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Anthrax Vaccinations Halted Again
United Press International
October 28, 2004

WASHINGTON - The U.S. District Court issued an injunction Wednesday against the mandatory vaccination of members of the armed forces and defense contractors with an anthrax vaccine manufactured by Bioport of Lansing, Mich.

"It is now illegal to administer the vaccine except if informed consent is given by the individual or the president (of the United States) waives informed consent for everyone," said Mark Zaid, managing partner at Krieger and Zaid and the attorney for the six plaintiffs in the case.

The product, called Anthrax Vaccine Absorbed or AVA, allegedly has sickened hundreds and been the subject of two other lawsuits, as well as a congressional inquiry and at least 18 safety studies.

The vaccine became so controversial that service personnel began refusing the 18-month series of shots, even though they faced disciplinary action and perhaps the end of their careers.

A total of 442 service members had refused to be vaccinated by October 2000, according to Department of Defense testimony before the House committee on Government Reform. At least 100 have been court-martialled, Zaid said.

Civilian defense employees also faced censure if they refused, according to the court ruling, including dismissal from their jobs. Some of the six anonymous plaintiffs in the current case are civilians.

"The scope of (Wednesday's ruling) applies to anyone that the DOD tries to inoculate meaning military, active Guard reserves and civilian contractors, civilian DOD employees -- anyone," Zaid told United Press International.

Secretary of Defense Donald Rumsfeld late Wednesday issued an order immediately halting anthrax vaccinations until further notice. The order will not halt new legal action, however.

"We absolutely will be filing additional civil lawsuits," Zaid said, adding he plans to name the Food and Drug Administration as one of the defendants. DOD may be named as well, he said.

"The FDA is reviewing the ruling," said FDA spokeswoman Lenore Gelb in an e-mail response to a UPI request for an interview.

In its ruling, the court issued an injunction "unless and until the FDA follows the correct procedures to certify (the anthrax vaccine) as a safe and effective drug for its intended use."


The issue of intended use is at the center of whether the Food and Drug Administration correctly expanded its approval of the vaccine for inhalational anthrax.

The drug originally was approved for prevention of cutaneous infections -- infections of the skin -- in high-risk populations -- primarily people who might be exposed to anthrax because they worked with wool and animal hides.

Though the drug had not been specifically approved as a vaccine against inhalation anthrax -- a more deadly type of the infection -- it was administered by DOD as such starting in the late 1990s.

In response to a lawsuit over the legality of the vaccination program, the court ruled on Dec. 22, 2003, that the drug was still "investigational" and issued a preliminary injunction against DOD's vaccination program.

Late in December 2003, or 18 years after the drug was first approved, and just over a week after the preliminary injunction was issued, FDA approved AVA for use against inhalational anthrax. The FDA based its decision on a 1950s study of just over 1,200 textile workers, during which 26 contracted inhalational anthrax. They also used surveillance data from the Centers for Disease Control and Prevention and a small DOD study, as well as information from the ongoing vaccine study and an independent examination by the Institute of Medicine, part of the National Academy of Sciences.

The plaintiffs take issue with the some of the scientific information used and the court found FDA's procedures did not give them the opportunity to bring forth their points.

"It is clear to this court," wrote Judge Emmet Sullivan, "that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency."

The ruling knocks AVA back down to the status of an investigational drug as far as using it for inhalational anthrax is concerned. As such, it cannot be legally administered by the DOD without consent of the person being vaccinated or a waver by the president.

Whether FDA now will try to approve AVA for inhalational anthrax remains to be seen. Other anthrax vaccines, including one by Vaxgen that uses recombinant DNA, are under development and conceivably could replace the now legally hamstrung AVA vaccine.

If the drug remains investigational, eventually it could impact Bioport's sales to the DOD and to outside customers as well.

The company has been in discussions with the Department of Health and Human Services to provide doses of the anthrax vaccine for the Strategic National Stockpile. It also has been selling the anthrax vaccine overseas, including to Taiwan, and has been in discussions for more domestic sales in the United States.

"We are indeed (talking to local and state governments)," Root told UPI. "We have received a number of calls of interest from county governments as well as city governments and states as well."

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Copyright 2004 United Press International. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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Copyright 2014 . All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


 


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