External Researchers Given Access to CDC Vaccine Safety Data

The Centers for Disease Control and Prevention's (CDC) National Immunization Program, and its managed care partners, today announced that researchers will be allowed access to data collected by the CDC's Vaccine Safety Datalink Project (VSD). Researchers will now be able to independently analyze immunization safety data.

The VSD was established to allow CDC to carefully monitor vaccine safety in the United States. The VSD, a large-linked database, contains medical and immunization information on more than seven million people. Information available in the database includes the date of birth, dates of vaccination, and medical visits. The VSD is a collaborative project involving CDC and several large managed-care organizations (MCOs).

Information from the VSD is used by CDC to conduct vaccine safety studies. With the development of this new data-sharing process, external researchers may now also use VSD data.

Dr. Walter Orenstein, Director of CDC's National Immunization Program, said, "Sound immunization policies and recommendations affecting the health of our nation depend upon the consistent monitoring of vaccines and ongoing assessment of immunization benefits and risks. The Vaccine Safety Datalink Project is one of our most important tools to ensure the safety and efficacy of vaccines."

After paying fees for the associated costs, researchers will have access to VSD data through the CDC's Research Data Center located in Hyattsville, Maryland. A process has been developed by CDC which permits researchers access to the VSD data while assuring protection of confidential medical information. Researchers will submit their request to the VSD project outlining what area of vaccine safety they intend to investigate and what VSD files are needed. In accordance with federal regulations, each proposal must then be approved by the institutional review board at each MCO whose data will be used in the study. After receiving approval, researchers will be required to follow standard, federally required guidelines to protect confidentiality and privacy of individuals and institutions.

###

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.