Monitoring new AESIs: harmonizing AESI X case definition
GACVS was informed of the status of a collaborative project between the Safety Platform for Emergency Vaccines and the Brighton Collaboration, funded by the Coalition for Epidemic Preparedness Innovations, to develop a process for rapid development of new definitions of cases of adverse events of special interest (AESI) (“AESI-X”) in emerging safety signals. Usually, development of new case definitions (CDs) takes about 18 months. Preparedness for future AESI-X requires consensus on rapid development of standardized Brighton Collaboration CDs for predicted and unexpected AESI-X. The aim of the AESI-X CD Preparedness Plan is to create a consensus process for rapid development of global CDs for new AESI-X. GACVS discussed how, in the event of emergence of an AEFI-X, the Brighton Collaboration could best coordinate and communicate with relevant stakeholders to rapidly develop a new CD. GACVS agreed on the importance of processes for rapid dissemination of new CDs to clinical practice once they are developed. The Committee agreed to review the proposed process and provide input.