The anthrax vaccine : is it safe? does it work? / Lois M. Joellenbeck ... [and others], editors ; Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-up Agency, Institute of Medicine.

Format:

Book

Contributor:

Institute of Medicine (U.S.). Committee to Assess the Safety and Efficacy of the Anthrax Vaccine.

Language:

English

Subjects (All):

Anthrax--Vaccination.

Anthrax.

Anthrax Vaccines.

Medical Subjects:

Anthrax Vaccines.

Physical Description:

xxi, 265 pages : illustrations ; 23 cm

Place of Publication:

Washington, D.C. : National Academy Press, [2002]

Summary:

The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study (TM)s conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

Contents:

Anthrax and Anthrax Vaccine 5

Anthrax Vaccine Efficacy 5

Anthrax Vaccine Safety 10

Anthrax Vaccine Manufacture 14

Future Needs 15

Study Process and Information Sources 34

Related Reports 35

General Principles Regarding Use of Vaccines 37

The Disease 41

Anthrax Vaccine Development 48

Use of Anthrax Vaccine 49

Concerns About Use of AVA 50

Available Data on AVA 51

3 Anthrax Vaccine Efficacy 56

Evaluating Efficacy of AVA for Inhalational Anthrax 57

Efficacy of AVA Against All Known B. anthracis Strains 69

Correlation of Protection: Animal Models and Human Immunity 72

Postexposure Use of Anthrax Vaccine 75

Conclusions Regarding Efficacy 76

4 Safety: Introduction 83

Safety Concerns About the Anthrax Vaccine 84

Identifying Vaccine-Related Adverse Events 85

Gaining Perspective on Adverse Events Following Vaccination 88

Sources of Information Regarding the Safety of AVA 93

Testing for Vaccine Contamination 95

5 Safety: Case Reports 102

Vaccine Adverse Event Reporting System 102

DoD and VAERS 107

Reports to VAERS Related to AVA 112

6 Safety: Epidemiologic Studies 118

Ad Hoc Studies 119

Record-Linkage Studies 155

Preliminary Information on Analysis of Data on Birth Defects 171

Conclusions Regarding AVA Vaccination and Adverse Events 172

Findings and Recommendations 175

7 Anthrax Vaccine Manufacture 180

Committee's Interpretation of the Charge 180

Regulatory Oversight of Vaccine Manufacture 181

Anthrax Vaccine Development 183

Regulatory Actions Concerning AVA Manufacture 190

Findings and Recommendations 194

8 Future Needs 198

Future Use of AVA 199

Surveillance for Adverse Events 201

New Anthrax Vaccine Development 207

A Statement of Task 213

C Information-Gathering Meeting Agendas 218

D Anthrax Vaccine Adsorbed Package Inserts 227

E Vaccine Adverse Event Reporting System (VAERS) Form 239

F Anthrax Vaccine Expert Committee (AVEC) Case Assessment Form 243

G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine 245

H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report 251.

Notes:

Includes bibliographical references.

ISBN:

0309083095

OCLC:

50072469