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Two days left to comment on HHS's vaccine category proposal

还剩两天对 HHS 的疫苗类别提案发表评论
2026-09-18  ·  Katelyn Jetelina | Your Local Epidemiologist (Substack)  ·  原文

Okay, this one’s a bit in the weeds, but it’s worth your attention.

好吧,这个有点杂乱,但值得你注意。

There’s a Federal Register notice that could narrow access to vaccines and sow further confusion in the United States.

联邦公报的一份通知可能会缩小疫苗的获取范围,并在美国造成进一步的混乱。

The Department of Health and Human Services gave the public an unusually short window to weigh in.

卫生与公共服务部给了公众一个异常短暂的参与权窗口。

There are legitimate ways to improve our systems, but what they’re likely planning isn’t one of them.

有一些合法的方法可以改进我们的系统,但他们计划的可能不是其中之一。

To ensure accountability, transparency, and continued broad access to vaccines, it’s worth taking a few minutes to submit a comment.

为了确保问责制、透明度和持续广泛获得疫苗,值得花几分钟时间提交评论。

They are due in two days (September 20, 2026).

截止日期为两天(2026 年 9 月 20 日)。

On August 24, 2026, HHS published a Request for Information (RFI) in the Federal Register titled “Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making.” On its face, it asks whether the current federal vaccine recommendation categories (routine/universal, risk-based, and shared clinical decision-making [SCDM]) are adequate or if other categories should be added.

2026 年 8 月 24 日,HHS 在《联邦公报》上发布了一份题为“联邦疫苗建议中使用的类别和共享临床决策的作用”的信息请求 (RFI)。从表面上看,它询问当前的联邦疫苗推荐类别(常规/通用、基于风险和共享临床决策 [SCDM])是否足够,或者是否应添加其他类别。

But it goes far beyond that by also asking the public to weigh in on how vaccines get recommended in the first place, including how to weigh scientific evidence, how to approach limited randomized controlled trial data, and how to handle issues of vaccine requirements, freedom, and parental consent.

但它远不止于此,它还要求公众首先考虑如何推荐疫苗,包括如何权衡科学证据,如何处理有限的随机对照试验数据,以及如何处理疫苗要求、自由和家长同意的问题。

Legitimate, narrow questions are mixed with much broader ones that signal an attempt to build the case for major policy shifts without going through the accountability process already in place for vaccines.

合法的、狭隘的问题与更广泛的问题混合在一起,表明试图在不经过疫苗现有问责程序的情况下为重大政策转变提供理由。

An RFI is a formal request for public input .

RFI 是征求公众意见的正式请求。

Agencies are required to go through steps like this before making major regulatory changes.

各机构在进行重大监管变更之前必须完成此类步骤。

This is often the first visible move in a longer process.

这通常是较长过程中的第一个可见举措。

The comments become the administrative record for whatever HHS does next.

这些评论将成为美国卫生与公众服务部下一步行动的行政记录。

If HHS later adopts changes that ignore the comments, that record is what a court looks at.

如果美国卫生与公众服务部后来采取忽略这些评论的改变,那么法庭就会考虑该记录。

A thin or one-sided record makes changes easier to defend.

薄弱或片面的记录使变革更容易被捍卫。

It follows Executive Order 14420 , which endorsed cutting the “gold standard” childhood schedule from 18 diseases to 11 and directed HHS to pursue single-antigen MMR shots instead of the combined vaccine.

它遵循第 14420 号行政命令,该命令支持将“黄金标准”儿童接种计划从 18 种疾病减少到 11 种,并指示 HHS​​ 推行单抗原 MMR 疫苗而不是联合疫苗。

This isn’t HHS’s first attempt.

这不是美国卫生与公众服务部的第一次尝试。

In January, HHS moved several routine childhood vaccines (including hepatitis A, hepatitis B, flu, and meningococcal) into the shared clinical decision-making category without ACIP input.

一月份,HHS 将几种常规儿童疫苗(包括甲型肝炎、乙型肝炎、流感和脑膜炎球菌)移至共享临床决策类别,无需 ACIP 参与。

A federal judge blocked those changes in March.

一名联邦法官在三月份阻止了这些改变。

The comment window is unusually short.

评论窗口异常短。

30 days (compared with the typical 60- or 90-day windows for significant HHS actions).

30 天(与 HHS 重大行动的典型 60 或 90 天窗口相比)。

Reclassifying a vaccine from “routine” to “shared clinical decision-making” or to a new, lower-confidence category may seem like a technical, semantic change, but it isn’t.

将疫苗从“常规”重新分类为“共同临床决策”或新的、置信度较低的类别可能看起来像是技术上、语义上的改变,但事实并非如此。

These categories are incredibly load-bearing:

这些类别的承载能力令人难以置信:

Confusion.

混乱。

New categories will create confusion among parents, caregivers, clinicians, and the public.

新的类别将在家长、看护者、临床医生和公众之间造成混乱。

Parents may misunderstand which vaccines are beneficial, and clinicians may be unsure about what they should confidently recommend.

父母可能会误解哪些疫苗是有益的,临床医生可能不确定他们应该自信地推荐什么疫苗。

Insurance coverage.

保险范围。

Right now, vaccines still get no-cost coverage under the ACA and the Vaccines for Children program.

目前,疫苗仍然可以根据平价医疗法案和儿童疫苗计划获得免费承保。

That’s because they’re still on the CDC schedule as ACIP recommendations.

这是因为它们仍然作为 ACIP 的建议列在 CDC 时间表上。

The ACIP link guarantees coverage.

ACIP链路保证覆盖。

The RFI is the first step in a longer process that could break that link, either by creating a category outside ACIP or by narrowing or removing recommendations.

RFI 是一个较长过程中的第一步,该过程可能会通过在 ACIP 之外创建一个类别或通过缩小或删除建议来打破这种联系。

A vaccine that loses its ACIP link could result in a copay, a prior authorization hurdle, or no coverage at all.

失去 ACIP 链接的疫苗可能会导致自付额、事先授权障碍或根本没有承保范围。

Default behavior in the system.

系统中的默认行为。

Electronic health record (EHR) and immunization information system (IIS) reminders, school-entry requirements, and pharmacist standing orders are all built around the status of “routine” recommendations.

电子健康记录(EHR)和免疫信息系统(IIS)提醒、入学要求和药剂师常规命令都是围绕“常规”建议的状态建立的。

Many state laws and pharmacists’ scope-of-practice rules key off that specific word, so relabeling creates confusion at the state level.

许多州法律和药剂师的执业范围规则都排除了该特定词,因此重新标签会在州一级造成混乱。

Moving a vaccine out of that category adds significant implementation barriers that will erode access to vaccines.

将疫苗移出该类别会增加重大的实施障碍,从而削弱疫苗的获取。

Rumors are circulating that comments supporting Secretary Kennedy’s approach substantially outnumber those opposing it in this docket, in part because opponents of the current CDC/ACIP process have been organizing to submit comments for months, while supporters of the existing vaccine schedule have not mobilized on the same scale.

有传言称,在这份清单中,支持肯尼迪部长的做法的评论远远多于反对的评论,部分原因是当前 CDC/ACIP 程序的反对者几个月来一直在组织提交评论,而现有疫苗计划的支持者却没有以同样的规模动员起来。

In fact, only 30 days were available, which is unusually short.

事实上,只有30天的时间,这是异常短暂的。

Here are four tips and details that may help guide your comment.

以下四个提示和细节可能有助于指导您的评论。

Upgrade your subscription to access more information.

升级您的订阅以访问更多信息。

Docket: HHS-OS-2026-0332 (Be sure to include the Docket number in your comment)

案卷:HHS-OS-2026-0332(请务必在评论中包含案卷编号)

Submit at: federalregister.gov – Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making → click “Submit a Public Comment” and follow the instructions.

提交至:federalregister.gov – 信息请求:联邦疫苗建议中使用的类别和共享临床决策的作用 → 单击“提交公共评论”并按照说明进行操作。

Identify the specific question you are discussing in the comment by placing the question number in brackets before each comment, such as [B.4] or [E.17].

通过将问题编号放在每条评论之前的括号中来识别您在评论中讨论的具体问题,例如 [B.4] 或 [E.17]。

You can find these questions under section 2, which is titled “ Request for information ” .

您可以在标题为“信息请求”的第 2 节中找到这些问题。

CIDRAP had great suggestions on what questions to answer, depending on your role (e.g., if you run a pediatric practice , questions 1, 7, and 11 are yours).

CIDRAP 对于要回答哪些问题提供了很好的建议,具体取决于您的角色(例如,如果您经营儿科诊所,则问题 1、7 和 11 就是您的)。

Please share this with others.

请与其他人分享。

If the docket is indeed skewed toward narrowing vaccine categories, that’s fixable, but only if people who support vaccine access take 10 minutes to submit a comment before September 20.

如果议程确实倾向于缩小疫苗类别,这是可以解决的,但前提是支持疫苗接种的人在 9 月 20 日之前花 10 分钟提交评论。

It’s up to the public to protect broad access to vaccines.

公众有责任保护疫苗的广泛使用。

Submitting a comment is one small way to hold accountable the systems meant to protect our health.

提交评论是让旨在保护我们健康的系统承担责任的一种小方法。

Your Local Epidemiologist (YLE) comprises a team of experts, ranging from physicians to immunologists to epidemiologists to nutritionists, working together with one goal: to “translate” ever-evolving public health science so that people are well-equipped to make evidence-based decisions.

您的当地流行病学家 (YLE) 由一个专家团队组成,其中包括医生、免疫学家、流行病学家和营养学家,他们共同努力实现一个目标:“转化”不断发展的公共卫生科学,以便人们有能力做出基于证据的决策。

The YLE suite of newsletters reaches over 475,000 people across more than 132 countries.

YLE 新闻通讯套件覆盖超过 132 个国家/地区的 475,000 多人。

This newsletter is free to everyone, thanks to the generous support of fellow YLE community members.

感谢 YLE 社区成员的慷慨支持,本通讯免费向所有人开放。

To support the effort, subscribe or upgrade below:

为了支持这项工作,请订阅或升级如下:

My question is one from the rabit hole, but I was wondering: at the moment I am writing this post there are over 29,000 comments made, however there are only 16 posted, all dated Aug 24, while the actual document was published Aug 26.

我的问题是一个来自兔子洞的问题,但我想知道:在我写这篇文章的那一刻,有超过 29,000 条评论,但只有 16 条发布,所有日期都是 8 月 24 日,而实际文件是在 8 月 26 日发布的。

Why is this happening?

为什么会发生这种情况?

I read the notice that “Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof).

我读到了通知,“各机构审查所有提交的内容,并可能选择编辑或保留某些提交的内容(或其部分)。

Submitted comments may not be available to be read until the agency has approved them.”

在该机构批准之前,提交的评论可能无法阅读。”

I understand this is typical government practice and lingo, but it doesn’t take too much to make one suspicious.

我知道这是典型的政府做法和行话,但不需要太多就能让人产生怀疑。

中文为机器翻译,仅供参考。