The Anthrax Vaccine Is It Safe? Does It Work? (2002) / Chapter Skim
Currently Skimming:
Appendix H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report
Appendix H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report
Pages 253-266
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 253... ...
Appendix H An Assessment of He Safety of Be Anthrax Vaccine A LeMer Report Co~iuCO OD Beam Etch Associated hit Bows Dam UST~UTE 0E MEDICS Washington, D.C.
|
From page 254... ...
The questions include the types and severity of adverse reactions, including gender differences; long-term health implications; efficacy of the vaccine against inhalational anthrax; correlation of animal models to safety and effectiveness in humans; validation of the manufacturing process; definition of vaccine components in terms of the protective antigen and other bacterial products and constituents; and identification of gaps in existing research. Because of immediate concern over anthrax vaccine safety issues, the IOM offered to draw relevant information from an ongoing study of Gulf War exposures funded by the Department of Veterans Affairs.
|
From page 255... ...
The ability of the IOM to conduct the more comprehensive study of the anthrax vaccine requested by the DoD assumes that the significant body of work that has been conducted by the DoD on this subject will be released for publication in peer-reviewed scientific journals. INTRODUCTION Currently there are two types of anthrax vaccine available for human use: a live attenuated spore vaccine that has been tested and used widely in the countries of the former Soviet Union (Shlyakhov and Rubinstein, 1994)
|
From page 256... ...
The committee notes a recent literature review (Demicheli et al., 1998) on anthrax vaccine studies conducted according to the Cochrane Collaboration guidelines for systematic reviews of health care interventions.
|
From page 257... ...
Long-Term Studies The committee located only one published series of studies that discussed long-term follow-up of individuals who received multiple vaccinations, including the anthrax vaccine, due to the nature of their employment. A group of employees at Fort Detrick, Maryland, were followed for an average of 25 years to investigate the potential subclinical effects of intensive vaccination.3 The participants underwent physical examinations and/or laboratory testing in 1956 (n = 93)
|
From page 258... ...
from 45 minutes to 4/ months after the vaccination. The reports of serious events include severe injection site reactions, a widespread allergic reaction, a case of aseptic meningitis, an onset of lupus, an onset of inflammatory demyelinating disease, a diagnosis of bipolar disease, and two cases of Guillain-Barre syndrome (Ellenberg, 1999~.
|
From page 259... ...
Army Medical Research Institute of Infectious Diseases (USAMRIID) who received 10,451 doses since 1973 An assessment of the safety of booster shots given to 486 male military personnel who had received initial anthrax vaccinations during the Gulf War Active monitoring of 576 persons in the Canadian military who received the anthrax vaccine in 1998 Pilot study involving 173 persons who received a reduced dose schedule or vaccination via a different route (intramuscular)
|
From page 260... ...
Reviewing the large body of results that have not yet been published would enable more definitive conclusions about the vaccine's safety. The committee strongly urges the investigators conducting studies on the safety of the anthrax vaccine to submit their results to peer-reviewed scientific journals for publication.
|
From page 261... ...
Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques. Vaccine.
|
From page 262... ...
LIVERMAN, Study Director SANDRA AU, Research Assistant KYSA CHRISTIE, Senior Project Assistant ROSE MARIE MARTINEZ, Director, Division of Health Promotion and Disease Prevention
|
From page 263... ...
Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine.
|
From page 264... ...
DAMD17-00-C-003. The views, opinions, and/or findings contained in this report are those of the Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War and should not be construed as an official Department of the Army position, policy, or decision unless so designated by other documentation.
|
From page 265... ...
Henderson, Johns Hopkins University Richard Johnston, University of Colorado Joyce Lashof, University of California, Berkeley Robert Miller, (retired) National Cancer Institute Gregory Poland, Mayo Clinic and Foundation Hugh Tilson, University of North Carolina at Chapel Hill Mary Wilson, Mount Auburn Hospital, Cambridge, MA While the individuals listed above have provided constructive comments and suggestions, responsibility for the final content of this report rests solely with the authoring committee and the Institute of Medicine.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.