DEPARTMENT OF THE ARMY OFFICE OF THE SURGEON GENERAL 5109 LEESBURG PIKE FALLS CHURCH, VA 22041-3258

Belleville News-Democrat
Letters-to-the-Editor
120 South Illinois Street
PO Box 427
Belleville, IL 62222-0427

Sir/Madam:

Rod Hafemeister's article "Anthrax Vaccine Expired" in the May 25,1998 issue presents a very unbalanced and misleading story about the safety and effectiveness of the anthrax vaccine produced at Michigan Biologic Products Institute, the sole source for this vitally important protection against a serious biologic threat. Although MBPI has had some production problems, mostly due to an aging facility, the FDA has inspected andapproved every lot of anthrax vaccine produced there since it was licensed in 1970. The FDA adheres to rigorous standards and would have certainly closed the facility and ordered the destruction of any products that they deemed unsafe.

The extension of expiration dates on vaccines and other pharmaceuticals is not uncommon after testing to ensure the product has not degraded. The extensions highlighted in this article were done with the knowledge and approval of the FDA.

In addition to FDA approval, the Department of Defense required supplemental testing for purity, potency, stability and sterility by an independent contractor. All lots of the vaccine were again found to meet or exceed standards.

 I am dismayed by Mr. Hafemeister's lack of understanding of the FDA vaccine approval process. I am equally distressed by his failure to contact the Department of Defense for an explanation of our policy. However, what is most disturbing is his quick acceptance of misinformation, half-truths and myths being spread about this program that jeopardize our efforts to protect our servicemen and women from a very real and dangerous threat. Inhalation anthrax infection is nearly always fatal. We know that some countries have worked to weaponize it. We have an FDA-licensed, safe vaccine that will protect our forces. It would be unethical and irresponsible not to use it.