The SARS-CoV-2 pandemic that has infected to date more than 200,000 people worldwide presents an extraordinary challenge to global health. Commercial vaccine manufacturers and other entities are developing SARS-CoV-2 vaccine candidates using different technologies and platforms including RNA, DNA, protein and viral vectored vaccines. The rapid spread of SARS-CoV-2 requires accelerated development timelines for SARSCoV-2 vaccine candidates to enter expeditiously into Phase 1 clinical trials. Hence, the type and extent of preclinical and preliminary clinical data needed to inform the clinical development program for SARS-CoV-2 vaccines must be weighed against the overall risk-benefit assessment of the unmet medical need for vaccines to confront this challenge.

During the first global regulatory workshop on 18 March 2020, delegates from 17 countries, representing more than 20 medicines regulatory authorities globally, and experts from the WHO and the European Commission discussed regulatory considerations related to the development of SARS-CoV-2 vaccine candidates and preclinical data required to support proceeding to first-in-human (FIH) clinical trials. The discussion was co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).