Percorrer por autor "Meijerink, Hinta"
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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.
- 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.
- Estimated number of lives directly saved by COVID-19 vaccination programmes in the WHO European Region from December, 2020, to March, 2023: a retrospective surveillance studyPublication . Meslé, Margaux M.I.; Brown, Jeremy; Mook, Piers; Katz, Mark A.; Hagan, José; Pastore, Roberta; Benka, Bernhard; Redlberger-Fritz, Monika; Bossuyt, Nathalie; Stouten, Veerle; Vernemmen, Catharina; Constantinou, Elisabet; Maly, Marek; Kynčl, Jan; Sanca, Ondrej; Krause, Tyra Grove; Vestergaard, Lasse Skafte; Leino, Tuija; Poukka, Eero; Gkolfinopoulou, Kassiani; Mellou, Kassiani; Tsintziloni, Maria; Molnár, Zsuzsanna; Aspelund, Gudrun; Thordardottir, Marianna; Domegan, Lisa; Kelly, Eva; O'Donell, Joan; Urdiales, Alberto-Mateo; Riccardo, Flavia; Sacco, Chiara; Bumšteinas, Viktoras; Liausediene, Rasa; Mossong, Joël; Vergison, Anne; Borg, Maria-Louise; Melillo, Tanya; Kocinski, Dragan; Pollozhani, Enkela; Meijerink, Hinta; Costa, Diana; Gomes, João Paulo; Leite, Pedro Pinto; Druc, Alina; Gutu, Veaceslav; Mita, Valentin; Lazar, Mihaela; Popescu, Rodica; Popovici, Odette; Musilová, Monika; Mrzel, Maja; Socan, Maja; Učakar, Veronika; Limia, Aurora; Mazagatos, Clara; Olmedo, Carmen; Dabrera, Gavin; Kall, Meaghan; Sinnathamby, Mary; McGowan, Graham; McMenamin, Jim; Morrison, Kirsty; Nitzan, Dorit; Widdowson, Marc-Alain; Smallwood, Catherine; Pebody, Richard; WHO European Respiratory Surveillance NetworkBackground: By March, 2023, 54 countries, areas, and territories (hereafter CAT) in the WHO European Region had reported more than 2·2 million COVID-19-related deaths to the WHO Regional Office for Europe. Here, we estimated how many lives were directly saved by vaccinating adults in the WHO European Region from December, 2020, to March, 2023. Methods: In this retrospective surveillance study, we estimated the number of lives directly saved by age group, vaccine dose, and circulating variant-of-concern (VOC) period, regionally and nationally, using weekly data on COVID-19 mortality and infection, COVID-19 vaccination uptake, and SARS-CoV-2 virus characterisations by lineage downloaded from The European Surveillance System on June 11, 2023, as well as vaccine effectiveness data from the literature. We included data for six age groups (25-49 years, 50-59 years, ≥60 years, 60-69 years, 70-79 years, and ≥80 years). To be included in the analysis, CAT needed to have reported both COVID-19 vaccination and mortality data for at least one of the four older age groups. Only CAT that reported weekly data for both COVID-19 vaccination and mortality by age group for 90% of study weeks or more in the full study period were included. We calculated the percentage reduction in the number of expected and reported deaths. Findings: Between December, 2020, and March, 2023, in 34 of 54 CAT included in the analysis, COVID-19 vaccines reduced deaths by 59% overall (CAT range 17-82%), representing approximately 1·6 million lives saved (range 1·5-1·7 million) in those aged 25 years or older: 96% of lives saved were aged 60 years or older and 52% were aged 80 years or older; first boosters saved 51% of lives, and 60% were saved during the Omicron period. Interpretation: Over nearly 2·5 years, most lives saved by COVID-19 vaccination were in older adults by first booster dose and during the Omicron period, reinforcing the importance of up-to-date vaccination among the most at-risk individuals. Further modelling work should evaluate indirect effects of vaccination and public health and social measures.
- 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 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.
- Unmeasured confounding and misclassification in studies estimating vaccine effectiveness against hospitalisation and death using electronic health records (EHRs): an evaluation of a multi-country European retrospective cohort studyPublication . Humphreys, James; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Holm Hansen, Christian; Moustsen-Helms, Ida Rask; Sacco, Chiara; Mateo-Urdiales, Alberto; Castilla, Jesús; Martínez-Baz, Iván; Machado, Ausenda; Soares, Patricia; de Gier, Brechje; Meijerink, Hinta; Monge, Susana; Bacci, Sabrina; Nunes, Baltazar; VEBIS-EHR working groupBackground: Electronic health record (EHR)-based observational studies can rapidly provide real-world data on vaccine effectiveness (VE), though EHR data may be prone to misclassification and unmeasured confounding. Methods: In VEBIS-EHR, a retrospective multi-country COVID-19 VE cohort study, we examined unmeasured confounding using a negative control outcome (death not related to COVID-19) and misclassification due to timing of data extraction. The evaluation spanned two periods (November-December 2023, January-February 2024), encompassing up to 18.7 million individuals across six EU/EEA countries. Vaccine confounding-adjusted hazard ratios (aHRs) were pooled using random-effects meta-analysis. Results: aHRs against non-COVID-19 mortality ranged from 0.35 (95% CI: 0.28-0.44) to 0.70 (0.66-0.73) when comparing vaccinated versus unvaccinated. Delaying EHR data extraction modestly increased the capture of outcome and exposure events, with some variation by vaccination status. Site-level fluctuations in aHRs did not meaningfully alter the overall pooled VE, suggesting stable estimates despite misclassification related to extraction timing. Conclusions: We observed some evidence of unmeasured confounding when using non-COVID-19 deaths as a negative outcome, though the specificity of our negative control must be considered. This result may suggest overestimation of VE, but also the need for further analysis with more specific negative control outcomes and confounding-adjustment techniques. Addressing such confounding using richer data sources and more refined approaches remains critical to ensure accurate, timely VE estimates based on retrospective cohorts constructed using registry data. Extending the delay between the end of observation and data extraction modestly improves the completeness of exposure and outcome data, with limited effect on pooled VE estimates.