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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.