Browsing by Author "Nicolay, Nathalie"
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- 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 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 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.
- Interim 2023/24 influenza A vaccine effectiveness: VEBIS European primary care and hospital multicentre studies, September 2023 to January 2024Publication . Maurel, Marine; Howard, Jennifer; Kissling, Esther; Pozo, Francisco; Pérez-Gimeno, Gloria; Buda, Silke; Sève, Noémie; McKenna, Adele; Meijer, Adam; Rodrigues, Ana Paula; Martínez-Baz, Iván; Mlinarić, Ivan; Latorre-Margalef, Neus; Túri, Gergő; Lazăr, Mihaela; Mazagatos, Clara; Echeverria, Aitziber; Abela, Stephen; Bourgeois, Marc; Machado, Ausenda; Dürrwald, Ralf; Petrović, Goranka; Oroszi, Beatrix; Jancoriene, Ligita; Marin, Alexandru; Husa, Petr; Duffy, Roisin; Dijkstra, Frederika; Gallardo García, Virtudes; Goerlitz, Luise; Enouf, Vincent; Bennett, Charlene; Hooiveld, Mariëtte; Guiomar, Raquel; Trobajo-Sanmartín, Camino; Višekruna Vučina, Vesna; Samuelsson Hagey, Tove; Lameiras Azevedo, Ana Sofía; Castilla, Jesús; Xuereb, Gerd; Delaere, Bénédicte; Gómez, Verónica; Tolksdorf, Kristin; Bacci, Sabrina; Nicolay, Nathalie; Kaczmarek, Marlena; Rose, Angela MC; European IVE groupInfluenza A viruses circulated in Europe from September 2023 to January 2024, with influenza A(H1N1)pdm09 predominance. We provide interim 2023/24 influenza vaccine effectiveness (IVE) estimates from two European studies, covering 10 countries across primary care (EU-PC) and hospital (EU-H) settings. Interim IVE was higher against A(H1N1)pdm09 than A(H3N2): EU-PC influenza A(H1N1)pdm09 IVE was 53% (95% CI: 41 to 63) and 30% (95% CI: −3 to 54) against influenza A(H3N2). For EU-H, these were 44% (95% CI: 30 to 55) and 14% (95% CI: −32 to 43), respectively.
- 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.
- 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.
- Vaccine effectiveness against COVID-19 hospitalisation in adults (≥ 20 years) during Alpha- and Delta-dominant circulation: I-MOVE-COVID-19 and VEBIS SARI VE networks, Europe, 2021Publication . Rose, Angela M.C.; Nicolay, Nathalie; Sandonis Martín, Virginia; Mazagatos, Clara; Petrović, Goranka; Niessen, F Annabel; Machado, Ausenda; Launay, Odile; Denayer, Sarah; Seyler, Lucie; Baruch, Joaquin; Burgui, Cristina; Loghin, Isabela I.; Domegan, Lisa; Vaikutytė, Roberta; Husa, Petr; Panagiotakopoulos, George; Aouali, Nassera; Dürrwald, Ralf; Howard, Jennifer; Pozo, Francisco; Sastre-Palou, Bartolomé; Nonković, Diana; Knol, Mirjam J.; Kislaya, Irina; Luong Nguyen, Liem binh; Bossuyt, Nathalie; Demuyser, Thomas; Džiugytė, Aušra; Martínez-Baz, Iván; Popescu, Corneliu; Duffy, Róisín; Kuliešė, Monika; Součková, Lenka; Michelaki, Stella; Simon, Marc; Reiche, Janine; Otero-Barrós, María Teresa; Lovrić Makarić, Zvjezdana; Bruijning-Verhagen, Patricia C.J.L.; Gómez, Verónica; Lesieur, Zineb; Barbezange, Cyril; Van Nedervelde, Els; Borg, Maria-Louise; Castilla, Jesús; Lazar, Mihaela; O’Donnell, Joan; Jonikaitė, Indrė; Demlová, Regina; Amerali, Marina; Wirtz, Gil; Tolksdorf, Kristin; Valenciano, Marta; Bacci, Sabrina; Kissling, Esther; I-MOVE-COVID-19 Hospital Study Team; VEBIS Hospital Study TeamIntroduction: Two large multicentre European hospital networks have estimated vaccine effectiveness (VE) against COVID-19 since 2021. Aim: We aimed to measure VE against PCR-confirmed SARS-CoV-2 in hospitalised severe acute respiratory illness (SARI) patients ≥ 20 years, combining data from these networks during Alpha (March–June)- and Delta (June–December)-dominant periods, 2021. Methods: Forty-six participating hospitals across 14 countries follow a similar generic protocol using the test-negative case–control design. We defined complete primary series vaccination (PSV) as two doses of a two-dose or one of a single-dose vaccine ≥ 14 days before onset. Results: We included 1,087 cases (538 controls) and 1,669 cases (1,442 controls) in the Alpha- and Delta-dominant periods, respectively. During the Alpha period, VE against hospitalisation with SARS-CoV2 for complete Comirnaty PSV was 85% (95% CI: 69–92) overall and 75% (95% CI: 42–90) in those aged ≥ 80 years. During the Delta period, among SARI patients ≥ 20 years with symptom onset ≥ 150 days from last PSV dose, VE for complete Comirnaty PSV was 54% (95% CI: 18–74). Among those receiving Comirnaty PSV and mRNA booster (any product) ≥ 150 days after last PSV dose, VE was 91% (95% CI: 57–98). In time-since-vaccination analysis, complete all-product PSV VE was > 90% in those with their last dose < 90 days before onset; ≥ 70% in those 90–179 days before onset. Conclusions: Our results from this EU multi-country hospital setting showed that VE for complete PSV alone was higher in the Alpha- than the Delta-dominant period, and addition of a first booster dose during the latter period increased VE to over 90%.
- Vaccine effectiveness against COVID-19 hospitalisation in adults (≥ 20 years) during Omicron-dominant circulation: I-MOVE-COVID-19 and VEBIS SARI VE networks, Europe, 2021 to 2022Publication . Rose, Angela M.C.; Nicolay, Nathalie; Sandonis Martín, Virginia; Mazagatos, Clara; Petrović, Goranka; Baruch, Joaquin; Denayer, Sarah; Seyler, Lucie; Domegan, Lisa; Launay, Odile; Machado, Ausenda; Burgui, Cristina; Vaikutyte, Roberta; Niessen, F Annabel; Loghin, Isabela I.; Husa, Petr; Aouali, Nassera; Panagiotakopoulos, George; Tolksdorf, Kristin; Horváth, Judit Krisztina; Howard, Jennifer; Pozo, Francisco; Gallardo, Virtudes; Nonković, Diana; Džiugytė, Aušra; Bossuyt, Nathalie; Demuyser, Thomas; Duffy, Róisín; Luong Nguyen, Liem binh; Kislaya, Irina; Martínez-Baz, Iván; Gefenaite, Giedre; Knol, Mirjam J.; Popescu, Corneliu; Součková, Lenka; Simon, Marc; Michelaki, Stella; Reiche, Janine; Ferenczi, Annamária; Delgado-Sanz, Concepción; Lovrić Makarić, Zvjezdana; Cauchi, John Paul; Barbezange, Cyril; Van Nedervelde, Els; O’Donnell, Joan; Durier, Christine; Guiomar, Raquel; Castilla, Jesús; Jonikaite, Indrė; Bruijning-Verhagen, Patricia C.J.L.; Lazar, Mihaela; Demlová, Regina; Wirtz, Gil; Amerali, Marina; Dürrwald, Ralf; Kunstár, Mihály Pál; Kissling, Esther; Bacci, Sabrina; Valenciano, Marta; I-MOVE-COVID-19 hospital study team; VEBIS hospital study team; Members of the I-MOVE-COVID-19 and VEBIS hospital study teams (in addition to authors above)Introduction: The I-MOVE-COVID-19 and VEBIS hospital networks have been measuring COVID-19 vaccine effectiveness (VE) in participating European countries since early 2021. Aim: We aimed to measure VE against PCR-confirmed SARS-CoV-2 in patients ≥ 20 years hospitalised with severe acute respiratory infection (SARI) from December 2021 to July 2022 (Omicron-dominant period). Methods: In both networks, 46 hospitals (13 countries) follow a similar test-negative case-control protocol. We defined complete primary series vaccination (PSV) and first booster dose vaccination as last dose of either vaccine received ≥ 14 days before symptom onset (stratifying first booster into received < 150 and ≥ 150 days after last PSV dose). We measured VE overall, by vaccine category/product, age group and time since first mRNA booster dose, adjusting by site as a fixed effect, and by swab date, age, sex, and presence/absence of at least one commonly collected chronic condition. Results: We included 2,779 cases and 2,362 controls. The VE of all vaccine products combined against hospitalisation for laboratory-confirmed SARS-CoV-2 was 43% (95% CI: 29-54) for complete PSV (with last dose received ≥ 150 days before onset), while it was 59% (95% CI: 51-66) after addition of one booster dose. The VE was 85% (95% CI: 78-89), 70% (95% CI: 61-77) and 36% (95% CI: 17-51) for those with onset 14-59 days, 60-119 days and 120-179 days after booster vaccination, respectively. Conclusions: Our results suggest that, during the Omicron period, observed VE against SARI hospitalisation improved with first mRNA booster dose, particularly for those having symptom onset < 120 days after first booster dose.