Pentagon appeals decision halting anthrax vaccinations

The Defense Department last week asked a federal appeals court to lift an injunction that stopped the mandatory anthrax vaccination program for military personnel.

Justice Department lawyers, in an appeal filed on behalf on the Pentagon, contend that the Food and Drug Administration's documentation on BioPort's Anthrax Vaccine Absorbed proves the vaccine is safe and effective in combating all forms of anthrax.

The vaccine is now only fully licensed as safe and effective against cutaneous anthrax.

"The Food and Drug Administration has repeatedly confirmed that [the vaccine's] label encompasses approval for use against all forms of anthrax, regardless of the route of exposure - including inhalation exposure," the Pentagon argues in the appeal.

The Pentagon is looking to set aside the decision of U.S. District Judge Emmet Sullivan, who ruled against mandatory vaccinations in October after finding that the FDA had not fully licensed the BioPort vaccine as effective against inhaled anthrax.

The Health and Human Services Department earlier this year granted the Pentagon emergency use authority to resume vaccinations on a voluntary basis. Mandatory vaccinations could resume if the government's appeal is accepted.

A Pentagon Web site lists the chances of adverse event from the vaccination at 1 in 100,000.

More than 1 million service members were inoculated before Sullivan stopped the mandatory vaccination program. Recently released figures indicate that hundreds of military personnel were treated for adverse events following vaccination.

The Pentagon argues that the vaccine's safety and effectiveness against inhalation anthrax are clear from the Food and Drug Administration's scientific records.

The agency has repeatedly declared the vaccine safe, the Pentagon argues. The Defense Department also points out that the agency did not object to use of the vaccine during the first Gulf War. Correspondence between FDA and Defense Department officials also illustrates the agency's belief that the drug is safe, the Pentagon said in the appeal.

A 1950s study in which the vaccine proved effective in protecting mill workers exposed to naturally occurring anthrax is also cited by the Pentagon as evidence of safety.

Finally, the Pentagon cited a January 2004 FDA order that found the vaccine to be safe against all forms of anthrax. Sullivan ruled that order invalid because the agency did not accept public comments and due to questions about the vaccine's safety.

The agency opened the order for comments late last year to comply with the court's order. The comment period closed at the end of March.

The Pentagon argued that in the face of FDA evidence that the vaccine was safe against all forms of anthrax, the court did not have the authority to stop the program because it believed the vaccine was unsafe.

"Even if the court believed that the FDA's January 2004 order did not have independent force as a result of a procedural failure to provide additional notice and comment, that failure would only support vacatur of the order," the Pentagon stated in the appeal. "It would not provide the district court with a basis for revisiting the scope of the [original] license - which has always authorized use of VA to prevent anthrax, without limitation on the route of exposure, and which remains in effect."

Finally, the Pentagon argues that Smith should not have stopped the vaccination program for the entire military, but only for the six anonymous Defense Department employees who filed suit challenging the program.

John Michels, attorney for the six plaintiffs, would not comment on the case until a response is filed on behalf of his clients. The plaintiffs' response is due June 30.