Orders to take the military's controversial anthrax shots are illegal because the vaccine is not licensed for use against aerosol anthrax used as a biological weapon, two senior Air Force officers argued in a legal brief.

As evidence, they cite a previously unpublicized application by the manufacturer, at the Pentagon's urging, to have federal regulators approve using the vaccine as an Investigational New Drug for biowarfare, a first step toward eventually changing the vaccine license.

Because both federal law and a September 1999 Presidential Executive Order prohibit using investigational drugs on service members without their “informed consent,” the brief concludes that “orders to military personnel to submit to the vaccine without their consent are per se
violative of a direct order from the President in his role as Commander in Chief.”

By law, informed consent must include as a minimum a notice that the drug being administered is an investigational new drug or drug unapproved for its applied use, the reasons why it is being administered and information regarding possible side effects.

And the service member must voluntarily consent to administration of the drug, unless the president waives the prior consent requirement because of national security or other concerns.

The Clinton administration has not issued such a waiver.

The memo, which was released by opponents of the vaccination program, was prepared by , Air Force Reserve lawyers who were involved in the defense of Maj. Sonnie Bates earlier this year.

Bates, a C-5 cargo pilot at Dover Air Force Base, Del., refused to take the vaccine and was scheduled to face a court martial earlier this year. But at his request, the Air Force dropped the court martial, fined him and allowed him to resign his commission.

Since the mandatory vaccination program began two years ago, it has been plagued by revelations of problems with the production plant, financial difficulties by the company that bought the plant last year and complaints by service members of severe reactions.

The Pentagon said it does not keep track of the number of personnel who have refused, but dozens of enlisted members have been thrown out of the service with less than honorable discharges for refusing the shot.

The legal brief could eventually provide grounds for appeals to overturn those discharges.

Military leaders have repeatedly stated that the existing license, which was issued in 1970 based on studies of wool-workers exposed to anthrax on their skin from handling diseased animal hides, is sufficient to allow its use against aerosol anthrax weapons.

Earlier this year, a congressional committee disagreed, stating that the vaccine should be considered an investigational drug.

Michels and Smith argue that even the Pentagon agrees, pointing to a 1995 meeting that led to the manufacturer submitting an investigational new drug application in September 1996 to “obtain a specific indication for inhalation anthrax and a reduced vaccination schedule.”

The head of Bioport, which took over the state-run manufacturer last year, told Congress that application was still pending.

Originally Published, April 19, 2000 Belleville News Democrat, Belleville, Illinois
(c) 2000, Belleville News-Democrat, Belleville, Ill.