National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
National Vaccine Advisory Committee, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Vaccine. 2024 Sep 17;42 Suppl 3(Suppl 3):125549. doi: 10.1016/j.vaccine.2023.12.059. Epub 2024 Feb 9.
During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.
在 COVID-19 大流行期间,候选 COVID-19 疫苗正在美国以前所未有的加速时间表进行开发,以潜在用于使用。预计一旦可用,根据美国食品和药物管理局 (FDA) 的紧急使用授权 (EUA) 或 FDA 批准,COVID-19 疫苗将广泛使用,并可能在短时间内接种给数百万人。在 EUA/许可后期间需要进行密集监测,以便及时发现和评估潜在的安全问题。为此,疾病预防控制中心 (CDC) 召集了一个免疫实践咨询委员会 (ACIP) 工作组,该工作组专门关注 COVID-19 疫苗安全性,由独立的疫苗安全专家和来自联邦机构的代表组成 - ACIP COVID-19 疫苗安全技术工作组 (VaST)。本报告概述了 VaST 的组织和活动,总结了作为 COVID-19 大流行期间监测疫苗安全性全面工作的一部分审查的数据,并重点介绍了 CDC、ACIP 和 FDA 为应对不断积累的授权后安全性数据而采取的选定行动。VaST 在 29 个月的时间里定期开会,从 2020 年 11 月到 2023 年 4 月;截至 2023 年 3 月,FDA 已发布了来自四家不同制造商的六种 COVID-19 疫苗的 EUA,并随后批准了其中两种 COVID-19 疫苗。这些独立的疫苗安全专家与联邦机构合作,以确保在此期间及时评估疫苗安全性数据。VaST 与 ACIP COVID-19 疫苗工作组密切合作;该工作组使用安全性数据和 VaST 的评估进行利益风险评估,并为 COVID-19 疫苗接种政策提供指导。VaST 审查的安全主题包括安全监测系统中确定的主题和其他具有科学或公共利益的主题。VaST 为 CDC 的 COVID-19 疫苗安全性监测工作提供了指导,为来自几个美国政府疫苗安全性系统的数据审查提供了一个论坛,并确保了一组多元化的科学家和临床医生(联邦政府以外的人员)迅速审查了疫苗安全性数据。在未来发生大流行或其他生物公共卫生紧急情况时,可以使用 VaST 模型加强疫苗安全性监测,通过将独立的、非政府的安全专家纳入监测过程,以及通过联邦和其他合作伙伴之间的密切合作,增强公众信心并提高透明度。
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