Title : Navigating european real-world data for vaccines: Key opportunities and challenges
Abstract:
Objective
Real-world data (RWD) in vaccine research has grown significantly in recent years, largely driven by the COVID-19 pandemic and an unprecedented need for accelerated vaccine development. RWD is critical for understanding disease burdens and health outcomes to inform public decision-making. To this aim, our objective was to understand future opportunities for and limitations of existing RWD sources in Europe for vaccines to guide RWD usability in vaccine research.
Methods
We conducted interviews with industry experts and reviewed WHO guidelines to understand opportunities and challenges for RWD in vaccines, considering varying evidence needs across the asset lifecycle. RWD variables of interest were identified and mapped to each evidence need. Primary market research was conducted with secondary data sources across 10 European countries to ascertain variable availability and suitability for conducting real-world studies on prophylactic vaccines.
Results
Our findings reveal key opportunities for RWD in vaccines as it enables the identification of high unmet need populations, the capture of rare safety and effectiveness outcomes, the surveillance of long-term effects across diverse groups, and provides insights into real-world uptake.
Unique challenges, however, include fragmented data across different settings of care (e.g., primary, secondary, community), variation in longitudinal data availability, and inconsistent documentation of key variables (e.g., vaccine brand information and vaccine administration date are not systematically documented). Furthermore, some RWD sources do not capture any vaccination information or only do for a subset of vaccines depending on administration setting.
Conclusion
While opportunities exist to leverage RWD for specific vaccine studies, there is heterogeneity in data coverage across European markets, and ensuring longitudinal follow-up across different settings of care remains a common challenge. Greater collaboration between data sources for key variable linkage is critical to accelerate the usefulness of RWD in contextualizing real-world impacts of vaccines for health systems.
Audience Take-Away:
- Our presentation sheds light on future opportunities and limitations of existing RWD sources, emphasizing their potential to optimize public health impact through vaccine research.
- It aims to inspire the audience to leverage RWD for vaccine research to effectively contextualize the real-world impacts of vaccines on health systems. This includes identifying vaccine uptake/underutilization, conducting long-term effectiveness and safety studies to support post- licensure risk/benefit assessments, as well as ongoing vaccine monitoring using secondary data.
- It also provides valuable insight into the suitability of secondary data sources across 10 European countries for conducting real-world studies on prophylactic vaccines.
