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- COVID-19 Vaccine Effectiveness Against Medically Attended Symptomatic SARS-CoV-2 Infection Among Target Groups in Europe, October 2024-January 2025, VEBIS Primary Care NetworkPublication . Delaunay, Charlotte Laniece; Verdasca, Nuno; Monge, Susana; Domegan, Lisa; Sève, Noémie; Buda, Silke; Meijer, Adam; Lucaccioni, Héloïse; Torrijos, Miriam López; McKenna, Adele; Enouf, Vincent; Dürrwald, Ralf; In't Velt, Eline; Laiglesia, Mª Ángel de Valcárcel; Bennett, Charlene; Masse, Shirley; Erdwiens, Annika; Hooiveld, Mariette; Mlinarić, Ivan; Túri, Gergő; Rodrigues, Ana Paula; Martínez-Baz, Iván; Lazar, Mihaela; Latorre-Margalef, Neus; Borges, Vitor; Kaczmarek, Marlena; Bacci, Sabrina; Kissling, Esther; European primary care VE groupWe estimated the effectiveness of 2024/25 COVID-19 vaccination against medically attended SARS-CoV-2 infection in Europe, among target groups. We included 3204 patients (8/139 cases vaccinated: 6%; 517/3065 controls vaccinated: 17%) from a multicentre, test-negative design study at primary care level. Vaccine effectiveness was 66% (95% CI: 34-85) overall, 73% (95% CI: 21-94) and 54% (95% CI: -3 to 83) in the first and second months post-vaccination, respectively. Overall vaccine effectiveness was 67% (95% CI: 33-86) among older adults (≥ 60 or ≥ 65 years). This relatively high COVID-19 VE (compared with previous seasons), as well as trends by time since vaccination, should be confirmed with additional data, as sample size was low.
- 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 COVID-19 vaccines administered in the 2023 autumnal campaigns in Europe: Results from the VEBIS primary care test-negative design study, September 2023–January 2024Publication . Laniece Delaunay, Charlotte; Melo, Aryse; Maurel, Marine; Mazagatos, Clara; Goerlitz, Luise; O’Donnell, Joan; Oroszi, Beatrix; Sève, Noémie; Rodrigues, Ana Paula; Martínez-Baz, Iván; Meijer, Adam; Mlinarić, Ivan; Latorre-Margalef, Neus; Lazăr, Mihaela; Pérez-Gimeno, Gloria; Dürrwald, Ralf; Bennett, Charlene; Túri, Gergő; Rameix-Welti, Marie-Anne; Guiomar, Raquel; Castilla, Jesús; Hooiveld, Mariëtte; Kurečić Filipović, Sanja; Samuelsson Hagey, Tove; Dijkstra, Frederika; Borges, Vitor; Ramos Marín, Violeta; Bacci, Sabrina; Kaczmarek, Marlena; Kissling, Esther; European primary care VE groupIn autumn 2023, European vaccination campaigns predominantly administered XBB.1.5 vaccine. In a European multicentre study, we estimated 2023 COVID-19 vaccine effectiveness (VE) against laboratory-confirmed symptomatic infection at primary care level between September 2023 and January 2024. Using a testnegative case–control design, we estimated VE in the target group for COVID-19 vaccination overall and by time since vaccination. We included 1057 cases and 4397 controls. Vaccine effectiveness was 40 % (95 % CI: 26–53 %) overall, 48 % (95 % CI: 31–61 %) among those vaccinated < 6 weeks of onset and 29 % (95 % CI: 3–49 %) at 6–14 weeks. Our results suggest that COVID-19 vaccines administered to target groups during the autumn 2023 campaigns showed clinically significant effectiveness against laboratory-confirmed, medically attended symptomatic SARS-CoV-2 infection in the 3 months following vaccination. A longer study period will allow for further variant-specific COVID-19 VE estimates, better understanding decline in VE and informing booster administration policies.
- 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.
- 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.
- 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.