COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic.

Autor: Markowitz LE; National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: lem2@cdc.gov., Hopkins RH Jr; National Vaccine Advisory Committee, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Broder KR; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Lee GM; Stanford University School of Medicine, Stanford, CA, USA., Edwards KM; Vanderbilt University School of Medicine, Nashville, TN, USA., Daley MF; Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA., Jackson LA; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA., Nelson JC; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA., Riley LE; Weill Cornell School of Medicine, New York, NY, USA., McNally VV; Franny Strong Foundation, West Bloomfield, MI, USA., Schechter R; Association of Immunization Managers, California Department of Public Health, Richmond, CA, USA., Whitley-Williams PN; Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA., Cunningham F; Department of Veterans Affairs, Veterans Affairs Center for Medication Safety - Pharmacy Benefit Management Services, Hines, IL, USA., Clark M; Indian Health Service (IHS), IHS National Pharmacy & Therapeutics Committee, Anchorage, AK, USA., Ryan M; Defense Health Agency, Immunization Healthcare Division, San Diego, CA, USA., Farizo KM; Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Wong HL; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Kelman J; Centers for Medicare & Medicaid Services, Baltimore, MD, USA., Beresnev T; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA., Marshall V; Office of the Assistant Secretary for Health, Department of Health and Human Services, Washington, DC, USA., Shay DK; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Gee J; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Woo J; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., McNeil MM; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Su JR; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Shimabukuro TT; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Wharton M; National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA., Keipp Talbot H; Vanderbilt University School of Medicine, Nashville, TN, USA.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2024 Feb 09. Date of Electronic Publication: 2024 Feb 09.
DOI: 10.1016/j.vaccine.2023.12.059
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Published by Elsevier Ltd.)
Databáze: MEDLINE
Externí odkaz: