Vaccine safety datalink multiple award IDIQ

The VSD Project provides the Centers for Disease Control and Prevention (CDC), Division of Healthcare Quality Promotion (DHQP), Immunization Safety Office (ISO) an “as needed” mechanism to obtain services through the issuance of task orders that support vaccine safety monitoring and evaluation, and that align with public health priorities for CDC.

1. 1. Overview of contract requirements for the VSD Project

1. 1. 1. Execute awarded task orders under three technical areas:
         • • VSD project infrastructure activities
           • Active surveillance and monitoring
           • Epidemiologic studies and evaluations

1. 1. VSD Project Objectives:  The purpose of this project is to conduct vaccine safety research and surveillance. Contractors will provide a data infrastructure and expertise in which adverse events following immunization can be evaluated and can support the enhancement and development of vaccine safety methodologies. The objectives of the VSD project are divided into two categories: Scientific and Programmatic.

Scientific Project Objectives

1. Monitor and evaluate the safety of newly licensed vaccines
2. Evaluate the safety of new vaccine recommendations for existing vaccines
3. Evaluate clinical disorders following immunizations
4. Assess vaccine safety in special high-risk populations
5. Develop and evaluate methodologies for vaccine safety assessment
6. Respond to vaccine safety concerns and/or vaccine safety signals through ad-hoc analyses and studies
7. Ad hoc vaccine effectiveness studies may also be conducted

Programmatic Project Objectives

1. Create quality core data infrastructure through administrative/computerized data files and data linkages to efficiently conduct vaccine safety monitoring and evaluation
2. Ensure quality data by regularly conducting data quality and data assurance checks
3. Ensure access to additional data sources such as medical chart review, member surveys, and ad-hoc data sources
4. Establish a secure distributed data model allowing each participating contractor to maintain ownership of their data while allowing access to researchers to transfer analytic datasets and/or summarized output and to conduct vaccine safety monitoring and evaluation.
5. Ensure high quality research though a rigorous research proposal process
6. Evaluate and monitor the safety of vaccines and respond to emerging vaccine safety concerns
7. Ad hoc vaccine effectiveness studies may also be conducted
8. Participate in a data sharing program, as outlined in the National Center for Health Statistics Research Data Center’s Guidelines for Proposal Submission (https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/accessing-data.html)