An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program (2003) / Chapter Skim
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Appendix G: Institute of Medicine: The Anthrax Vaccine: Is It Safe? Does It Work?--Findings and Recommendations
Appendix G: Institute of Medicine: The Anthrax Vaccine: Is It Safe? Does It Work?--Findings and Recommendations
Pages 155-160
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From page 155... ...
· The available data indicate that immunity to anthrax is associated with the presence of antibody to protective antigen. 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 Imown or plausible engineered swains of B
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From page 156... ...
Concerns of service members that reporting to VAERS is sometimes discouraged within the military setting have been responded to appropriately with reminders to physicians that DoD policy requires submission of a VAERS report for postvaccination health events that result in hospitalization or the loss of time from duty of more than 24 hours. Additional steps, however, are possible to facilitate reporting to VAERS, including improvements in the coding of health care visits that are potentially vaccine related.
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From page 157... ...
Examination of data from the DMSS database to investigate potential signals suggested by VAERS reports related to vaccination with AVA has not detected elevated risks for any of these signals for the vaccinated population, although continued monitoring is warranted. 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.
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From page 158... ...
CHAPTER 8 Findings Current events in both the military and the civilian arenas highlight and confirm the importance of ensuring both the availability and the quality of the nation's anthrax vaccine! The AVA product produced in a renovated facility by a newly validated manufacturing process could differ from the prerenovation product in terms of its reactogenicity, immunogenicity, and stability.
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From page 159... ...
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. The proposed advisory committee can also assist on an ad hoc basis in the interpretation of potential signals detected in VAERS or other sources regarding the safety of any vaccine.
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From page 160... ...
DoD should develop ad hoc prospective cohort studies in one or more military settings to test hypotheses that emerge from VAERS, DMSS, or other sources. However, the committee does not recommend that such studies targeted at AVA be conducted at present since no convincing evidence of new adverse events in AVA recipients sufficient to merit a prospective investigation has been presented.
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