Accelerating the approval of mpox vaccines based on lessons learnt from COVID-19 vaccines through the lens of regulatory science

The expedited approval of mpox vaccines is critical to addressing this public health emergency. Building on the practice in approving COVID-19 vaccines, this analysis investigates the regulatory pathways used to accelerate vaccine approvals and their implications for mpox vaccine development. The study highlights the regulatory frameworks of the WHO Emergency Use Listing, the U.S. Food and Drug Administration Emergency Use Authorisation, the European Medicines Agency Conditional Marketing Authorisation and Japan's Pharmaceuticals and Medical Devices Agency Emergency Approval. A comparative analysis of these pathways reveals differences in application conditions, data requirements, review timelines and post-approval obligations. The study also draws key lessons from the case analysis of COVID-19 vaccine approvals, providing additional insights for the approval of mpox vaccines. Our study underscores the importance of maintaining rigorous regulatory standards while expediting vaccine development and identifies fit-for-purpose strategies to enhance global preparedness for future public health crises, ensuring the availability of safe, effective and high-quality vaccines.