,” Offit added. “We eliminated hepatitis B in the United States in children virtually within years of starting that program, so the benefits are clear.”Schaltz-Buchholzer also cast doubt on the effectiveness and safety of the hepatitis B vaccine at birth, noting that he believes the study was canceled because it challenges “prevailing medical assumptions, such as that HBV0 does not have non-specific effects”.
除了关注死亡率，该研究还本将考察皮肤病和神经发育疾病等副作用。数十项研究已显示疫苗接种与自闭症无关。
The study, in addition to looking at mortality, would have also examined side effects like skin conditions and neurodevelopmental conditions. Dozens of studies have shown no link between vaccination and autism.
奥菲特说：“所有新生儿都应接种出生剂量乙肝疫苗。几内亚比绍是一个慢性乙肝高发国家。可以说，那个国家比任何其他国家都更需要启动这一项目。”
“All newborns should be given a birth dose of hepatitis B vaccine,” Offit said. “Guinea-Bissau is a country that suffers a high incidence of chronic hepatitis B. That country, more than any other country, arguably, needs to launch this program.”