Clinical vaccine trials contribute to public health promotion by providing tools for prevention

Abstract Background FVR - Finnish vaccine research is a research network organization focusing on vaccine research. The history of FVR since 2022 and its predecessor Tampere University Vaccine Research Center date back to 1997. In this study we aimed to review the studies conducted by the FVR and its predecessors and estimate the proportion of the clinical vaccine trials leading to marketing authorization of the investigational medicinal product (IMP). Methods We reviewed our own databases and identified the IMP used in each of the trials. Then, public databases of European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) were reviewed to define whether 1) the IMP had received a market authorization, 2) in which target population the authorization was granted and 3) whether the authorization was still valid in 2025. Results Since 1997, a total of 168 vaccine trials have been conducted. The clinical trials covered all development phases (1-4) with a majority of phase 3 trials (n = 106/168; 62%). Trials were conducted in all age groups from infants to elderly with the largest proportion of pediatric studies (children 1-10 years of age; n = 75/168; 44%). Of IMPs included in the phase 1-3 trials completed before 2023, 91/122 (75%) have currently a marketing authorization in the study population granted by EMA or FDA. Conclusions Majority of investigational vaccines in clinical trials conducted in Finland has ended up in a marketing authorization. This highlights the importance of conducting clinical vaccine trials to enable implementation of new preventive tools to promote public health. This is also reassuring for volunteers considering participating in clinical vaccine trials. Key messages • Since 1997 FVR – Finnish Vaccine Research has conducted 168 clinical vaccine trials and 75% of the investigational vaccines have later received market authorization in the target population. • Conducting and participating in clinical vaccine trials contribute to the public health promotion by enabling implementation of new preventive tools for the control of communicable diseases.