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8 Future Needs
Pages 198-210

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From page 198...
... The committee's research also suggested that the manufacturing process could be validated. As discussed in Chapter 3, the efficacy of the licensed anthrax vaccine indeed, of any anthrax vaccine for the stimulation of protective immunity against inhalational anthrax in humans cannot be demonstrated in clinical trials or field trials, as clinical trials that challenged humans with the anthrax bacillus would be impossible and intolerable and humans naturally encounter aerosolized Bacillus anthracis spores in few situations.
From page 199...
... That BioPort has successfully met FDA requirements is welcome news. Nevertheless, the committee is convinced that relying only on the current anthrax vaccine and the current specifications for its use is far from satisfactory.
From page 200...
... As mentioned above and as discussed in more detail in Chapter 7, the AVA manufacturing facility and the AVA production process have both been the subject of numerous FDA citations and responses. Indeed, the manufacturer undertook a thorough renovation of its manufacturing facility starting in 1998 and modernized several aspects of the production process.
From page 201...
... , DoD has supported the review of each VAERS report associated with AVA by an independent civilian advisory pane! called the Anthrax Vaccine Expert Committee (AVEC)
From page 202...
... The resources supporting AVEC activities related to AVA alone could be more wisely invested in improved monitoring of the safety of vaccines in general. Recommendation: DoD should disband AVEC in its current form and instead assist FDA and CDC in establishing an independent advisory committee charged with overseeing the entire process of evaluating vaccine safety.
From page 203...
... TABLE 8-1 Functions of AVEC and Post-AVEC Panels Function AVEC Redeployed AVEC Panel Replacing AVEC Mission Individual review of Provide ad hoc Provide oversight and VAERS reports to advice as needed on advice on safety assess causal interpretation of evaluations and advice in relationship of AVA potential signals in specific cases and adverse events VAERS or other sources relevant to vaccine safety Scope All AVA-related All vaccines Entire process of vaccine VAERS reports administered to safety evaluations, plus service personnel provision of advice as needed on interpretation of potential signals from VAERS or other sources relevant to the safety of any vaccine Model Advisory Committee Advisory committee FDA Drug Safety and on Causality (responding to ad Risk Management Assessment (Canada) hoc agency requests Advisory Committee for advice on (broad mandate and specific products)
From page 204...
... Additional Sources of Data on Adverse Events Although the IOM committee does not recommend continuation of AVEC as a program that monitors AVA-specific reports in VAERS, the committee does believe that it is essential for DoD to continue to work with CDC and FDA to ensure that VAERS reports are regularly and carefully monitored for any signals that vaccines administered to military service personnel might be associated with adverse health effects. Ensuring the best use and interpretation of VAERS reports, however, requires complementary information from other sources that can be used to help analyze the signals that may be suggested by VAERS reports.
From page 205...
... A formal mechanism for the direct examination of signals from VAERS using DMSS data should be established. The committee was impressed with information presented on the types of data maintained in DMSS datasets on medical encounters for any reason in the military health care system.
From page 206...
... Recommendation: DoD should investigate mechanisms that can be used to make DMSS data available to civilian researchers, as is done by civilian agencies, with appropriate controls and protections for privacy. The main limitations of the DMSS databases with respect to the study of adverse events associated with vaccination are actually related to its main strength.
From page 207...
... The study will monitor a total of 140,000 U.S. military personnel during and after their military service for up to 21 years to evaluate the health risks of military deployment, military occupations, and general military service (see http:// www.millenniumcohort.org/about.html)
From page 208...
... Finding: The current anthrax vaccine is difficult to standardize, is incompletely characterized, and is relatively reactogenic (probably even more so because it is administered subcutaneously) , and the dose schedule is long and challenging.
From page 209...
... 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;
From page 210...
... DOES IT WORK? · DoD should pursue and encourage research to map the epitopes of the protective antigen that correlate with specific functional activities; · 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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