Apr 9, 2001
Dave Eberhart
Stars and Stripes Veterans Affairs Editor
The federal Centers for Disease Control and Prevention
announced last week that it will begin human clinical trials of the
controversial anthrax vaccine this summer if the tests are approved by a CDC
committee that oversees the use of humans in research.
The trials, which would involve 1,300 volunteers, are
intended to yield information on how the vaccine works and what causes adverse
reactions to it.
The program would compare administration of the vaccine
under the skin with injection into muscle tissue, according to the CDC. The
military’s mandatory six shots (with annual boosters) are injected
subcutaneously. The tests would determine whether intramuscular injections
would reduce rashes and swelling, both common reactions.
The Pentagon—despite concerns voiced by Congress, the
General Accounting Office and recently the Connecticut attorney general—remains
committed to vaccinating all 2.4 million servicemembers.
Defense Department officials have said that the
vaccination program, recently curtailed because of problems involving the sole
manufacturer of the vaccine, will resume at top speed as soon as the BioPort
Corp. is authorized to make the drug again.
BioPort, in Lansing Mich., renovated its laboratories in
1998-99 and since August 1999 has been seeking Food and Drug Administration
approval to resume making the anthrax vaccine in the new labs. Still unresolved
are quality-control requirements that lots of the vaccine conform to the same specifications
each time.
We believe the testing will again confirm the safety and
efficacy of the vaccine.
·
Kim Root
“Any testing done by the CDC is highly credible,” said Kim
Root, a BioPort spokesperson. “We believe the testing will again confirm the
safety and efficacy of the vaccine.”
The DoD says it hopes that the CDC studies can determine
whether the vaccine can be effective with fewer doses. About 500,000 military
personnel have received at least one dose in the six-shot series. According to
the Pentagon, the vaccine is vital to protection against a deadly biological weapon
now in the arsenals of perhaps a dozen countries.
The tests will not involve exposure to the colorless,
odorless and tasteless anthrax spores, which can destroy the lungs if inhaled.
But Meryl Nass, a physician and anthrax vaccine critic, sees the CDC trials as “unethical”
and suggests that the military use personnel who have already been vaccinated
in a long-term study of side effects.
The CDC’s National Immunization Program currently is
examining safety issues related to the anthrax vaccine and procedures for
reporting adverse effects. Also
underway, in accordance with testing mandated last year by Congress, are
studies involving rhesus monkeys.
More than 30 members of
Congress, in a bipartisan effort, last year called on the military to end the
vaccination program. An estimated 400 military personnel have refused to take
the drug.
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INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
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KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
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ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.