How does the government monitor vaccine safety? Part 2 of 2

As we wrote in our first article on vaccine safety monitoring, the VAERs system provides the bulk of vaccine safety data.

VAERS data are monitored to detect new, unusual, or rare vaccine adverse events, monitor increases in known adverse events, identify potential patient risk factors for particular types of adverse events, identify vaccine lots with increased numbers or types of reported adverse events, and to assess the safety of newly licensed vaccines. While VAERS provides useful information on vaccine safety, the data are somewhat limited. Specifically, judgments about whether the vaccine was truly responsible for an adverse event cannot be made from VAERS reports because of incomplete information.

Researchers are now using large-linked databases (LLDB) to study vaccine safety. LLDB provide scientists with access to the complete medical records of millions of individuals receiving vaccines. One example of a LLDB is the Vaccine Safety Datalink (VSD) Project.

The Vaccine Safety Datalink (VSD) project is a collaborative effort between CDC’s Immunization Safety Office and eight managed care organizations (MCOs). The VSD project was established in 1990 to monitor immunization safety and address the gaps in scientific knowledge about rare and serious events following immunization.

The VSD project includes a large linked database that uses administrative data sources at each MCO. Each participating site gathers data on vaccination (vaccine type, date of vaccination, concurrent vaccinations), medical outcomes (outpatient visits, inpatient visits, urgent care visits), birth data, and census data.

The VSD project allows for planned immunization safety studies as well as timely investigations of hypotheses that arise from review of medical literature, reports to the VAERS, changes in immunization schedules, or the introduction of new vaccines.  Since 1990, investigators from the VSD project published more than 75 scientific articles.

The CDC says that the VSD project has proven to be a highly effective tool for evaluating immunization safety.  Other monitoring programs include the Clinical Immunization Safety Assessment (CISA) Network, and the Brighton Collaboration.

The CISA Network of six medical research centers conducts clinical research on vaccine-associated health risks, and the Brighton Collaboration develops standard case definitions for problems following immunization as well as guidelines for data collection, analysis, and presentation.


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