The Children's Vaccine Initiative

Achieving the Vision

Author: Sanford, Jay P.; Philipose, Nalini M.; Mitchell, Violaine S.
Publisher: National Academies Press
ISBN: 9780309049405
eISBN Pdf: 9780309585835
Place of publication: United States
Year of digital publication: 1993
Month: January
Pages: 238
DDC: 614
Language: English

Caption

The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.

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 & 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&D and Pilot Manufacture
      - Contribution to the Global CVI
    - Option 2: Develop an Entity with CVI-Related R&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