BioCentury
ARTICLE | Regulation

Global regulators at odds on Phase III efficacy threshold for COVID-19 vaccines

July 13, 2020 9:40 PM UTC

Regulators are aligning their guidance on COVID-19 vaccine development through the the International Coalition of Medicines Regulatory Authorities, but they have yet to agree on the criteria for vaccine efficacy.

A report released last Friday from the second COVID-19 vaccines workshop held by ICMRA detailed regulators’ guidance on the preclinical and clinical data required to start Phase III testing of COVID-19 vaccines and how those Phase III trials should be designed...