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.