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

Vaccine, Journal Year: 2024, Volume and Issue: 42, P. 125549 - 125549

Published: Feb. 9, 2024

During the COVID-19 pandemic, candidate vaccines were being developed for potential use in 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, would be broadly used potentially administered to millions of individuals a short period time. Intensive monitoring post-EUA/licensure necessary timely detection assessment safety concerns. To address this, Centers Disease Control Prevention (CDC) convened Advisory Committee Immunization Practices (ACIP) work group focused solely vaccine safety, consisting independent experts representatives from federal agencies - ACIP Vaccine Safety Technical Work Group (VaST). This report provides overview organization activities VaST, summarizes data reviewed as part comprehensive effort monitor during highlights selected actions taken by CDC, ACIP, response accumulating post-authorization data. VaST regular meetings over course 29 months, November 2020 through April 2023; March 2023 issued EUAs six four different manufacturers subsequently licensed two these vaccines. The collaborated with ensure this worked closely Vaccines Group; VaST's assessments benefit-risk guidance vaccination policy. topics included those identified systems other scientific public interest. provided CDC's efforts, forum review several government systems, assured diverse scientists clinicians, external government, promptly In event future pandemic biological health emergency, model could strengthen monitoring, enhance confidence, increase transparency incorporation independent, non-government into process, strong collaboration among partners.

Language: Английский

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COVID-19 vaccination: challenges in the pediatric population

Frontiers in Public Health, Journal Year: 2025, Volume and Issue: 12

Published: Jan. 29, 2025

Vaccination is considered to be one of the most effective means protecting individuals and populations from risks associated with exposure various pathogens. The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), affected people all ages worldwide. In response, several pharmaceutical companies rapidly leveraged their resources develop vaccines within a very short period time, leading introduction new, improved, combination for community-wide immunization. This review aims provide summary available literature on efficacy safety in pediatric population ranging 0 18 years. An analysis recent published studies reveals that majority clinical trials have reported sustained immune response following vaccination children across age groups authors highlighted effectiveness immunization schedules adolescents. population-level this remains determined, provided benefits outweigh potential risks. Long-term side effects must still monitored enable development safer more future pandemics.

Language: Английский

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Umbrella review of the safety of Chikungunya vaccine platforms used in other vaccines

Human Vaccines & Immunotherapeutics, Journal Year: 2025, Volume and Issue: 21(1)

Published: Feb. 11, 2025

Chikungunya virus (CHIKV), transmitted through Aedes mosquitoes, is a significant global health concern. Various vaccine platforms have been explored to combat CHIKV, including formalin inactivation, live-attenuated strains, virus-like particles (VLPs), viral vectors, and mRNA technologies. This umbrella review synthesizes evidence on the safety profiles of used in vaccines that applied other vaccines, focusing adverse events special interest (AESI) pregnant persons, children, adolescents. A comprehensive overview systematic reviews (SRs) was conducted. Results: Seven were included complemented with primary studies. Vaccines like influenza, human papillomavirus (HPV), COVID-19, which share showed no increase AESI. Moderate-to high-quality SRs supported favorable profiles. sharing generally exhibit acceptable

Language: Английский

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Active Surveillance for Vaccine Safety Using Sequential Analysis with Application to COVID-19 Vaccines in Korea (Preprint)

Published: March 28, 2025

With the advent of new vaccines, including COVID-19 vaccines introduced during recent pandemic, need for near-real-time active surveillance has increased to support timely regulatory decision-making. This study aimed assess feasibility sequential monitoring potential adverse events following immunization in Korea, focusing on vaccines. population-based utilized a linked database that combined registry with national health insurance claims data. Subjects included are individuals aged over 12 years who received either monovalent or bivalent Korea between February 2021 and March 2023. Monthly retrospective testing was performed three pre-specified outcomes (acute myocardial infarction, myocarditis, anaphylaxis) as well negative control event (colonic diverticulitis). A Poisson-based maximized probability ratio test applied compare post-vaccination incidence rates historical background rates, accounting multiple processing delays. Analyses were stratified by age group, vaccine platform, dose. 43 million 6.3 recipients. Sequential analyses identified statistical signals myocarditis mRNA 12–64 years, protein subunit those 40–64 years. Signals anaphylaxis observed non-replicating viral vector 18 No safety acute infarction colonic diverticulitis. detected before authorities took actions, earliest September 30 April 30, 2021, respectively. Near-real-time vaccination. These recognized authority associated demonstrating this approach detect requiring further causality assessments, particularly newly at an early stage.

Language: Английский

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Timing Matters: Exploring the Role of the Time to Onset in Recall Bias for Adverse Events Following Immunization (AEFIs) of COVID-19 Vaccines from Spontaneous Reports

Pharmacoepidemiology, Journal Year: 2025, Volume and Issue: 4(2), P. 8 - 8

Published: April 7, 2025

Objective: The aim of this study was to investigate a possible relationship between the time onset (TTO) adverse events following immunization (AEFIs) and recall bias compare it AEFIs COVID-19 vaccines reported though spontaneous reporting system (SRS) those from cohort event monitoring (CEM) study. Methods: A retrospective comparing TTO patterns four SRS CEM performed. Reports concerning related vaccination were used for stratified dose number, perceived burden AEFI, being pre-defined. Additionally, since menstrual disorders received much media attention, their effect on pattern investigated reports only. Results: total 160,613 19,979 CEM, containing 755,647 103,703 AEFIs, respectively, included. For with short TTO, no differences in observed. However, median lower increasing duration. There both before during episodes but correlation two could be found. Conclusions: Based performed analyses, does not seem more evident compared studies TTO. longer may pronounced.

Language: Английский

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Development of COVID-19 vaccine policy — United States, 2020–2023

Vaccine, Journal Year: 2023, Volume and Issue: unknown, P. 125512 - 125512

Published: Dec. 1, 2023

COVID-19 vaccines represent a great scientific and public health achievement in the face of overwhelming pressures from global pandemic, preventing millions hospitalizations deaths due to United States. Over 675 million doses have been administered States, over 80% U.S. population has had at least 1 dose vaccine. course pandemic one people died COVID-19, six were hospitalized. It estimated that prevented more than 18 additional 3 From beginning 2020 through June 2023, ACIP 35 focused meetings 24 votes for vaccine recommendations. critical task rapidly thoroughly reviewing emerging evolving data on epidemiology vaccines, as well making comprehensive population-based recommendations policy considerations implementation transparent evidence-based framework. Safe effective recommended discussions with ACIP, remain best tool we prevent serious illness, hospitalization death COVID-19.

Language: Английский

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Planning for the future of maternal immunization: Building on lessons learned from the COVID-19 pandemic

Vaccine, Journal Year: 2024, Volume and Issue: 42, P. 125644 - 125644

Published: Feb. 29, 2024

Language: Английский

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Autoimmune Encephalitis, Neuromyelitis Optica Spectrum Disorder and Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease: Analysis of the Vaccine Adverse Event Reporting System (VAERS)

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2024, Volume and Issue: unknown

Published: July 19, 2024

ABSTRACT Introduction Autoimmune encephalitis (AE), neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) are complex debilitating neurological disorders. Methods This study uses the Vaccine Adverse Event Reporting System (VAERS) to investigate potential relationship between vaccinations incidence of NMOSD, AE, MOGAD. Potential risk factors, such as age, sex, type vaccine, previous history autoimmune diseases, were examined using multivariate logistic regression analysis. Results Our analysis included 161 cases: 72 82 7 The COVID-19 vaccine was implicated in 19/72 (26.3%) 43/82 (52.4%) AE 6/7 (85.7%) subacute temporal profile ( OR 24.4, p = 0.004 ) presence any comorbidity 12.49, significantly associated with hospitalization for those NMOSD. onset symptoms encephalopathy statistically significant 6.15, 0.048 10.3, 0.005 respectively patients AE. Anti-NMDAR (N-methyl D-aspartate) antibodies observed 16/24 (66.7%) Treatment often involved high-dose corticosteroids or intravenous immunoglobulin (IVIG). Conclusions Most cases induced MOGAD occurred secondary SARS-CoV-2 vaccine. most hospitalization.

Language: Английский

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Risk of adverse events after Omicron XBB-adapted BNT162b2 COVID-19 vaccination in the United States

Vaccine, Journal Year: 2024, Volume and Issue: 45, P. 126629 - 126629

Published: Dec. 18, 2024

Language: Английский

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