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This vaccine meets FDA high standards for safety and efficacy. FDA is also allowing three lots of the vaccine manufactured in the renovated facility to be released today, after thorough testing and review.

Since BioPort is the only licensed manufacturer of the anthrax vaccine, today's approval is especially important. Although the Centers for Disease Control and Prevention (CDC) does not recommend vaccination for the general public, this product is a critical component in our arsenal against bioterrorism.

In addition, HHS is aggressively supporting efforts to develop new vaccines and diagnostic tools for the disease agents most likely to be used in a bioterrorism attack. In particular, the National Institutes of Health (NIH) is moving rapidly in developing a possible new generation anthrax vaccine. As with the existing vaccine, NIH efforts are subject to the rigorous safety and effectiveness standards of the FDA.

I am proud of all our HHS agencies, particularly the efforts of the FDA employees responsible for the inspections and reviews required for these approvals, and the hard work they are doing to protect Americans from bioterrorism.

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