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- Follow‐up of the re‐evaluation of silver (E 174) as a food additive (EFSA‐Q‐2023‐00169)Publication . EFSA Panel on Food Additives and Flavourings (FAF); Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Castle, Laurence; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Kurek, Marcin Andrzej; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Oomen, Agnes; Corsini, Emanuela; Wright, Matthew; Furst, Peter; Gaffet, Eric; Loeschner, Katrin; Mast, Jan; Undas, Anna; Mech, Agnieszka; Rincon, Ana Maria; Ruggeri, Laura; Smeraldi, CamillaSilver (E 174) is a food colour that was re‐evaluated by the EFSA ANS Panel (2016). The ANS Panel concluded that the information available then, was insufficient to assess the safety of silver as food additive. The major issues included limited characterisation of silver E 174 (e.g. quantity of nanoparticles) and release of ionic silver. Following a European Commission call for further data to fill the data gap, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of silver (E 174). One interested business operator (IBO) submitted limited data on particle size distribution and morphology, two genotoxicity studies and one subchronic study. The Panel concluded that the technical data submitted on physicochemical characterisation of all types of silver used as food additive E 174 were not adequate. As a result, the Panel was unable to propose changes to the EU specifications of E174 on particle size and morphology. As the additional information requested was not provided, the assessment was based solely on the submitted data. Nonetheless, given the data provided and silver insolubility in water, the Panel concluded that E174 requires risk assessment at the nanoscale following the EFSA Guidance on Risk assessment of nanomaterials to be applied in the food and feed chain, to complement the conventional risk assessment. The Panel considered that the genotoxicity data and sub‐chronic toxicity data were inadequate. Consequently, the Panel could not conclude on the safety of the food additive silver E 174.
- Long term bivalent mRNA vaccine effectiveness against COVID-19 hospitalisations and deaths in Portugal: a cohort study based on electronic health recordsPublication . Machado, Ausenda; Kislaya, Irina; Soares, Patricia; Magalhães, Sarah; Nunes, Baltazar; On behalf of PT-EHR vaccine groupBackground: In Autumn 2022, there were recommendations for a COVID-19 booster vaccination with adapted bivalent vaccines to eligible population. Evaluating vaccine effectiveness (VE), in a short period after the vaccination, is key to guide public health decisions on the vaccine performance, allowing implementation of mitigation strategies promptly. However, to assess long-term protection post-vaccination and evaluate the need for additional boosters, it is crucial to conduct studies that span the maximum duration of the vaccination program. This study aims to estimate the VE of bivalent mRNA vaccines against COVID-19-related hospitalisation and death in the Portuguese population aged 65 years or older, from September 2022 to May 2023. Methods: We used a cohort approach to analyse six electronic health registries using deterministic linkage, with a follow-up period of eight months. Severe outcomes included COVID-19-related hospitalisations and death, classified using discharge ICD-10 codes as proxies. The exposure of interest was the bivalent mRNA vaccine. VE was estimated for 14-97, 98-181 and 182-240 days after bivalent vaccination. Confounder-adjusted hazard ratio (aHR) was obtained by fitting a time-dependent Cox regression model with time-dependent vaccination status, adjusted for sociodemographic, history of influenza and pneumococcus vaccination, previous SARS-CoV-2 tests and infection, and comorbidities. VE was estimated by one minus the aHR between vaccinated with bivalent vaccine person-years versus those without bivalent vaccine person-years. Results: The cohort included 2,151,531 individuals aged 65 or older (27.8% with 80 or more years). In the ≥ 80 years old, VE was 41.3% (95%CI: 34.5-47.5%) and 50.3% (95%CI: 44.6-55.3%) against COVID-19-related hospitalisation and death, respectively. In the 65-79 years old, VE was 58.5% (95%CI: 51.9-64.2%) against COVID-19-related hospitalisation, and 65.1% (95%CI: 59.0-70.4%) against COVID-19-related death. VE waned for both age groups and outcomes. Among adults aged 65 years or older, we observed long-term moderate VE estimates against severe COVID-19-related outcomes. Conclusions: These results support the need for yearly boosters of COVID-19 vaccination to maximise the protection of the senior population against COVID-19 severe disease. Additional (spring boosters) during a vaccination campaign should be evaluated considering the epidemiological context and results from long-term VE studies.
- An overview of work-related stress assessmentPublication . Lavreysen, Olivia; Bakusic, Jelena; Abatzi, Thalia-Anthi; Geerts, Annelien; Mateusen, Mies; Bashkin, Osnat; Koscec Bjelajac, Adrijana; Dopelt, Keren; du Prel, Jean-Baptist; Franic, Zrinka; Guseva Canu, Irina; Kiran, Sibel; Merisalu, Eda; Pereira, Cristiana Costa; Roquelaure, Yves; Godderis, LodeObjective: Work-related stress (WRS) is associated with the development of various health issues and long-term absence from the workplace. Adequate measurement of WRS is essential to assess its prevalence, risks, and effectiveness of preventive interventions. The aim of this review was to provide an overview of different categories of WRS assessment: 1) self-assessment, 2) external assessment, and 3) biomarkers. Methods: The databases MEDLINE, PsycINFO, EMBASE, CINAHL, and Web of Science have been searched until July 2024 for studies comprising self-assessment or external assessment of WRS, and WRS biomarkers. The self-assessment studies were further evaluated following the COSMIN guidelines. Results: In this review, a total of 15,749 articles were screened. The final analysis included 53 studies on self-assessment of WRS, 33 articles on external assessment of WRS and 167 articles on stress biomarkers. Within self-assessment studies, four instruments were included in the analysis: Job Content Questionnaire, Effort Reward Imbalance Questionnaire, Copenhagen Psychosocial Questionnaire II and the Demand-Control-Support Questionnaire. The studies applying external assessment used job-exposure matrices, work register data, ethnography, digital tools, and external observation. The identified WRS biomarkers were associated with the sympathetic adrenal medullary axis, the hypothalamic pituitary adrenal axis, immune response and inflammation, and haemostatic, metabolic and (epi)genetic biomarkers. Conclusion: The available evidence does not support the claim that there is a singular golden standard for assessing WRS. Inclusion of objective parameters and the interaction with subjective parameters and biological markers has to be studied to receive a broader view of WRS.
- Monitorização da ingestão de aditivos alimentares em PortugalPublication . Vasco, Elsa; Oliveira, Luísa; Fernandes, PauloA monitorização da ingestão de aditivos alimentares pela população deve ser realizada regularmente, pois a mesma pode variar ao longo do tempo devido a mudanças nos padrões de consumo alimentar e no uso desses aditivos pela indústria. Esse acompanhamento contínuo permite a atualização das avaliações de segurança e, se necessário, a revisão dos limites estabelecidos para proteger a saúde dos consumidores. Em Portugal, o Instituto Nacional de Saúde Doutor Ricardo Jorge (INSA) é a entidade oficial responsável pela monitorização, através do sistema de monitorização da ingestão de aditivos alimentares – MONITADITIVOS.
- Farmacogenómica: Uma Competência Emergente para FarmacêuticosPublication . Cardoso, Maria LuisLecture on Pharmacogenomics delivered during the first session of the “Conference Cycle of the Scientific Council – Academia and the Pharmaceutical Profession”, organized by the Scientific Council of the Faculty of Pharmacy of the University of Porto.