Concept paper on the revision of the COVID-19 vaccines guidance documents
HumanScientific guidelinesVaccines
During the COVID-19 pandemic, the EMA Emergency Task Force (ETF) issued two guidance documents on regulatory requirements for COVID-19 vaccines. The first, issued in November 2020, covered clinical requirements for COVID-19 vaccine approval, and the second, issued in February 2021, addressed quality, non-clinical, clinical and clinical requirements for SARS-CoV-2 variant vaccines. Since these documents were published there have been several developments in the field of COVID-19 vaccines. In parallel, the predominant circulating variants of SARS-CoV-2 continue to evolve over time and the immunity of the European Union (EU) population to prior and current variants has increased due to natural exposures and vaccination campaigns. Experience with applications for scientific advice and for marketing authorisation since 2021 have pointed to the need for revision of the guidance documents. It is proposed to consolidate the two guidance documents into a single guideline that covers the non-clinical and clinical aspects of the development of vaccines against COVID-19.
Keywords: Vaccine platforms, mRNA, immunobridging, effectiveness, SARS-COV-2, regulatory requirements, sarbecovirus, broad coverage