​Utility of expanded hands-on training approach to workforce capacity development for vaccines lot release in Africa: experiences of the GHPP VaccRelease project

Background: Training regulatory staff in Africa as a means of providing technical support for the official lot release (LR) of vaccines is an established approach to sustainably strengthen the regulatory capacity for overseeing the quality, safety and efficacy of vaccines. In this study, we analysed the suitability and effectiveness of a series of expanded hands-on trainings in vaccines LR conducted by the VaccRelease project at the Paul-Ehrlich-Institut (PEI), and herein present the lessons learned.Method: Using a systematized mixed-methods approach, we collected post-training feedback from trained individuals of six trainings conducted on-site at PEI from August 2023 to November 2025 for 16 participants from three partner countries.Results: Employing the expanded hands-on approach to trainings contributed to enhancing the competencies and expertise of trained fellows in a spectrum of vaccines LR disciplines - including quality management system, approach to method transfer and biostatistics, LR process flow, experimental testing and lot summary protocol review - for which trainings were offered. Amongst the several cited strengths of the training, the experience, competence and work ethics of the trainers was most prominent. Moreover, the training’s on-site nature emerged as an invaluable asset that offered a practical understudy template vital for the implementation of training outputs. The most cited area for improvement of the trainings conducted - mainly by the trainees with limited baseline LR expertise - was the limited time for specific hands-on practice. Notwithstanding, that offered in the training proved optimal enough in averting any significant impairment to the achievement of training outputs. Further, the trained fellows showed a clear implementation plan to ultimately improve the performance of the LR function in their respective institutions.Conclusion: Overall, these findings have significant practical implications, and offer evidence-based recommendations for developing similar future hands-on training initiatives.