Ainslie, this issue).Īn outline of the standard timeline for vaccine development and the expedition for SARS-CoV-2 vaccines. Apart from infrastructure, there are a number of novel vaccine technologies that are accelerating the time from formulation to preclinical testing and to formal clinical trials (as reviewed by K. All of these programs are designed to fund and coordinate the accelerated development, manufacturing and global distribution of SARS-CoV-2 pandemic countermeasures. ), with the help of newly created programs like HHS’ Operation Warp Speed (OWS), NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH's Rapid Acceleration of Diagnostics (RADx) initiative, and the WHO's Solidarity Vaccine Trial. Here, the aspirational timeline is 12–18 months ( Fig. The process of vaccine research and development is typically an investment of 10–15 years from discovery to licensure, prior to manufacturing and distribution. Additionally, data from pre-clinical and limited clinical trials of vaccine candidates that were developed following the severe acute respiratory syndrome (SARS) outbreak in 2003 and the Middle East respiratory syndrome (MERS) outbreak in 2012, along with research from recent years characterizing new/next-generation vaccine platforms and adjuvants have all contributed to the rapid development of numerous SARS-CoV-2 vaccine candidates, , ]. The scientific development process has been guided largely by insights gained from platforms and viral targets that have already been used in successful anti-viral vaccines for humans. In less than one year since the first cases of COVID-19 were identified, vaccines showing early signs of promise are already in the later phases of clinical testing and in some cases are approved for emergency use.
The current international efforts toward quelling the ongoing SARS-CoV-2 pandemic are unprecedented in pace, resource allocation and scientific focus.