American Forces Press Service

Anthrax Vaccine Safe, Effective, Top Doctor Says


  By Douglas J. Gillert
 American Forces Press Service

 WASHINGTON -- 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. Since 1977, more than 
 10,000 doses of vaccine have been administered to DoD personnel. 
 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 "Concerning the Anthrax Threat" on the Internet at