Reference:
U.S. Department of Health and Human Services. (2020). Contains nonbinding recommendations: Development and licensure of vaccines to prevent COVID-19 guidance for industry. Food and Drug Administration.
Summary:
In June 2020, the U.S. Food and Drug Administration (FDA) issued guidance to assist the development and licensure of COVID-19 vaccines amidst the public health emergency. This document outlines key considerations for vaccine sponsors, including requirements for chemistry, manufacturing, controls, and nonclinical and clinical data. The FDA emphasises the importance of traditional approval based on direct evidence of vaccine safety and efficacy, given the absence of established surrogate endpoints. The guidance covers essential aspects such as trial populations, trial design, and post-licensure safety evaluations. It also highlights the need for rigorous nonclinical studies to assess potential safety risks, including vaccine-associated enhanced respiratory disease. The FDA encourages early communication with its officials to facilitate compliance with regulatory standards. This guidance aims to ensure that vaccines developed are safe and effective in combating COVID-19.