DoD and Bioport assert the vaccine is safe, pointing to 18 studies, including one by the Institute of Medicine saying the vaccine is no more dangerous than any other vaccine.
Federal District Court Judge Emmet Sullivan agreed with critics and granted an injunction Oct. 27 against the mandatory program for a second time, pending new steps by the Food and Drug Administration to finish the proper approval process and clear the vaccine for its specific use against inhalational anthrax.
Though it would still be possible to give soldiers the vaccine with their informed consent under the injunction, DoD sought an alteration of the injunction in light of the HHS ruling.
"When the Bioshield Act first passed the House, Mr. Shays was very concerned about a provision in the original bill that talked about waivers of certain informing requirements for emergencies in the military," said a congressional staff member speaking on condition of anonymity. "We put it in Title 10, some years before, that if you are going to use an (investigational drug) on U.S. forces, that has to be presidentially approved after a process where the secretaries of HHS and DoD say what it means and why they have to do it that way."
After some negotiation, the aide said, the House agreed that members of the military should be allowed to consent to receive either unapproved drugs or drugs that were licensed but used in an unapproved way.
"There was a colloquy on the floor between then chairman (Billy) Tauzin (R-La) and Mr. Shays to the effect that the (Bioshield) provision was too broadly written."
Colloquies are a form of scripted conversation held during a congressional session as a way to enter discussion into the record and often are used to express congressional intent.
The Senate also acknowledged restrictions to waivers, even if the situation involved a new use for an already licensed product.
"You still need to inform those receiving the drug," said the aide.
A spokesman for HHS said the department was drafting response to both letters, but he would not comment on the letters of the possibility of a hearing.