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Stars and Stripes: CDC May Start Human Testing
Of Anthrax Vaccine
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CDC May Start Human Testing Of Anthrax Vaccine
April 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.
DoD Committed
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.”
Wants Fewer Doses
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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Last revised: March 2004