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- COVID-19 vaccine effectiveness against symptomatic infection with SARS-CoV-2 BA.1/BA.2 lineages among adults and adolescents in a multicentre primary care study, Europe, December 2021 to June 2022Publication . Lanièce Delaunay, Charlotte; Martínez-Baz, Iván; Sève, Noémie; Domegan, Lisa; Mazagatos, Clara; Buda, Silke; Meijer, Adam; Kislaya, Irina; Pascu, Catalina; Carnahan, AnnaSara; Oroszi, Beatrix; Ilić, Maja; Maurel, Marine; Melo, Aryse; Sandonis Martín, Virginia; Trobajo-Sanmartín, Camino; Enouf, Vincent; McKenna, Adele; Pérez-Gimeno, Gloria; Goerlitz, Luise; de Lange, Marit; Rodrigues, Ana Paula; Lazar, Mihaela; Latorre-Margalef, Neus; Túri, Gergő; Castilla, Jesús; Falchi, Alessandra; Bennett, Charlene; Gallardo, Virtudes; Dürrwald, Ralf; Eggink, Dirk; Guiomar, Raquel; Popescu, Rodica; Riess, Maximilian; Horváth, Judit Krisztina; Casado, Itziar; García, M. del Carmen; Hooiveld, Mariëtte; Machado, Ausenda; Bacci, Sabrina; Kaczmarek, Marlena; Kissling, EstherBackground: Scarce European data in early 2021 suggested lower vaccine effectiveness (VE) against SARS-CoV-2 Omicron lineages than previous variants. Aim: We aimed to estimate primary series (PS) and first booster VE against symptomatic BA.1/BA.2 infection and investigate potential biases. Methods: This European test-negative multicentre study tested primary care patients with acute respiratory symptoms for SARS-CoV-2 in the BA.1/BA.2-dominant period. We estimated PS and booster VE among adults and adolescents (PS only) for all products combined and for Comirnaty alone, by time since vaccination, age and chronic condition. We investigated potential bias due to correlation between COVID-19 and influenza vaccination and explored effect modification and confounding by prior SARS-CoV-2 infection. Results: Among adults, PS VE was 37% (95% CI: 24–47%) overall and 60% (95% CI: 44–72%), 43% (95% CI: 26–55%) and 29% (95% CI: 13–43%) < 90, 90–179 and ≥ 180 days post vaccination, respectively. Booster VE was 42% (95% CI: 32–51%) overall and 56% (95% CI: 47–64%), 22% (95% CI: 2–38%) and 3% (95% CI: −78% to 48%), respectively. Primary series VE was similar among adolescents. Restricting analyses to Comirnaty had little impact. Vaccine effectiveness was higher among older adults. There was no signal of bias due to correlation between COVID-19 and influenza vaccination. Confounding by previous infection was low, but sample size precluded definite assessment of effect modification. Conclusion: Primary series and booster VE against symptomatic infection with BA.1/BA.2 ranged from 37% to 42%, with similar waning post vaccination. Comprehensive data on previous SARS-CoV-2 infection would help disentangle vaccine- and infection-induced immunity.
- COVID-19 Vaccine Effectiveness in Autumn and Winter 2022 to 2023 Among Older EuropeansPublication . Laniece Delaunay, Charlotte; Mazagatos, Clara; Martínez-Baz, Iván; Túri, Gergő; Goerlitz, Luise; Domegan, Lisa; Meijer, Adam; Rodrigues, Ana Paula; Sève, Noémie; Ilić, Maja; Latorre-Margalef, Neus; Lazar, Mihaela; Maurel, Marine; Melo, Aryse; Andreu Ivorra, Blanca; Casado, Itziar; Horváth, Judit Krisztina; Buda, Silke; Bennett, Charlene; de Lange, Marit; Guiomar, Raquel; Enouf, Vincent; Mlinarić, Ivan; Samuelsson Hagey, Tove; Dinu, Sorin; Rumayor, Mercedes; Castilla, Jesús; Oroszi, Beatrix; Dürrwald, Ralf; O’Donnell, Joan; Hooiveld, Mariëtte; Gómez, Verónica; Falchi, Alessandra; Kurečić Filipović, Sanja; Dillner, Lena; Popescu, Rodica; Bacci, Sabrina; Kaczmarek, Marlena; Kissling, Esther; Gallardo García, Virtudes; Perez Morilla, Esteban; Pedrosa Corral, Irene; García Vázquez, Miriam; Milagro-Beamonte, Ana; Fernandez Ibañez, Ana; Margolles Martins, Mario; Giménez Duran, Jaume; Sastre Palou, Bartolomé; López Causapé, Carla; Viloria Raymundo, Luis Javier; Vega Alonso, Tomás; Ordax Díez, Ana; Lozano Alonso, Jose Eugenio; Rojo Bello, Silvia; Mendioroz, Jacobo; Basile, Luca; Martínez Mateo, Ana Isabel; Ruiz de Porras, Carlota; Moya Garcés, Alba; Marcos, Mª Ángeles; López Maside, Aurora; Botella Quijal, Francesc; Miralles Espi, Maite; Andreu Salete, Cristina; García Rodríguez, María del Carmen; Linares, Juan Antonio; García Comas, Luis; Barranco, Mª Isabel; Chirlaque, María-Dolores; Moreno Docón, Antonio; Ramos Marín, Violeta; Castrillejo, Daniel; Gómez Anés, Atanasio; Larrauro, Amparo; Pérez-Gimeno, Gloria; Lozano Álvarez, Marcos; Vega, Lorena; Galindo, Silvia; Puma, Tania; Monge, Susana; Pozo, Francisco; Casas, Inmaculada; Sandonis, Virginia; Vázquez-Morón, Sonia; Echeverría, Aitziber; Trobajo-Sanmartín, Camino; García Cenoz, Manuel; Ezpeleta, Guillermo; Ezpeleta, Carmen; Navascués, Ana; Krisztalovics, Katalin; Mucsányiné Juhász, Krisztina; Kristóf, Katalin; Preuss, Ute; Wedde, Marianne; Biere, Barbara; Reiche, Janine; Oh, Djin-Ye; McKenna, Adele; Connell, Jeff; Joyce, Michael; Bagheri, Mariam; Bos, Sanne; van den Brink, Sharon; Dijkstra, Frederika; Eggink, Dirk; van Gageldonk-Lafeber, Rianne; Goderski, Gabriel; Herrebrugh, Chantal; Jenniskens, Liz; Reukers, Daphne; Sluimer, John; Sprong, Tara; Teirlinck, Anne; Veldhijzen, Nienke; van der Burgh, Ruben; Kager, Cathrien; Klinkhamer, Mayra; Knottnerus, Bart; Riethof, Marloes; van den Broek, Ruud; Wortel, Safira; Machado, Ausenda; Kislaya, Irina; Aniceto, Carlos; Gomes, Licínia; Verdasca, Nuno; Henriques, Camila; Dias, Daniela; Lança, Miguel; Blanchon, Thierry; Guerrisi, Caroline; Renard, Aubane; Launay, Titouan; Masse, Shirley; Chazelle, Marie; Ferenčak, Ivana; Kaić, Bernard; Višekruna Vučina, Vesna; Čusek Adamić, Katica; Kosanović Ličina, Mirjana Lana; Lakošeljac, Danijela; Mihin Huskić, Ivana; Nonković, Diana; Carnahan, Annasara; Hansson-Pihlainen, Eva; Arvesen, Elin; Nid, Nora; Hansen, Anna-Lena; Andersson, Emmi; Dillner, Lena; Jidovu, Adrian; Timnea, Olivia Carmen; Pascu, Cătălina; Oprea, Mihaela; Bistriceanu, Iulia; Ivanciuc, Alina; Mihai, Maria Elena; VEBIS Primary Care Vaccine Effectiveness GroupKey Points: - Question: What was the effectiveness of COVID-19 vaccines administered in autumn and winter 2022 to 2023 against symptomatic SARS-CoV-2 infection among people aged 60 years or older in Europe, and how did different exposed or reference groups affect effectiveness? - Findings: In this case-control study of 9308 primary care patients at 11 European sites, within 3 months of vaccination, all COVID-19 vaccine effectiveness (CVE) estimates were 29% to 39% against SARS-CoV-2 viruses and 44% to 52% against the XBB variants. All point estimates decreased by time after vaccination, with no vaccine protection after 6 months. - Meaning: Findings of this study suggest that COVID-19 vaccination campaigns should precede peaks in SARS-CoV-2 incidence and that effectiveness of new vaccines against emerging variants should be continually monitored using seasonal CVE approaches.
- Effectiveness of complete primary vaccination against COVID-19 at primary care and community level during predominant Delta circulation in Europe: multicentre analysis, I-MOVE-COVID-19 and ECDC networks, July to August 2021Publication . Kissling, Esther; Hooiveld, Mariëtte; Martínez-Baz, Iván; Mazagatos, Clara; William, Naoma; Vilcu, Ana-Maria; Kooijman, Marjolein N.; Ilić, Maja; Domegan, Lisa; Machado, Ausenda; de Lusignan, Simon; Lazar, Mihaela; Meijer, Adam; Brytting, Mia; Casado, Itziar; Larrauri, Amparo; Murray, Josephine-L.K.; Behillil, Sylvie; de Gier, Brechje; Mlinarić, Ivan; O’Donnell, Joan; Rodrigues, Ana Paula; Tsang, Ruby; Timnea, Olivia; de Lange, Marit; Riess, Maximilian; Castilla, Jesús; Pozo, Francisco; Hamilton, Mark; Falchi, Alessandra; Knol, Mirjam J.; Kurečić Filipović, Sanja; Dunford, Linda; Guiomar, Raquel; Cogdale, Jade; Cherciu, Carmen; Jansen, Tessa; Enkirch, Theresa; Basile, Luca; Connell, Jeff; Gómez, Verónica; Sandonis Martín, Virginia; Bacci, Sabrina; Rose, Angela M.C.; Pastore Celentano, Lucia; Valenciano, Marta; I-MOVE-COVID-19 and ECDC primary care study teamsIntroduction: In July and August 2021, the SARS-CoV-2 Delta variant dominated in Europe. Aim: Using a multicentre test-negative study, we measured COVID-19 vaccine effectiveness (VE) against symptomatic infection. Methods: Individuals with COVID-19 or acute respiratory symptoms at primary care/community level in 10 European countries were tested for SARS-CoV-2. We measured complete primary course overall VE by vaccine brand and by time since vaccination. Results: Overall VE was 74% (95% CI: 69–79), 76% (95% CI: 71–80), 63% (95% CI: 48–75) and 63% (95% CI: 16–83) among those aged 30–44, 45–59, 60–74 and ≥ 75 years, respectively. VE among those aged 30–59 years was 78% (95% CI: 75–81), 66% (95% CI: 58–73), 91% (95% CI: 87–94) and 52% (95% CI: 40–61), for Comirnaty, Vaxzevria, Spikevax and COVID-19 Vaccine Janssen, respectively. VE among people 60 years and older was 67% (95% CI: 52–77), 65% (95% CI: 48–76) and 83% (95% CI: 64–92) for Comirnaty, Vaxzevria and Spikevax, respectively. Comirnaty VE among those aged 30–59 years was 87% (95% CI: 83–89) at 14–29 days and 65% (95% CI: 56–71%) at ≥ 90 days between vaccination and onset of symptoms. Conclusions: VE against symptomatic infection with the SARS-CoV-2 Delta variant varied among brands, ranging from 52% to 91%. While some waning of the vaccine effect may be present (sample size limited this analysis to only Comirnaty), protection was 65% at 90 days or more between vaccination and onset.
- Exploring the effect of previous inactivated influenza vaccination on seasonal influenza vaccine effectiveness against medically attended influenza: results of the European I-MOVE multicentre test-negative case-control study, 2011/2012-2016/2017Publication . Valenciano, Marta; Kissling, Esther; Larrauri, Amparo; Nunes, Baltazar; Pitigoi, Daniela; O'Donnell, Joan; Reuss, Annicka; Horváth, Judit Krisztina; Paradowska-Stankiewicz, Iwona; Rizzo, Caterina; Falchi, Alessandra; Daviaud, Isabelle; Brytting, Mia; Meijer, Adam; Kaic, Bernard; Gherasim, Alin; Machado, Ausenda; Ivanciuc, Alina; Domegan, Lisa; Schweiger, Brunhilde; Ferenczi, Annamária; Korczyńska, Monika; Bella, Antonino; Vilcu, Ana-Maria; Mosnier, Anne; Zakikhany, Katherina; de Lange, Marit; Kurečić Filipovićović, Sanja; Johansen, Kari; Moren, Alain; I-MOVE primary care multicentre case-control teamBACKGROUND: Results of previous influenza vaccination effects on current season influenza vaccine effectiveness (VE) are inconsistent. OBJECTIVES: To explore previous influenza vaccination effects on current season VE among population targeted for vaccination. METHODS: We used 2011/2012 to 2016/2017 I-MOVE primary care multicentre test-negative data. For each season, we compared current season adjusted VE (aVE) between individuals vaccinated and unvaccinated in previous season. Using unvaccinated in both seasons as a reference, we then compared aVE between vaccinated in both seasons, current only, and previous only. RESULTS: We included 941, 2645 and 959 influenza-like illness patients positive for influenza A(H1N1)pdm09, A(H3N2) and B, respectively, and 5532 controls. In 2011/2012, 2014/2015 and 2016/2017, A(H3N2) aVE point estimates among those vaccinated in previous season were -68%, -21% and -19%, respectively; among unvaccinated in previous season, these were 33%, 48% and 46%, respectively (aVE not computable for influenza A(H1N1)pdm09 and B). Compared to current season vaccination only, VE for both seasons' vaccination was (i) similar in two of four seasons for A(H3N2) (absolute difference [ad] 6% and 8%); (ii) lower in three of four seasons for influenza A(H1N1)pdm09 (ad 18%, 26% and 29%), in two seasons for influenza A(H3N2) (ad 27% and 39%) and in two of three seasons for influenza B (ad 26% and 37%); (iii) higher in one season for influenza A(H1N1)pdm09 (ad 20%) and influenza B (ad 24%). CONCLUSIONS: We did not identify any pattern of previous influenza vaccination effect. Prospective cohort studies documenting influenza infections, vaccinations and vaccine types are needed to understand previous influenza vaccinations' effects.
- Influenza vaccine effectiveness in Europe and the birth cohort effect against influenza A(H1N1)pdm09: VEBIS primary care multicentre study, 2023/24Publication . Kissling, Esther; Maurel, Marine; Pozo, Francisco; Pérez-Gimeno, Gloria; Buda, Silke; Sève, Noémie; Domegan, Lisa; Hooiveld, Mariëtte; Oroszi, Beatrix; Martínez-Baz, Iván; Guiomar, Raquel; Latorre-Margalef, Neus; Mlinarić, Ivan; Lazar, Mihaela; Giménez Duran, Jaume; Dürrwald, Ralf; Enouf, Vincent; McKenna, Adele; de Lange, Marit; Túri, Gergő; Trobajo-Sanmartín, Camino; GOMEZ TEIXEIRA PINTO, VERÓNICA DEL PILAR; Samuelsson Hagey, Tove; Višekruna Vučina, Vesna; Cherciu, Maria Carmen; García Vazquez, Miriam; Erdwiens, Annika; Masse, Shirley; Bennett, Charlene; Meijer, Adam; Kristóf, Katalin; Castilla, Jesús; Rodrigues, Ana Paula; Kurečić Filipović, Sanja; Ivanciuc, Alina Elena; Bacci, Sabrina; Kaczmarek, MarlenaIntroduction: Influenza A(H1N1)pdm09, A(H3N2) and B/Victoria viruses circulated in Europe in 2023/24, with A(H1N1)pdm09 dominance. First influenza infections in childhood may lead to different vaccine effectiveness (VE) in subsequent years. Aim: The VEBIS primary care network estimated influenza VE in Europe using a multicentre test-negative study. Methods: Primary care practitioners collected information and specimens from patients consulting with acute respiratory infection. We estimated VE against influenza (sub)type and clade, by age group and by year of age for A(H1N1)pdm09, using logistic regression. Results: We included 29,958 patients, with 3,054, 1,053 and 311 influenza A(H1N1)pdm09, A(H3N2) and B cases, respectively. All-age VE against influenza A(H1N1)pdm09 was 52% (95% CI: 44-59). By year of age, VE was 27% (95% CI: -2 to 47) at 44 years with peaks at 72% (95% CI: 52-84) and 54% (95% CI: 41-64) among children and those 65 years and older, respectively. All-age A(H1N1)pdm09 VE against clade 5a.2a was 41% (95% CI: 24-54) and -11% (95% CI: -69 to 26) against clade 5a.2a.1. The A(H3N2) VE was 35% (95% CI: 20-48) among all ages and ranged between 34% and 40% by age group. All-age VE against clade 2a.3a.1 was 38% (95% CI: 1-62). All-age VE against B/Victoria was 83% (95% CI: 65-94), ranging between 70 and 92% by age group. Discussion: The 2023/24 VEBIS primary care VE against medically attended symptomatic influenza infection was high against influenza B/Victoria, but lower against influenza A(H1N1)pdm09 and A(H3N2). Clade- and age-specific effects may have played a role in the lower A(H1N1)pdm09 VE.
- The potential bias introduced into COVID-19 vaccine effectiveness studies at primary care level due to the availability of SARS-CoV-2 tests in the general populationPublication . Lanièce Delaunay, Charlotte; Nunes, Baltazar; Monge, Susana; de Lange, Marit; Túri, Gergő; Machado, Ausenda; Latorre-Margalef, Neus; Mlinarić, Ivan; Lazar, Mihaela; Botella Rocamora, Paloma; Erdwiens, Annika; Sève, Noémie; Domegan, Lisa; Martínez-Baz, Iván; Hooiveld, Mariëtte; Oroszi, Beatrix; Guiomar, Raquel; Sperk, Maike; Kurečić Filipović, Sanja; Pascu, Catalina; Linares Dopido, Juan Antonio; Dürrwald, Ralf; Rameix-Welti, Marie-Anne; McKenna, Adele; Castilla, Jesús; van Hagen, Cheyenne; Knol, Mirjam; Bacci, Sabrina; Kaczmarek, Marlena; Kissling, Esther; VEBIS Primary Care Vaccine Effectiveness GroupBackground: With SARS-CoV-2 self-tests, persons with acute respiratory infections (ARI) can know their COVID-19 status. This may alter their decision to consult a general practitioner (GP), potentially biasing COVID-19 vaccine effectiveness (VE) studies. We explore bias mechanisms, simulate magnitude, and verify control methods. Methods: We used directed acyclic graphs (DAGs) to illustrate the bias mechanisms. Based on the European primary care VEBIS multicentre test-negative design (TND) study, we simulated populations with varying true VE (20%-60%), proportions of persons with ARI self-testing (10%-30%), effect of COVID-19 vaccination on self-testing (1.5-2.5), and effect of self-test result on GP consultation (0.5-2). We performed 5000 runs per scenario, estimating VE among those consulting a GP. We calculated bias as true VE minus mean simulated VE, unadjusted and adjusted for self-testing, using logistic regression. Results: DAGs suggested collider stratification bias if vaccination had an effect on self-testing and if self-test results affected GP consultation. Bias was -12% to 18% at 20% true VE, with the most extreme associations and 30% self-testing. With 60% true VE and 10%-20% self-testing, bias was lower. Bias was higher (-18% to 45%) if both positive and negative self-test results affected GP consultation. Adjusting for self-testing removed the bias. Conclusions: Self-testing may bias COVID-19 VE TND studies in primary care if self-testing is high, particularly with low VE. We recommend primary care TND VE studies collect self-testing information to eliminate potential bias. Observational studies are needed to understand the relationship between vaccination, self-testing, and GP consultation, in these studies' source population.
- Vaccine effectiveness against symptomatic SARS-CoV-2 infection in adults aged 65 years and older in primary care: I-MOVE-COVID-19 project, Europe, December 2020 to May 2021Publication . Kissling, Esther; Hooiveld, Mariette; Sandonis Martín, Virginia; Martínez-Baz, Iván; William, Naoma; Vilcu, Ana-Maria; Mazagatos, Clara; Domegan, Lisa; de Lusignan, Simon; Meijer, Adam; Machado, Ausenda; Brytting, Mia; Casado, Itziar; Murray, Josephine-L.K.; Belhillil, Sylvie; Larrauri, Amparo; O’Donnell, Joan; Tsang, Ruby; de Lange, Marit; Rodrigues, Ana Paula; Riess, Maximilian; Castilla, Jesús; Hamilton, Mark; Falchi, Alessandra; Pozo, Francisco; Dunford, Linda; Cogdale, Jade; Jansen, Tessa; Guiomar, Raquel; Enkirch, Theresa; Burgui, Cristina; Sigerson, Debbie; Blanchon, Thierry; Martínez Ochoa, Eva María; Connell, Jeff; Ellis, Joanna; van Gageldonk-Lafeber, Rianne; Kislaya, Irina; Rose, Angela M.C.; Gomez, Verónica; Nunes, Baltazar; Roquette, Rita; Silva, Adriana; Melo, Aryse; Costa, Inês; Verdasca, Nuno; Conde, Patrícia; Valenciano, Marta; I-MOVE-COVID-19 primary care study teamThe I-MOVE-COVID-19 network collates epidemiological and clinical information on patients with coronavirus disease (COVID-19), including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virological characterisation in 11 European countries [1]. One component of I-MOVE-COVID-19 is the multicentre vaccine effectiveness (VE) study at primary care/outpatient level in nine European study sites in eight countries. We measured overall and product-specific COVID-19 VE against symptomatic SARS-CoV-2 infection among those aged 65 years and older. We also measured VE by time since vaccination.