Update:
The Anthrax Dilemma: Safety Issues Revisited
[Editor's note: On April 29, 1999 Meryl Nass, MD testified before the US Congressional Subcommittee on National Security, Veterans Affairs, and International Relations about a number of issues related to the mandatory anthrax vaccination program implemented by the US Department of Defense in 1998 (see Sidel VW, Nass M, Ensign T. The Anthrax Dilemma. M&GS 1998;5:97-104)]. Hundreds of service men and women have refused to take the vaccine, citing concerns for their health and prompting congressional hearings [see page 6]. Following are excerpts about safety issues from Dr. Nass's written testimony. The complete transcript is available on the Web .]
Two studies at Fort Detrick, in 1986 and 1998, found that 9 and 27 anthrax strains, respectively, killed at least half the immunized guinea pigs injected with these strains [1,2]. The strains are all naturally occurring, and were isolates from around the world. The Department of Defense [DOD] has had other concerns about the vaccine, [stating in a 1991 report that] "Vaccine-induced protection is undoubtedly overwhelmed by extremely high spore challenge" [3].
Safety Considerations
Even if the vaccine were not effective against all anthrax strains, and not against large inoculums of anthrax spores, one might still wish to use it for its residual efficacy if it were perfectly safe. As of February 1999 the DOD reported only 39 adverse reactions in 550,000 inoculations given.
Other data sources suggest this grossly underestimates the true rate. The US Army Medical Research Institute of Infectious Diseases (USAMRIID) reports a rate of systemic reactions of 0.7-1.3% [4]. It also acknowledges the lack of definition of constituents and quantities of material in the vaccine and the significant variation from lot to lot in the content of PA and all the other vaccine components.
Three unpublished DOD studies shed some light on the adverse reaction rate for the vaccine [5-7].
1) An ongoing side effects study by the Tripler Army Medical Center indicates that:
- 7.9% of 595 vaccinees reported systemic symptoms after the first inoculation.
- 5.4% stated they could not perform their normal duties due to symptoms.
- 4.2% sought medical care.
- 2.5% lost duty time.
- 2.2% both sought medical care and lost duty time after the first anthrax vaccination [5].
2) A report sent to the Food and Drug Administration (FDA) by BioPort (formerly the Michigan Biologic Products Institute) leads one to conclude that there were shortcomings in the collection of data during the vaccination trials conducted in the study:
- Blood was collected from volunteers at least monthly for the first year and at 15 months, 18 months, 21 months and 24 months.
- Information on adverse reactions, however, was only collected for the first 30 days.
This was an ideal schedule to inquire about possible long term side effects, but these data were never collected [6].
3) Researchers at Fort Bragg who investigated the serologic response to anthrax and botulinum vaccines among 486 volunteers found that "one or more systemic symptoms occurred in 44% of recipients of vaccines within the first seven days after the booster doses" [7].
The Fort Bragg study looked at persons immunized with anthrax vaccine alone, botulism toxoid vaccine alone, or, in the majority of cases, the combination. Therefore, the reaction rates reflect dual vaccination. In each of the three studies above, however, the rate of systemic reactions is at least 7% and possibly as high as 40%. These rates do not square with the package insert which claims a 0.2% rate of systemic reactions, or the material presented by DOD, which claims a rate of 0.007%.
It is clear from these data that the actual reaction rate being experienced by service members inoculated today is grossly underreported. One must ask why, and one must also inquire about the ethical implications of this underreporting. Accurate reporting is essential for the public health.
References
1. Little SF, Knudsen GB. Comparative efficacy of bacillus anthracis live spore vaccine and protective antigen vaccine against anthrax in the guinea pig. Infection and Immunity May 1986:509-512. [Return to text]
2. Fellows P et al. Anthrax vaccine efficacy against b. anthracis strains of diverse geographic origin. Paper presented at 3rd International Anthrax Conference. Plymouth, England. Sept.ember 9, 1998. [Return to text]
3. US Department of Defense. J-4A01206-91 Joint Staff Action Processing Form. Washington, DC: DOD. August 16, 1991. [Return to text]
4. USAMRIID. Problems with current MDPH vaccine; briefing slide. Fort Detrick, MD. 1997. [Return to text]
5. Tripler Army Medical Center. Study of anthrax vaccine systemic reactions, preliminary report. Hawaii: TAMC. 1999 (ongoing). [Return to text]
6. BioPort. IND Study (BB IND 6847 Preliminary FDA report. September 15, 1998. [Return to text]
7. USAMRIID. Serologic response to anthrax and botulinum vaccines. Final report to the US FDA. Protocol #FY92-5, M109, Log #A-5747. Fort Detrick, Maryland. October 24, 1997. [Return to text]
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