A Web Service for Communicating Vaccine Safety Surveillance Information on Adverse Events Following Vaccination to Partners

Project Name: A web service for communicating vaccine safety surveillance information on adverse events following vaccination to partners

Project Status: Proposed

Point of Contact: Rongxia Li

Center: National Center for Emerging and Zoonotic Infectious Diseases

Keywords: Web Service, Surveillance, Vaccine Safety, Shared Data, Graphical Visualization, Signal Detection

Project Description: Post marketing surveillance i.e., monitoring and early detection of unexpected adverse events after vaccination is very important as rare adverse events in particular may go undetected during vaccine clinical trials. It also assures policy makers, stakeholders and the public that new vaccines are safe.

The Vaccine Safety Datalink (VSD) is a collaboration between the Centers for Disease Control and Prevention and 9 integrated health care organizations nationwide, encompassing electronic databases on approximately 9 million members annually, with an annual birth cohort of approximately 95,000 [1]. Currently, the VSD uses rapid cycle analysis (RCA) to screen for elevated risks of pre specified adverse events following seasonal influenza vaccines. Similar surveillance projects have been carried out for other vaccines, including human papillomavirus vaccine (HPV), and rotavirus vaccines, etc. In such surveillance systems, electronic data from all VSD sites is collected and analyzed on a weekly basis. Data include patients’ vaccination history and diagnosis information, as well as patients’ demographic profile. Using statistical sequential analysis, a signal is generated once an elevated risk of medical outcomes is detected following vaccine(s). Each week monitoring reports are provided to and accessed by Immunization Safety Office (ISO) and our collaborating healthcare partners.

The current VSD vaccine safety surveillance system lacks an effective way to communicate monitoring findings internally and externally in a timely matter. Large amounts of data and reports are stored on the CDC shared network drive, which greatly limits the access from our external partners. We propose development of a standards-based web service to support data communications/interactions between CDC and partner health care organizations regarding the rapid cycle analysis for vaccine safety. Specifically, interactive web graphics based on live data indicating real-time surveillance activities will be presented on the web to partners, as well as various downloadable summary reports. The proposed web-service will provide a secure, re-useable, and interpretable solution to the existing vaccine safety surveillance systems. It will enhance the efficiency of VSD surveillance activities.

The success of this project will provide a standard for integrating real-surveillance systems into web applications, and promote the timeliness and reuse of electronic health care data. This project will also aid in the VSD’s efforts to provide timely reliable data to alert policy makers of any unexpected vaccine safety issues.

Applicability of project for reuse within other public health programs: This proposed project can be easily reused by other public health programs within or outside the CDC. The proposed web service provides a standard platform and interface for rapid data exchange and communicating surveillance results. Other healthcare programs can adopt the framework and adapt to different surveillance applications.

Methodology: The VSD team in ISO will lead and implement this project, along with an IT developer who has extensive knowledge and experience in interactive and database website development.
 

The specific steps include:

1. Design the infrastructure of the website
2. Collect electronic data from current vaccine safety surveillance systems
3. Create graphical visualization and tabular reports on the web
4. Publish the website internally and gather feedback
5. Modify and fine-tune the website and publish it to the public with restricted
6. access Expected results with how you will determine overall project success

The project will be considered a success if both ISO at the CDC and our external healthcare partners use the web service to facilitate and communicate the safety surveillance activities.

For more information about this project, please contact the CHIIC at chiic@cdc.gov or Brian Lee at brian.lee@cdc.hhs.gov.