Vaccine Adverse Events

Rare, serious autoimmune and other immunologically mediated adverse events that follow vaccination are poorly understood. Immune-mediated responses of inflammation against self could result from host responses to any component of the vaccine, including the immunogen, adjuvants, preservatives, or stabilizers, or be affected by the route of vaccine administration. However, because autoimmune diseases are generally rare, may occur coincidentally after vaccination, and lack fully elucidated mechanisms of occurrence, it is difficult to evaluate whether autoimmune diseases reported after vaccination are truly caused by vaccination. A better understanding of related molecular pathways would be useful and facilitate better understanding of these autoimmune and other inflammatory adverse events.

In this project, we are working on exploring relationships between genes / single nucleotide polymorphisms / pathways and autoimmune diseases. Our ultimate goal is development of a model with an immunological and molecular basis to assess vaccine safety.

This project is part of the Georgetown Center for Excellence in Regulatory Science Innovation (CERSI) program funded by the FDA. A primary goal of the GU CERSI is to help the FDA in their mission of incorporating genomics information into drug development and regulatory review processes.