A rapid human vaccine process development map outlining lessons learnt from ChAdOx1 nCoV-19 vaccine during the...

In 2015 the UK Vaccine Network through its Working Group 3 began the creation of a website describing the conventional development of human and veterinary vaccines, which routinely takes several years to complete from concept through to licensure, in the form of process development maps. This website has proved to be a valuable resource for those involved in commercial vaccine development and it has also highlighted the potential bottlenecks within the processes. However, during the COVID-19 pandemic, vaccines were created, licenced and administered within 1 year of the SARS-CoV-2 virus sequence being made available to researchers globally, through the use of novel platform technologies, such as viral vectors and mRNA. The paper describes the updating of this vaccine process development website and the inclusion of a rapid development map with 14 Stages based knowledge gained during the development of the University of Oxford/Astra Zeneca ChAdOx-1 vectored COVID-19 vaccine. The map captures the key steps required to expedite human vaccine development in the face of a pandemic threat from pre-clinical discovery, vaccine platform development, regulatory review and approval through to the administration of the first dose in humans.