Publication

Vaccine Safety Research, Data Access, and Public Trust


Released:

The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991.  It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations.  Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations.  The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database.

In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible. 

The Centers for Disease Control and Prevention, which oversees the VSD and the data sharing program, should create a new, independent committee to review researchers' proposals to use VSD data, monitor adherence to protocols, and advise the agency and its partners on when and how to release preliminary findings based on the data, the report says. 

In addition, CDC should create a new subcommittee of the National Vaccine Advisory Committee (NVAC), or tap an existing one, to enable stakeholders to review and provide input on the VSD research plan every year.

The committee makes additional recommendations on specific aspects of the VSD data sharing program and on conditions governing whether, when, and how preliminary findings should be shared with others.