Strengthening Vaccine Safety Systems, Research, and Regional Collaboration in Africa: A Call to Action.

Abstract

The 8th meeting of the African Advisory Committee on Vaccine Safety (AACVS), constituted in 2021, convened by the Vaccine Research and Innovation Unit within the Vaccine Preventable Diseases Program, WHO Regional Office for Africa, was held virtually from 14 to 16 April 2025. The meeting brought together independent vaccine experts to provide advice to the Regional Director, WHO, on vaccine safety issues critical to the African region. Discussions focused on critical updates regarding ongoing regional outbreaks, safety data, and associated safety concerns, with emphasis on newly introduced vaccines, including the malaria vaccines (RTS, S and R21), the MenFive pentavalent meningitis vaccine, and the Mpox vaccines-MVA-BN and LC16-alongside the ongoing Mpox response. The Committee conducted a deep dive into comprehensive safety considerations for new vaccine introduction, active surveillance strategies, strengthening the responsiveness of pharmacovigilance systems, and advancing vaccine research and development in Africa. Key observations highlighted significant gaps in safety surveillance systems. These included delays in data collection, access, and signal detection; a lack of harmonized real-time monitoring frameworks; the underutilization of digital technologies; and inadequate manufacturer responsibilities and accountability in post-market safety monitoring. The meeting concluded with a call to action emphasizing the need for sustainable pharmacovigilance funding mechanisms, improved regional coordination, real-time data sharing, standardized early safety study protocols, strengthened manufacturer accountability, and investments in risk communication and community engagement to bolster public trust. Strengthening vaccine safety systems and enhancing regional collaboration were recognized as urgent priorities to support the safe and effective deployment of vaccines and protect public health across Africa.