The children's vaccine initiative : achieving the vision / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine.

Format:

Book

Contributor:

Sanford, Jay P., 1928-

Mitchell, Violaine S.

Philipose, Nalini M.

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.

Language:

English

Subjects (All):

Vaccination of children.

Vaccines.

Immunization of children.

Vaccination.

Children.

Infants.

Immunization Programs.

Child.

Immunization Schedule.

Infant.

Medical Subjects:

Immunization Programs.

Vaccination.

Child.

Immunization Schedule.

Infant.

Vaccines.

Physical Description:

1 online resource (xiii, 221 pages) : illustrations

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1993.

Language Note:

English

Summary:

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.

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

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

Task Force for Child Survival and Development

Save the Children Fund

4 Vaccine Demand and Supply

GLOBAL DEMAND AND SUPPLY

Regional Demand

Procurement

DEMAND AND SUPPLY IN THE UNITED STATES

Pricing

Vaccine Innovation

5 Investing in New and Improved Vaccines

MARKET CONSIDERATIONS

Market Size

Intellectual Property

Patent Rights and Limitations

Patents and Vaccines

Infringement

LIABILITY

6 Stages of Vaccine Development

PRIORITY SETTING

BASIC AND APPLIED RESEARCH

CLINICAL EVALUATION

LICENSURE

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

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

Monitoring and Evaluation

Management and Organization

Funding

Location

Points to Consider for Locating the CVI in an Existing Federal Agency

Options

U.S. Food and Drug Administration

The National Vaccine Program

Independent Organization

Appendixes

A Relevant Intellectual Property Rights Law

PATENTS

Rights and Limitations

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

B National Vaccine Injury Compensation Program

DEFINITION AND PURPOSE

BACKGROUND

FILING A CLAIM UNDER NVICP

KEY CHARACTERISTICS

C Regulatory Aspects of Vaccine Development, Manufacture, and Distribution

THE LICENSURE PROCESS.

POSTLICENSING

Distribution

THE DRUG EXPORT AMENDMENTS ACT OF 1986

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

Option 3: Improve Vaccine Delivery

STRATEGY 2: FORGING NEW PARTNERSHIPS BETWEEN THE PUBLIC AND PRIVATE SECTORS

Option 1: Broker CVI R&amp

D and Pilot Manufacture

Option 2: Develop an Entity with CVI-Related R&amp

D and Pilot Manufacturing Capabilities

STRATEGY 3: EMBARK ON A PUBLIC-SECTOR MODEL

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.

Notes:

Support provided by the Agency for International Development, the Dept. of Health and Human Services, the Pharmaceutical Manufacturers Association, the United Nations Development Program, and the World Health Organization, Children's Vaccine Initiative.

Includes bibliographical references.

Other Format:

Print version: Staff, Institute of Medicine. Children's Vaccine Initiative : Achieving the Vision.

ISBN:

9786610196012

9781280196010

1280196017

9780309585835

030958583X

9780585143521

0585143528

OCLC:

923261820