Global Regulatory Workshop Offers Regulatory Considerations, Data Requirements for Phase 1 COVID-19 Vaccine Trials
A meeting report from a regulatory workshop held virtually under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) provides an overview of new regulatory considerations for the development of COVID-19 vaccines and data requirements for phase 1 COVID-19 vaccine trials.
In the report, delegates from 17 countries and more than 20 global medicine regulatory authorities provide several generally agreed-upon positions regarding the clinical data required to support proceeding with a COVID-19 vaccine to first-in-human clinical trials. The report also provides consensus positions on how to address the theoretical risk of COVID-19 vaccine-induced disease enhancement before proceeding to first-in-human clinical trials.
The report also lays the groundwork on how global regulatory authorities should address the balance between rapid vaccine development and the need to produce sufficient robust data. Read the full report here: https://bit.ly/2WUX4cW.