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Anthrax Vaccine Safe, Effective, Top Doctor Says

By Douglas J. Gillert
American Forces Press Service

WASHINGTON, Feb. 9, 1999 – The Defense Department's top doctor categorically denied reports that contaminated anthrax vaccine has been shipped to military units.

"There have been no vials shipped or any immunizations given to any of our service members with lots or vials that were contaminated in any way," Dr. Sue Bailey, assistant secretary of defense for health affairs, said Feb. 3.

Bailey was responding to recent press reports to the contrary. She said neither DoD nor Food and Drug Administration investigations of the vaccine had found evidence of microbial contamination. She also said the manufacturing process for the anthrax vaccine has met all FDA requirements for producing and shipping the vaccine safely and contaminant-free.

Last February, the manufacturer found some vials with bits of stopper material or other particles floating in them and pulled from scheduled shipments, Bailey said. "That is part of the usual quality assurance practices," she said. The company doesn't ship any lots of the vaccine without FDA certification, she said.

Safety is just one of the concerns that have arisen since Defense Secretary William Cohen ordered anthrax vaccinations for all service members last year. Some people have raised questions about the need for the drug as well as its side effects. Some service members have refused the series of six inoculations given over an 18-month period.

Bailey said the vaccines are key to protecting deployed service members against weapons-borne anthrax, which is virtually incurable if it's inhaled and takes hold. Shots aren't the only form of protection -- properly fitted and worn protective clothing and gas masks help, she said, as do detection systems that alert units to the presence of the disease spores.

There have been some reactions to the shots, including at least one severe case, Bailey said. Most, however, were minor, temporary swellings or knots and soreness that had no long-term effects, she said. In the few cases where reactions were more severe, the service members fully recovered and returned to duty, she said.

Anthrax vaccinations aren't new to DoD. About 150,000 personnel received at least one dose during Desert Shield and Desert Storm in 1990-91. More than 184,000 service members have received shots in DoD's current program; about 80 have resisted or refused. The latest controversy involved Connecticut Air National Guard members who refused the shots en masse in January.

"There are always going to be people who are concerned about the safety of any medication," Bailey said. "But I feel through our communication efforts and due to the fact that anthrax is so lethal and so easily weaponized, most of our force understands the need for the immunization."

Bailey said it's been more difficult to communicate the drug's safety and efficacy to reservists because they aren't on duty all the time. "We are not with them frequently enough to provide as much in terms of the intense communication that I think assures the success of a program like this," she said. "We are now funded for and implementing programs that account for the differences in the time of communication for reservists."

Reserve component chiefs attempted to reassure Guard and Reserve members Jan. 25 when they appeared on Capitol Hill to receive their first shots. Charles Cragin, acting assistant secretary of defense for reserve affairs, said the leaders wanted to set the example for the 900,000 reservists scheduled to receive the vaccinations by 2003.

To bolster members' confidence, Bailey, Cohen and Joint Chiefs of Staff Chairman Gen. Henry Shelton were among the first to roll up their sleeves. Also, more than 600 medics at Tripler Army Medical Center, Hawaii, participated in a population base study of the drug's safety and effectiveness during September and October 1998. Only one service member missed one workday after getting the first inoculation, Bailey said, and fewer than 15 percent reported any adverse reaction.

Bailey said she agrees with Cohen and other defense leaders that the anthrax program is safe, effective and important to force protection. "As a physician, I feel this is a completely safe vaccine and provides the protection that our forces depend upon when they are sent into harm's way," she said.

For more information on anthrax and the DoD vaccine program, visit "Arm Yourself Against Anthrax" on the Internet at http://www.anthrax.osd.mil/.

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