Medicines regulatory authorities from around the world have published a report today highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
The report describes the regulatory positions agreed by the meeting participants on two key topics:
Data needed from laboratory, animal and human studies to allow initiation of phase 3 clinical trials for a COVID-19 vaccine; and
Considerations for study design for phase 3 clinical trials.
Phase 3 is the last phase of
