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Objectives: COVID-19 caused more than 260,000 hospitalizations and nearly 64,000 deaths in France in 2020. Vaccination has become the best hope for gaining control of the pandemic. Our objective is to map the major risks associated with organization of the start of a COVID-19 immunization campaign in the Provence-Alpes-Côte d'Azur region, from December 2020 to April 2021 (inclusive)., Materials and Methods: The process associated with organization of a COVID-19 immunization campaign was described. Risks, causes, consequences and control elements were identified by 14 semi-structured interviews, involving 19 professionals involved in the important stages in the process. The analysis was performed using the process approach and by a Failure Mode, Effects and Criticality Analysis (FMECA)., Results: The process is divided into two approaches, one collective and one individual. Forty-seven risks have been identified and 15 actions proposed. Regional supply logistics chain, vaccination sites, appointment management and the Vaccine-COVID information system are the critical points. Overwork is the most common risk, which has been experienced by the study participants (n=18). It favours the disaffection of the health professionals, which is the major threat of this organization. Eligibility, medical consultation, and the post-vaccination period are under control., Conclusions: Principal risks associated with organization of a COVID-19 immunization campaign have been identified and action plans have been proposed to optimize current and future practices. It gives a regional vision, to be compared with other regional, national, and international data., (Copyright © 2022 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)