Serious illnesses or even deaths may rarely occur after childhood vaccinations. Public health programs are faced with great challenges to establish if the events presenting after the administration of a vaccine are due to other conditions, and hence a coincidental presentation, rather than caused by the administered vaccines. Given its priority, the Global Advisory Committee for Vaccine Safety (GACVS) commissioned a group of experts to review the previously published World Health Organization (WHO) Adverse Event Following Immunization (AEFI) causality assessment methodology and aide-memoire, and to develop a standardized and user friendly tool to assist health care personnel in the processing and interpretation of data on individual events, and to assess the causality after AEFIs. We describe a tool developed for causality assessment of individual AEFIs that includes: (a) an eligibility component for the assessment that reviews the diagnosis associated with the event and identifies the administered vaccines; (b) a checklist that systematically guides users to gather available information to feed a decision algorithm; and (c) a decision support algorithm that assists the assessors to come to a classification of the individual AEFI. Final classification generated by the process includes four categories in which the event is either: (1) consistent; (2) inconsistent; or (3) indeterminate with respect of causal association; or (4) unclassifiable. Subcategories are identified to assist assessors in resulting public health decisions that can be used for action. This proposed tool should support the classification of AEFI cases in a standardized, transparent manner and to collect essential information during AEFI investigation. The algorithm should provide countries and health officials at the global level with an instrument to respond to vaccine safety alerts, and support the education, research and policy decisions on immunization safety.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.vaccine.2013.08.087 | DOI Listing |
BMC Infect Dis
December 2024
Institute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, No. 3399 Binsheng Road, Binjiang District, Hangzhou, P.R. China.
Background: Previous evidence had suggested age and sex affect the reporting rate of adverse events following immunization (AEFI), but with little exploration of potential their non-linear and interaction effects on AEFIs. Examining these non-linear effects could be beneficial for identifying high-risk populations.
Methods: Using AEFI records and vaccination data from national passive surveillance system of adverse event following immunization and Zhejiang provincial immunization information system in the 2021-2022 influenza season, respectively.
Euro Surveill
December 2024
Epi-Informatics, Centre for Health Analytics, Melbourne Children's Campus, Melbourne, Australia.
IntroductionNuvaxovid became available in Australia from February 2022, a year after the first COVID-19 vaccines. This protein-based vaccine was an alternative for people who had had an adverse event to and/or were hesitant to receive an mRNA or adenovirus-based COVID-19 vaccine. Although safety from clinical trials was reassuring, small trial populations, low administration rates and limited post-licensure intelligence meant potential rare adverse events were underinformed.
View Article and Find Full Text PDFVaccine
December 2024
National Institute for Communicable Diseases, Division of Public Health Surveillance and Response, Johannesburg, South Africa; University of the Witwatersrand, Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa.
Background: Surveillance systems for monitoring and reporting adverse events following immunisation (AEFI) and adverse events of special interest (AESI) are vital in understanding safety profiles of post-marketed vaccines. Evaluation of surveillance systems is necessary for systems strengthening. We conducted the first evaluation of the South African AEFI surveillance system in its current form, established in 2018.
View Article and Find Full Text PDFDrug Saf
December 2024
Service d'Audiologie and d'Explorations Otoneurologiques, Hospices Civils de Lyon, Lyon, France.
Introduction: Improving adverse events following immunisation (AEFI) detection is vital for vaccine safety surveillance, as an early safety signal can help minimize risks. In February 2022, the World Health Organization reported a preliminary signal on sudden sensorineural hearing loss (SSNHL) following coronavirus disease 2019 (COVID-19) vaccination, 54 million persons in France received at least one dose, covering 78.8% of the population within a year.
View Article and Find Full Text PDFIndian J Med Res
December 2024
Department of Internal Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Background & objectives The COVID-19 pandemic has led to unprecedented global immunization efforts, with drive-through vaccination campaigns established to expedite and ensure safe coverage. However, research on immediate adverse events following immunization (AEFI) in these settings is limited. This study aims to evaluate the frequency and characteristics of immediate AEFI during drive-through COVID-19 vaccination campaigns in Yogyakarta, Indonesia, using the Sinovac/CoronaVac vaccine Methods This cross-sectional study utilized secondary data from the local vaccine registry managed by the Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Indonesia, from July 27 to September 6, 2021.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!