The children's vaccine initiative : achieving the vision

The children's vaccine initiative achieving the vision

Bibliographic Details
Corporate Authors: Institute of Medicine (U.S.). Committee on the Children's Vaccine Initiative: Planning Alternative Strategies Toward Full U.S. Participation (-), Institute of Medicine (U.S.). Division of International Health
Other Authors: Sanford, Jay P., 1928- (-), Mitchell, Violaine S., Philipose, Nalini M.
Format: eBook
Language:Inglés
Published: Washington, D.C. : National Academy Press 1993.
Edition:1st ed
Subjects:
Vaccination of children.
Vaccines.
Immunization of children.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820335206719
Table of Contents:
  • The Children's Vaccine Initiative
  • Copyright
  • Preface
  • Acknowledgments
  • Contents
  • 1 Executive Summary
  • THE CHILDREN'S VACCINE INITIATIVE
  • THE INSTITUTE OF MEDICINE REPORT
  • COMMITTEE FINDINGS
  • Resources and Infrastructure
  • Vaccine Demand and Supply
  • Demand
  • Supply
  • Innovation
  • Investing in New and Improved Vaccines
  • Stages of Vaccine Development
  • Pilot Production
  • Clinical Trials
  • Scaleup and Large-Scale Manufacture
  • Technology Transfer
  • A STRATEGY TO ENHANCE U.S. PARTICIPATION
  • NOTE
  • REFERENCE
  • 2 Why a Children's Vaccine Initiative?
  • PROGRESS TOWARD UNIVERSAL CHILDHOOD IMMUNIZATION
  • Limits of the Expanded Program on Immunization
  • THE CHILDREN'S VACCINE INITIATIVE
  • Characteristics of CVI Vaccines
  • Vaccines Should Be Single Dose
  • Vaccines Should Be Administered Near Birth
  • Vaccines Should Be Combined in Novel Ways
  • Vaccines Should Be Heat Stable
  • Vaccines Should Be Effective Against Additional Diseases
  • Vaccines Should Be Affordable
  • Concerns About the CVI
  • RELEVANCE OF THE CVI TO U.S. IMMUNIZATION EFFORTS
  • Status of Immunization Efforts in the United States
  • A Role for the CVI in the United States
  • REFERENCES
  • 3 Resources and Infrastructure
  • RESOURCES IN THE UNITED STATES
  • U.S. Federal Agencies and Programs
  • U.S. Agency for International Development
  • Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
  • Centers for Disease Control and Prevention
  • U.S. Department of Defense
  • National Institutes of Health
  • National Vaccine Program
  • Other Federal Programs
  • U.S. State Vaccine Manufacturers
  • Massachusetts
  • Michigan
  • U.S.-Based Pharmaceutical Firms
  • Connaught Laboratories, Inc.
  • Lederle-Proxis Biologicals
  • Merck &amp
  • Co., Inc.
  • SmithKline Beecham
  • Wyeth-Ayerst
  • Development-Stage Companies.
  • North American Vaccine
  • MedImmune
  • Univax Biologics, Inc.
  • Nongovernmental Organizations
  • The Children's Defense Fund
  • March of Dimes Birth Defects Foundation
  • Rockefeller Foundation
  • Rotary Foundation
  • INTERNATIONAL RESOURCES
  • Multilateral Organizations
  • Pan American Health Organization
  • PAHO Revolving Fund
  • SIREVA Project
  • United Nations Development Program
  • United Nations Children's Fund
  • Vaccine Independence Initiative
  • World Bank
  • World Health Organization
  • Expanded Program on Immunization
  • Program for Vaccine Development
  • Children's Vaccine Initiative
  • Public-Sector Resources
  • Private-Sector Resources
  • Nongovernmental Organizations
  • Task Force for Child Survival and Development
  • Save the Children Fund
  • REFERENCES
  • 4 Vaccine Demand and Supply
  • GLOBAL DEMAND AND SUPPLY
  • Demand
  • Regional Demand
  • Supply
  • Procurement
  • Innovation
  • DEMAND AND SUPPLY IN THE UNITED STATES
  • Demand
  • Supply
  • Pricing
  • Vaccine Innovation
  • NOTE
  • REFERENCES
  • 5 Investing in New and Improved Vaccines
  • MARKET CONSIDERATIONS
  • Market Size
  • Intellectual Property
  • Patent Rights and Limitations
  • Patents and Vaccines
  • Infringement
  • LIABILITY
  • REFERENCES
  • 6 Stages of Vaccine Development
  • PRIORITY SETTING
  • BASIC AND APPLIED RESEARCH
  • CLINICAL EVALUATION
  • LICENSURE
  • PRODUCTION
  • Pilot Production
  • ScaleUp and Full-Scale Manufacture
  • Vaccine Production in Developing Countries
  • RECOMMENDATIONS FOR USE
  • PROCUREMENT
  • DISTRIBUTION AND DELIVERY
  • SURVEILLANCE
  • Immunization Status
  • Monitoring Effectiveness of Vaccines
  • Adverse Reactions
  • Setting Priorities for Vaccine Use and New Vaccines
  • REFERENCES
  • 7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative
  • A NATIONAL VACCINE AUTHORITY
  • Mission
  • Functions.
  • Setting Priorities and Product Characterization
  • Basic Research
  • Applied Research and Exploratory Development
  • Intellectual Property Rights
  • Product Development
  • Clinical Evaluation
  • Regulation
  • Manufacture
  • Procurement
  • Monitoring and Evaluation
  • Management and Organization
  • Funding
  • Location
  • Points to Consider for Locating the CVI in an Existing Federal Agency
  • Options
  • U.S. Agency for International Development
  • Centers for Disease Control and Prevention
  • U.S. Department of Defense
  • U.S. Food and Drug Administration
  • National Institutes of Health
  • The National Vaccine Program
  • Independent Organization
  • NOTE
  • REFERENCES
  • Appendixes
  • A Relevant Intellectual Property Rights Law
  • PATENTS
  • Rights and Limitations
  • Infringement
  • Potential Barriers and Incentives
  • First-to-File Versus First-to-Invent
  • Backlog in the Patent and Trademark Office
  • Costs
  • Disclosure to Government Agencies
  • Relevant Legislation and Terminology
  • Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417)
  • Omnibus Trade and Competitiveness Act (P.L. 100-418)
  • Grace Period
  • Orphan Drug Act of 1983 (P.L. 99-91)
  • Patent and Trademark Amendments of 1980 (P.L 96-517)
  • Experimental Use Exception
  • TRADE SECRETS (KNOW-HOW)
  • Definition
  • Confidentiality
  • Rights of the Trade Secret Owner
  • Rights Against Individuals in Privity
  • Protection by Contract
  • Implied Contract/Special Relationships
  • Rights Against Third Parties
  • Additional Rights of a Trade Secret Owner
  • Rights to Use Another's Trade Secrets
  • REFERENCES
  • B National Vaccine Injury Compensation Program
  • DEFINITION AND PURPOSE
  • BACKGROUND
  • FILING A CLAIM UNDER NVICP
  • KEY CHARACTERISTICS
  • REFERENCES
  • C Regulatory Aspects of Vaccine Development, Manufacture, and Distribution
  • THE LICENSURE PROCESS.
  • POSTLICENSING
  • Manufacture
  • Distribution
  • THE DRUG EXPORT AMENDMENTS ACT OF 1986
  • REFERENCES
  • D Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative
  • STRATEGY 1: RETAIN THE CURRENT SYSTEM
  • Option 1: Increased Funding for CVI Vaccine Research
  • Contribution to the Global CVI
  • Option 2: Purchase Existing Vaccines
  • Contribution to the Global CVI
  • Option 3: Improve Vaccine Delivery
  • Contribution to the Global CVI
  • STRATEGY 2: FORGING NEW PARTNERSHIPS BETWEEN THE PUBLIC AND PRIVATE SECTORS
  • Option 1: Broker CVI R&amp
  • D and Pilot Manufacture
  • Contribution to the Global CVI
  • Option 2: Develop an Entity with CVI-Related R&amp
  • D and Pilot Manufacturing Capabilities
  • Contribution to the Global CVI
  • STRATEGY 3: EMBARK ON A PUBLIC-SECTOR MODEL
  • Contribution to the Global CVI
  • E Public Health Service Act (1944)
  • PUBLIC LAWS-CH. 373-JULY 1, 1944 PART F-BIOLOGICAL PRODUCTS Regulation of Biological Products
  • Interference With Officers
  • Penalties for Offenses
  • F National Vaccine Program Legislation
  • TITLE XXI-VACCINES SUBTITLE 1-NATIONAL VACCINE PROGRAM
  • Establishment
  • Program Responsibilities
  • Plan
  • Report
  • National Vaccine Advisory Committee
  • Authorizations
  • G Immunization Schedules
  • H Historical Record of Vaccine Product License Holders in the United States
  • I Working Group Participants June 11-13, 1992
  • NOTES
  • J Committee and Staff Biographies
  • K Acronyms.

Similar Items