Development of the Vaccine Analytic Unit's research agenda for investigating potential adverse events associated with anthrax vaccine adsorbed.
OBJECTIVE
In 2002, the Centers for Disease Control and Prevention established the Vaccine Analytic Unit (VAU) in collaboration with the Department of Defense (DoD). The focus of this report is to describe the process by which the VAU's anthrax vaccine safety research plan was developed following a comprehensive review of these topics.


METHODS
Public health literature, surveillance data, and clinical sources were reviewed to create a list of adverse events hypothesized to be potentially related to anthrax vaccine adsorbed (AVA). From this list, a consensus process was used to select 11 important research topics. Adverse event background papers were written for each of these topics, addressing predetermined criteria. These were independently reviewed and ranked by a National Vaccine Advisory Committee (NVAC) workgroup. The adverse events included in the final priority list will be the subject of observational or other post marketing surveillance studies using the Defense Medical Surveillance System (DMSS) database.


RESULTS
A review of various information sources identified over 100 potential adverse events. The review process recommended 11 topics as potentially warranting further study. The NVAC workgroup identified the following adverse event topics for study: arthritis, optic neuritis, and Stevens-Johnson syndrome/Toxic epidermal necrolysis. Two additional topics (systemic lupus erythematosus (SLE) and multiple, near-concurrent military vaccinations) were added in response to emerging public health and military concerns.


CONCLUSIONS
The experience described, while specific for establishing the VAU's research agenda for the safety of the current anthrax vaccine, may be useful and adapted for research planning in other areas of public health research.
Payne
Daniel C
DC
Bacterial Vaccine Preventable Diseases Branch, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. DVP6@CDC.GOV
Franzke
Laura H
LH
Stehr-Green
Paul A
PA
Schwartz
Benjamin
B
McNeil
Michael M
MM
D022122:Anthrax Vaccines / Q000009:adverse effects* / Q000276:immunology; D018771:Arthralgia / Q000175:diagnosis / Q000209:etiology; D001168:Arthritis / Q000175:diagnosis / Q000209:etiology; D002487:Centers for Disease Control and Prevention, U.S.; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000209:etiology; D008887:Military Medicine / Q000379:methods / Q000592:standards; D009902:Optic Neuritis / Q000175:diagnosis / Q000209:etiology; D009937:Organizational Objectives; D011634:Public Health / Q000379:methods* / Q000592:standards; D012106:Research / Q000458:organization & administration / Q000592:standards; D012107:Research Design; D012871:Skin Diseases / Q000175:diagnosis / Q000188:drug therapy; D013262:Stevens-Johnson Syndrome / Q000175:diagnosis / Q000209:etiology; D014481:United States; D037041:United States Government Agencies
D022122:Anthrax Vaccines