Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004–2009

Lee

et al. 2017

Clin Exp Vaccine Res

PurposeIn recent years, research on reported adverse events following immunization (AEFI) and claims filed for compensation has been lacking. We reviewed reported AEFIs and compensation claims in Korea from 2011 to 2016.Materials and MethodsWe listed all of the AEFI registered in the Integrated Management System of Disease and Public Health and reviewed the list of claims filed and serious AEFIs reported from 2011 to 2016.ResultsAn average of 278 AEFI cases was reported annually from 2011 to 2016. Of these, 31 deaths were reported. However, there was no association found between these deaths and vaccinations when evaluating vaccine lot, reviewing autopsies, and considering underlying diseases. AEFI reporting rate was as high as 20.8 cases for bacillus Calmette–Guérin (BCG) vaccine, 7.3 cases for 23-valent pneumococcal polysaccharide vaccine (PPV23), and 5.4 cases for human papillomavirus vaccine per 100,000 vaccination doses in 2016. Of the 469 total cases that claimed vaccine injury compensation from 2011 to 2016, the BCG vaccine was most commonly involved, with 235 cases (50%), followed by influenza vaccine and PPV23, with 90 and 55 cases, respectively. Of these cases, 96% of BCG-related AEFI were compensated, while only 31% and 49% of AEFI following influenza and PPV23 vaccination, respectively, were compensated. Common characteristics of uncompensated cases included the elderly subjects, receiving influenza vaccine, having underlying disease, or a very short time interval between vaccination and symptoms.ConclusionWe have maintained vaccine safety management system through both rapid response to serious AEFI and vaccine injury compensation in order to sustain public trust in the National Immunization Program.

Section: Introductionmentioning

confidence: 99%

Surveillance and compensation claims for adverse events following immunization from 2011 to 2016 in the Republic of Korea

Lee

et al. 2017

Clin Exp Vaccine Res

Paediatrics &Amp; Child Health

“…This role is important because there is growing evidence to suggest that the occurrence of an AEFI significant enough to require medical attention may adversely affect a family's confidence in the safety of immunization and lead to refusal of future immunizations (13)(14)(15). For these reasons, a specialized service for patients with previous AEFI or potential contraindications to immunization should be considered to be an essential component of every universal immunization program (9)(10)(11)16,17).…”

Section: Discussionmentioning

confidence: 99%

Canadian paediatricians' approaches to managing patients with adverse events following immunization: The role of the Special Immunization Clinic network

Top

Zafack

et al. 2014

“…26 Each site contributes electronic health data that can be used to monitor vaccine safety and conduct studies about rare and serious adverse events. 27 The CISA Project, 28 using the statistical signals reported by the Vaccine Safety Datalink, enables vaccine safety experts to conduct detailed clinical reviews of patients who had an adverse event possibly caused by a vaccine, and to identify possible risk factors. 29 These studies are particularly important for understanding adverse events in certain populations, such as pregnant women and immunocompromised patients, who are typically excluded from pre-licensure clinical trials.…”

Section: Safety Studiesmentioning

confidence: 99%

An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19

et al. 2021

The Food and Drug Administration generally approves vaccines when their benefits outweigh their risks for their intended use. In this paper, we review current and potential approaches to this critical role of the FDA. The FDA has established pathways to accelerate vaccine availability prior to approval, such as emergency use authorization, and to channel resources to high-priority products and allow more flexibility in the evidence required for approval, including accelerated approval based on surrogate markers of effectiveness. Among the 35 new vaccines approved in the US from 2006-2020, about two-thirds of their pivotal trials used the surrogate outcome of immune system response, and just one-third evaluated actual disease incidence. Post-approval safety surveillance of new vaccines-particularly vaccines receiving expedited approval-is crucial. Currently this is accomplished through such mechanisms as the Centers for Disease Control and Prevention/FDA Vaccine Adverse Event Reporting System, the CDC Vaccine Safety Datalink, and the CDC Clinical Immunization Safety Assessment Project. Adverse events detected in this way may lead to changes in a vaccine's recommended use or its withdrawal from the market. Regulatory oversight of new vaccines will have to balance speed with rigor and decisiveness to effectively address the coronavirus disease 2019 (COVID-19) pandemic.