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CDC的疫苗建议陷入停滞,未解答的问题越来越多CDC vaccine recommendations are at a standstill, and unanswered questions are piling up

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迈克·斯托贝 纽约 — 美国食品药品监督管理局(FDA)近期批准了一种在老年人中测试效果良好的新型流感疫苗。但负责告知医生和公众如何使用该疫苗的联邦机构却未对此提出任何建议。

MIKE STOBBE NEW YORK — The Food and Drug Administration recently approved a new flu vaccine that tested well in older adults. But the federal agency responsible for telling doctors and the general public how to use it has made no recommendation on it.

美国疾病控制与预防中心(CDC)对 mFlusiva 疫苗的不作为,标志着长期惯例的中断。这也是该机构疫苗审查与推荐流程在过去一年被打乱、导致决策陷入停滞的一个例证。

The Centers for Disease Control and Prevention’s inaction on the mFlusiva vaccine marks a break in longstanding practice. It’s also an example of how the agency’s vaccine review-and-recommendation process has been blown up in the past year, grinding decision-making to a halt.

特朗普政府中对疫苗持怀疑态度的官员试图缩减接种建议的努力已被搁置。针对新疫苗的联邦指导意见已停止发布。而本可跨越政治分歧、公开探讨的疫苗政策问题——包括是否有确凿证据支持减少儿童接种剂量——的讨论也随之减少。

Efforts by vaccine-wary officials in President Donald Trump’s administration to scale back shot recommendations have been put on hold. Federal guidance on new vaccines has stopped. And public discussion of vaccine policy questions that might cross political divides — including whether there’s solid evidence to justify giving fewer shots to kids — has diminished.

卫生部长小罗伯特·F·肯尼迪推翻疫苗政策的运动及针对其的法律诉讼,扰乱了长期以来向美国民众提供关键健康指导的体系,影响了人们能否获得针对可预防疫苗疾病的最佳保护。

Health Secretary Robert F. Kennedy Jr.’s crusade to upend vaccine policy and the legal action opposing it have disrupted longstanding systems that deliver crucial health guidance to Americans, affecting whether people are getting the best available protection against vaccine-preventable diseases.

耶鲁大学研究政府卫生机构的卫生政策研究员杰森·施瓦茨表示:“我们发现自己正处于这样一个境地:即使新疫苗政策的可信证据已达到临界点,我们也缺乏一个显而易见的机制来将这种变化正式化。”

“We find ourselves at a point where even if credible evidence (for a new vaccine policy) has reached a tipping point, we don’t have an obvious mechanism that can formalize that change,” said Jason Schwartz, a Yale University health policy researcher who studies government health agencies.

60年来,免疫实践咨询委员会(ACIP)一直指导CDC的疫苗推荐工作。该委员会公开召开会议,审查疫苗数据,并征求各类健康团体的意见。专家组对推荐意见进行投票,提交给CDC主任,后者几乎总是采纳这些意见作为政府指导方针,从而促使公私保险机构为疫苗接种买单。

For 60 years, the Advisory Committee on Immunization Practices guided the CDC’s vaccine recommendations. The committee met publicly, reviewed vaccine data and sought input from various health groups. The panel voted on recommendations that went to the CDC director, who almost always adopted them as the government’s guidance, leading public and private insurers to pay for the shots.

共和党人特朗普任命肯尼迪负责监管包括疾控中心在内的联邦卫生机构。去年,肯尼迪解散了该委员会,并组建了一个新小组,其中包括几位反疫苗人士。随后出现了一系列有争议的决定,导致美国儿科学会和其他一些医学团体提起诉讼。

Trump, a Republican, appointed Kennedy to oversee federal health agencies, including the CDC. Kennedy last year dismissed the committee and replaced it with a group that included several anti-vaccine voices. Controversial decisions followed, leading to a lawsuit from the American Academy of Pediatrics and some other medical groups.

3月,一名联邦法官裁定肯尼迪很可能违反了联邦程序,叫停了肯尼迪小组的进一步会议,并暂停了肯尼迪减少儿童推荐疫苗数量的决定。

In March, a federal judge said Kennedy likely violated federal procedures, stopped Kennedy’s panel from holding further meetings and suspended Kennedy’s decision to reduce the number of vaccines recommended for children.

医学和公共卫生界的许多人欢迎这一决定,并将该命令视为特朗普政府对疫苗发动“攻势”中的一段喘息期。

Many in the medical and public health communities celebrated the decision and took the order as a respite from what they saw as the Trump administration’s assault on vaccines.

美国内科医师学会会长杰森·戈德曼博士表示,他希望“这意味着将回归一个透明且循证驱动的流程,以保障所有社区的健康和患者的最佳利益。”随着法院命令关闭了肯尼迪的委员会,过去常与免疫实践咨询委员会(ACIP)合作的医生团体另起炉灶。他们与明尼苏达大学的一位研究人员合作,非公开地讨论了以前在ACIP会议上提交的那类医学证据,并发布了他们自己的建议。

Dr. Jason Goldman, president of the American College of Physicians, said he hoped “it will mean a return to a transparent and evidence-driven process that safeguards the health of all communities and the best interests of our patients.” With Kennedy’s committee shut down by the court order, doctors’ groups that used to collaborate with the ACIP have gone their own way. Working with a University of Minnesota researcher, they have debated — not publicly — the kind of medical evidence formerly presented at ACIP meetings and issued their own recommendations. The trade association for private health insurers decided to heed the medical societies’ choices, and the insurers have continued to pay for shots recommended by those organizations.

私人健康保险商会决定遵循这些医学学会的选择,保险公司继续为这些组织推荐的疫苗接种买单。

The trade association for private health insurers decided to heed the medical societies’ choices, and the insurers have continued to pay for shots recommended by those organizations.

这些团体的许多建议与肯尼迪上任前ACIP和疾控中心做出的建议一致。但它们也做出了自己的更新。

Many of the groups’ recommendations match prior ones made by ACIP and the CDC before Kennedy’s arrival. But they also made their own updates.

例如,ACIP此前建议孕晚期女性接种一种新疫苗:针对呼吸道合胞病毒(RSV)的疫苗,该病毒对新生儿可能构成危险。政府专家组建议在大部分美国地区于9月至次年1月期间接种该疫苗,以配合RSV感染最常见的季节。

For example, ACIP previously recommended that a new shot be given to women late in pregnancy: a vaccine against respiratory syncytial virus, or RSV, which can be dangerous to newborns. The government panel recommended that the vaccine be given between September and January in most of the U.S., to coincide with the time of year when RSV infections are most common.

但RSV季节有时会持续更久。因此,医学团体最近表示,该疫苗应提供给这些女性,直至3月初。

But RSV season sometimes remains active longer. For that reason, the medical groups recently said the shot should be offered to those women through the beginning of March.

“我们都认识到这需要演变,”美国健康保险计划协会(健康保险行业协会)临床创新总监Chris Regal在最近的网络研讨会上表示。官方CDC指南保持不变。

“We all recognized this needs to evolve,” Chris Regal, director of clinical innovation at America’s Health Insurance Plans, the health insurance trade association, said in a recent webinar. The official CDC guidance remains unchanged. The mFlusiva flu shot is another example of the unusual way vaccine policy updates have stalled.

mFlusiva流感疫苗是疫苗政策更新以异常方式停滞的另一个例子。

The shot is the first flu vaccine made with the mRNA technology that was key to ending the COVID-19 pandemic. Kennedy has criticized mRNA vaccines and last year canceled contracts for the development of new ones. The shots also took a tortuous path through the FDA, which finally granted full approval in people ages 50 to 64.

该疫苗是首款采用mRNA技术制造的流感疫苗,该技术是结束COVID-19大流行的关键。Kennedy曾批评mRNA疫苗,并于去年取消了新疫苗的开发合同。该疫苗在FDA的审批过程也颇为曲折,最终才获批用于50至64岁人群。

The shot is the first flu vaccine made with the mRNA technology that was key to ending the COVID-19 pandemic. Kennedy has criticized mRNA vaccines and last year canceled contracts for the development of new ones. The shots also took a tortuous path through the FDA, which finally granted full approval in people ages 50 to 64.

但CDC本月悄然发布消息称,由于“法律不确定性和调查”,决定维持去年的流感疫苗推荐。这意味着mFlusiva不在今秋向公众推荐的流感疫苗名单之中。然而,医学学会建议将其作为一种选择。

But the CDC this month quietly posted that it has decided to maintain its flu vaccine endorsements from last year due to “legal uncertainties and inquiries.” That means mFlusiva is not among the listed flu vaccines recommended to the public this fall. The medical societies are recommending it as an option, however. Another ACIP function was to vote on whether certain vaccines should be covered by Vaccines for Children, a government program that pays for shots for children who have no health insurance.

ACIP的另一项职能是投票决定某些疫苗是否应纳入“儿童疫苗计划”,这是一个为无医保儿童支付疫苗费用的政府项目。

The FDA approved updated COVID-19 vaccines, but as the summer dragged on — and fall vaccination campaigns got underway — the government would not say if the VFC program will pay for those shots. It was only this week that officials confirmed orders could be placed through that program.

FDA批准了更新版COVID-19疫苗,但随着夏季拖延——秋季疫苗接种活动已启动——政府不愿说明VFC计划是否将为这些疫苗买单。直到本周,官员才确认可以通过该计划下单。

The FDA approved updated COVID-19 vaccines, but as the summer dragged on — and fall vaccination campaigns got underway — the government would not say if the VFC program will pay for those shots. It was only this week that officials confirmed orders could be placed through that program. Another question concerns the HPV vaccine, given to preteens to prevent certain cancers.

另一个问题涉及HPV疫苗,该疫苗接种给青春期前儿童以预防某些癌症。

Two HPV shots are recommended, but some recent research has suggested that perhaps one shot could be enough — at least for girls. Indeed, in 2024 the ACIP formed a working group to begin a reassessment of the recommendations.

建议接种两剂HPV疫苗,但一些近期研究表明,或许一剂就足够——至少对女孩而言。事实上,2024年ACIP成立了一个工作组,开始重新评估相关建议。

That work was derailed when Kennedy fired the entire committee. In January, he decided on his own to order that the number of recommended doses be reduced to one as part of a dramatic contraction of the childhood vaccination schedule. His decision was suspended by the judge’s order.

当肯尼迪解散整个委员会时,这项工作被迫中止。今年1月,他单方面决定下令将建议接种剂量减少至一剂,作为大幅缩减儿童疫苗接种计划的一部分。法官的命令暂停了他的决定。

Experts are trying to better understand the timing and the duration of protection from just one dose, particularly in boys. The American Academy of Pediatrics is weighing a change to its HPV vaccination recommendations and could reach a conclusion later this year, said the AAP’s Dr. James Campbell.

专家们正试图更好地了解单剂接种的保护时机和持续时间,尤其是在男孩方面。美国儿科学会(AAP)正在权衡是否修改其HPV疫苗接种建议,可能在今年晚些时候得出结论,AAP的詹姆斯·坎贝尔医生表示。

Experts are trying to better understand the timing and the duration of protection from just one dose, particularly in boys. The American Academy of Pediatrics is weighing a change to its HPV vaccination recommendations and could reach a conclusion later this year, said the AAP’s Dr. James Campbell. It’s possible that the medical societies will end up agreeing with Kennedy on just how many HPV shots make sense. But that might not necessarily clear up the current mess, Schwartz said.

医学协会最终可能会同意肯尼迪关于HPV疫苗接种多少剂合理的观点。但施瓦茨表示,这未必能理清目前的混乱局面。

“The credibility of the Trump administration, when it comes to vaccine recommendations, is so compromised in the eyes of the mainstream medical and public health communities,” he said, “that even recommendations that might align with where the public health community was trending are likely to be viewed with skepticism or distrust.” Meanwhile, the Trump administration is considering changing the federal government’s categories for vaccine recommendations, although a specific proposal has not been released and a Department of Health and Human Services spokesperson did not respond to questions about what is being contemplated. Public comments were due earlier this week.

他说:“在主流医学和公共卫生界眼中,特朗普政府在疫苗建议方面的公信力已严重受损,以至于即使建议可能符合公共卫生界的发展趋势,也很可能会遭到怀疑或不信任。”

“The credibility of the Trump administration, when it comes to vaccine recommendations, is so compromised in the eyes of the mainstream medical and public health communities,” he said, “that even recommendations that might align with where the public health community was trending are likely to be viewed with skepticism or distrust.” Meanwhile, the Trump administration is considering changing the federal government’s categories for vaccine recommendations, although a specific proposal has not been released and a Department of Health and Human Services spokesperson did not respond to questions about what is being contemplated. Public comments were due earlier this week.

与此同时,特朗普政府正在考虑更改联邦政府的疫苗建议分类,尽管具体提案尚未发布,卫生与公众服务部发言人未回应有关拟议内容的提问。公众意见征询截止日期为本周早些时候。

“The credibility of the Trump administration, when it comes to vaccine recommendations, is so compromised in the eyes of the mainstream medical and public health communities,” he said, “that even recommendations that might align with where the public health community was trending are likely to be viewed with skepticism or distrust.” Meanwhile, the Trump administration is considering changing the federal government’s categories for vaccine recommendations, although a specific proposal has not been released and a Department of Health and Human Services spokesperson did not respond to questions about what is being contemplated. Public comments were due earlier this week.

由15位民主党籍州长组成的联盟表示,拟议的变更可能会增加混乱和行政复杂性。

An alliance of 15 Democratic state governors said the proposed changes are likely to increase confusion and administrative complexity.

州长公共卫生联盟执行董事安吉拉·博蒂切拉在声明中表示:“因仓促做出的联邦变更引发的混乱而导致疾病暴发增加,承担主要冲击的是州长及其居民。”

“It’s Governors and their residents who bear the brunt of any increased disease outbreaks due to confusion related to hastily made federal changes,” Angela Botticella, managing director of the Governors Public Health Alliance, said in a statement.

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