Project Lightspeed: leveraging the experience of a COVID-19 vaccine development to shape the future of expedited programmes

11:30 AM - 11:55 AM

The development programs that led to the approval of the first vaccines for the prevention of COVID-19 followed unprecedented timelines, achieved with close communication between developers and regulatory agencies and exploiting the full potential of pre-existing regulatory pathways. The experience of these developments should be used to improve preparedness frameworks for future pandemics and selected key topics should be further explored and incorporated in new or revised guidelines to support the continuous improvement of regulatory science for non-pandemic medicinal products.

In particular, we will review the key regulatory milestones and success factors for COMIRNATY and discuss how the prior pandemic preparedness initiatives were applied to the SARS-CoV-2 pandemic to provide guidance and global alignment for the initial development of vaccines, as well as to support lifecycle and provide a framework to the potential development of variant-specific vaccines.