CDC Anthrax Vaccine Safety & Efficacy Research Program Interim Report (2001) / Chapter Skim
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1. Introduction and Background
1. Introduction and Background
Pages 11-20
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From page 11... ...
But in acIdition to supply problems, the anthrax vaccine and AVTP have also been the subject of an unusual degree of concern from service personnel, regarding possible adverse events associated with the vaccine. Because of the importance of protecting service personnel against biological warfare using B
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From page 12... ...
The study shall address: (1J the risk factors for adverse events, including differences in rates of adverse events between men and women; (2J determining immunological correlates of protection and documenting vaccine efficacy; and (3J optimizing the vaccination schedule and administration to assure efficacy while minimizing the number of doses recluired and the occurrence of adverse events. It is intended that NIH, CD C, and the Department of Defense will fully cooperate in this effort." This excerpt of PL 106-113 is the language that formed the basis of the contract for this project.
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From page 13... ...
The issues include the types and severity of adverse reactions, including gender differences; long-term health implications; inhalational efficacy of the vaccine against all known anthrax strains; correlation of animal models to safety and effectiveness in humans; validation of the manufacturing process focusing on, but not limited to discrepancies identified by the Food and Drug Administration in February 1998; definition of vaccine components in terms of the protective antigen and other bacterial products and constituents; and identification of gaps in existing research. ANTHRAX DISEASE AND PREVENTION Anthrax Disease Anthrax disease is caused by an infection with Bacillus anthracis (Brachman ant!
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From page 14... ...
Anthrax Vaccine Adsorbed, or AVA. The current vaccine differs slightly from the initial field trial tested vaccine in that it starts with a different avirulent strain cultured under different conclitions, and uses a different aluminum preparation (Myers, presentation, 2001~.
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From page 15... ...
Rather it is a signal-capturing or hypothesis-generating system: for example, if VAERS should receive a significant increase in reports of adverse events associated with some particular product, then that serves as a signal to investigate possible causes such as perhaps a particular lot or batch of the product that might be unusually reactogenic (see also Tilson, 19921. In the special case of the anthrax vaccine, the VAERS reports receive indiviclual review by an inclependent civilian committee of medical experts, the Anthrax Vaccine Expert Committee (AVEC)
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From page 16... ...
In addition to supply problems, some vaccinees have objected to the immunization policy. There have been, for example, complaints among Gulf War veterans of chronic multisystem clinical conditions that still lack definable relationship to anthrax vaccine and to other events in the Gulf War experience (for farther information on Gulf War experience and concerns, see, for example, Presidential Advisory Committee, 1996; Iowa Persian Gulf Study Group, 1997; Fukuda et al., 1998; Hotopf et al., 2000; lOM, 1996, 2000a, 2000b)
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From page 17... ...
study to evaluate CDC research plan on safety and efficacy of anthrax vaccine Congressional actions regarding IOM study of anthrax vaccine research T T DoD Appropriations Act 2000 PL 106-79 DoD is directed to enter into a contract with the IOM to independently study the effectiveness and safety of the anthrax vaccine IOM letter report an anthrax | ~t vaccine afety3/3012000 DoD contracted With IOM to study the safety and efficacy of the anthrax vaccine 1 IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine Meetings to date: October 3, 2000 January 29-30, 2001 April 17-18, 2001 ! Final Report due June 2002 l DHHS Appropriations Act, 2000 PL 106-113 CDC is provided $20 million for a collaborative effort to study the safety and efficacy of anthrax vaccine L CDC requested that IOM review the CDC research plan IOM Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Meetings to date: October 31, 2000 February 8-9, 2001 April 18-19, 2001 Interim Report due June 2001 | Final Report due August 2002 | FIGURE ~ Origins of TOM Activities Related to the Anthrax Vaccine
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From page 18... ...
The NIP is, as noted, concerned with tracking vaccine adverse events and improving vaccine acceptability. In order to assess the vaccine adverse event profile' the NIP hopes to improve the detection of true adverse events, and in orcler to improve vaccine acceptability, the NIP hopes to
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From page 19... ...
The plans of the NIP to improve the adverse event profile ant! the acceptability of the vaccine include research and programmatic components, with only the former (research)
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