Innovative vaccine approaches—a Keystone Symposia report

Abstract

The rapid development of COVID-19 vaccines was the result of decades of research to establish flexible vaccine platforms and understand pathogens with pandemic potential, as well as several novel changes to the vaccine discovery and development processes that partnered industry and governments. And while vaccines offer the potential to drastically improve global health, low-and-middle-income countries around the world often experience reduced access to vaccines and reduced vaccine efficacy. Addressing these issues will require novel vaccine approaches and platforms, deeper insight how vaccines mediate protection, and innovative trial designs and models. On June 28-30, 2021, experts in vaccine research, development, manufacturing, and deployment met virtually for the Keystone eSymposium "Innovative Vaccine Approaches" to discuss advances in vaccine research and development.

Accelerating clinical trial development in vaccinology: COVID-19 and beyond

“…This was helped by an unparalleled influx of USG dollars to oversee the vaccine development process for all 5 of the companies involved in the initial effort and assist in moving vaccine products forward with oversight at all levels. Preclinical manufacturing, animal studies, supply chain logistics, initial Phase 1 and 2 clinical trial funding, provision of laboratories for immunogenicity studies, preclinical use of nonhuman primate (NHP) challenge models, and funding of largescale efficacy trials with a common design and overseen by a common Data and Safety Monitoring Board were all components of the program 1 , 2 , 3 . Importantly, government officials and government supported contractors experienced in vaccine discovery, process development, and manufacturing served as constant liaisons with Operation Warp Speed (OWS) officials and the company executives involved in manufacturing and preclinical/clinical oversight of the program.…”