Post-Marketing Surveillance Investigation of a Possible Relationship between Anthrax Vaccine Adsorbed and Optic Neuritis in the U.S. Military, 1998-2003


Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

4219.0: Tuesday, December 13, 2005 - 3:35 PM

Abstract #114635

Daniel C. Payne, PhD, MSPH and Charles Rose, PhD. National Immunization Program, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mailstop E61, Atlanta, GA 30333, 404-639-8843, DVP6@CDC.GOV

Optic neuritis is an acute inflammation of the optic nerve often associated with non-infectious demyelinating disease. The most prominent symptoms of optic neuritis are severe vision disturbances and vision loss, typically proceeding over the course of a week. This investigation estimates whether a possible association exists between anthrax vaccination and idiopathic cases of optic neuritis among U.S. military personnel between 1998 and 2003. This research topic was specifically approved for study by the Anthrax Vaccine Safety Workgroup of the National Vaccine Advisory Committee. For over a quarter-century, numerous case reports have suggested an association between optic neuritis and certain immunizations. Speculation regarding a relationship with the anthrax vaccine revolves around two published military cases and other vaccine safety hypothesis generating findings.

A retrospective case control method was conducted using 1,195 idiopathic cases of optic neuritis. This post-marketing surveillance investigation analyzed linked medical outcomes, immunization histories, demographics, and administrative/military service variables for U.S. military personnel using the Defense Medical Surveillance System (DMSS). DMSS is an active surveillance database collecting data from military treatment facilities and administrative offices worldwide.

Results will be presented that further the understanding of the safety of anthrax vaccine, a biodefense vaccine that has been administered to U.S. personnel since 1998. This project employs an innovative algorithm used to screen out cases having obvious alternative etiologies and erroneous reports. This post-marketing surveillance investigation represents the first of several Vaccine Analytic Unit vaccine safety reports on anthrax vaccine in the U.S. military.

Learning Objectives:

At the conclusion of this presentation, the participant will be able to

a) understand whether a statistical association was observed between anthrax vaccine and optic neuritis in the U.S. military,
b) describe the post-marketing surveillance investigation techniques developed by the CDC's Vaccine Analytic Unit for studies of biodefense vaccine adverse events.

Keywords: Surveillance, Veterans' Health

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

Vaccine Preventable Disease Epidemiology

The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA