When the vaccine works: data, AI, and governance readiness in CCHF vaccine research

Presentation given by the Independent Ethics Advisor to the CCHFVACIM project at the consortium's Annual Meeting in Thessaloniki on 8 October 2026, in the joint session 'Word from the Ethics and Scientific Advisors'. The presentation argues that governance readiness, in ethics, in regulation, and in data, is a precondition for clinical translation rather than a downstream concern, and that the question is the readiness of the institutions asked to review and oversee this research rather than the properties of any single tool. It sets out the governance position of a Crimean-Congo haemorrhagic fever (CCHF) vaccine programme at the point where a candidate has been through a first-in-human trial in the predecessor project and the next phase is in prospect: material and data crossing nine countries, three of them outside the European Union; artificial intelligence tools whose regulatory and ethics status is unsettled entering the safety analysis pipeline; and consent taken for convalescent sampling rather than for what the samples now support. It poses three governance questions for the consortium, on data sovereignty, on the status of an output when an artificial intelligence tool flags a safety signal, and on the architecture of consent. It identifies four instruments already available for deliberate application to CCHF: the guidance of the EOSC-Future/RDA AI and Data Visitation Working Group (AIDV-WG) together with Global Ethics and Regulatory Preparedness (GERP); the African Vaccine Regulatory Forum (AVRF) and the African Medicines Agency (AMA), with the direction of travel toward one world, one dossier; monitored emergency use of unregistered and investigational interventions (MEURI) and the Ebola ring vaccination trial in Guinea in 2015; and the Ethics, Legal, and Societal Impact (ELSI) Working Group of the Human Genome Project II (HGP2). It closes with three asks of the consortium: that the HGP2 ELSI Working Group be named a governance partner in the next phase of the CCHFVACIM protocol, that a working group session map CCHFVACIM data flows to existing ethics and regulatory frameworks, and that a CCHFVACIM governance annex to the GERP protocol be co-authored.