CDC May Start Human Testing Of Anthrax Vaccine

xmlns:o="urn:schemas-microsoft-com:office:office" xmlns:w="urn:schemas-microsoft-com:office:word" xmlns="http://www.w3.org/TR/REC-html40"> CDC May Start Human Testing Of Anthrax Vaccine

 

CDC May Start Human Testing Of Anthrax Vaccine

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.

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.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.