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 Three unpublished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] |
