LEADER 11101nam 2200973 a 450 001 9910970771503321 005 20251017110140.0 010 $a9786610196012 010 $a9781280196010 010 $a1280196017 010 $a9780309585835 010 $a030958583X 010 $a9780585143521 010 $a0585143528 035 $a(CKB)110986584751336 035 $a(SSID)ssj0000121214 035 $a(PQKBManifestationID)11138552 035 $a(PQKBTitleCode)TC0000121214 035 $a(PQKBWorkID)10110810 035 $a(PQKB)10848514 035 $a(MiAaPQ)EBC3376183 035 $a(Au-PeEL)EBL3376183 035 $a(CaPaEBR)ebr10055178 035 $a(OCoLC)923261820 035 $a(Perlego)4740513 035 $a(DNLM)760143 035 $a(BIP)256917 035 $a(EXLCZ)99110986584751336 100 $a19931007d1993 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 04$aThe children's vaccine initiative $eachieving the vision /$fViolaine 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 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1993 215 $a1 online resource (xiii, 221 pages) $cillustrations 300 $aSupport provided by the Agency for International Development, the Dept. of Health and Human Services, the Pharmaceutical Manufacturers Association, the United Nations Development Program, and the World Health Organization, Children's Vaccine Initiative. 311 08$aPrint version: Staff, Institute of Medicine. Children's Vaccine Initiative : Achieving the Vision. Washington : National Academies Press, ©1900 9780309049405 311 0 $a0309049407 320 $aIncludes bibliographical references. 327 $aThe 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. 327 $aNorth 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. 327 $aSetting 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. 327 $aPOSTLICENSING -- 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. 330 $aThe 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. 606 $aVaccination of children 606 $aVaccines 606 $aImmunization of children 606 $aVaccination 606 $aChildren 606 $aInfants 606 $aImmunization Programs 606 $aVaccination 606 $aChild 606 $aImmunization Schedule 606 $aInfant 606 $aVaccines 615 0$aVaccination of children. 615 0$aVaccines. 615 0$aImmunization of children. 615 0$aVaccination. 615 0$aChildren. 615 0$aInfants. 615 12$aImmunization Programs. 615 12$aVaccination. 615 22$aChild. 615 22$aImmunization Schedule. 615 22$aInfant. 615 2$aVaccines. 676 $a614.4/7/083 701 $aSanford$b Jay P.$f1928-$01808928 701 $aMitchell$b Violaine S$01808929 701 $aPhilipose$b Nalini M$01808930 712 02$aInstitute of Medicine (U.S.).$bCommittee on the Children's Vaccine Initiative: Planning Alternative Strategies Toward Full U.S. Participation. 712 02$aInstitute of Medicine (U.S.).$bDivision of International Health. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910970771503321 996 $aThe children's vaccine initiative$94359435 997 $aUNINA