A Review of Selected Federal Vaccine and Immunization Policies, Based on Case Studies of Pneumococcal Vaccine

NTIS order #PB80-116106

Report cover
Full Report ~4588K
Front Matter ~50K
Table of Contents ~42K

Chapters
1: SUMMARY ~834K
2: A CASE STUDY: FINANCING THE RESEARCH AND DEVELOPMENT OF PNEUMOCOCCAL VACCINE ~202K
3: A CASE STUDY: EVALUATING THE SAFETY AND EFFICACY OF PNEUMOCOCCAL VACCINE ~1065K
4: A CASE STUDY: COST-EFFECTIVENESS ANALYSIS OF VACCINATION AGAINST PNEUMOCOCCAL PNEUMONIA ~260K
5: A REVIEW: LEGAL LIABILITY AND COMPENSATION FOR VACCINE-RELATED INJURIES ~269K
6: FINDINGS AND ISSUES ~93K
7: POLICY OPTIONS ~365K

Appendixes
1.1: PNEUMOCOCCAL VACCINE RESEARCH AND DEVELOPMENT (1881-1966) ~37K
2.1: HISTORICAL REVIEW AND TREND ANALYSIS OF VACCINE ESTABLISHMENT AND PRODUCT LICENSURE IN THE UNITED STATES (1902-67) ~9K
2.2: PROFILE OF VACCINE ESTABLISHMENTS AND PRODUCTS CURRENTLY LICENSED IN THE UNITED STATES (1979) ~140K
2.3: CHRONOLOGICAL INTRODUCTION OF TYPES OF VACCINE PRODUCTS THAT ARE STILL LICENSED IN THE UNITED STATES ~78K
3.1: THE DEVELOPMENT OF THE FEDERAL GOVERNMENT'S STATUTORY AUTHORITY TO REGULATE VACCINE SAFETY AND EFFICACY (1902-73) ~13K
3.2: STATUTORY AUTORITY AND PROCEDURES FDA USES TO EVALUATE THE SAFETY AND EFFICACY OF PRESCRIPTION DRUGS ~14K
3.3: BOB'S VACCINE PRODUCT LICENSURE APPLICATION AND PRODUCT REVIEW PROCESSES ~61K
3.4: TYPES OF DATA BOB USES TO EVALUATE THE SAFETY AND EFFICACY OF BIOLOGICAL PRODUCTS ~17K
3.5: TYPES OF STUDIES BOB USED TO EVALUATE THE SAFETY AND EFFICACY OF POLYVALENT PNEUMOCOCCAL VACCINE ~32K
3.6: REVIEW OF PREMARKETING CLINICAL TRIALS AND STUDIES BOB USED TO EVALUATE THE SAFETY AND EFFICACY OF POLYVALENT... ~70K
3.7: CDC'S PASSIVE, VOLUNTARY CASE REPORTING SYSTEM FOR MONITORING ADVERSE REACTIONS TO LICENSED VACCINES ~171K
4.1: FACTORS THAT CAN AFFECT CONSUMERS' AND PHYSICIANS' USE OF VACCINES ~163K
4.2: THE IMPACT OF FEDERALLY FINANCED STATE AND LOCAL IMMUNIZATION PROGRAMS ON THE INCIDENCE OF MEASLES (1962-78) ~64K
4.3: HISTORICAL CONTEXT OF COST-EFFECTIVENESS ANALYSIS ~29K
4.4: VALUES ASSIGNED TO SELECTED VARIABLES IN OTA'S COST-EFFECTIVENESS ANALYSIS OF VACCINATION AGAINST PNEUMOCOCCAL PNEUMONIA ~103K
4.6: A METHOD OF CALCULATING ATTRIBUTABLE RISK FOR PNEUMOCOCCAL PNEUMONIAI ~60K
5.1: GUILLAIN-BARRE SYNDROME ~9K
Bibliography ~582K