BACKGROUND: The COVID-19 emergency has accentuated the importance of conducting post-authorisation safety studies (PASS) in the context of monitoring vaccines’ effectiveness and safety. The PASS studies are conducted in a collaborative manner within the Vaccine monitoring Collaboration for Europe (VAC4EU) consortium. PASS study teams are led by scientific coordinators and monitored by study managers to implement and execute the research protocols. We aim to describe and discuss the challenges and lessons learnt from the perspective of the study managers of PASS studies implemented during the COVID-19 pandemic.
OBJECTIVES: We describe challenges and learnings from the management of selected VAC4EU PASS studies for COVID-19 vaccine monitoring studies, with the goal of improving the quality of COVID-19 vaccine post-marketing monitoring research.
METHODS: We conducted interviews with consortium members involved in #8 studies upon the completion of each of the regulatory reporting cycles to assess the challenges in the management and coordination of the research activities.
RESULTS: The dynamic regulatory environment due to shifting vaccine registration strategies and administration prioritization, emerging COVID-19 vaccine safety signals, a lack of unified global regulatory pathways as well as the evolution of SARS-CoV-2 added complexity to the execution of the studies. The main challenge in managing and coordinating multi-centre PASS studies for COVID-19 vaccines was meeting the study reporting timelines, as mandated by the regulators. The demanding schedule, urgent onboarding of participating data access providers (DAPs), data availability, and data refresh frequencies were the main factors for the constant need for flexibility to meet these deadlines. Due to the large number and heterogeneity of study team members and the continuously evolving regulatory context, communication challenges among different study working groups were also identified. Moreover, resource planning for the study execution phase and staff capacity building in the context of the pandemic situation had an impact on the timely and smooth execution of the studies.
CONCLUSIONS: A variety of challenges and learnings were identified while coordinating and managing the multi-centre COVID-19 vaccine monitoring studies. The successful conduct of such studies requires careful planning and a dedicated collaborating multi-skilled team to execute and monitor study activities, as well as flexibility and fluent communication among the study members.
