Percorrer por autor "Nicolay, Nathalie"
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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 Against Hospitalization in Older Adults, VEBIS Hospital Network, Europe, September 2024-May 2025Publication . Rojas-Castro, Madelyn; Verdasca, Nuno; Monge, Susana; De Mot, Laurane; Trobajo-Sanmartín, Camino; Duffy, Róisín; Túri, Gergő; Kuliese, Monika; Duerrwald, Ralf; Borg, Maria-Louise; Popovici, Odette; Gomez, Verónica; Makarić, Zvjezdana Lovrić; Launay, Odile; Marques, Diogo F.P.; Pozo, Francisco; Witdouck, Arne; Martínez-Baz, Iván; Fitzgerald, Margaret; Oroszi, Beatrix; Jančorienė, Ligita; Buda, Silke; Dziugyte, Ausra; Lazăr, Mihaela; Machado, Ausenda; Tabain, Irena; Nguyen, Liem Binh Luong; Wagner, Eva Rivas; Dufrasne, François; Castilla, Jesús; Domegan, Lisa; Velkey, Viktória; Majauskaite, Fausta; Hackmann, Carolin; Nicolay, Nathalie; Bacci, Sabrina; Rose, Angela M.C.; European Hospital Vaccine Effectiveness GroupWe estimated COVID-19 vaccine effectiveness (VE) against PCR-confirmed SARS-CoV-2 hospitalization in patients ≥ 60 years with severe acute respiratory infection, using a multicenter, test-negative, case-control study across seven sites in six European countries between September 2024 and May 2025. We included 352 cases (115 vaccinated; 33%) and 9980 controls (5024 vaccinated; 50%). VE was 42% (95% CI: 15; 61) 14-59 days post-vaccination, 32% (95% CI: -1; 54) at 60-119 days, and 36% (95% CI: 2; 60) at 120-179 days, and no effect thereafter. Among adults aged 60-79 and ≥ 80 years, we observed moderate VE against COVID-19 hospitalization for up to 2 and 4 months, respectively.
- 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.
- Early COVID‐19 XBB.1.5 Vaccine Effectiveness Against Hospitalisation Among Adults Targeted for Vaccination, VEBIS Hospital Network, Europe, October 2023–January 2024Publication . Antunes, Liliana; Mazagatos, Clara; Martínez‐Baz, Iván; Naesens, Reinout; Borg, Maria‐Louise; Petrović, Goranka; Fatukasi, Terra; Jancoriene, Ligita; Machado, Ausenda; Oroszi, Beatrix; Husa, Petr; Lazar, Mihaela; Dürrwald, Ralf; Howard, Jennifer; Melo, Aryse; Pérez‐Gimeno, Gloria; Castilla, Jesús; Bernaert, Eva; Džiugytė, Aušra; Makarić, Zvjezdana Lovrić; Fitzgerald, Margaret; Mickienė, Auksė; Gómez, Verónica; Túri, Gergő; Součková, Lenka; Marin, Alexandru; Tolksdorf, Kristin; Nicolay, Nathalie; Rose, Angela M.C.; European Hospital Vaccine Effectiveness GroupWe conducted a multicentre test-negative case–control study covering the period from October 2023 to January 2024 among adult patients aged ≥18 years hospitalised with severe acute respiratory infection in Europe. We provide early estimates of the effectiveness of the newly adapted XBB.1.5 COVID-19 vaccines against PCR-confirmed SARS-CoV-2 hospitalisation. Vaccine effectiveness was 49% overall, ranging between 69% at 14–29days and 40% at 60–105days post vaccination. The adapted XBB.1.5 COVID-19 vaccines conferred protection against COVID-19 hospitalisation in the first 3.5months post vaccination, with VE>70% in older adults (≥65 years) up to 1month post vaccination.
- Effectiveness of JN.1 monovalent COVID-19 vaccination in EU/EEA countries between October 2024 and January 2025: a VEBIS electronic health record network studyPublication . Humphreys, James; Blake, Alexandre; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Hansen, Christian Holm; Moustsen-Helms, Ida Rask; Sacco, Chiara; Mateo-Urdiales, Alberto; Castilla, Jesús; Martínez-Baz, Iván; Machado, Ausenda; Brito, André; Ljung, Rickard; Pihlstrom, Nicklas; Mansiaux, Yohann; Monge, Susana; Bacci, Sabrina; Nunes, Baltazar; VEBIS-Lot 4 working groupWe estimated vaccine effectiveness (VE) of Omicron JN.1-adapted COVID-19 vaccines administered during the 2024 autumnal vaccination campaign against COVID-19 hospitalisation and death among eligible individuals aged ≥65 years. The study period was October 2024-January 2025. Using a common protocol across six EU/EEA study sites, we linked electronic health records to construct retrospective cohorts and applied Cox modelling to estimate VE via confounder-adjusted hazard ratios. The majority of vaccines administered during the study period were Omicron JN.1-adapted COVID-19 vaccines (99 %). VE against hospitalisation was 60 % (95 % Confidence Interval: 48-70 %) and against COVID-19-related death was 78 % (95 %CI: 64-87 %) among individuals aged 65-79 years; 58 % (95 %CI: 48-66 %) and 62 % (95 %CI: 32-79 %) among those aged ≥80 years. These results indicate high effectiveness in the initial months of the campaign. Continued monitoring is necessary to confirm these results, including estimates of VE in those with longer time since vaccination and during different variant predominance periods.
- Effectiveness of long-acting monoclonal antibodies against laboratory-confirmed RSV in children aged < 24 months and hospitalised for severe acute respiratory infection, European pilot study, 2024 to 2025Publication . Savulescu, Camelia; Ganser, Iris; Nicolay, Nathalie; Lajot, Adrien; Campos, Sandra; Martínez-Baz, Iván; Rodrigues, Ana Paula; Vandromme, Mathil; Cara-Rodríguez, Marta; Echeverría, Aitziber; Gaio, Vânia; Parsy, Marie-Pierre; Garrido, Ana Roldan; Castilla, Jesús; Guiomar, Raquel; Bacci, Sabrina; Rose, Angela Mc; VEBIS hospital network RSV IE groupWe measured effectiveness of nirsevimab against laboratory-confirmed respiratory syncytial virus (RSV) infection in a test-negative case-control study among children aged < 24 months hospitalised for severe acute respiratory infection in three European countries. The overall effectiveness in the 2024/25 season among 2,201 children was 79% (95% CI: 58 to 89) and 85%, 78% and 69% at < 30, 30-89 and 90-215 days since immunisation. Immunisation was effective for preventing RSV-related hospitalisation in children, but effectiveness by time since immunisation needs monitoring in future seasons.
- 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 adapted bivalent mRNA COVID-19 vaccines against hospitalisation in individuals aged ≥ 60 years during the Omicron XBB lineage-predominant period: VEBIS SARI VE network, Europe, February to August, 2023Publication . Antunes, Liliana; Mazagatos, Clara; Martínez-Baz, Iván; Gómez, Verónica; Borg, Maria-Louise; Petrović, Goranka; Duffy, Róisín; Dufrasne, François E; Dürrwald, Ralf; Lazar, Mihaela; Jancoriene, Ligita; Oroszi, Beatrix; Husa, Petr; Howard, Jennifer; Melo, Aryse; Pozo, Francisco; Pérez-Gimeno, Gloria; Castilla, Jesús; Machado, Ausenda; Džiugytė, Aušra; Karabuva, Svjetlana; Fitzgerald, Margaret; Fierens, Sébastien; Tolksdorf, Kristin; Popovici, Silvia-Odette; Mickienė, Auksė; Túri, Gergő; Součková, Lenka; Nicolay, Nathalie; Rose, Angela MC; on behalf of the European Hospital Vaccine Effectiveness GroupThe European Medicines Agency (EMA) authorised four adapted bivalent mRNA COVID-19 vaccines for use against COVID-19 in September/October 2022: Comirnaty (BNT162b2; Pfizer-BioNTech) and Spikevax (mRNA-1273; Moderna) Original/Omicron BA.1 and Original/Omicron BA.4–5 [1]. During autumn 2022, all European Union/European Economic Area (EU/EEA) countries had vaccination campaigns in place to administer a booster dose, with several countries using the adapted bivalent vaccines [2]. The Omicron-descendent XBB lineage and XBB.1.5 sub-lineage became variants of interest in March 2023 [3]. We estimated the effectiveness of the COVID-19 bivalent vaccines against hospitalisation with PCR-confirmed SARS-CoV-2 infection among patients aged ≥ 60 years with severe acute respiratory infection (SARI) during the XBB lineage-predominant period.
- Effectiveness of the XBB.1.5 COVID-19 Vaccines Against SARS-CoV-2 Hospitalisation Among Adults Aged ≥ 65 Years During the BA.2.86/JN.1 Predominant Period, VEBIS Hospital Study, Europe, November 2023 to May 2024Publication . Antunes, Liliana; Rojas-Castro, Madelyn; Lozano, Marcos; Martínez-Baz, Iván; Leroux-Roels, Isabel; Borg, Maria-Louise; Oroszi, Beatrix; Fitzgerald, Margaret; Dürrwald, Ralf; Jancoriene, Ligita; Machado, Ausenda; Petrović, Goranka; Lazar, Mihaela; Součková, Lenka; Bacci, Sabrina; Howard, Jennifer; Verdasca, Nuno; Basile, Luca; Castilla, Jesús; Ternest, Silke; Džiugytė, Aušra; Túri, Gergő; Duffy, Roisin; Hackmann, Carolin; Kuliese, Monika; Gomez, Verónica; Makarić, Zvjezdana Lovrić; Marin, Alexandru; Husa, Petr; Nicolay, Nathalie; Rose, Angela M.C.; VEBIS SARI VE network teamWe estimated the effectiveness of the adapted monovalent XBB.1.5 COVID-19 vaccines against PCR-confirmed SARS-CoV-2 hospitalisation during the BA.2.86/JN.1 lineage-predominant period using a multicentre test-negative case-control study in Europe. We included older adults (≥ 65 years) hospitalised with severe acute respiratory infection from November 2023 to May 2024. Vaccine effectiveness was 46% at 14-59 days and 34% at 60-119 days, with no effect thereafter. The XBB.1.5 COVID-19 vaccines conferred protection against BA.2.86 lineage hospitalisation in the first 4 months post-vaccination.
- Effectiveness of the XBB.1.5 COVID-19 Vaccines Against SARS-CoV-2 Hospitalisation Among Adults Aged ≥ 65 Years During the BA.2.86/JN.1 Predominant Period, VEBIS Hospital Study, Europe, November 2023 to May 2024Publication . Antunes, Liliana; Rojas-Castro, Madelyn; Lozano, Marcos; Martínez-Baz, Iván; Leroux-Roels, Isabel; Borg, Maria-Louise; Oroszi, Beatrix; Fitzgerald, Margaret; Dürrwald, Ralf; Jancoriene, Ligita; Machado, Ausenda; Petrović, Goranka; Lazar, Mihaela; Součková, Lenka; Bacci, Sabrina; Howard, Jennifer; Verdasca, Nuno; Basile, Luca; Castilla, Jesús; Ternest, Silke; Džiugytė, Aušra; Túri, Gergő; Duffy, Roisin; Hackmann, Carolin; Kuliese, Monika; Gomez, Verónica; Makarić, Zvjezdana Lovrić; Marin, Alexandru; Husa, Petr; Nicolay, Nathalie; Rose, Angela M. C.; VEBIS SARI VE network teamWe estimated the effectiveness of the adapted monovalent XBB.1.5 COVID-19 vaccines against PCR-confirmed SARS-CoV-2 hospitalisation during the BA.2.86/JN.1 lineage-predominant period using a multicentre test-negative case-control study in Europe. We included older adults (≥ 65 years) hospitalised with severe acute respiratory infection from November 2023 to May 2024. Vaccine effectiveness was 46% at 14-59 days and 34% at 60-119 days, with no effect thereafter. The XBB.1.5 COVID-19 vaccines conferred protection against BA.2.86 lineage hospitalisation in the first 4 months post-vaccination.
