Percorrer por autor "Nardone, Anthony"
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- Comparison of two methods for the estimation of COVID-19 vaccine effectiveness of the autumnal booster within the VEBIS-EHR network in 2022/23Publication . Monge, Susana; Humphreys, James; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Hansen, Christian Holm; Emborg, Hanne-Dorthe; Fabiani, Massimo; Sacco, Chiara; Castilla, Jesús; Martínez-Baz, Iván; de Gier, Brechje; Hahné, Susan; Hinta Meijerink; Kristoffersen, Anja Bråthen; Machado, Ausenda; Soares, Patricia; Fontán-Vela, Mario; Nardone, Anthony; Kissling, Esther; Nunes, Baltazar; VEBIS-Lot 4 working groupWithin an infrastructure to monitor vaccine effectiveness (VE) against hospitalization due to COVID-19 and COVID-19 related deaths from November 2022 to July 2023 in seven countries in real-world conditions (VEBIS network), we compared two approaches: (a) estimating VE of the first, second or third COVID-19 booster doses administered during the autumn of 2022, and (b) estimating VE of the autumn vaccination dose regardless of the number of prior doses (autumnal booster approach). Retrospective cohorts were constructed using Electronic Health Records at each participating site. Cox regressions with time-changing vaccination status were fit and site-specific estimates were combined using random-effects meta-analysis. VE estimates with both approaches were mostly similar, particularly shortly after the start of the vaccination campaign, and showed a similar timing of VE waning. However, autumnal booster estimates were more precise and showed a clearer trend, particularly compared to third booster estimates, as calendar time increased after the vaccination campaign and during periods of lower SARS-CoV-2 activity. Moreover, the decrease in protection by increasing calendar time was more clear and precise than when comparing protection by number of doses. Therefore, estimating VE under an autumnal booster framework emerges as a preferred method for future monitoring of COVID-19 vaccination campaigns.
- COVID-19 vaccine effectiveness in the paediatric population aged 5-17 years: a multicentre cohort study using electronic health registries in six European countries, 2021 to 2022Publication . Soares, Patricia; Machado, Ausenda; Nicolay, Nathalie; Monge, Susana; Sacco, Chiara; Hansen, Christian Holm; Meijerink, Hinta; Martínez-Baz, Iván; Schmitz, Susanne; Humphreys, James; Fabiani, Massimo; Echeverria, Aitziber; AlKerwi, Ala'a; Nardone, Anthony; Mateo-Urdiales, Alberto; Castilla, Jesús; Kissling, Esther; Nunes, Baltazar; VEBIS-Lot 4 working groupBackground: During the first year of the COVID-19 pandemic, vaccination programmes targeted children and adolescents to prevent severe outcomes of SARS-CoV-2 infection. Aim: To estimate COVID-19 vaccine effectiveness (VE) against hospitalisation due to COVID-19 in the paediatric population, among those with and without previously documented SARS-CoV-2 infection. Methods: We established a fixed cohort followed for 12 months in Denmark, Norway, Italy, Luxembourg, Navarre (Spain) and Portugal using routine electronic health registries. The study commenced with paediatric COVID-19 vaccination campaign at each site between June 2021 and January 2022. The outcome was hospitalisation with a laboratory-confirmed SARS-CoV-2 infection or COVID-19 as the main diagnosis. Using Cox proportional hazard models, VE was estimated as 1 minus the confounder-adjusted hazard ratio of COVID-19 hospitalisation between vaccinated and unvaccinated. A random-effects meta-analysis was used to pool VE estimates. Results: We included 4,144,667 5-11-year-olds and 3,861,841 12-17-year-olds. In 12-17-year-olds without previous infection, overall VE was 69% (95% CI: 40 to 84). VE declined with time since vaccination from 77% ≤ 3 months to 48% 180-365 days after immunisation. VE was 94% (95% CI: 90 to 96), 56% (95% CI: 3 to 80) and 41% (95% CI: -14 to 69) in the Delta, Omicron BA.1/BA.2 and BA.4/BA.5 periods, respectively. In 12-17-year-olds with previous infection, one dose VE was 80% (95% CI: 18 to 95). VE estimates were similar for 5-11-year-olds but with lower precision. Conclusion: Vaccines recommended for 5-17-year-olds provided protection against COVID-19 hospitalisation, regardless of a previously documented infection of SARS-CoV-2, with high levels of protection in the first 3 months of the vaccination.
- Effectiveness of the 2023 Autumn XBB.1.5 COVID-19 Booster During Summer 2024 in the EU/EEA: A VEBIS Electronic Health Record Network StudyPublication . Humphreys, James; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Hansen, Christian Holm; Moustsen-Helms, Ida Rask; Sacco, Chiara; Fabiani, Massimo; Castilla, Jesús; Martinez-Baz, Ivan; Machado, Ausenda; Soares, Patricia; Ljung, Rickard; Pihlstrom, Nicklas; Kissling, Esther; Nardone, Anthony; Monge, Susana; Bacci, Sabrina; Nunes, Baltazar; VEBIS-EHR Working GroupBackground: After a period of low SARS- CoV-2 activity, viral circulation increased in Europe from May 2024, driven byimmune-evasive KP sublineages of the JN.1 variant. We estimated vaccine effectiveness (VE) of the XBB.1.5 dose administeredin autumn 2023 against COVID-19-related hospitalisations and deaths in individuals 65 years of age or older during this period. Methods: We conducted a multi-country cohort study across six EU nations in the VEBIS-EHR network using linked electronichealth records. VE against COVID-19-related hospitalisation and death during June–August 2024 was estimated using Cox re-gression in a two-stage analysis, adjusting for demographics, comorbidities and prior vaccination history. Results: Among individuals 65–79 and ≥ 80 years old, respectively, VE of the XBB.1.5 dose ≥ 6 months post administration was13% (95% CI: −12% to 33%) and 7% (95% CI: −7% to 19%) against hospitalisation and 39% (95% CI: −7% to 65%) and 3% (95% CI:−23% to 23%) against deaths. Conclusions: XBB.1.5 vaccination provided minimal residual protection against severe COVID-19 outcomes among adults aged≥ 65 years more than 6 months after vaccination, during the summer 2024 period of increased SARS- CoV-2 activity.
- Effectiveness of the autumn 2023 COVID-19 vaccine dose in hospital-based healthcare workers: results of the VEBIS healthcare worker vaccine effectiveness cohort study, seven European countries, season 2023/24Publication . Savulescu, Camelia; Prats-Uribe, Albert; Brolin, Kim; Uusküla, Anneli; Bergin, Colm; Fleming, Catherine; Murri, Rita; Zvirbulis, Viesturs; Zavadska, Dace; Gaio, Vania; Popescu, Corneliu P.; Hrisca, Raluca; Cisneros, Maria; Latorre-Millán, Miriam; Lohur, Liis; McGrath, Jonathan; Ferguson, Lauren; De Gaetano Donati, Katleen; Abolina, Ilze; Gravele, Dagne; Machado, Ausenda; Florescu, Simin-Aysel; Lazar, Mihaela; Subirats, Pilar; Clusa Cuesta, Laura; Sui, Jacklyn; Kenny, Claire; Santangelo, Rosaria; Krievins, Dainis; Barzdina, Elza Anna; Valadas Henriques, Camila; Kosa, Alma Gabriela; Pohrib, Saftica-Mariana; Muñoz-Almagro, Carmen; Milagro, Ana; Bacci, Sabrina; Nardone, Anthony; VEBIS HCW VE study group; Collaborators in VEBIS HCW study groupCOVID-19 vaccination recommendations prioritise healthcare workers (HCWs), considering their exposure to severe acute respiratory coronavirus 2 (SARS-CoV-2) and their key role in the functioning of healthcare systems. In the European Union/European Economic Area (EU/EEA), HCWs were considered a priority for COVID-19 revaccination during the autumn 2023 campaign [1], and the World Health Organization (WHO) recommended revaccination of HCWs 12 months after their last dose [2]. Because the Omicron sub-lineage XBB.1.5 predominated in spring 2023, the COVID-19 vaccines were adapted to target this emerging strain, and the first XBB.1.5 vaccine was authorised for use in the EU/EEA in August 2023. Omicron BA.2.86/JN.1 emerged in the EU/EEA at the end of 2023, according to data available on the European Respiratory Virus Surveillance Summary (ERVISS) [3]. Evidence for COVID-19 vaccine recommendation in the HCW population remains scarce. Within the Vaccine Effectiveness, Burden and Impact (VEBIS) project, we aimed to measure the COVID-19 vaccine effectiveness (CVE) in HCWs, in the winter season 2023/24.
- Effectiveness of XBB.1.5 Monovalent COVID‐19 Vaccines During a Period of XBB.1.5 Dominance in EU/EEA Countries, October to November 2023: A VEBIS‐EHR Network StudyPublication . Monge, Susana; Humphreys, James; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Holm Hansen, Christian; Emborg, Hanne‐Dorthe; Sacco, Chiara; Mateo‐Urdiales, Alberto; Castilla, Jesús; Martínez‐Baz, Iván; de Gier, Brechje; Hahné, Susan; Meijerink, Hinta; Kristoffersen, Anja Bråthen; Machado, Ausenda; Soares, Patricia; Nardone, Anthony; Bacci, Sabrina; Kissling, Esther; Nunes, BaltazarUsing a common protocol across seven countries in the European Union/European Economic Area, we estimated XBB.1.5 monovalent vaccine effectiveness (VE) against COVID-19 hospitalisation and death in booster-eligible ≥ 65-year-olds, during October–November 2023. We linked electronic records to construct retrospective cohorts and used Cox models to estimate adjusted hazard ratios and derive VE. VE for COVID-19 hospitalisation and death was, respectively, 67% (95%CI: 58–74) and 67% (95%CI: 42–81) in 65- to 79-year-olds and 66% (95%CI: 57–73) and 72% (95%CI: 51–85) in ≥ 80-year-olds. Results indicate that periodic vaccination of individuals ≥ 65 years has an ongoing benefit and support current vaccination strategies in the EU/EEA.
- Monitoring COVID‐19 vaccine effectiveness against COVID‐19 hospitalisation and death using electronic health registries in ≥65 years old population in six European countries, October 2021 to November 2022Publication . Kislaya, Irina; Sentís, Alexis; Starrfelt, Jostein; Nunes, Baltazar; Martínez‐Baz, Iván; Nielsen, Katrine Finderup; AlKerwi, Ala'a; Braeye, Toon; Fontán‐Vela, Mario; Bacci, Sabrina; Meijerink, Hinta; Castilla, Jesús; Emborg, Hanne‐Dorthe; Hansen, Christian Holm; Schmitz, Susanne; Van Evercooren, Izaak; Valenciano, Marta; Nardone, Anthony; Nicolay, Nathalie; Monge, Susana; VEBIS‐Lot4 working groupBackground: Within the ECDC-VEBIS project, we prospectively monitored vaccine effectiveness (VE) against COVID-19 hospitalisation and COVID-19-related death using electronic health registries (EHR), between October 2021 and November 2022, in community-dwelling residents aged 65-79 and ≥80 years in six European countries. Methods: EHR linkage was used to construct population cohorts in Belgium, Denmark, Luxembourg, Navarre (Spain), Norway and Portugal. Using a common protocol, for each outcome, VE was estimated monthly over 8-week follow-up periods, allowing 1 month-lag for data consolidation. Cox proportional-hazards models were used to estimate adjusted hazard ratios (aHR) and VE = (1 - aHR) × 100%. Site-specific estimates were pooled using random-effects meta-analysis. Results: For ≥80 years, considering unvaccinated as the reference, VE against COVID-19 hospitalisation decreased from 66.9% (95% CI: 60.1; 72.6) to 36.1% (95% CI: -27.3; 67.9) for the primary vaccination and from 95.6% (95% CI: 88.0; 98.4) to 67.7% (95% CI: 45.9; 80.8) for the first booster. Similar trends were observed for 65-79 years. The second booster VE against hospitalisation ranged between 82.0% (95% CI: 75.9; 87.0) and 83.9% (95% CI: 77.7; 88.4) for the ≥80 years and between 39.3% (95% CI: -3.9; 64.5) and 80.6% (95% CI: 67.2; 88.5) for 65-79 years. The first booster VE against COVID-19-related death declined over time for both age groups, while the second booster VE against death remained above 80% for the ≥80 years. Conclusions: Successive vaccine boosters played a relevant role in maintaining protection against COVID-19 hospitalisation and death, in the context of decreasing VE over time. Multicountry data from EHR facilitate robust near-real-time VE monitoring in the EU/EEA and support public health decision-making.
- Protocol to measure COVID-19 XBB.1.5 vaccine effectiveness in the immunocompromised population during the 2023 autumn vaccination campaignPublication . Nunes, Baltazar; Humphreys, James; Blake, Alexandre; Savulescu, Camelia; Kissling, Esther; Nardone, Anthony; Monge Corella, Susana; Martínez-Baz, Iván; Casado, Itziar; Echeverría, Aitziber; Trobajo-Sanmartín, Camino; Castilla, Jesús; Hansen, Christian Holm; Moustsen-Helms, Ida Rask; Fabiani, Massimo; Mateo Urdiales, Alberto; Sacco, Chiara; Meijerink, Hinta; Bråthen Kristoffersen, Anja; Soares, Patricia; Machado, Ausenda; Ljung, Rickard; Pihlström, NicklasThe European Centre for Disease Prevention and Control (ECDC) started several vaccine effectiveness (VE) studies in 2020. These were included in the Vaccine Effectiveness, Burden and Impact Studies (VEBIS) project in 2021 to monitor VE in different settings and using different methods, and to provide information on different outcomes (severe disease, moderate disease, infection, transmission, etc) (1–3). Within the VEBIS project, the protocol describes the methods to estimate the Coronavirus disease 2019 (COVID-19) XBB.1.5. monovalent-adapted VE in immunocompromised persons (ICP), against COVID-19 hospitalisations and deaths, using established health data registries across six participating European Union/European Economic Area (EU/EEA) countries. The protocol is aimed at implementing a specific question that has been identified as an area where additional scientific evidence is beneficial, in the context of the ECDC/EMA Vaccine Monitoring Platform research agenda (4), adding on the routine vaccine effectiveness monitoring performed across the six countries (5). This work is performed within the VEBIS Lot 4 framework contract. The study design is a retrospective cohort study using data from ICPs eligible for COVID-19 vaccination at the start of the 2023 autumn vaccination campaign, collected routinely in electronic health record (EHR) databases. The study starts at the beginning of the vaccination campaign for each study site and ends 12 months after that. The study has two outcomes of interest: hospitalisations and deaths due to COVID-19. Data to be collected, besides the outcomes of interest, include sociodemographic (age, sex), clinical (ICP group) and COVID-19 vaccination history (brand, number of doses and dates of prior vaccine dose administration). The protocol outlines the study design and methods for analysing the data at country level and includes a plan for the pooled analysis across countries. This protocol is primarily intended to guide the implementation of the ECDC funded studies within the VEBIS project with a focus on specific objectives. Nevertheless, ECDC encourages the conduct of VE studies using this protocol and other VEBIS-related protocols as a basis in countries that do not currently plan to participate in ECDC-funded studies. Consistent protocols will facilitate the comparability of results across studies, countries, and sites.
- Relative effectiveness of the second booster COVID-19 vaccines against laboratory confirmed SARS-CoV-2 infection in healthcare workers: VEBIS HCW VE cohort study (1 October 2022-2 May 2023)Publication . Savulescu, Camelia; Prats-Uribe, Albert; Brolin, Kim; Uusküla, Anneli; Bergin, Colm; Fleming, Catherine; Zvirbulis, Viesturs; Zavadska, Dace; Szułdrzyński, Konstanty; Gaio, Vânia; Popescu, Corneliu Petru; Craiu, Mihai; Cisneros, Maria; Latorre-Millán, Miriam; Lohur, Liis; McGrath, Jonathan; Ferguson, Lauren; Abolina, Ilze; Gravele, Dagne; Machado, Ausenda; Florescu, Simin Aysel; Lazar, Mihaela; Subirats, Pilar; Clusa Cuesta, Laura; Sui, Jacklyn; Kenny, Claire; Krievins, Dainis; Barzdina, Elza Anna; Melo, Aryse; Kosa, Alma Gabriela; Miron, Victor Daniel; Muñoz-Almagro, Carmen; Milagro, Ana María; Bacci, Sabrina; Kramarz, Piotr; Nardone, Anthony; VEBIS HCW Study GroupIntroduction: Repeated COVID-19 booster vaccination was recommended in healthcare workers (HCWs) to maintain protection. We measured the relative vaccine effectiveness (rVE) of the second booster dose of COVID-19 vaccine compared to the first booster, against laboratory-confirmed SARS-CoV-2 infection in HCWs. Methods: In a prospective cohort study among HCWs from 12 European hospitals, we collected nasopharyngeal or saliva samples at enrolment and during weekly/fortnightly follow-up between October 2022 and May 2023. We estimated rVE of the second versus first COVID-19 vaccine booster dose against SARS-CoV-2 infection, overall, by time since second booster and restricted to the bivalent vaccines only. Using Cox regression, we calculated the rVE as (1-hazard ratio)*100, adjusting for hospital, age, sex, prior SARS-CoV-2 infection and at least one underlying condition. Results: Among the 979 included HCWs eligible for a second booster vaccination, 392 (40 %) received it and 192 (20 %) presented an infection during the study period. The rVE of the second versus first booster dose was -5 % (95 %CI: -46; 25) overall, 3 % (-46; 36) in the 7-89 days after receiving the second booster dose. The rVE was 11 % (-43; 45) when restricted to the use of bivalent vaccines only. Conclusion: The bivalent COVID-19 could have reduced the risk of SARS-CoV-2 infection among HCWs by 11 %. However, we note the limitation of imprecise rVE estimates due to the proportion of monovalent vaccine used in the study, the small sample size and the study being conducted during the predominant circulation of XBB.1.5 sub-lineage. COVID-19 vaccine effectiveness studies in HCWs can provide important evidence to inform the optimal timing and the use of updated COVID-19 vaccines.
- Relative vaccine effectiveness against COVID-19 hospitalisation in persons aged ≥ 65 years: results from a VEBIS network, Europe, October 2021 to July 2023Publication . Fontán-Vela, Mario; Kissling, Esther; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Holm Hansen, Christian; Emborg, Hanne-Dorthe; Fabiani, Massimo; Mateo-Urdiales, Alberto; AlKerwi, Ala'a; Schmitz, Susanne; Castilla, Jesús; Martínez-Baz, Iván; de Gier, Brechje; Hahné, Susan; Meijerink, Hinta; Starrfelt, Jostein; Nunes, Baltazar; Caetano, Constantino; Derrough, Tarik; Nardone, Anthony; Monge, Susana; VEBIS-Lot 4 working groupSince 2021, the Vaccine Effectiveness, Burden and Impact Studies of coronavirus disease 2019 (COVID-19) and influenza (VEBIS) project monitors vaccine effectiveness (VE) in real-world conditions to inform vaccination programmes in the European Union/European Economic Area (EU/EEA) countries [1]. One project aims to monitor real-time COVID-19 VE using electronic health registries (EHR) in multiple countries, with initial findings previously published [2-4]. We report pooled VE results against hospitalisation due to COVID-19 by number of doses received and time since vaccination in a community-dwelling resident population aged ≥ 65 years between October 2021 and July 2023.
- Trends in human immunodeficiency virus diagnoses among men who have sex with men in North America, Western Europe, and Australia, 2000-2014Publication . Chapin-Bardales, Johanna; Schmidt, Axel J.; Guy, Rebecca J.; Kaldor, John M.; McGregor, Skye; Sasse, André; Archibald, Chris; Rank, Claudia; Casabona Barbarà, Jordi; Folch, Cinta; Vives, Núria; Cowan, Susan A.; Cazein, Françoise; Velter, Annie; an der Heiden, Matthias; Gunsenheimer-Bartmeyer, Barbara; Marcus, Ulrich; Op de Coul, Eline L.M.; van Sighem, Ard; Aldir, Isabel; Cortes Martins, Helena; Berglund, Torsten; Velicko, Inga; Gebhardt, Martin; Delpech, Valerie; Hughes, Gwenda; Nardone, Anthony; Hall, H. Irene; Johnson, Anna S.; Sullivan, Patrick S.Purpose: The aim of the article was to investigate recent trends in human immunodeficiency virus (HIV) diagnosis rates among men who have sex with men (MSM) in high-income countries in North America, Western Europe, and Australia. Methods: Data on annual rates of HIV diagnoses among MSM aged 15 to 65 years from 2000 to 2014 were collected from 13 high-income countries. Joinpoint regression software was used to empirically determine country-specific trend periods. Trends in HIV diagnosis rates and in the proportion of diagnoses occurring in young MSM aged 15 to 24 years were analyzed using Poisson regression and log-binomial regression, respectively. Results: Six countries experienced an increasing trend from 2000 to 2007-08 followed by either a stable or declining trend through 2014. Five countries had recently increasing trends, and two countries had one stable trend from 2000 to 2014. All 13 countries experienced increases in the proportion of diagnoses occurring in young MSM. Conclusions: Since 2008, half of the 13 high-income countries examined experienced stable or decreasing trends. Still, some countries continue to experience increasing HIV trends, and young MSM are increasingly represented among new diagnoses. Efforts to support early sexual health promotion, reduce barriers to pre-exposure prophylaxis, and improve care engagement for young MSM are critical to addressing current HIV trends.