US FDA Guidance on the Development of COVID-19 Vaccine and Some Issues Regarding Domestic Vaccine Development
US Food and Drug Administration issued Guidance for Industry titled Development and Licensure of Vaccines to Prevent COVID-19 in June 2020. The guidance describes the Agency’s thinking and is the most importance reference regarding anti-COVID-19 vaccines development. There are 8 candidate vaccines have moved or moving into phase III clinical trial. Study designs of all of the trials are comparable with the considerations in guidance. This article is to introduce the special considerations in the guidance, and then to address some issues regarding domestic anti- COVID-19 vaccines development.