The Anthrax Vaccine Is It Safe? Does It Work? (2002) / Chapter Skim
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4 Safety: Introduction
4 Safety: Introduction
Pages 83-101
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From page 83... ...
military personnel during the Gulf War and more recently under the Anthrax Vaccine Immunization Program (AVIP) substantially increased the numbers of persons vaccinated and produced concerns among some that the vaccine might be responsible for serious adverse health effects.
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From page 84... ...
Some have proposed that vaccination with AVA could have contributed to the chronic multisystem health complaints of some Gulf War veterans (GAO, l999b,c; Nicolson et al., 2000~. With the expansion of mandatory vaccination under AVIP, there have also been concerns that the health impact of vaccination with AVA was being missed because adverse events were underreported to military health care providers and to the Vaccine Adverse Event Reporting System (VAERS)
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From page 85... ...
Recent reports from an IOM committee examining the potential health effects of agents to which Gulf War veterans may have been exposed concluded that receipt of AVA was associated with transient acute local and systemic effects (e.g., redness, swelling, and fever) but that the available evidence was "inadequate/insufficient" to determine whether any association with long-term adverse health effects exists (IOM, 2000a,b)
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From page 86... ...
Immediate-onset events are ones that have an observed onset within minutes, hours, or days following vaccination, whereas ~ter-onset events are ones that arise months or years after vaccination. The characterization of events as "short term" and "long term" has been avoided in this report because these terms can be confusing; sometimes they refer to the duration of the event (standing for "acute" and "chronic," respectively)
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From page 87... ...
Instead, postmarketing surveillance efforts, such as those that are conducted by vaccine manufacturers and through VAERS (see Chapter 5) and that include formal epidemiologic studies of the type described in Chapter 6, are used to help identify less common adverse events after a vaccine is marketed and used by larger numbers of individuals.
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From page 88... ...
Means of Data Collection As noted above, routine monitoring for adverse events following vaccination depends primarily on spontaneous reports of cases of adverse events. Such reports can signal possible vaccine-related problems but cannot be used to determine incidence rates of adverse events.
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From page 89... ...
Local pain of any degree was reported by 50 percent or more of recipients of acellular pertussis vaccine (Englund et al., 1992; Halperin et al., 2000a,b; Keite! et al., 1999; Van der Wielen et al., 2000)
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From page 90... ...
DOES IT STORK? TABLE 4-1 Local and Systemic Event Rates Reported in Selected Prospective Vaccine Trials Percent ~ Sy Number Vaccine Reference of Subjects Fever Anyb Acellular pertussis Van der Wielen et al., 2000 96 4 27 Halperin et al., 2000a 126 0 17 Halperin et al., 2000b 149 7 29 Hepatitis A Scheifele and Bjornson, 1993 64 3 16 Westblom et al., 1994 186 0 22 Hoke et al., 1995 91 3 4 Czeschinski et al., 2000 75 0 14 Hepatitis B Halliday et al., 1990 594 1 Schiff et al., 1995 382 0.3 Czeschinski et al., 2000 75 4 10 Influenza Schiefele et al., 1990 266 13 al-Mazrou et al., 1991 330 9 33 Aoki et al., 1993 76 2 17 Nichol et al., 1996 418 6 34 Banzhoff et al., 2000 61 2 18 Banzhoff et al., 2000 61 1 18 Halperin et al., 1998 1 11 Rabies Anderson et al., 1980 234 3 3 Chutivongse et al., 1995 202 18 Jaiiaroensup et al., 1998 599 2 Fritzell et al., 1992 46 Tetanus-diphtheria Middaugh, 1979 697 Macko and Powell, 1985 100 7 Van der Wielen et al., 2000 98 9 17 Halperin et al., 2000a 126 0.8 26 aSystemic side effects include malaise, fatigue, and decreased energy, but headache was not included.
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From page 91... ...
SAFETY: INTRODUCTION 91 Percent of Subjects Reporting the Following Side Effects Following Vaccination Systemica Erythema or Swelling Pain Moderate Moderate Moderate Any Fever Anyb or Severe Any or Severe Any or Severe Disability 4 27 1c 12 1c 72 or d 0 17 8 15 3 51 7 7 29 10 13 Joe 77 11 3 16 8 52 0 22 5 47 3 4 4 40 0 14 0 40 2 41 1 9 16 0.3 0.5 1 1 4 10 7 99 3 43 6 13 20 86 9 33 18 24 1 2 17 61 6 34 64 21 6 2 18 4 21 0 28 2 1 18 4 21 0 28 2 1 1 1 1c 1 1 8c 35 3c 3 3 18 14 18 2 1 20 13 52 - 35 43 7 30 75 27 9 17 1c 35 6c 83 or 0.8 26 8 22 1 1e 85 15 CIn these studies, the descriptor "clinically significant" was used in place of "moderate or severe" or "greater than moderate." dNot reported. eIn these studies, local reactions were dichotomized as >10 mm or <10 mm in diameter.
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From page 92... ...
rates of systemic reactions, including fever, chills, muscle aches, and decreased activity (Ward, 2001~. An unpublished study of higher and lower doses of influenza vaccine also found a significantly higher rate of local pain among women who received the lower vaccine dose (Treanor, 2001~.
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From page 93... ...
The committee also heard personal testimony regarding adverse events following vaccination with AVA. These statements, some of which concerned cases reported to VAERS, added valuable insight into the conditions that some military personnel are expe.
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From page 94... ...
The committee decided, however, to consider unpublished epidemiologic analyses conducted by DoD and other researchers, because such studies offered the best available and most direct analyses of the possible association between AVA and various health outcomes. Many of the manuscripts describing these studies were under review or were being prepared for submission to a journal at the time they were presented to the committee.
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From page 95... ...
Mycoplasma Mycoplasma contamination of the anthrax vaccine has been suggested as a possible cause of illness among Gulf War veterans (Nicolson et al., 2000~. Mycoplasmas are a distinctive type of bacteria that lack cell walls (Baseman and Tully, 1997~.
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From page 96... ...
Squalene Some Gulf War veterans and others have expressed concerns about whether squalene might be present in the anthrax vaccine and whether it has the potential to cause health effects. Squalene is a hydrocarbon compound found in many natural sources, including olive oil and the human body.
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From page 97... ...
1991. Comparison of adverse reactions to whole-virion and split-virion influenza vaccines in hospital personnel.
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From page 98... ...
2000b. Adult formulation of a five component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine is safe and immunogenic in adolescents and adults.
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From page 99... ...
1995. Experimental anthrax vaccines: efficacy of adjuvants combined with protective antigen against an aerosol Bacillus anthracis spore challenge in guinea pigs.
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1999. Anthrax Vaccine Adverse Event Reporting.
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From page 101... ...
2001, September 29. Demand growing for anthrax vaccine: fear of bioterrorism attack spurs requests for controversial shot.
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