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DoD Asks Court To Reinstate Mandatory Anthrax Vaccine Program

By Sandra Basu
Source: http://www.usmedicine.com/dailyNews.cfm?dailyID=266

Posted: 18-Jan-2006

WASHINGTON - U.S. government officials asked a federal appeals court last month to reinstate mandatory anthrax inoculations for military personnel, while a lawyer for soldiers who refused the vaccinations argued that the vaccine was not intended for the broad use of it for military personnel that the Department of Defense (DoD) is advocating.

At issue during the federal appeals court hearing last month was whether the anthrax vaccine was intended and limited for use against anthrax contracted through spores transmitted by touch, or whether the vaccine was also intended for inhalation anthrax.

U.S. District Judge Emmet Sullivan had suspended anthrax vaccinations in October 2004 after he found fault in the Food and Drug Administration's process for approving the drug. He gave the DoD permission to resume vaccinating servicemembers against anthrax earlier this year, but he said that the vaccine must be given on a voluntary basis. In granting DoD's request to modify the injunction, which allows the resumption of vaccinations as long as they are voluntary, Sullivan said that he was requiring the government to provide weekly reports to the court that show that the vaccine is given voluntarily.

The U.S. government would like the federal appeals court to reverse Sullivan's decision, allowing for the vaccinations to be mandatory. At the hearing in Washington, D.C., Appeals Judge David Tatel asked John J. Michels, an attorney who represented the six plaintiffs in the case, why the language on the label of the vaccine was not broad enough to cover inhalation anthrax.

Michels told the judges that the vaccine was never intended to be used for inhalation anthrax and does not specify inhalation anthrax on its label. Rather, he said it was intended to protect veterinarians and certain types of industrial workers who have a high-risk exposure to anthrax.

"Nobody ever thought that this stuff was licensed for inhalation anthrax," said Michels.

Michael S. Raab, a Department of Justice attorney who represented the U.S. government, argued that while the labeling does not specifically say that it protects against inhalation anthrax, the labeling does not include any limitations on the routes of exposure that it protects against.

"The labeling does not include any limitations to the route of exposure," Raab told the judges.

The court could take months to arrive at a decision to either affirm or reverse Sullivan's decision, according to lawyers of the plaintiffs. The court's decision can also be appealed.

Anthrax Controversy
On Oct. 27, 2004, U.S. District Court Judge Emmet Sullivan said that the anthrax vaccine had not gone through the appropriate Food and Drug Administration (FDA) approval process and was therefore an experimental drug that could not be given to troops without their consent. The court imposed a permanent injunction prohibiting the government from vaccinating any individual without informed consent or a presidential waiver.

DoD asked the court at a hearing in March of 2005 to modify its injunction so as to allow the vaccines to resume under an emergency waiver, known as an Emergency Use Authorization (EUA). The EUA was issued in January by the Department of Health and Human Services and the FDA under authority granted by Project BioShield. Project BioShield was signed into law July 21, 2004 with the aim of facilitating a faster process to research, develop, purchase, and make available medications to combat bioterrorist threats that could cause public health emergencies.

In his April 6 subsequent court order, Judge Sullivan said that he was not ruling on the merits of any EUA, but would modify the injunction, allowing for the voluntary administration of the anthrax vaccine.

With that ruling, military personnel have been given an option of whether they would like to accept or decline the vaccine. Deputy Director for Clinical Operations for the Military Vaccine Agency, in Virginia, Lt. Col. Stephen Ford said during a presentation at the Combined Forces Pharmacy Seminar in October that about 50 per cent of military personnel were accepting the vaccine. He said that in the event of a biological attack where anthrax is deployed, 50 per cent of the troops that have not taken the vaccine could be rendered ineffective.

"We believe that it [the vaccine] is effective and safe," he said.

Since 2001, the Pentagon has inoculated more than one million soldiers with the vaccine. The vaccine program has been controversial since its creation in 1998 when mandatory vaccinations against anthrax were required of all active duty military personnel. Some military personnel who took the vaccine said it made them sick and questioned whether the vaccine was safe.