The world is experiencing an unprecedented pandemic caused by the Severe Acute Respiratory Syndrome-coronavirus-2 (SARS-CoV-2). Development of new vaccines are important to achieve long-term prevention and control of the virus. Experience gained in the development of vaccines for Ebola virus disease provide important lessons in the regulatory, clinical, and manufacturing process that can be applied to SARS-CoV-2 and other epidemic pathogens. This presentation will outline lessons learned during development of an Ebola vaccine, highlighting focus areas for regulatory harmonization that can be directly applied to current vaccine development efforts for SARS-CoV-2.
Understand the regulatory, clinical and manufacturing requirements for vaccine licensure.
Determine how activities can be conducted in parallel to accelerate vaccine development.
Define how harmonization in global regulations can accelerate access of vaccines in global pandemics.
Understand how learnings from one vaccine program can be applied to another using the same platform technology.