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FDA撤回冠状病毒肺炎带状疱疹疫苗研究结果的出版

2026-05-06 08:51 -ABC  -  浏览量:305024

  美国食品药品监督管理局(FDA)撤回了追踪新冠肺炎和带状疱疹疫苗安全性的研究报告。

  “这些研究被撤回了,因为作者得出了没有基础数据支持的广泛结论,”HHS卫生与公众服务部的一位发言人告诉ABC新闻。“FDA采取行动保护其科学过程的完整性,并确保与该机构相关的任何工作符合其高标准。”

  在就职之前和之后,HHS国务卿小罗伯特·F·肯尼迪对几种疫苗的安全性和有效性普遍表示怀疑。

  在2021年12月路易斯安那州众议院讨论要求学龄儿童接受新冠肺炎疫苗的提案时,肯尼迪错误地称这种疫苗是“有史以来最致命的疫苗”

  在去年的听证会上,肯尼迪声称疾病控制和预防中心批准新冠肺炎疫苗“没有任何科学依据”

  然而,冠状病毒肺炎疫苗是历史上研究最多的疫苗之一,大量临床研究表明,其健康益处远远超过任何潜在风险。

  此外,卫生官员表示,新冠肺炎疫苗在数万人参与的临床试验后是安全有效的,并已帮助拯救了数百万人的生命。

  CDC也声明带状疱疹疫苗是安全的,“与严重的不良事件无关”

  前CDC官员Fiona Havers博士曾负责疫苗政策,并领导CDC跟踪新冠肺炎和RSV的住院情况,她在给ABC新闻的一份声明中说,“HHS领导人现在有一个明确的模式,阻止高质量的研究,包括不支持他们整体反疫苗叙事的结果。

  “这种对纳税人资助的科学的审查非常令人担忧,”哈弗斯补充道。

  撤回研究是肯尼迪任期内的最新举措,因为部长试图重塑美国的疫苗政策

  今年8月,肯尼迪宣布政府将取消至少5亿美元的联邦资助mRNA疫苗开发,专家当时表示,这可能会影响美国对未来流行病的准备,并抑制人们对被誉为癌症和艾滋病疫苗潜在前景的技术的热情。

  也许最引人注目的是,肯尼迪撤掉了疾控中心疫苗咨询委员会的所有17名成员,并用新成员取而代之,其中许多人表达了对疫苗持怀疑态度的观点。今年早些时候,一名联邦法官中止了肯尼迪提名成员的所有投票,包括取消出生时接种乙肝疫苗的普遍建议,并缩小了预防麻疹、腮腺炎、风疹和水痘的MMRV联合疫苗的现有建议。

  FDA withdraws publication of COVID, shingles vaccine research findings

  The Food and Drug Administration (FDA) withdrew the publication of studies that tracked the safety of the COVID-19 and shingles vaccines.

  "The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data,” a spokesperson for the Department of Health and Human Services (HHS) told ABC News. "The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards."

  Both before and since taking office, HHS Secretary Robert F. Kennedy Jr. has widely sown doubt in the safety and efficacy of severalvaccines.

  During a December 2021Louisiana House of Representatives meetingdiscussing a proposal to require schoolchildren to receive the COVID-19 vaccine, Kennedy falsely called the vaccine the "deadliest vaccine ever made."

  During his confirmation hearings last year, Kennedy claimed the Centers for Disease Control and Prevention (CDC) approved COVID-19 vaccines "without any scientific basis."

  However, COVID vaccines areamong the most studied vaccines in history, with large clinical studies showing the health benefits far exceed any potential risks.

  Additionally, health officials say COVID-19 vaccines are safe and effective following clinical trials that involved tens of thousands of people, and have sincehelped save millions of lives.

  The CDC has alsostatedthat the shingles vaccine is safe and "not associated with serious adverse events."

  Dr. Fiona Havers, a former CDC official who worked on vaccine policy and led the CDC's tracking of hospitalizations from COVID-19 and RSV, said in a statement to ABC News, “HHS leaders now have a clear pattern of blocking high-quality studies that include results that don’t support their overall anti-vaccine narrative.

  "This censorship of taxpayer-funded science is extremely concerning,” Havers added.

  The withdrawal of the studies is the latest move under Kennedy's tenure, as the secretary has attempted to reshape vaccine policy in the U.S.

  In August, Kennedy announced that the government was canceling at least $500 million of federally funded mRNA vaccine development, which experts said at the time could affect U.S. preparedness for future pandemics and squashed enthusiasm for technology that has been hailed as a potential promise for cancer and HIV vaccines.

  Perhaps most notably, Kennedy removed all 17 members of the CDC's vaccine advisory committee and replaced them with new members, many of whom have expressed vaccine-skeptic views. Earlier this year, a federal judge stayed all votes taken by the Kennedy-nominated members, which included the removal of the universal recommendation for the hepatitis B shot at birth and to narrow existing recommendations for the combined MMRV shot that protects against measles, mumps, rubella and chickenpox.

  The judge also temporarily blocked changes to the childhood vaccine schedule that were made at the beginning of this year, in which Kennedy reduced the number of recommended shots from 17 to 11.

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