December 15, 2004The Defense Department has asked the Health and Human Services Department for emergency authority to resume its anthrax vaccination program for military personnel, Government Executive has learned.
Deputy Defense Secretary Paul Wolfowitz issued a Dec. 10 memo asking HHS Secretary Tommy Thompson to declare an emergency in order to justify using the vaccine for protection against inhaled anthrax. The military's anthrax vaccination program was suspended in late October by a federal judge in response to a lawsuit filed by six anonymous plaintiffs. The lawsuit argued that the vaccine was not proven to protect against inhaled anthrax, and led to health problems.
In the memo, Wolfowitz said he has "determined there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax."
"In making this determination," Wolfowitz added, "I have considered a classified November 2004 Intelligence Community assessment of the anthrax threat. This heightened risk has been and continues to be the basis for the DoD program of vaccinating personnel serving in the areas of the Central Command and Korea."
Central Command is responsible for operations in Iraq and Afghanistan. More than 1.2 million troops have been inoculated under the anthrax vaccination program since 1998.
A HHS spokesman was unaware of the request and had no comment. The Defense Department did not provide comment by press time.
Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled Oct. 27 that the military must stop administering the BioThrax vaccine, also known as Anthrax Vaccine Adsorbed, to service members. The vaccine is produced by BioPort Corp. of Lansing, Mich.
The Food and Drug Administration previously issued a final rule and order in December 2003 that licensed the vaccine as safe and effective for anthrax, regardless of the route of exposure. The judge, however, vacated that final rule and order, saying FDA did not follow proper procedures to determine whether the vaccine is safe and effective against inhaled anthrax.
"Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military's] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug," Sullivan wrote. "Accordingly, the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a presidential waiver."
The chief lawyer for the lawsuit called DoD's request for emergency authority "legally ineffective."
"This is just another attempt to betray the members of the military and circumvent the now judicially determined problems with the vaccine," said Mark Zaid, managing partner of Krieger & Zaid in Washington.
He cited a provision under Project BioShield stating that only the defense secretary has the authority to determine if there is an emergency, as opposed to the deputy defense secretary. Even then, Zaid claimed, the military must seek consent from military personnel or a presidential waiver in order to resume the vaccination program.
"Neither DoD or HHS has the authority to grant a waiver. It has to be the president," Zaid said.
"Just because they declare a military emergency doesn't allow resumption of the program. It is a step toward it but it doesn't allow resumption," he added. "This changes nothing but raises a tremendous amount of questions that Congress … should immediately demand answers for."
BioPort spokeswoman Kim Brennen Root said her company considers the BioThrax vaccine as fully licensed and validated by the FDA.
"Our license is in place regardless of the route of exposure," she said. "I don't think it's the judgment of any of the appropriate agencies that this is an investigational vaccine."
She said the emergency request from DoD is a mechanism that can be used to resume the military's vaccination program.
Emergent BioSolutions Inc., the parent company of BioPort, recently announced the acquisition of a 150,000-square-foot facility in Frederick, Md, which will be used as an additional vaccine manufacturing site. Brennen Root said the facility is being designed to produce multiple vaccines. The company is waiting, however, for contracts before it begins production at the center.
HHS announced in November that it plans to buy 5 million doses of the BioThrax vaccine for civilian inoculations. Brennan Root said the company expects a contract for actual work to be let early next year.
HHS also awarded another contract in November worth almost $880 million to VaxGen Inc. of California to produce 75 million doses of a new type of anthrax vaccine.
December 15, 2004