专家:特朗普拆分麻腮风疫苗的目标或需十年才能实现


2026年8月12日 美国东部时间上午10:02 / 路透社
作者:迈克尔·厄尔曼

[1/2]2025年2月27日,美国得克萨斯州拉伯克市拉伯克市卫生部门内的麻腮风疫苗。路透社/安妮·赖斯

美国自2008年起不再供应单一麻疹、腮腺炎和风疹疫苗
默克公司表示,获得FDA批准并实现商业化或需长达10年时间
默克与葛兰素史克称无公开证据支持拆分麻腮风联合疫苗

8月12日(路透社)——美国总统唐纳德·特朗普下令美国民众接种单独的麻疹、腮腺炎和风疹疫苗,该命令面临直接障碍:目前美国没有任何单一疫苗获得许可,专家表示,即便有可能实现,相关疫苗也需要数年时间才能投入使用。

美国仅有两家制造商——默克公司(纽约证券交易所代码:MRK.N)和葛兰素史克(伦敦证券交易所代码:GSK.L)——获批为美国患者生产麻腮风联合疫苗。自默克2008年停止生产单一疾病疫苗以来,美国市场上就再也没有此类单一疫苗供应,且这类单一疫苗在大多数其他国家也并未常规使用。

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默克与葛兰素史克在声明中表示,没有公开的科学证据支持拆分疫苗,且有数十年来的证据证明联合疫苗的安全性。

默克公司称:“即便走当前的快速审批通道,要获得FDA批准并开始生产和商业化单一疾病疫苗,也可能需要数年时间——最多可能长达10年。”

特朗普周一签署了这项呼吁减少儿童疫苗接种的行政命令,他称此举将为美国儿童提供“黄金标准”的保护。根据该命令,“一旦此类产品在国内获批上市,麻腮风联合疫苗应分三次接种,分别对应三种单一疾病疫苗”。

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在周一的新闻发布会上,特朗普暗示疫苗会引发自闭症,尽管没有科学证据证明二者存在关联。一些公共卫生专家表示,该命令可能会加剧疫苗犹豫,使更多儿童暴露于可通过疫苗预防的疾病风险中。

美国疾病控制与预防中心(CDC)和众多主流医疗团体长期以来一直推荐使用联合疫苗,因为它能减少注射次数,并降低儿童错过针对三种疾病之一的接种保护的风险。

美国儿科学会主席安德鲁·拉辛博士表示,尽管有可能将麻腮风疫苗拆分为其组成成分,但每种不同的成分都必须重新生产并接受测试。

“他们可能至少还需要10年才能做到这一点,而且目前没有迹象表明他们有兴趣这么做。”

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美国食品药品监督管理局前首席科学家杰西·古德曼表示,仅为单一疫苗的生产流程建立并获得监管批准,就是一个耗时且耗资巨大的过程。

“他们需要生产三倍数量的小瓶或疫苗,并完成三倍数量的灌装工作,”古德曼说,“这不像他们有闲置的生产设施——因此他们可能需要改造现有设施,甚至需要额外扩建产能。”

尽管如此,一位白宫官员周一表示,本届政府将与私营部门合作,为家长提供单独接种疫苗的选择,依靠市场解决方案来实现这一目标。

“目前有很多美国民众和美国父母希望看到更多选择,”这位官员说。

专注于疫苗政策的旧金山加州大学法学院教授多里特·赖斯表示,过去新型疫苗获得许可至少需要10到18个月。考虑到特朗普的四年任期已经过去了一年半多,疫苗制造商可能会拖延执行该命令。

“如果公司本身不愿意,这事可能就成不了。公司可能会说,‘好吧,我们就等这届政府下台……或许不值得为此投资’,”赖斯说。

迈克尔·厄尔曼在新泽西州报道;朱莉·斯廷胡伊森在芝加哥、艾哈迈德·阿布勒内因在华盛顿补充报道;林肯·费斯特编辑。

我们的准则:汤姆森路透社信任原则。

Trump’s goal to split MMR vaccine could take a decade, experts say

August 12, 2026 10:02 AM UTC / Reuters

By Michael Erman

[1/2]A view shows MMR vaccine at the City of Lubbock Health Department in Lubbock, Texas, U.S. February 27, 2025. REUTERS/Annie Rice

Single measles, mumps and rubella shots have not been available in US since 2008
FDA approval and commercialization could take as many as 10 years, Merck says
Merck and GSK say no published evidence supports splitting combined MMR vaccine

Aug 12 (Reuters) – President Donald Trump’s order directing Americans to receive separate ​measles, mumps and rubella vaccines faces an immediate obstacle: none of the individual shots are licensed in the United States ‌and experts say it could take years before any become available, if they ever do.

Two manufacturers – Merck & Co MRK.N and GSK GSK.L – are licensed to make combined measles, mumps and rubella shots for patients in the United States. Single disease shots for these diseases have not been available in the U.S. since Merck stopped making them in 2008. They are ​not routinely used in most other countries.

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Merck and GSK said in statements there is no published scientific evidence supporting the separation of ​the vaccines and decades of evidence supporting the safety of their combined shots.

“Even under current expedited review pathways, it ⁠could take years – potentially as many as 10 – to meet the safety and efficacy requirements to obtain FDA approval and then begin manufacturing and commercialization” ​of single disease shots, Merck said.

Trump signed the executive order on Monday calling for fewer childhood vaccinations, which he said would give U.S. children “gold-standard” protection. ​According to the order, “the combined measles, mumps, rubella (MMR) vaccine should be administered in three separate single-disease shots once such products are domestically available.”

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At a press conference on Monday, Trump suggested that vaccines cause autism, despite a lack of scientific evidence that there is a link. Some public health experts said the order could increase vaccine hesitancy, exposing more ​children to vaccine preventable illnesses.

The CDC and many major medical groups have long recommended the combined vaccine because it reduces the number of injections ​and lowers the risk that children will miss protection against one of the three diseases.

Dr. Andrew Racine, president of the American Academy of Pediatrics, said although it’s possible ‌to separate ⁠out the MMR vaccine into its constituent components, each of those different components would have to be manufactured and have to be tested.

“They wouldn’t be able to do that probably for another 10 years, and there’s no indication that they have any interest in doing that.”

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Establishing and receiving regulatory approval for just the manufacturing processes for the separate shots could be a timely and costly process, said Jesse Goodman, former Chief Scientist at the FDA.

“They’d be ​making three times as many vials ​or vaccines and filling three ⁠times as many,” Goodman said. “It’s not like they have facilities sitting around idle – so they might need to either change current facilities or even create additional capacity for them.”

Still, a White House official said on Monday the administration ​would work with the private sector to make the option of separate vaccines available for parents, relying on ​market-based solutions.

“Right now we ⁠have a lot of Americans and a lot of American parents who want to see additional options,” the official said.

Dorit Reiss, a professor of law at UC Law San Francisco who focuses on vaccine policy, said in the past it took at least 10 to 18 months to get new vaccines licensed. ⁠Given Trump is ​already more than a year-and-a-half into a four-year term, vaccine makers might try to ​hold off on following the order.

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“It might not happen if the companies don’t really want it. The companies might say, ‘Well, we are going to wait this administration out… Maybe it’s not ​worth investing,” Reiss said.

Reporting by Michael Erman in New Jersey; Additional reporting by Julie Steenhuysen in Chicago and Ahmed Aboulenein in Washington; Editing by Lincoln Feast.

Our Standards: The Thomson Reuters Trust Principles.

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