1. Brand-specific estimates of influenza vaccine effectiveness for the 2021–2022 season in Europe: results from the DRIVE multi-stakeholder study platform
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Anke L. Stuurman, Antonio Carmona, Jorne Biccler, Alexandre Descamps, Miriam Levi, Ulrike Baum, Ainara Mira-Iglesias, Stefania Bellino, Uy Hoang, Simon de Lusignan, Roberto Bonaiuti, Bruno Lina, Caterina Rizzo, Hanna Nohynek, Javier Díez-Domingo, DRIVE Study Contributors, Anca Cristina Drăgănescu, Oana Săndulescu, Daniela Piţigoi, Victor Daniel Miron, Anca Streinu-Cercel, Anuţa Bilaşco, Adrian Streinu-Cercel, Dragoş Florea, Ovidiu Vlaicu, Simona Paraschiv, Leontina Bănică, Dan Oţelea, Monika Redlberger-Fritz, Eva Geringer, Amparo López-Bernus, Ana Haro Perez, Nieves Gutierrez Zufiaurre, Cristina Carbonell Muñoz, Miguel Marcos Martin, Muñoz Juan Luis Bellido, Isabel Gil Rodríguez, Antonio Muro Alvarez, Moncef Belhassen Garcia, Giancarlo Icardi, Stefano Mosca, Donatella Panatto, Emanuele Montomoli, Silvana Castaldi, Andrea Orsi, Alexander Domnich, Maria Chironna, Daniela Loconsole, Ilaria Manini, Christian Napoli, Alessandra Torsello, Elena Pariani, and Piero Luigi Lai, Susana Otero-Romero, Andrés Antón Pagarolas, Cristina Andrés, Ingrid Carbonés, Oleguer Pares, Mar Fornaguera, Anna Oller, Xavier Salgado, Patricia Tejerina, Cristina Martinez, Alejandro Orrico-Sánchez, F. Xavier López-Labrador, Beatriz Mengual-Chuliá, Judit Sánchez Soler, María Jinglei Casanova Palomino, Juan Mollar-Maseres, Miguel Tortajada-Girbés, Noelia Rodríguez-Blanco, Mario Carballido-Fernández, Raquel Andreu Ivorra, Àngels Sierra Fortuny, Beatriz Segura Segura, Cristina Mingot Ureta, Sagrario Corrales Díaz-Flores, Ángela Sánchez Pla, María Dolores Tirado Balaguer, Juan Alberola, José Miguel Nogueira, Juan J Camarena, Francisco Arjona-Zaragozí, Maruan Shalabi Benavent, José Luis López-Hontangas, María Dolores Gómez, Alejandro Martín-Quirós, Carlos Cañada Illana, Emilio Cendejas, Irma Casas García, Guillermo Mena Pinilla, María Esteve Pardo, Lola Álamo Junquera, Cristina Casañ, Sandra Fernandez Morodo, Agueda Hernández, Pere-Joan Cardona, Marta Segura, Andreu C. Pelegrin, Sara González-Gómez, Verónica Saludes, Elisa Martró, Valtýr Stefánsson Thors, Kristín L. Björnsdóttir, Liem Luong, Zineb Lesieur, Yacine Saidi, Rebecca Bauer, Christine Pereira, Philippe Vanhems, Fabrice Lainé, Florence Galtier, Xavier Duval, Christine Durier, Paolo Bonanni, Alfredo Vannacci, and Claudia Ravaldi
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vaccine effectiveness ,influenza ,influenza vaccines ,test-negative design ,post authorization ,real-world evidence ,Public aspects of medicine ,RA1-1270 - Abstract
IntroductionDevelopment of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public–private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public health purposes. DRIVE was launched in 2017 under the umbrella of the Innovative Medicines Initiative (IMI) and conducted IVE studies from its pilot season in 2017–2018 to its final season in 2021–2022.MethodsIn 2021–2022, DRIVE conducted four primary care-based test-negative design (TND) studies (Austria, Italy, Iceland, and England; involving >1,000 general practitioners), nine hospital-based TND studies (France, Iceland, Italy, Romania, and Spain, for a total of 21 hospitals), and one population-based cohort study in Finland. In the TND studies, patients with influenza-like illness (primary care) or severe acute respiratory infection (hospital) were enrolled, and laboratory tested for influenza using RT-PCR. Study contributor-specific IVE was calculated using logistic regression, adjusting for age, sex, and calendar time, and pooled by meta-analysis.ResultsIn 2021–2022, pooled confounder-adjusted influenza vaccine effectiveness (IVE) estimates against laboratory-confirmed influenza (LCI) overall and per type and subtype/lineage was produced, albeit with wide confidence intervals (CI). The limited circulation of influenza in Europe did not allow the network to reach the optimal sample size to produce precise IVE estimates for all the brands included. The most significant IVE estimates were 76% (95% CI 23%−93%) for any vaccine and 81% (22%−95%) for Vaxigrip Tetra in adults ≥65 years old and 64% (25%−83%) for Fluenz Tetra in children (TND primary care setting), 85% (12%−97%) for any vaccine in adults 18–64 years (TND hospital setting), and 38% (1%−62%) in children 6 months−6 years (population-based cohort, mixed setting).DiscussionOver five seasons, DRIVE collected data on >35,000 patients, more than 60 variables, and 13 influenza vaccines. DRIVE demonstrated that estimating brand-specific IVE across Europe is possible, but achieving sufficient sample size to obtain precise estimates for all relevant stratifications remains a challenge. Finally, DRIVE's network of study contributors and lessons learned have greatly contributed to the development of the COVID-19 vaccine effectiveness platform COVIDRIVE.
- Published
- 2023
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