小罗伯特·肯尼迪宣布将终止针对新冠疫苗制造商的紧急责任豁免权
RFK Jr. Announces He's Ending Emergency Liability Protection For COVID-19 Vaccine Makers

原始链接: https://www.zerohedge.com/covid-19/rfk-jr-announces-hes-ending-emergency-liability-protection-covid-19-vaccine-makers

卫生部长小罗伯特·F·肯尼迪宣布终止针对新冠疫苗、疗法及医疗器械的紧急状态声明,并指出支撑这些紧急措施的条件已不复存在。 这些发布于2020年的声明曾为制造商提供了广泛的责任豁免,并降低了产品审批的证据门槛。尽管上届政府官员曾以风险持续为由将这些保护措施延长至2029年,但肯尼迪认为,此类措施破坏了透明度与问责制。他指出,美国食品药品监督管理局(FDA)已将所有新冠疫苗转为常规审批,因此紧急授权已无必要。 为确保平稳过渡,终止措施将分阶段进行:针对疫苗和药物的声明将于2027年6月29日终止,而针对测试等医疗器械的声明将于2026年12月26日终止。FDA目前正与制造商协调,协助其为产品的持续使用寻求标准监管审批。肯尼迪强调,此举旨在确保紧急权力保持严格的临时性和针对性,从而重塑公众信心。

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原文

Authored by Zachary Stieber via The Epoch Times,

Health Secretary Robert F. Kennedy Jr. is ending emergency declarations for COVID-19 vaccines, treatments, and medical devices, after determining that the circumstances that resulted in the declarations are no longer in place.

The health secretary in office in early 2020 issued emergency declarations, providing liability protections for companies that made products for COVID-19 and enabling regulators to issue emergency authorizations, which have a lower evidentiary threshold than regular approval.

The declarations were extended multiple times, most recently in 2024 by then-Health Secretary Xavier Becerra through the end of 2029.

They provided broad immunity to manufacturers of the products, as well as people who administered them to others.

Becerra said in the latest extension that while the COVID-19 public health emergency expired in May 2023, COVID-19 “continues to present a credible risk of a future public health emergency” and that keeping the protections in place was necessary to keep the United States prepared for that threat.

Kennedy disagreed, writing in a notice of termination that “circumstances no longer exist to justify emergency use of drugs and biological products during the COVID-19 pandemic.”

He cited how regulators in 2025 revoked emergency authorization for COVID-19 vaccines, transitioning to typical approval for all the shots across all available ages.

“Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” Kennedy said in a statement.

“By ending these COVID-19 emergency use authorization declarations, we’re reinforcing public confidence that emergency authorities are temporary and targeted.”

To terminate emergency declarations, a health secretary has to provide advance notice that would give a reasonable amount of time to companies to withdraw the products that have been generated under the declarations.

The Food and Drug Administration determined that 12 months is a sufficient period of time, according to health officials. The declarations for vaccines and drugs will thus terminate effective June 29, 2027.

The declarations for medical devices such as COVID-19 tests will only stay in place for 180 days, or until Dec. 26, 2026.

The FDA has been working with manufacturers of all products still under emergency authorization about seeking approval for continued use, and it is reasonable to conclude that manufacturers will be able to generate data that would support fresh filings to regulators, the notice stated.

Officials plan to notify Congress of the development, the Department of Health and Human Services said.

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