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
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
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
"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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