Until last week, the future of vaccination for human papillomavirus, or HPV, in the United States seemed clear.
直到上周,在美国,人类乳头瘤病毒或HPV的疫苗接种未来似乎很明显。
For several years, a growing body of evidence has suggested that just a single dose of the vaccine may be as effective as two are, offering decades of protection against the virus, which is estimated to cause roughly 700,000 cases of cancer each year. More than 50 other countries have already adopted the one-dose schedule, and many experts hoped that the United States might follow suit this year.
几年来,越来越多的证据表明,只有一剂疫苗的疫苗可能与两剂一样有效,对病毒提供了数十年的保护,据估计,每年造成约70万例癌症病例。其他50多个国家已经采用了一剂量时间表,许多专家希望美国今年可能会效仿。
The decision rests, primarily, on the deliberations of the Advisory Committee on Immunization Practices, a vaccine-advisory committee to the CDC. ACIP was initially expected to put to a vote, as early as next week, the questions of HPV-vaccine dosing and, simultaneously, whether to strengthen the recommendations that advise vaccination starting at 9 years of age. Several experts told me that they had tentatively expected both motions to pass, making HPV vaccination easier, cheaper, and quicker. The HPV vaccine is one of the most powerful vaccines ever developed: It is unusual among immunizations in that it durably prevents infection and disease at rates close to 100 percent. If it was deployed more widely, “we could see the end of cervical cancer,” Kirthini Muralidharan, a global-health expert and HPV-vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, told me.
该决定主要是基于免疫实践咨询委员会的审议,该委员会是疾病预防控制中心的疫苗顾问委员会。最初预计ACIP最早在下周投票,这是HPV-Vaccine剂量的问题,同时,是否加强了从9岁开始的疫苗接种建议的建议。几位专家告诉我,他们暂时期望这两种动议都可以通过,这使HPV疫苗接种更加容易,更便宜,更快。HPV疫苗是有史以来开发的最强大的疫苗之一:在免疫中,它是不寻常的,因为它持久地以接近100%的速度阻止感染和疾病。如果它被更广泛地部署,“我们可以看到宫颈癌的终结,”约翰·霍普金斯彭博公共卫生学院的全球卫生专家和HPV-VACCINE研究人员Kirthini Muralidharan告诉我。
That was before Robert F. Kennedy Jr., the nation’s health secretary, abruptly dismissed all 17 members of ACIP. Among their replacements—each apparently handpicked by Kennedy—are several researchers who have spread misinformation about vaccines or been embroiled in litigation against vaccine manufacturers; at least one of the new members has exaggerated the harms of the HPV vaccine specifically. Now the anticipated votes on the vaccine, among other immunizations, have been removed from the proposed agenda for ACIP’s coming meeting, leaving the fate of the vaccine far murkier.
那是在美国卫生部长小罗伯特·肯尼迪(Robert F. Kennedy Jr.)突然驳回了ACIP的所有17名成员。在他们的替代者中,显然是由肯尼迪(Kennedy)挑选的,是几位研究人员,这些研究人员已经传播了有关疫苗的错误信息,或者被卷入针对疫苗制造商的诉讼;至少一个新成员特别夸大了HPV疫苗的危害。现在,对疫苗的预期投票以及其他免疫接种已被从拟议的议程中删除,参加了ACIP即将举行的会议,这使疫苗的命运远不及。
ACIP has, for decades, been one of the world’s most respected expert panels on vaccines. The group’s charter is to rigorously evaluate the evidence on the immunizations that the FDA has green-lighted. The advice it gives the CDC then helps devise the official immunization schedule that guides how insurers cover vaccines, how states mandate immunizations in schools, and how primary-care physicians advise their patients. Only under the rarest of circumstances has a CDC director rejected the committee’s advice. Effectively, the members of ACIP “decide who gets the vaccine, at what age, and how many doses,” Noel Brewer, a vaccine expert and health-behavior researcher at UNC Gillings School of Global Public Health, who served on ACIP until last week, told me.
几十年来,ACIP一直是世界上最受尊敬的疫苗专家小组之一。该集团的宪章是严格评估FDA绿色光的免疫的证据。然后,它给予疾病预防控制中心的建议有助于设计官方的免疫时间表,以指导保险公司介绍疫苗的方式,要求如何在学校中授权免疫以及小学保健医师如何为患者提供建议。只有在最罕见的情况下,CDC主管拒绝了委员会的建议。有效地,ACIP的成员“决定谁在几岁和多少剂量中获取疫苗”。
The group’s rigorous, data-driven approach is a primary reason the HPV-dosing strategy has yet to change. In particular, the committee was awaiting formal results from a large clinical trial in Costa Rica that has been comparing dosing strategies in adolescent girls. So far, the data, recently presented at a cancer conference, suggest that one dose is just as effective as two, the current CDC-backed regimen. Earlier this year, the ACIP working group focused on HPV vaccines was leaning toward supporting the dose drop, Brewer, who was part of that group, told me. The proposal to routinely recommend the vaccine as early as 9 years of age, he added, seemed likely to pass, too. (Currently, the CDC allows for HPV vaccination as early as 9 years of age, but only actively recommends it starting at 11 years of age.)
该小组严格,数据驱动的方法是HPV剂量策略尚未改变的主要原因。特别是,该委员会正在等待哥斯达黎加的一项大型临床试验的正式结果,该试验一直在比较青少年女孩的剂量策略。到目前为止,最近在一次癌症会议上提出的数据表明,一剂剂量与当前的CDC支持方案一样有效。今年早些时候,专注于HPV疫苗的ACIP工作组正倾向于支持剂量下降。他补充说,该提议最早在9岁时推荐该疫苗,这似乎也可能通过。(目前,疾病预防控制中心允许最早在9岁时进行HPV疫苗接种,但仅主动建议它从11岁开始。)
Those amendments to HPV-vaccination guidelines would make the shot simpler to get, for a wider range of children—which could dramatically increase its uptake, Gretchen Chapman, a health-psychology researcher at Carnegie Mellon University, told me: “The more you can make getting vaccinated easy and convenient, the higher vaccination rates will be.” Only about 60 percent of 13-to-17-year-olds in the U.S. are up-to-date on their HPV shots—a gap that public-health experts consider a major missed opportunity. That the shot can almost perfectly prevent infection and disease for decades is “like the fantasy we have of vaccines,” Brewer told me. Its rock-solid protection “just keeps rolling.”
对HPV疫苗接种指南的修订将使射击更容易获得,对于更广泛的儿童而言,卡内基·梅隆大学的健康心理学研究人员Gretchen Chapman告诉我,这可能会大大增加其吸收率,您对我说:在美国,只有大约60%的13至17岁年轻人是他们的HPV射击最新的,这一差距是公共卫生专家认为是一个主要错过的机会。布鲁尔告诉我,镜头几乎可以完全防止感染和疾病几十年来“就像我们对疫苗的幻想一样。”它的岩石固定保护“只是不断滚动。”
But the new ACIP may see matters differently. Kennedy has yet to fill the committee’s roster, but his initial picks include individuals who appear to have a beef with HPV immunization. One member, Vicky Pebsworth, co-wrote an analysis detailing adverse events following HPV vaccination for an anti-vaccine organization, which she serves on the board of. Another new member, Martin Kulldorff, provided expert testimony in cases against the drugmaker Merck over its Gardasil vaccine, the only HPV shot available in the U.S., and received thousands of dollars from plaintiffs who accused the company of downplaying the vaccine’s risks. (A judge in North Carolina overseeing one of those cases ruled in favor of Merck; another, in Los Angeles, is going to trial later this year.) And Kennedy, an environmental lawyer, has himself been instrumental in organizing the litigation campaign against Merck—and has described Gardasil as “the most dangerous vaccine ever invented.” (Under pressure from senators, Kennedy has said that he will relinquish any proceeds from these lawsuits to his son.) He has also falsely claimed that the HPV vaccine—which data show has dramatically reduced rates of cervical cancer in the U.S. and elsewhere—“actually increases the risk of cervical cancer.” (HHS, the CDC, Pebsworth, and Kulldorff did not respond to a request for comment.)
但是新的ACIP可能会有所不同。肯尼迪尚未填补委员会的阵容,但他的最初选择包括似乎患有HPV免疫的牛肉的人。一位成员Vicky Pebsworth共同撰写了一个分析,详细介绍了HPV疫苗接种后为反疫苗组织提供的不良事件,她在董事会中担任该组织。另一位新成员马丁·库尔多尔夫(Martin Kulldorff)就其Gardasil疫苗(美国唯一可用的HPV摄影剂)提供了针对制药商默克的案件的专家证词,并从原告那里获得了数千美元,这些原告指控该公司淡化了疫苗的风险。(北卡罗来纳州的一名法官负责监督其中一项裁定默克的案件;洛杉矶的另一个案件将于今年晚些时候进行审判。)环保律师肯尼迪本人在组织反对默克的诉讼方面发挥了作用,并将其描述为“曾经发明过的最危险的疫苗”。(在参议员的压力下,肯尼迪表示,他将放弃这些诉讼的任何收益给儿子。)他还错误地声称,数据显示的HPV疫苗大大降低了美国和其他地方的宫颈癌率,“实际上增加了宫颈癌的风险。”(HHS,CDC,Pebsworth和Kulldorff没有回应置评请求。)
At some point, the current ACIP might see fit to soften the existing guidelines, or even advise the CDC to remove the vaccine recommendations for certain groups. If it does, those decisions could prompt insurers to stop covering the vaccines, or disincentivize health-care providers from offering them to families. The committee could also remove the vaccine from the Vaccines for Children program, which provides shots to kids whose parents cannot afford them. (An initial agenda for the ACIP meeting scheduled to start on Wednesday initially included a recommendation vote for the HPV vaccine, as well as a vote on its status in Vaccines for Children; those items no longer appear in the CDC’s draft agenda.)
在某个时候,当前的ACIP可能认为适合软化现有准则,甚至建议CDC删除某些组的疫苗建议。如果是这样,这些决定可能会促使保险公司停止涉及疫苗,或者不愿将医疗保健提供者提供给家人。该委员会还可以从儿童疫苗计划中取出疫苗,该计划为父母负担不起的孩子提供了照片。(原定于周三开始的ACIP会议的最初议程最初包括对HPV疫苗的建议投票,以及对其儿童疫苗状况的投票;这些项目不再出现在CDC的议程草案中。)
A few of the experts I spoke with raised the possibility that this new ACIP might still amend the HPV-vaccine recommendation to a single dose, but with a different rationale: not because the members are swayed by the data on its effectiveness, but because they’d support any option that cleaves a vaccine dose from the immunization schedule. Kennedy, too, seems likely to back such a move. “Any window to roll back the number of times a child receives a vaccine injection, he’s going to push for,” Alison Buttenheim, a behavioral scientist at Penn Nursing, told me.
我与之交谈的一些专家提出了这一新ACIP可能仍然可以将HPV-Vaccine建议修改为单一剂量的建议,而是有不同的理由:不是因为成员对其有效性的数据摇摆不定,而是因为他们支持任何可以从免疫计划中切除疫苗剂量的选择。肯尼迪也似乎很可能支持这样的举动。宾夕法尼亚州护理的行为科学家艾莉森·巴特海姆(Alison Buttenheim)告诉我:“任何窗口都可以撤回儿童接收疫苗注射的次数。”
The net effect might at first seem the same: Fewer doses of the HPV vaccine would be on the schedule. But the reasoning behind a decision can matter just as much as the end result. Robert Bednarczyk, an epidemiologist and vaccine researcher at Emory University’s Rollins School of Public Health, noted that, although much of the evidence so far has pointed toward one dose being enough, the case isn’t yet a slam dunk: Some of the trials investigating the single-dose strategy are using different formulations of Gardasil, or non-Gardasil brands, which may perform differently. (The Costa Rica trial, notably, does include the same Gardasil recipe used in the U.S.) And some experts still wonder if the protection offered by a single shot may fade faster than a double-dose regimen—a more challenging aspect of vaccine protection to assess without many years of follow-up. If that’s the case, prematurely dropping the second dose could later force the U.S. to add a shot back into the vaccine schedule—a confusing message that could erode trust. The last thing the country needs now is “another hit to public confidence around vaccines,” Bednarczyk said.
最初的净效果似乎看起来一样:HPV疫苗的剂量更少。但是,决定背后的推理与最终结果一样重要。埃默里大学罗林斯公共卫生学院的流行病学家和疫苗研究员罗伯特·贝德纳尔奇克(Robert Bednarczyk)指出,尽管到目前为止,许多证据都指向一个剂量足够,但此案尚未扣篮:某些试验的一些试验调查了单剂量策略使用Gardasil,或非Gardasil of Gardasil,或非Gardasasil Brands的不同表现。(特别是哥斯达黎加的试验确实包括美国使用的Gardasil食谱),一些专家仍然怀疑,单次射击提供的保护是否可能比双剂量方案更快,这是疫苗保护的更具挑战性的评估方面,而无需多年的随访。如果是这样的话,过早地放下第二剂可能会迫使美国在疫苗时间表中添加镜头,这一令人困惑的信息可能会侵蚀信任。贝德纳尔奇克说,该国现在需要的最后一件事是“对疫苗的公众充满信心”。
How Kennedy and his allies publicly justify these choices, then, matters quite a bit. Vaccines, on the whole, are now being billed by the government not as vital, lifesaving tools, but as unnecessary risks, deserving of additional scrutiny. Of the multitude of vaccines on the childhood-immunization schedule, many people already see HPV “as the troublesome one,” Brewer told me. Its ability to prevent cancer has been underemphasized; some critics have stoked unfounded fears that, because the vaccine guards against a sexually transmitted virus, it will increase promiscuity. And unlike other vaccines recommended in the early adolescent years, such as the meningococcal vaccine and the Tdap booster—which are required by most or all states for entry into secondary school—HPV is mandated for preteens in only a handful of jurisdictions.
肯尼迪和他的盟友如何公开证明这些选择的合理性很重要。总体而言,疫苗现在被政府收费并不是重要的,救生工具,而是不必要的风险,应受到额外的审查。Brewer告诉我,在童年免疫计划中的众多疫苗中,许多人已经将HPV视为“麻烦的疫苗”。它预防癌症的能力被低调;一些批评家激起了毫无根据的恐惧,因为疫苗防止了针对性传播病毒的疫苗,这会增加滥交。并且与青少年初期推荐的其他疫苗不同,例如脑膜炎球菌疫苗和TDAP助推器(大多数或所有州都进入中学要求的疫苗)仅在几乎没有司法管辖区中为Preteens授权HHPV。
All of these pressures make the vaccine more vulnerable to being rejected, Chapman told me. And should Kennedy’s new vaccine team openly discard HPV doses primarily for the sake of dropping a shot, that could set a precedent—for removing other vaccines from the schedule, in part or entirely.
查普曼告诉我,所有这些压力使疫苗更容易被拒绝。而且,如果肯尼迪的新疫苗团队公开放弃HPV剂量,主要是为了放弃射击,这可能会树立先例 - 以部分或全部从时间表中删除其他疫苗。