DOD REACTS TO ANTHRAX VACCINE PRODUCTION LICENSURE
January 31, 2002

“We are pleased to learn of the Food and Drug Administration’s (FDA) approval of BioPort’s new manufacturing facility to produce anthrax vaccine,” Assistant Secretary of Defense for Health Affairs William Winkenwerder Jr. said today. “This action by the FDA will result in an assured availability of vaccine, which meets high standards for safety and efficacy, to protect our troops against the very real threat of anthrax.”

“The FDA approval recognizes efforts expended by BioPort and the Department of Defense to ensure high quality manufacturing processes that meet FDA requirements,” said Deputy Assistant to the Secretary of Defense (Chemical and Biological Defense) Anna Johnson-Winegar.

The department will continue to protect designated special mission units with the anthrax vaccine and is undertaking a thorough review of all factors to decide its future use of the vaccine.

In doing so, the department’s healthcare leaders have been consulting with the Department of Health and Human Services regarding possible civilian needs for the vaccine. We are also collaborating in our efforts to develop new vaccines and treatments for agents most likely to be used in a bioterrorism attack.

The DoD expects an announcement regarding its anthrax vaccination policy in the near future.

The FDA release is at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00792.html .