In June 2001, the program was halted by the DoD due to changes in the manufacturing process not approved by the Food and Drug Administration (FDA).
Secretary of Defense William Cohen stated that "anthrax poses a clear and present danger to our armed forces.
The Japanese attack was part of a larger program of biological warfare and human experimentation that is estimated to have killed 580,000 people.
Following the 9/11 attacks, an exemption requested by marine James Muhammad led to his court martial, with his lawyer advising him to plead guilty because he would not be allowed to present his religious reasons and might be subject to the death penalty.
[13] The Petition was later utilized as the foundational basis for a Preliminary Injunction by a Federal Court to temporarily halt the program [Doe v. Rumsfeld, 297 F. Supp.
On June 28, 2002, in the wake of the 2001 anthrax attacks and leading up to the 2003 invasion of Iraq, all military personnel were required to receive AVA in addition to their other vaccinations of smallpox.
[16] Later that month, the DOD made it policy to include any personnel spending 15 days or more in high anthrax-risk areas, such as the Persian Gulf or the Korean peninsula.
On December 15, 2005, the FDA re-issued a Final Rule & Order[24] on the license status of AVA, clearing the way for mandatory vaccination reinstatement.
After reviewing extensive scientific evidence and carefully considering comments from the public, the FDA again determined that the vaccine is licensed for the prevention of anthrax, regardless of the route of exposure.
Pertaining to the previous ruling, the DC District Federal Appeals Court declined to vacate or overturn the injunction in 2006, instead mooting the case based on the FDA's new 2005 licensing of the vaccine.
[26] On December 13, 2006, a new class-action lawsuit,[27] filed on behalf of six unnamed plaintiffs, revived the legal battle over the military's mandatory anthrax immunization program.
The suit also says the DOD has failed to follow presidential orders and federal laws that require the government to obtain informed consent before giving an unapproved and experimental vaccine to anyone.
[28] By August 2007, the original court affirmed that the AVIP was not substantially justified prior to the consequent FDA licensure and requisite rule making for the vaccine in December 2005.
The Court ultimately granted "prevailing party" status for the plaintiffs against defendants DoD and FDA [Doe v. Rumsfeld, 501 F. Supp.
By March 2008, a different Federal Judge affirmed the prior ruling in its opinion regarding corrections of records writing, "Taken as a whole, Judge Sullivan's decisions in Doe v. Rumsfeld conclude that, prior to the FDA's December 2005 rulemaking, it was a violation of federal law for military personnel to be subjected to involuntary AVA inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax.
FBI released emails by Ivins showing the vaccine "isn't passing the potency test" and that "no approved lots" were available just prior to the letter attacks.
FBI affidavits also documented Ivins receiving the highest Defense Department honors for "getting the anthrax vaccine back into production".
According to his e-mails and statements to friends, in the months leading up to the anthrax attacks in the fall of 2001, Dr. Ivins was under intense personal and professional pressure.
"[35] To date, the DOD has not announced a reevaluation of the AVIP, nor consideration of correcting the records of previously punished soldiers, in light of the above-mentioned legislative, legal and criminal findings related to the anthrax vaccine.