美国法院叫停肯尼迪顾问委员会后,新冠疫苗及新型疫苗陷入停滞


2026-04-21T10:02:12.386Z / 路透社

作者:朱莉·斯滕胡森
2026年4月21日 美国中部夏令时间上午10:02 更新于26分钟前

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2025年12月5日,美国佐治亚州亚特兰大市疾控中心,罗伯特·马龙博士在免疫实践咨询委员会(ACIP)会议上倾听亚伦·西丽的发言,该会议旨在讨论儿童疫苗接种计划的推荐方案。路透社/艾莉莎·波因特/档案照片 购买授权,打开新标签页

  • 内容摘要
  • 企业动态
  • 疾控中心失去推荐新疫苗或更新疫苗的顾问委员会
  • 专家警告,新疫苗的保险覆盖范围可能受影响
  • 多款FDA批准疫苗等待ACIP指导

芝加哥,4月21日(路透社)——美国联邦法院上月的一项裁决导致多款疫苗陷入停滞,美国人可能在即将到来的呼吸道疾病季中无法获得新冠疫苗和更新版流感疫苗的明确接种指导,同时也引发了新获批产品是否会被保险公司覆盖的疑问。

总部位于波士顿的美国地区法官布莱恩·墨菲作出的这项裁定,冻结了免疫实践咨询委员会的工作。该委员会是向美国疾病控制与预防中心提供疫苗使用建议的专家小组。

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墨菲法官裁定,罗伯特·F·肯尼迪 Jr. 去年任命的委员会多数成员资质不合格,并下令暂停他们的投票,实质上恢复了美国卫生部长及其盟友此前试图修订的原有儿童免疫接种计划。

这一裁定导致疾控中心失去了能够正常运作的顾问机构,无法为新疫苗或现有疫苗的新用途提供推荐意见。

“这完全是未知领域,”疾控中心国家免疫与呼吸道疾病中心前主任德米特雷·达斯卡拉斯博士说道,他去年因抗议肯尼迪改写美国疫苗政策的举措而离职。

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范德堡大学传染病专家、长期担任ACIP顾问的威廉·沙夫纳博士表示,如果没有ACIP的推荐,新获批的疫苗和扩大的适应症——尽管合法开具——可能不会被保险公司覆盖,也不会被纳入联邦项目。

肯尼迪尚未表明他是否会重新组建该委员会,利用他修订后的ACIP章程绕过法院裁决,或是上诉法官的命令,或是两者并行。

肯尼迪领导的美国卫生与公众服务部未回应有关ACIP计划或疫苗推荐现状的置评请求。

秋季新冠及流感疫苗

最大的未知数围绕着更新版新冠疫苗。

正常年份里,ACIP会在6月的会议上审议并更新流感和新冠疫苗的推荐方案。前疾控中心官员告诉路透社,季节性流感疫苗长期以来普遍推荐给6个月及以上人群,这意味着今年可能不需要ACIP重新投票。

他们表示,新冠疫苗的情况可能并非如此。新冠疫苗每年也会更新,但针对的是新型病毒,使用记录也更短。作为长期反疫苗活动人士,肯尼迪领导下的ACIP一直将新冠疫苗的安全性作为重点议题。

“你可以说它(新冠疫苗)仍在接种计划中,因此应当被推荐,也可以说之前的推荐针对的是2025-26年度的疫苗,所以不再有效,”一位要求匿名的前疾控中心疫苗官员在谈到新冠疫苗时表示。

美国健康保险贸易组织AHIP已承诺,将覆盖截至2025年9月1日疫苗咨询委员会推荐的所有疫苗,覆盖至2026年底——这一时间段早于疫苗接种计划的重大调整。

一位保险行业消息人士称,今年及未来的健康保险计划将继续评估最新的医学证据以及美国儿科学会、传染病学会和美国妇产科学院等机构的临床指南。

法官的暂停令也对默克公司(MRK.N)的Enflonsia提出了疑问,这是一种用于预防婴儿 RSV 感染的单克隆抗体治疗药物。由肯尼迪任命的ACIP在6月投票推荐了该疗法。默克表示,该产品并非诉讼的焦点。

“我们尚未听闻Enflonsia的供应出现任何变化,”全国州与地方免疫官员组织免疫管理者协会执行董事克莱尔·汉南说道。

等待指导的疫苗

多款已获美国食品药品监督管理局批准的疫苗正在等待ACIP的推荐。其中包括三款针对18至49岁重症风险升高成年人的RSV疫苗——辉瑞公司(PFE.N)的Abrysvo、莫德纳公司(MRNA.O)的mResvia以及葛兰素史克公司(GSK.L)的Arexvy。

目前,呼吸道合胞病毒疫苗仅推荐给75岁及以上成年人以及50至74岁的高风险成年人。ACIP原本还将就75岁及以上已接种RSV疫苗的成年人是否需要加强针提供建议。

ACIP通常负责的其他工作也已暂停,包括一项长期审议:减少HPV疫苗接种剂量是否仍可预防宫颈癌。

“这正是ACIP应当开展的工作,”前ACIP主席何塞·罗梅罗博士说道,“他们可能因此脱轨。”

这种瘫痪状态还可能影响预计今年晚些时候获得FDA批准的疫苗。

本月早些时候发布的ACIP新章程仍要求委员会在FDA批准疫苗后召开的首次会议上对其进行审议。但若没有委员会到位,疫苗可能会在市场上滞留,无法获得联邦推荐。

其中包括莫德纳的实验性mRNA流感疫苗,这将是美国首款此类疫苗。FDA预计将于8月初作出决定。

若辉瑞与瓦尔内瓦公司(VLS.PA)的莱姆病疫苗获批,也需要ACIP提供推荐。该疫苗未达到主要试验终点,但在后期试验中显示出约70%的有效性,辉瑞已表示计划寻求FDA授权。

“如果疫苗未获得全面推荐,且属于新型疫苗,付款方会买单吗?”明尼苏达大学传染病专家迈克尔·奥斯特霍姆说道,“我们对此毫无保障。”

朱莉·斯滕胡森在芝加哥报道;米歇尔·格什伯格与比尔·伯克罗特编辑

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COVID shots, newer vaccines in limbo after US court halts Kennedy’s advisory panel

2026-04-21T10:02:12.386Z / Reuters

By Julie Steenhuysen

April 21, 2026 10:02 AM UTC Updated 26 mins ago

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Dr. Robert Malone listens to Aaron Siri during a meeting of the Advisory Committee on Immunization Practices (ACIP) to discuss recommendations for the childhood vaccine schedule at the Centers for Disease Control and Prevention in Atlanta, Georgia, U.S., December 5, 2025. REUTERS/Alyssa Pointer/File Photo Purchase Licensing Rights, opens new tab

  • Summary
  • Companies
  • CDC left without advisory panel to recommend new or updated vaccines
  • Insurance coverage for new vaccines may be impacted, experts warn
  • Several FDA-approved vaccines await ACIP guidance

CHICAGO, April 21 (Reuters) – Americans may face the next respiratory disease season without clear guidance for COVID shots and updated flu vaccines after a federal court ruling last month left several vaccines in limbo, and raised questions about whether some newly approved products would be covered ​by insurers.

The decision by Boston-based U.S. District Judge Brian Murphy froze the work of the Advisory Committee on Immunization Practices, the panel that advises the U.S. Centers for Disease Control and ‌Prevention on how vaccines should be used.

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Murphy ruled that most members of a panel appointed last year by Robert F. Kennedy Jr. were unqualified and ordered that their votes be put on hold, effectively restoring the previous childhood immunization schedule that the U.S. Health Secretary and his allies had sought to revamp.

The ruling leaves the CDC without a functioning advisory body to recommend new vaccines or updated uses of existing ones.

“It’s just uncharted territory,” said Dr. Demetre Daskalakis, former director of the CDC’s National Center for ​Immunization and Respiratory Diseases, who left the agency last year in protest over Kennedy’s moves to rewrite U.S. vaccine policies.

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Without ACIP recommendations, newly licensed vaccines and expanded indications — while legal to prescribe — may ​not be covered by insurers or included in federal programs, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and longtime ACIP adviser.

Kennedy has yet ⁠to say whether he will reconfigure the panel, using his revamped ACIP charter to circumvent the court ruling, appeal the judge’s order, or both.

The Department of Health and Human Services, which Kennedy leads, did not respond to ​requests for comment on plans for ACIP or the status of vaccine recommendations.

AUTUMN COVID AND FLU SHOTS

The biggest question mark surrounds updated COVID-19 vaccines.

In a normal year, ACIP reviews and updates recommendations for flu and COVID shots ​during its June meeting. Seasonal flu vaccines have a long-standing universal recommendation for everyone six months and older, which means they may not require a new ACIP vote this year, former CDC officials told Reuters.

That may not be the case for COVID vaccines, which are also modified each year but target a newer virus and have a shorter track record of use, they said. The safety of COVID vaccines has been a major focus of ACIP under Kennedy, a longtime anti-vaccine activist.

“You could argue ​that it’s recommended because it’s on the (immunization) schedule, or that it’s not because the previous recommendations were for the 2025-26 vaccine,” said one former CDC vaccine official, who requested anonymity, of COVID shots.

AHIP, the health insurance ​trade organization, has pledged to cover, opens new tab all vaccines that had been recommended by the vaccine advisory panel as of September 1, 2025, through the end of 2026 – a period before major changes to the vaccine schedule had been made.

An insurance industry ‌source said health ⁠plans this year and beyond will continue evaluating the latest medical evidence and clinical guidelines from groups such as the American Academy of Pediatrics, the Infectious Diseases Society of America and the American College of Obstetricians and Gynecologists.

The judge’s stay order also raised questions about Merck’s (MRK.N), opens new tab Enflonsia, a monoclonal antibody treatment for preventing RSV infection in infants. The Kennedy-appointed ACIP voted in June to recommend the treatment. Merck said the product was not a focus of the litigation.

“We have not heard of any changes to the availability of Enflonsia,” said Claire Hannan, executive director of the Association of Immunization Managers, a national organization of state and local immunization officials.

VACCINES AWAITING GUIDANCE

Several vaccines ​already approved by the Food and Drug Administration await ​ACIP recommendations. They include three RSV vaccines for ⁠adults aged 18–49 who are at increased risk of severe disease — Pfizer’s (PFE.N), opens new tab Abrysvo, Moderna’s (MRNA.O), opens new tab mResvia and GSK’s (GSK.L), opens new tab Arexvy.

Currently, respiratory syncytial virus vaccines are recommended only for adults aged 75 and older and for adults aged 50–74 at high risk. ACIP was also due to advise on whether adults 75 and older who already received an ​RSV shot will need a second dose.

Other work typically handled by ACIP has also been put on hold, including a long-running review of whether fewer doses ​of the HPV vaccine could ⁠still prevent cervical cancer.

“That’s the type of work the ACIP should be doing,” said Dr. Jose Romero, a former ACIP chair. “They may be derailed from that.”

The paralysis could also affect vaccines expected to win FDA approval later this year.

ACIP’s new charter, issued earlier this month, still guides the panel to review new vaccines at its first meeting after FDA licensure. If no panel is in place, however, vaccines could linger on the market without any federal recommendation.

That includes ⁠Moderna’s experimental mRNA-based ​flu vaccine, which would be the first of its kind in the United States. An FDA decision is expected by early August.

ACIP ​recommendations would be needed if Pfizer and Valneva’s (VLS.PA), opens new tab Lyme disease vaccine wins approval. The vaccine missed its primary goal but showed about 70% efficacy in a late-stage trial, and Pfizer has said it plans to seek FDA authorization.

“If the vaccine is not fully recommended and it’s ​a newer vaccine, will the payers pay?” said Michael Osterholm, an infectious disease expert at the University of Minnesota. “We don’t have any guarantee of that.”

Reporting by Julie Steenhuysen in Chicago; Editing by Michele Gershberg and Bill Berkrot

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