International – ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies

After meeting last week to discuss vaccine development for the coronavirus disease (COVID-19), the International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday released guidelines for the data required before proceeding to first-in-human (FIH) studies for candidates.
 
So far, two vaccine candidates developed by Moderna and CanSino Biologics have moved into Phase I clinical testing, while many other companies and researchers have said they are in preclinical development.
 
In a summary report from the meeting, ICMRA says that pre-clinical and preliminary data must be generated to support moving to Phase I studies and to address the potential risk that a candidate vaccine could make patients more susceptible to the virus.
 
Vaccine-induced disease enhancement has been documented for multiple types of viruses, including other coronaviruses such as the original SARS virus