Speed, safety, and politics: The next generation of vaccine regulation

The processes around vaccine licensure today are still built on a shared core: robust evidence for quality, safety, and efficacy, demonstrated through standardized preclinical testing, phased clinical trials, and stringent manufacturing controls. What has changed in the last two decades is the toolbox around this core, with conditional approvals, emergency pathways, and WHO prequalification now used to speed access for priority vaccines while keeping post‑licensure monitoring and additional data generation as non‑negotiable requirements. 1. Where we are today: core requirements for licensure Modern vaccine licensure still rests on the classic pillars of quality, safety, and efficacy, implemented via stepwise development from preclinical studies through phased clinical trials and post-marketing surveillance. EMA, FDA, and WHO each apply this triad, but with distinct procedural frameworks, legal bases, and tools to manage urgency, uncertainty, and global access. For EMA, centralised marketing authorisation via the Committee for Medicinal Products for Human Use (CHMP) is mandatory for most...