The Vaccine Safety Datalink Project (VSD) was established in 1990 by the

United States Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency, under the United S ...

(CDC) to study the

adverse effect An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...

s of

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...

s. Four large

health maintenance organization In the United States, a health maintenance organization (HMO) is a medical insurance group that provides health services for a fixed annual fee. It is an organization that provides or arranges managed care for health insurance, self-funded healt ...

s, including

Kaiser Permanente Kaiser Permanente (; KP), commonly known simply as Kaiser, is an American integrated managed care consortium, based in Oakland, California, United States, founded in 1945 by industrialist Henry J. Kaiser and physician Sidney Garfield. Kaiser P ...

, were initially recruited to provide the CDC with medical data on

vaccination Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating ...

histories, health outcomes, and subject characteristics. The VSD database contains data compiled from

surveillance Surveillance is the monitoring of behavior, many activities, or information for the purpose of information gathering, influencing, managing or directing. This can include observation from a distance by means of electronic equipment, such as c ...

on more than seven million people in the United States, including about 500,000 children from birth through age six years (2% of the U.S. population in this age group). The VSD data-sharing program is now being administered by the

National Center for Health Statistics The National Center for Health Statistics (NCHS) is a U.S. government agency that provides statistical information to guide actions and policies to improve the public health of the American people. It is a unit of the Centers for Disease Control ...

Research Data Center. The data sharing guidelines have been revised to include comments from interested groups as well as recommendations from the

Institute of Medicine The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM) until 2015, is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, E ...

(IOM). The

Vaccine Adverse Event Reporting System The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveil ...

(VAERS), the VSD, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA

measure Measure may refer to: * Measurement, the assignment of a number to a characteristic of an object or event Law * Ballot measure, proposed legislation in the United States * Church of England Measure, legislation of the Church of England * Mea ...

vaccine safety to fulfill their duty as

regulatory agencies A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulatin ...

charged with protecting the public. Data from the VSD Project have been used to address a number of vaccine safety concerns; examples include a study clarifying the risk of

anaphylaxis Anaphylaxis is a serious, potentially fatal allergic reaction and medical emergency that is rapid in onset and requires immediate medical attention regardless of use of emergency medication on site. It typically causes more than one of the follow ...

after vaccine administration and several studies examining the rejected hypothesis of a link between thimerosal-containing vaccines and autism.

Participating healthcare organizations

The following organizations are members of the project: * Group Health Cooperative, Seattle, Washington * Harvard Pilgrim Health Care, Boston, Massachusetts * HealthPartners Institute, Bloomington, Minnesota * Kaiser Permanente Northwest, Portland, Oregon * Kaiser Permanente Northern California, Oakland, California * Kaiser Permanente Colorado, Denver, Colorado * Kaiser Permanente Georgia, Atlanta, Georgia * Marshfield Clinic Research Foundation, Marshfield, Wisconsin * Kaiser Permanente Southern California, Los Angeles, California

Notes

External links

NationalAcademies.org
– 'Independent Oversight of Vaccine Safety Data Program Needed To Ensure Greater Transparency and Enhance Public Trust',

National Academies A national academy is an organizational body, usually operating with state financial support and approval, that co-ordinates scholarly research activities and standards for academic disciplines, most frequently in the sciences but also the humanit ...

(February 17, 2005)
WHO.int (pdf)
– 'The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA', R.T. Chen, F. DeStefano, R.L. Davis, L.A. Jackson, R.S. Thompson, J.P. Mullooly, S.B. Black, H.R. Shinefield, C.M. Vadheim, J.I. Ward, S.M. Marcy & the Vaccine Safety Datalink Team,

World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...

{{Vaccine safety Vaccination-related organizations Drug safety Vaccination in the United States Centers for Disease Control and Prevention