Country readiness in responding to COVID-19 Vaccine-Related Events (VREs) in Malawi.

Introduction: The Malawi Ministry of Health (MMoH) and partners developed a comprehensive Coronavirus Disease 2019 (COVID-19) Vaccine Related Events (VREs) response plan in 2022. A VRE is any anticipated threat that could erode the public's trust in vaccines or vaccination delivery. We explored the MMoH's readiness to implement the plan by assessing the availability of VRE-related documents describing the overall process of identifying, reporting, investigating, and coordinating a VRE response; and by assessing the strengths and weaknesses of the current system. Methods: We conducted a cross-sectional assessment among MMoH staff involved in VRE response at national, district, and health facility level using a survey and a semi-structured interview guide in ten districts in Malawi in 2023. Ten VRE-related documents were assessed and their availability visually confirmed. We assessed each of the survey findings by district and zone. Ten key themes pertaining to VRE identification, reporting, investigation, and response were explored in 109 Key Informant Interviews (KIIs) and six Focus Group Discussions (FGDs). Results: More than 60% of respondents reported having access to VRE-related documentation, but less than 10% reported access to non-Adverse Events Following Immunisation (non-AEFIs)-related guidance. Participants identified existing processes for AEFIs, but noted the lack of training, coordination, and budgetary support for both AEFI and non-AEFI activities. Health facilities with VRE response teams or committees had implemented aspects of the response plan, emphasizing the need to formulate teams or committees in all health facilities. Conclusion: Adequate implementation of Malawi's VRE response plan will require expanded training opportunities, sustained funding, and improved coordination across all levels of the health system.