ARTICLE | Regulation
Global regulators’ report offers framework for data needed to move COVID-19 vaccines into clinic
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March 25, 2020 12:09 AM UTC
Updated on Mar 25, 2020 at 12:54 AM UTC
An international report released Tuesday provides a framework for what data COVID-19 vaccine developers should gather before moving into first-in-human studies. The coalition emphasized the need for preclinical data to address the potential of a candidate to worsen the disease.
The recommendations come from a March 18 workshop of the International Coalition of Medicines Regulatory Authorities (ICMRA), which was co-chaired by EMA and FDA...