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The tangential growth of the human visual cortex and maternal smoking during pregnancy.

Authors: Navarri X, Liao Z, Hengenius JB, Bénitière F, Jacquemont S, Pausova Z, Paus T
Journal: Cerebral cortex (New York, N.Y. : 1991)
mental health psychology open access

Abstract

Anthrax is a globally distributed zoonotic disease caused by and is characterized by high transmissibility and potentially severe outcomes []. It remains endemic in resource-limited regions, where poor sanitation and frequent human-livestock contact increase transmission risks, making vaccination an important component of anthrax prevention in poverty-affected settings []. The 2001 United States bioterrorist attacks, in which spores contaminated more than 30,000 people and caused five deaths, further highlighted its potential threat as a bioweapon []. Clinically, anthrax can present as cutaneous, gastrointestinal, or pulmonary disease, with untreated pulmonary anthrax associated with particularly high mortality [, ]. Adsorbed anthrax vaccine (AVA, BioThrax) is licensed for preexposure prophylaxis in adults aged 18–65 years at high risk of exposure and is the only United States-authorized anthrax vaccine []. Although AVA has generally been considered to have an acceptable safety profile, post-marketing concerns regarding adverse events (AEs) remain clinically relevant [, ]. Local injection-site reactions and systemic symptoms such as fever, malaise, and myalgia have been commonly described, whereas mental health-related AEs have received less attention [, ]. Emerging clinical and preclinical evidence suggests that bacterial vaccination may be associated with depressive symptoms or depression-related AEs, as reported in the context of Bacillus Calmette-Guérin vaccination [, ]. However, evidence regarding depression-related AEs after AVA remains limited and inconsistent, with few studies specifically addressing depression as a post-vaccination safety outcome []. In resource-limited settings, where mental health services may be scarce, unrecognized depression-related AEs could affect vaccine confidence, adherence to vaccination schedules, and the implementation of anthrax prevention programs. To address this evidence gap, we conducted an integrated real-world pharmacovigilance study to characterize depression-related AEs following AVA and to evaluate related safety signals for antibacterial agents used in anthrax treatment or chemoprophylaxis. We used the Vaccine Adverse Event Reporting System (VAERS) to identify AVA-associated depression-related AEs, and Food and the Drug Administration Adverse Event Reporting System (FAERS) to assess depression-related AEs associated with anthrax-related antibacterial agents [–]. Disproportionality and sensitivity analyses were used for signal detection, machine learning with Shapley Additive Explanation (SHAP) interpretation was applied to explore potential predictive features, and transcriptomic analysis was performed to identify exploratory immune-inflammatory clues. This integrated approach identified a potential depression-related safety signal following AVA, with distinct demographic and early time-to-onset patterns, and suggested additional depression-related reporting signals for levofloxacin and doxycycline, providing evidence to support post-vaccination mental health monitoring and risk communication in anthrax prevention programs.