analyses of associations between immunizations and vaccine side effects.
The VSD uses electronic health data from partner organizations including the
type of vaccine administered, the date of immunization, and other vaccines
administered on the same day.
91 The VSD gathers information on illnesses
diagnosed at providers’ offices, urgent care and emergency room visits, and
92 The VSD uses this information to develop vaccine safety
studies as well as studies based on questions or concerns raised from the
medical literature and reports to the VAERS.
The project prioritizes studies evaluating the safety of vaccines given to
women during pregnancy.
94 When new vaccines are recommended for use
in the United States or if there are changes in vaccine recommendation (as
there was for Tdap for pregnant women in 2013), the VSD monitors the
safety of these vaccines and recommendations.
95 Because VSD has nine
databases and retains information regarding up to 2 percent of the United
States’ population, VSD enables performance of active surveillance by using
data mining processes.
Results from VAERS and VDS are also linked with larger databases like
the CDC’s Clinical Immunization Safety Assessment Network (“CISA”).
CISA is a resource for healthcare providers who may have safety questions
with respect to certain patients.
98 CISA combines expertise in neurology,
allergy, immunology, pediatrics, hematology, and obstetrics/gynecology to
design research studies assessing influenza vaccine safety, vaccine safety in
persons with autoimmune diseases, and vaccine safety in pregnant women.
Most relevantly for the changes proposed in this article, CISA studies are
designed to address clinical vaccine safety questions in targeted or special
populations that are often excluded from pre-licensure clinical trials, like
IV. BRIDGING THE GAP BETWEEN REGULATORY PATHWAYS FOR
ASSESSMENT (CISA) PROJECT,
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/ (last updated Aug. 28,