The Anthrax Vaccine Is It Safe? Does It Work? (2002) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-32
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The Department of Defense (DoDJ vaccinated some of the military personnel deployed for the Gulf War in 1991 and in 1998 initiated" the Anthrax Vaccine Immunization Program, calling for mandatory vaccination of all U.S. service members.
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The committee found no evidence that vaccine recipients face an increased risk of experiencing life-threatening or permanently disabling adverse events immediately after receiving A VA, when comparedt with the general population. Nor did it fin dt any convincing evidence that vaccine recipients face elevated risk of developing adverse health effects over the longer term, although data are limited in this regard (as they are for all vaccinesJ.
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military personnel to protect them against possible exposure to anthrax spores used as biological weapons. The terrorist attacks of September 11, 2001, and the subsequent distribution through the U.S.
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Committee members were selected for their expertise in microbiology; vaccine research, development, manufacture, and evaluation; postmarketing surveillance of adverse events; regulatory and licensing procedures; epidemiology; biostatistics; immunology; and health surveillance. The charge to the committee included consideration of the types and severity of adverse reactions, sex differences in adverse reactions, long-term health implications, the efficacy of AVA against inhalational exposure to all known anthrax strains, and the correlation of the safety and efficacy of the vaccine in animal models to its safety and efficacy in humans.
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ANTHRAX VACCINE EFFICACY The committee's observations and findings addressed the efficacy of immunization with the licensed vaccine, AVA, against inhalational anthrax and all known anthrax strains (see Chapter 3~. Of particular concern is exposure to anthrax spores processed for use in biological weapons.
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Finding: Because additional clinical trials to test the efficacy of AVA in humans are not feasible and challenge trials with volunteers are unethical, by necessity animal models represent the only sources of the supplementary data needed to evaluate AVA's efficacy. Animal models with pathological and immunological characteristics similar to those of humans could be considered the most appropriate ones for the evaluation of vaccine efficacy.
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Finding: It is unlikely that either naturally occurring or anthrax strains with bioengineered protective antigen could both evade AVA and cause the toxicity associated with anthrax. Establishing Animal Model Correlates of Anthrax Vaccine Efficacy Several recent studies have used passive protection to demonstrate a relationship between levels of circulating anti-PA antibody and protection from challenge with anthrax spores (Barnard and Friediander, 1999; Beedham et al., 2001; Little et al., 1997; McBride et al., 1998; Pitt et al., 2001; Reuveny et al., 2001~.
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The data from animal studies already developed suggest that serological correlates of human immunity can be developed in appropriate animal models. The committee commends this work and encourages its further development.
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Additional studies on the postexposure use of AVA with antibiotics are needed. Recommendation: DoD should pursue or support additional research with laboratory animals on the efficacy of AVA in combination with antibiotics administered following inhalational exposure to anthrax spores.
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Finally, the available data indicate that immunity to anthrax is associated with the presence of antibodies to PA, such as those stimulated by the anthrax vaccine. Finding: The committee finds that the available evidence from studies with humans and animals, coupled with reasonable assumptions of analogy, shows that AVA as licensed is an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by any known or plausible engineered strains of B
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, a passive surveillance system that collects reports on adverse events following the use of any vaccine licensed in the United States (see Chapter 5~. A subset of the committee reviewed each of 120 VAERS reports on serious adverse events associated with AVA.
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Finding: The data available from VAERS, DMSS, and epidemiologic studies indicate the following regarding immediate-onset health events following receipt of AVA: · Local events, especially redness, swelling, or nodules at the injection site, are associated with receipt of AVA, are similar to the events observed following receipt of other vaccines currently in use by adults, and are fairly common. · Systemic events, such as fever, malaise, and myaigia, are associated with receipt of AVA, are similar to the events observed following receipt of other vaccines currently in use by adults but are much less common than local events.
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Finding: The currently licensed subcutaneous route of administration of AVA and the six-dose vaccination schedule appear to be associated with a higher incidence of immediate-onset, local effects than is intramuscular administration or a vaccination schedule with fewer doses of AVA. The frequencies of immediate-onset, systemic events were low and were not affected by the route of administration.
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Finding: The available data are limited but show no convincing evidence at this time that personnel who have received AVA have elevated risks of later-onset health events. Recommendation: DoD should develop systems to enhance the capacity to monitor the occurrence of later-onset health conditions that might be associated with the receipt of any vaccine; the data reviewed by the committee do not suggest the need for special efforts of this sort for AVA.
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Finding: AVA will now be produced by a newly validated manufacturing process under strict controls, according to current FDA requirements. As a result, the postrenovation product has greater assurance of consistency than that produced at the time of original licensure.
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The information available to the committee suggests that AVA lots manufactured postrenovation may show less variation in reactogenicity because of greater consistency in the production process, and there is no a priori basis to believe that the postrenovation product will be more reactogenic or less immunogenic than the older vaccine. Recommendation: As with all vaccines, AVA lots produced postrenovation should be monitored for immunogenicity and stability, and individuals receiving these lots should be monitored for possible acute or chronic adverse events of immediate or later onset.
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Instead, a signal is merely an indication that further investigation is needed. Although AVA appears to be associated with certain undesirable but self-limited or easily treated adverse events, the committee saw no indication from the currently available data of a need to continue special monitoring programs for AVA.
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and reported to VAERS or other sources regarding the safety of all vaccines administered to service personnel rather than continuing the panel's current role of rereviewing each VAERS report related to AVA. Additional Sources of Data on Adverse Events Ensuring the best use and interpretation of VAERS reports requires complementary information from other sources that can be used to help analyze the signals that may be suggested by VAERS reports.
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DMSS data could therefore yield valuable insights in the hands of civilian researchers. Recommendation: DoD should actively support and advance the development of DMSS data resources and the staffing of units that will allow the continuing rapid and careful analysis of these data, including but not limited to the proposed collaboration between CDC and the Army Medical Surveillance Activity.
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Linking of data from DMSS to data from VA is a possible tool. Even though those who receive their medical care through VA may be an unrepresentative minority of all former military personnel, valid comparisons may be possible between those within that population who received a vaccine or other exposure and those who did not.
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Research related to anthrax should include, in particular, efforts such as the following: · DoD should pursue and encourage research to develop an anthrax vaccine product that can be produced more consistently and that is less reactogenic than AVA; · DoD should pursue and encourage research regarding the B anthracis capsule; · DoD should pursue and encourage research on the mechanisms of action of the anthrax toxins; such research could lead to the development of small-molecule inhibitors; · DoD should pursue and encourage research to map the epitopes of the protective antigen that correlate with specific functional activit~es; · DoD should pursue and encourage research to test the therapeutic potential of antitoxin proteins or antibodies; and · DoD should pursue and encourage research into additional potential virulence factors in B
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Surveillance of Adverse Effects of Anthrax Vaccine Adsorbed. Washington, D.C.: Army Medical Surveillance Activity, U.S.
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2001a. Update: investigation of bioterrorism-related anthrax and adverse events from antimicrobial prophylaxis.
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2001a. Screening for adverse events following anthrax immunization using the Defense Medical Surveillance System.
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2001. DoD-wide medical surveillance for potential long-term adverse events associated witI7 antI7rax immunization: I7ospitalizations.
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1986. Development of antibodies to protective antigen and lethal factor components of anthrax toxin in humans and guinea pigs and their relevance to protective immunity.
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