Conference Program

RL35: Leveraging Real-World Evidence (RWE) in Vaccine Clinical Research and Development (VCRD) (303607)

Jennifer Kirk, US Food and Drug Administration 
*Veena Somayaji, Pfizer Inc. 

Keywords: Vaccines, Real World Evidence, Real World Data, Vaccine Clinical Research and Development

The availability of Real World Data (RWD) and evolving statistical and analytical techniques to generate RWE have created interest in using RWD/RWE to enhance clinical research and support regulatory decision making. However, RWE’s utilization specifically in VCRD is not commonly known nor presented at conferences. COVID-19 has presented a greater need and urgency for exploring the use of RWE in VCRD. This session attempts to address this unmet need by drawing upon pre-COVID-19 experiences to inform the ever-changing COVID-19 world. The current standard in VCRD is a randomized clinical trial with clinical and immunologic endpoints and the evaluation of safety. Unlike drug development where there is a myriad of patient databases that provide readily available RWD sources, vaccine studies are conducted in healthy volunteers where RWD sources may not be obvious. Moreover, in the case of COVID-19, new variants of concern (VOC) are regularly emerge which begs the question if the approved vaccines are sufficiently effective against those new VOCs. Since VOCs can emerge anywhere in the world, it is prudent to use public data to answer research questions typically answered by clinical trials. It is important for the scientific community to explore the utility of those data for research and development leading to regulatory decision making. The latest FDA guidance on RWD/RWE aids in this effort by focusing on clinical study designs that are non-interventional thus creating a framework to evaluate the potential use of RWE to support regulatory decision-making. Note that RWD have been used even prior to COVID-19 in areas such as the assessment of long term safety, vaccine adherence, health care resource utilization and costs, and evaluation of effectiveness of vaccine post approval. The proposal for this roundtable is to discuss examples of applications of RWE in vaccine studies and the challenges and opportunities for the future.