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Meta-Analysis
. 2023 Jul 20:11:1195409.
doi: 10.3389/fpubh.2023.1195409. eCollection 2023.

Brand-specific estimates of influenza vaccine effectiveness for the 2021-2022 season in Europe: results from the DRIVE multi-stakeholder study platform

Anke L Stuurman #  1 , Antonio Carmona #  2   3 , Jorne Biccler  1 , Alexandre Descamps  4 , Miriam Levi  5 , Ulrike Baum  6 , Ainara Mira-Iglesias  2   3 , Stefania Bellino  7 , Uy Hoang  8 , Simon de Lusignan  8 , Roberto Bonaiuti  9 , Bruno Lina  10 , Caterina Rizzo  11 , Hanna Nohynek  6 , Javier Díez-Domingo  2   3 ; DRIVE Study Contributors
Collaborators, Affiliations
Meta-Analysis

Brand-specific estimates of influenza vaccine effectiveness for the 2021-2022 season in Europe: results from the DRIVE multi-stakeholder study platform

Anke L Stuurman et al. Front Public Health. .

Abstract

Introduction: Development 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.

Methods: In 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.

Results: In 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).

Discussion: Over 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.

Keywords: Europe; influenza; influenza vaccines; post authorization; real-world evidence; test-negative design; vaccine effectiveness.

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Conflict of interest statement

AS and JB declare that they were employees of P95; P95 has held/holds contracts with Seqirus, Sanofi, GSK, and AstraZeneca. AC reports remunerated collaborations with HIPRA, GSK, and MSD for lectures and seminars. JD-D declares that FISABIO receives research grants from Sanofi, GSK, and Seqirus, that he has been principal investigator in clinical trials with influenza vaccine for GSK, SP, Abbott, and that he has acted as an advisor for Sanofi and MSD. He also declares he is a Member of Monitoring committee of clinical trials for Janssen and GSK. AD reports grants from Innovative Medicines Initiative 2 Joint Undertaking (grant agreement No 777363) and from Sanofi (outside the submitted work). SL reports that through his University he has had grants not directly relating to this work, from AstraZeneca, GSK, Sanofi, Seqirus, and Takeda for vaccine related research, and membership of advisory boards for AstraZenca Sanofi and Seqirus. CR declares that she has received funding for participating in AB from Seqirus, Sanofi and MSD. HN declares that she is an employee of the Finnish Institute for Health and Welfare, which has a major phase IV study on influenza vaccine funded by Sanofi; however, she is not personally involved in the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
In the 2021–2022 season, the DRIVE network consisted of 12 independent study contributors in seven European countries conducting test-negative design (TND) studies and a population-based cohort study in Finland.
Figure 2
Figure 2
Number of vaccinated subjects among enrolled subjects and distribution of vaccine brands; TND studies, 2021–2022.
Figure 3
Figure 3
Any influenza vaccine: pooled confounder-adjusted (age, sex, and date of symptom onset) influenza vaccine effectiveness against laboratory-confirmed influenza, overall and by type and subtype/lineage, by setting and age group, 2021–2022—TND studies. For some study contributors, IVE could not be calculated (e.g., due to a value of 0 in the 2 × 2 table), and/or the estimate was both outlying and influential (and therefore excluded). Consequently, data from these sites are not included in the pooled estimate, and therefore, the number of subjects in this figure may be lower than described in Table 3.
See this image and copyright information in PMC

References

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