Posted by Michael Wonder on 24 Mar 2020
Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points:
- Pre-clinical data required to support proceeding to first-in-human clinical trials with investigational medicinal products; and
- The need to address the known theoretical risk that vaccines against COVID-19 enhance the disease prior to starting first-in-human clinical trials.
