Abstract

During the COVID-19 pandemic, an unprecedented level of regulatory flexibility accelerated the authorisation of COVID-19 products. This flexibility was a key factor in enabling rapid patient access to highly needed vaccines and therapies. In the wake of the pandemic, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) started developing new guidelines on COVID-19 prophylactics and therapeutics, as well as updating their guidance on vaccine development. This article discusses the current regulatory status and its impact on the early development of vaccines and prophylactic treatments for infectious diseases.