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Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.

ABSTRACT: OBJECTIVES:To determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies). DESIGN:Simulation study. SETTING:Western Australian vaccine influenza coverage and adverse event surveillance data. OUTCOME MEASURES:Simulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years. PARTICIPANTS:None. RESULTS:We estimated a >90% probability of a safety signal being detected by AusVaxSafety based on solicited reports for either fever or medical attendance at or before the week ending 28 March 2010, 3 weeks after the start of vaccine distribution. Suspension of the national paediatric influenza vaccination programme as a result of the passive adverse events surveillance operating at the time did not occur until 23 April 2010. CONCLUSIONS:Active vaccine safety surveillance leading to rapid detection of a safety signal would likely have resulted in earlier suspension of Fluvax from the vaccination programme, prevention of many febrile convulsions and maintenance of public confidence in influenza vaccination for young children.

SUBMITTER: Jacoby P

PROVIDER: S-EPMC7050305 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.

Jacoby Peter P Glover Catherine C Damon Chloe C Fathima Parveen P Pillsbury Alexis A Durrheim David D Gold Michael S MS Leeb Alan A Snelling Tom T

BMJ open 20200301 2

<h4>Objectives</h4>To determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies).<h4>Design</h4>Simulation study.<h4>Setting</h4>Western Australian vaccin ...[more]

PMID: 32122906

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Project description:BackgroundWomen/females report more adverse events (AE) following immunization than men/males for many vaccines, including the influenza and COVID-19 vaccines. This discrepancy is often dismissed as a reporting bias, yet the relative contributions of biological sex and gender are poorly understood. We investigated the roles of sex and gender in the rate of AE following administration of the high-dose seasonal influenza vaccine to older adults (≥ 75 years) using an AE questionnaire administered 5-8 days post-vaccination. Participant sex (male or female) was determined by self-report and a gender score questionnaire was used to assign participants to one of four gender categories (feminine, masculine, androgynous, or undifferentiated). Sex steroid hormones and inflammatory cytokines were measured in plasma samples collected prior to vaccination to generate hypotheses as to the biological mechanism underpinning the AE reported.ResultsA total of 423 vaccines were administered to 173 participants over four influenza seasons (2019-22) and gender data were available for 339 of these vaccinations (2020-22). At least one AE was reported following 105 vaccinations (25%), by 23 males and 82 females. The majority of AE occurred at the site of injection, were mild, and transient. The odds of experiencing an AE were 3-fold greater in females than males and decreased with age to a greater extent in females than males. The effects of gender, however, were not statistically significant, supporting a central role of biological sex in the occurrence of AE. In males, estradiol was significantly associated with IL-6 and with the probability of experiencing an AE. Both associations were absent in females, suggesting a sex-specific effect of estradiol on the occurrence of AE that supports the finding of a biological sex difference.ConclusionsThese data support a larger role for biological sex than for gender in the occurrence of AE following influenza vaccination in older adults and provide an initial investigation of hormonal mechanisms that may mediate this sex difference. This study highlights the complexities of measuring gender and the importance of assessing AE separately for males and females to better understand how vaccination strategies can be tailored to different subsets of the population.

Project description:BackgroundOral adverse events (AEs) following COVID-19 vaccination have been sporadically reported during the previous months, warranting further investigation for their prevalence and suspected relationship with vaccine-elicited immune response.MethodsA retrospective analysis using the Vaccine Adverse Event Reporting System (VAERS) data was conducted to evaluate AEs within the oral cavity (mucosa, tongue, lips, palate, dentition, salivary glands) and AEs involving taste and other sensations. Oral AEs reported after receiving COVID-19 vaccination (test group) and seasonal influenza vaccination (control group) were extracted and cross-tabulated to assess their relative prevalence.ResultsAmong the 128 solicited (suspected) oral AEs, oral paresthesia (0.872%) was most reported after receiving COVID-19 vaccines, followed by the swelling of lips (0.844%), ageusia (0.722%), oral hypoesthesia (0.648%), swollen tongue (0.628%), and dysgeusia (0.617%). The reported prevalence of oral AEs was higher in the COVID-19 vaccine group than in the seasonal influenza group. The distribution pattern of the most reported oral AEs was similar for both COVID-19 and seasonal influenza vaccines. Female sex, older age (>39 years old), primer doses, and mRNA-based COVID-19 vaccines exhibited a higher reported prevalence of oral AEs.ConclusionWithin the limitations of this study, COVID-19 vaccines were found to be associated with rare oral AEs that are predominantly similar to those emerging following seasonal influenza vaccines. The most commonly reported oral AEs were oral paraesthesia (mouth-tingling), lip swelling, and ageusia, representing various pathophysiologic pathways that remain unclear. Taste-related AEs should be acknowledged in the context of the COVID-19 pandemic and the public should be adequately informed about a potential taste dysfunction after receiving the COVID-19 vaccination. Dentists and dental teams need to be aware of the prevalence, severity, and prognosis of oral AEs to inform their patients and increase public confidence in vaccines.

Project description:BackgroundWe studied completeness and timeliness of vaccination and determinants for low and delayed uptake in children born between 2008 and 2009 in Zhejiang province in eastern China.MethodsWe used data from a cross-sectional cluster survey conducted in 2011, which included 1146 children born from 1 Jan 2008 to 31 Dec 2009. Various vaccination history, social-demographic factors, attitude and satisfaction toward immunization from caregivers were collected by a standard questionnaire. We restricted to the third dose of HepB, PV, and DPT (HepB3, PV3, and DPT3) as outcome variables for completeness of vaccination and restricted to the first dose of HepB, PV, DPT, and MCV(HepB1, PV1, DPT1, and MCV1) as outcome variables for timeliness of vaccination. The χ(2) test and logistic regression analysis were applied to identify the determinants of completeness and timeliness of vaccination. Survival analysis by the Kaplan-Meier method was performed to present the timeliness vaccination.ResultsCoverage for HepB1, HepB3, PV1, PV3, DPT1, DPT3, and MCV1 was 93.22%, 90.15%, 96.42%, 91.63%, 95.80%, 90.16%, and 92.70%, respectively. Timely vaccination occurred in 501/1146(43.72%) children for HepB1, 520/1146(45.38%) for PV1, 511/1146(44.59%) for DPT1, and 679/1146(59.25%) for MCV1. Completeness of specific vaccines was associated with mother' age, immigration status, birth place of child, maternal education level, maternal occupation status, socio-economic development level of surveyed areas, satisfaction toward immunization service and distance of the house to immunization clinic. Timeliness of vaccination for specific vaccines was associated with mother' age, maternal education level, immigration status, siblings, birth place, and distance of the house to immunization clinic.ConclusionDespite reasonably high vaccination coverage, we observed substantial vaccination delays. We found specific factors associated with low and/or delayed vaccine uptake. These findings can help to improve strategies such as Reaching Every District (RED), out-reach vaccination services and health education to reach children who remain inadequately protected.

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Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.

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Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.

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