Anthrax Vaccine? No, Not Yet
With the U.S. Army and the
Institutes of Health (NIH) racing to perfect a minimal side-effects anthrax
vaccine, and BioPort, the sole
Department of Defense (DoD) supplier benched by the Federal Pure Food and
Drug Agency (FDA) for violations, less than 25,000 doses of the controversial
vaccine remain available for military use and none for the civilian
Unlike Cipro and other antibiotics that are
prescribed for those who have been exposed to anthrax, the vaccine is
administered as a preventive measure.
The count of remaining doses is according to
Dr. Meryl Nass of Freeport, Maine, an internist and author of vaccine studies
who has treated military members suffering reactions. DoD spokesman Jim Turner
said his agency would not disclose the particulars of anthrax vaccine
stockpiles. "Current events have led us to a state of war, he said.
"Weve gotten a tremendous amount of
calls asking about the vaccine, said Bernie Adams, a spokesman for BioPort
Corp. of Lansing, Mich., which has about 6 million unusable doses still under
federal quarantine. Presently BioPort is awaiting FDA approval on renovations
it has made to its labs to sell its vaccine to the DoD. The FDA revoked
BioPorts license to make the vaccine in 1998.
BioPort received $126 million from the
Pentagon as part of its efforts to eliminate problems in quality control.
However, according to the Office of the
Special Assistant Secretary of Defense for Gulf War Illnesses (OSAGWI), even if
BioPort were up and running "vaccination against anthrax is not
recommended for the general public.
Perhaps behind the recent OSAGWI
recommendation: tough Hill testimony last Tuesday regarding BioPort by the
General Accounting Offices (GAO) Managing Director, Nancy Kingsbury. According
to Kingsbury, the BioPort vaccine insert claims that only about 34% of the
vaccines recipients would suffer mild reactions.
"By comparison, in a study we conducted
in calendar year 2000, 85% of National Guard and reserve forces in our survey
who were given the [BioPort] anthrax vaccine reported some reactions, said Kingsbury,
"with local reactions experienced by 76.2% of recipients and systemic
reactions experienced by 23.8%...
At another Hill session, BioPort President
Robert Kramer testified, "We have the right people doing the right things
to get this job done. We will get approval for the renovated facility.
The U.S. Army vaccine program is utilizing
modern genetic-engineering techniques, Carl McNair of Dynport Vaccine Company
of Maryland (under Army contract) told the Wall Street Journal last week. Human
trials are expected to begin this fall, he added.
Mr. McNair said that the great challenge was
to manufacture a vaccine that will be effective against as many as possible of
the more than 1,000 known anthrax strains. Comparing the problem to the flu, he
said, "The minute you have a vaccine that takes care of one type of flu,
then boom, someone gets another type of flu.
Both the Army program and the NIH program
are working on creating a vaccine that will not have the side-effects track
record of the BioPort product.
NIH researcher John Robbins told the Journal
that the new vaccine will be more pure than the existing vaccine. Robbins added
that the NIH vaccine in the works, features an ingredient to thoroughly
mobilize the bodys immune system against any future anthrax infection.
Despite BioPorts problems of the past,
Health and Human Services Secretary Tommy Thompson told the House Government
Reform subcommittee this week that if BioPort facilities win FDA approval,
"they should be operational by Nov. 22.
Defense Secretary Donald H. Rumsfeld has
given the beleaguered BioPort a vote of confidence of sorts. "What were
trying to do is figure out a way where we might get some help so that they
might improve their performance, he told reporters at a recent Pentagon
Rumsfeld said Pentagon officials were
meeting with representatives of the Department of Health and Human Services
"to try to fashion some sort of an arrangement whereby we give one more
crack at getting the job done with that outfit.
In the meantime, BioPort faces more than
just the FDA hurdles.
· Air Force Reserve Maj. Tom Rempfer has co-authored a citizens
petition, filed recently, asking the FDA to declare the vaccine "unsafe,
ineffective or misbranded.
Among other points the petition alleges the
militarys mandatory anthrax inoculation policy "is leaving an indelible
stain on the integrity of the U.S. military.
· A private multimillion-dollar lawsuit
alleging negligence against BioPort Corp. was filed in federal District on behalf
of soldiers allegedly harmed by vaccine shots they were required to take.
The named plaintiffs are the survivors of
deceased Army Specialist Sandra Larson of Spokane, Wash., and Ronda Wilson, of
Savannah, Ga., a former soldier whose chronic ill health allegedly resulted
from the vaccine.
The lawsuit alleges that the efficacy of the
vaccine in the mass immunization program for the military was not sufficiently
tested and adverse reactions by soldiers were not accurately assessed.
BioPort spokeswoman Kim Brennen Root, who
was unable to comment until company attorneys studied the complaint, conceded
that the FDA had noted deficiencies, but the company expected a good report on
its revised procedures and new plant from federal regulators.
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