The committee appreciates the opportunity to provide advice to the National Immunization Program (NIP) and the National Center for Health Statistics (NCHS) on the Vaccine Safety Datalink (VSD) data sharing program and to the NIP on the release of preliminary findings based on VSD data. The VSD database has many strengths, but it also has limitations. The value of the VSD data sharing program will be enhanced by easy access to the data so that a variety of researchers can conduct a range of studies and have their findings reviewed by peers and discussed in ways conducive to the advancement of knowledge about vaccine safety.
The VSD is a valuable resource for the nation. Efforts should be made to facilitate access to VSD data and their appropriate utilization while protecting the confidentiality of information contained therein. Ensuring the independence, transparency, and fairness of VSD research activities is important for ensuring public trust in the VSD as a tool for addressing critical vaccine safety questions.
Throughout the course of this study, the commitment of NIP and NCHS staff, of the managed care organizations participating in the VSD, of advocacy groups, and of parents to ensuring the safety of vaccines was evident to the committee. The committee believes that the debates about access to and use of VSD data have arisen from the dedication of those groups to different aspects of their common cause—ensuring vaccine safety. All the groups bring unique and important perspectives to the debate. The committee is confident that the melding of those unique perspectives will contribute to a VSD that always protects data confidentiality and is used appropriately by a wide variety of researchers to provide high-quality information on vaccine safety that will be trusted by the public.