학술논문

Brand-specific estimates of influenza vaccine effectiveness for the 2021–2022 season in Europe: results from the DRIVE multi-stakeholder study platform
Document Type
article
Author
Anke L. StuurmanAntonio CarmonaJorne BicclerAlexandre DescampsMiriam LeviUlrike BaumAinara Mira-IglesiasStefania BellinoUy HoangSimon de LusignanRoberto BonaiutiBruno LinaCaterina RizzoHanna NohynekJavier Díez-DomingoDRIVE Study ContributorsAnca Cristina DrăgănescuOana SăndulescuDaniela PiţigoiVictor Daniel MironAnca Streinu-CercelAnuţa BilaşcoAdrian Streinu-CercelDragoş FloreaOvidiu VlaicuSimona ParaschivLeontina BănicăDan OţeleaMonika Redlberger-FritzEva GeringerAmparo López-BernusAna Haro PerezNieves Gutierrez ZufiaurreCristina Carbonell MuñozMiguel Marcos MartinMuñoz Juan Luis BellidoIsabel Gil RodríguezAntonio Muro AlvarezMoncef Belhassen GarciaGiancarlo IcardiStefano MoscaDonatella PanattoEmanuele MontomoliSilvana CastaldiAndrea OrsiAlexander DomnichMaria ChironnaDaniela LoconsoleIlaria ManiniChristian NapoliAlessandra TorselloElena Parianiand Piero Luigi LaiSusana Otero-RomeroAndrés Antón PagarolasCristina AndrésIngrid CarbonésOleguer ParesMar FornagueraAnna OllerXavier SalgadoPatricia TejerinaCristina MartinezAlejandro Orrico-SánchezF. Xavier López-LabradorBeatriz Mengual-ChuliáJudit Sánchez SolerMaría Jinglei Casanova PalominoJuan Mollar-MaseresMiguel Tortajada-GirbésNoelia Rodríguez-BlancoMario Carballido-FernándezRaquel Andreu IvorraÀngels Sierra FortunyBeatriz Segura SeguraCristina Mingot UretaSagrario Corrales Díaz-FloresÁngela Sánchez PlaMaría Dolores Tirado BalaguerJuan AlberolaJosé Miguel NogueiraJuan J CamarenaFrancisco Arjona-ZaragozíMaruan Shalabi BenaventJosé Luis López-HontangasMaría Dolores GómezAlejandro Martín-QuirósCarlos Cañada IllanaEmilio CendejasIrma Casas GarcíaGuillermo Mena PinillaMaría Esteve PardoLola Álamo JunqueraCristina CasañSandra Fernandez MorodoAgueda HernándezPere-Joan CardonaMarta SeguraAndreu C. PelegrinSara González-GómezVerónica SaludesElisa MartróValtýr Stefánsson ThorsKristín L. BjörnsdóttirLiem LuongZineb LesieurYacine SaidiRebecca BauerChristine PereiraPhilippe VanhemsFabrice LainéFlorence GaltierXavier DuvalChristine DurierPaolo BonanniAlfredo VannacciClaudia Ravaldi
Source
Frontiers in Public Health, Vol 11 (2023)
Subject
vaccine effectiveness
influenza
influenza vaccines
test-negative design
post authorization
real-world evidence
Public aspects of medicine
RA1-1270
Language
English
ISSN
2296-2565
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.