DOCSLIB.ORG

A Review of Selected Federal Vaccine and Immunization Policies, Based on Case Studies of Pneumococcal Vaccine

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
A Review of Selected Federal Vaccine and Immunization Policies, Based on Case Studies of Pneumococcal Vaccine A Review of Selected Federal Vaccine and Immunization Policies, Based on Case Studies of Pneumococcal Vaccine September 1979 NTIS order #PB80-116106 Library of Congress Catalog Card Number 79-600165 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D.C. 20402 Stock No. 052-003 -00701-1 — FOREWORD This work originated in April 1978 as a background study in OTA’S Congressional Fellowship Program. The study initially was limited to an analysis of the benefits and costs of pneumococcal vaccine, with particular emphasis on vaccine reimbursement under Medicare for the elderly. As a result of encouragement by several reviewers, the scope of investigation was broadened substantially to include three other areas of vaccine policy concerns: research, development, and production; safety and efficacy; and 1iabili- ty. Cost-effectiveness analysis was selected to assess benefits and costs, and the entire report was incorporated into a larger OTA study entitled Cost-Effectiveness of Medical Technologies. This report is the first of six documents to be published as a part of the larger cost-effectiveness study. A Review of Selected Federal Vaccine and Immunnization Policies was prepared by OTA staff in consultation with several authorities in the relevant subject areas. The authors’ professional backgrounds include training in pubic health, pharmacy, econom- ics, law, medicine, public administration, public policy, and political science. Consult- ants included representatives from pharmaceutical companies, including Eli Lilly and Company, Merck Sharp and Dohme, and Lederle Laboratories; Government agencies, including the Bureau of Biologics (BOB), Center for Disease Control (CDC), National In- stitute of Allergy and Infectious Diseases (NIAID), National Center for Health Statistics (NCHS), and Bureau of the Census; and academic institutions, in particular, Duke Uni- versity, Harvard University, the University of Pennsylvania, and the University of Cali- fornia at San Francisco. Drafts of the report were reviewed by members of two OTA advisory bodies: the Health Program Advisory Committee and the Cost-Effectiveness of Medical Technol- ogies Advisory Panel. Various drafts also were reviewed by approximately so other indi- viduals representing a wide range of professional disciplines. We were grateful for these many contributions to the work. ~ JOHN H. GIBBONS Director iii * OTA HEALTH GROUP STAFF Joyce C. Lashof, Assistant Director Health and Life Sciences Division H. David Banta, Health Group Manager Michael A. Riddiough, Project Director Jane Sisk Willems, Health Econonmics and Policy Co-Project Director (April-September 1978) Claudia Sanders, Health Policy Lawrence Miike, Vaccine Liability John Bell, Computer Modeling Clyde Behney, Health Policy Editorial Staff Kerry B. Kemp, Editor and Writer’ Page S. Gardner, Editor Administrative Staff Virginia Cwal ina Shirley Ann Gayheart William S. Burnett OTA PUBLISHING STAFF John C. Holmes, Publishing Officer Kathie S. Boss Joanne Heming + Independent cc)ntrac I(,r OTA HEALTH GROUP ADVISORY COMMITTEE Frederick C. Robbins, Chairman Dean, School of Medicine, Case Western Reserve University Stuart H. Altman Sidney S. Lee Dean Associate Dean Floremce Heller School Community Medicine Brandeis University McGill Unversity Robert M. Ball Mark Lepper Senior Scholar Vice President for Evaluation Institute of Medicine Rush-Presbyterian Medical School National Academy of Sciences St. Luke’s Medical Center Bernard Barber Professor C. Frederick Mosteller Professor and Chairman Department of Sociology Barnard College Department of Biostatistics Columbia University School of Public Health Harvard University Lewis H. Butler Adjunct Professor of Health Policy Beverlee Myers Health Policy Program Director University of California Department of Health Services State of California Kurt Deuschle Professor of Community Medicine Helen Ewing Nelson Mount Sinai School of Medicine President Consumer Research Foundation Rashi Fein Mill Valley, Calif. Professor of tile Economics of Medicine Center for Comunity Health and Medical Care Charles A. Sanders General Director Harzard Medical School Massachusetts General Hospital Melvin A. Glasser Director Kerr L. White Social Security Department Deputy Director of Health Sciences United Auto Workers Rockefeller Foudation COST-EFFECTIVENESS OF MEDICAL TECHNOLOGIES ADVISORY PANEL MEMBERS John R. Hogness, Chairman President, Association for Academic Health Centers Sheldon Leonard Mnager Regulatory Affairs General Electric Company Barbara J. McNeil Department of Radiology Peter Bent Brigham Hospital Robert H. Moser Executive Vice President American College of Physicians C. Frederick Mosteller Chirman Department of Biostatistics Harward University Robert M. Sigmond Advisor in Hospital Affairs Blue Cross and Blue Shield Associates Jane Sisk Willems V.A. Scholar Veterans Administration vii — ACKNOWLEDGMENTS Several people provided valuable assistance in the preparation of this report. Indi- viduals at the National Center for Health Statistics (NCHS), in particular, were very in- strumental in developing data sets for the cost-effectiveness analysis. While OTA must assume ultimate responsibility for the content of this report, it greatly appreciates the contributions of—among many others—the following individuals: Clarence A. Abramson Alan R. Hinman, M. D., M.P.H. Paul D. Parkman, M.D. Senior Counsel Center for Disease Control Deputy Director Merck and Company, Inc. Atlanta, Ga. Bureau of Biologics Rahway, N.J. Food and Drug Administration Robert Austrian, M.D. Mark Hornbrook, Ph.D. Bethesda, Md. Department of Research Medicine National Center for Health University of Pennsylvania Services Research Frederick C, Robbins, M.D. School of Medicine Hyattsville, Md. Dean, School of Medicine Philadelphia, Pa. Irving S. Johnson, Ph.D. Case Western Reserve University Michael Beatrice, R. Ph., M.S. Vice President of Research Cleveland, Ohio Bureau of Biologics Eli Lilly and Company Food and Drug Administration Indianapolis, Ind. John Robbins, M.D. Bethesda, Md. Bureau of Biologics Joel Kavet, D. SC. Claire Broome, M.D. Food and Drug Administration Department of Health, Education, Center for Disease Control Bethesda, Md. and Welfare Atlanta, Ga. Rockville, Md. David W. Fraser, M. D., Donald Shepard, Ph.D. Center for Disease Control Kenneth Manton, Ph.D. Harvard School of Public Health Atlanta, Ga. Duke University Boston, Mass. Donald Hill Durham, N.C, Bureau of Biologics Eric Stollard Food and Drug Administration Barbara J. McNeil, M. D., Ph.D. Duke University Bethesda, Md. Harvard Medical School Durham, N.C. Boston, Mass. James Hill, Ph.D. Judith Wagner, Ph.D. National Institute of Allergy and Harry M. Meyer, Jr., M.D. Infectious Diseases Director Urban Institute Washington, D.C. Bethesda, Md. Bureau of Biologics Maurice Hilleman, Ph. D., D. SC. Food and Drug Administration Director Bethesda, Md. Ronald Wilson Merck Institute for National Center for Health Statistics Elena Nightingale, M.D. Department of Health, Education, Therapeutic Research Institute of Medicine and Welfare West Point, Pa. Washington, D.C. Hyattsville, Md. CONTENTS Page . Glossary of Terms . Xlll Glossary of Acronyms. xvi chapter 1. SUMMARY . 3 Introduction . ., . 3 Vaccine Research, Development, and Production . 4 Vaccine Safety and Efficacy. 7 Cost-Effectiveness Analysis of Vaccination Programs . 10 General Applications of CEA . 10 CEA and Its Relationship to Reimbursement for Vaccinations . 11 CEA Methodology and Data . 12 Legal Liability and Compensation for Vaccine-Related Injuries ., . 13 Scope of the Study. 16 Organization of the Report . ., . 17 2. A CASE STUDY: FINANCING THE RESEARCH AND DEVELOPMENT OF PNEUMOCOCCAL VACCINE . 23 Background and Introduction . , . 23 Early Pneumococcal Vaccine Research and Development (1881-1966) . 32 Federal Government Participation in the Research and Development of Pneumococ- cal Vaccine (1967-79). 33 Industry Participation in the Research and Development of Pneumococcal Vaccine (1967-79) . 34 The Role of Federal Financing in the Research and Development of Pneumococcal Vaccine . 36 3. A CASE STUDY: EVALUATING THE SAFETY AND EFFICACY OF PNEUMOCOCCAL VACCINE . 41 Background and Introduction . 41 Types of Studies Used To Evaluate the Safety and Efficacy of Polyva Pneumococcal -. Vaccine . 43 Results of Premarketing Clinical Trials of Pneumococcal Vaccine . 47 Clinical Safety . 47 Clinical Efficacy . 49 BOB’s Prelicensing Evaluation of Pneumococcal Vaccine. 51 Postmarketing Data Regarding the Safety and Efficacy of Pneumococcal Vaccine . 52 Limitations of Premarketing Evaluations of the Safety and Efficacy of Pneumococcal Vaccine . 56 Inherent Limitations of Premarketing Clinical Studies . 56 Vaccine Testing Among Foreign Populations . 57 Lack of Vaccine Testing Among High Risk Populations . 60 4. A CASE STUDY: COST-EFFECTIVENESS ANALYSIS OF VACCINATION AGAINST PNEUMOCOCCAL pneumonia . 65 Background and Introduction . 65 ix — CONTENTS—continued Page Measurement of Health Effects and Societal Medical Costs of Pneumococcal Vaccination . 66 Health Effects . 67 Medical Care Costs. 68 Cost-EffectivenessEquationand Model . 68 Base Case and Sensitivity Analysis. 69 Data Sources . 70 Results . 71 Base Case . 72 Sensitivity Analysis. 73 Modification of the Model for the High Risk Population . 76 Modification of the Societal Model for Medicare . 77 Discussion of Results . 78 5. A REVIEW: LEGAL LIABILITY AND COMPENSATION FOR VACCINE-RELATED INJURIES. 83 Background and Introduction . 83 Case Law onVaccine-Related Injuries . 87 Legal Determination of Liability by Courts of Different Jurisdictions . 87 Causes of Action for Vaccine-Related Injuries . 88 Legal LiabilityTheories Embodied in Recent Case Law . 89 Principles Underlying Pricing of Liability Insurance. 92 Coverage . 93 Ratemaking . 95 Vaccine Risks, Adverse Reactions, and Liability Claims. ..
Load more

Recommended publications
  • 0 January to July 2021
    0 www.journalsofindia.com January to July 2021 SCIENCE & TECH ............................................................................................................................................................... 6 1. REUSABLE LAUNCH VEHICLE TECHNOLOGY DEMONSTRATION PROGRAMME(RLV-TD) ................................................. 6 2. GAGANYAAN MISSION ..................................................................................................................................................... 6 3. MARS ORBITER MISSION (MOM) ..................................................................................................................................... 6 4. CHANDRAYAAN MISSION................................................................................................................................................. 7 5. SOLAR MISSION ............................................................................................................................................................... 8 6. ARTEMIS ACCORD ............................................................................................................................................................ 9 7. NATIONAL MISSION ON INTERDISCIPLINARY CYBER-PHYSICAL SYSTEM (NMICPS) ....................................................... 10 8. SMART ANTI-AIRFIELD WEAPON (SAAW) ...................................................................................................................... 10 9. AQUAPONICS ................................................................................................................................................................
    [Show full text]
  • View Introduction and Presentation from Dr
    1 We are here tonight to honor and celebrate the outstanding accomplishments and contributions in the field of vaccines of our colleague, our mentor, our friend, Mathu Santosham. Mathu’s professional titles attest to his accomplishments at the highest levels. He is professor of Pediatrics and International Health at Johns Hopkins University and is the Founder and Director of the Center for American Indian Health. 2 He is a widely recognized and celebrated international expert in the area of vaccines against rotavirus, pneumococcus and Haemophilus influenzae type b----the area of work and contribution for which he is being awarded this year’s Sabin Gold Medal Award. But he has also made equally impactful contributions in the area of oral rehydration therapy for diarrheal disease, neonatal survival strategies and more broadly in the area of reducing health disparities for this country’s first nations American Indian people. Millions of deaths around the world have been prevented because of his medical and scientific contributions. Ostensibly this is what we are here to celebrate. 3 Mathu has been celebrated with numerous awards from the Indian Health Service, the Thrasher Research Fund, and the pneumococcal scientific community through the Robert Austrian Award along with awards from his own institution to recognize him from among the many outstanding alumnae of the school. 4 His work and sage advice valued by many around the world, including shown here ABC’s Chief Health and Medical Editor, Dr. Rich Besser. 5 Here with Martin Sheen at the Native Vision Camp in 2012. 6 Here working with Robert Redford on American Indian health disparity issues.
    [Show full text]
  • Journal of Vaccines & Vaccination
    ccines & a V f V a o c l c i a n n a r t u i o o n J Ching, et al., J Vaccines Vaccin 2014, 5:6 Journal of Vaccines & Vaccination DOI: 10.4172/2157-7560.1000257 ISSN: 2157-7560 Research Article Open Access Evaluation of a Recombinant Vaccine Candidate r56Lc-1 in a Chigger Challenge Mouse Model Wei-Mei Ching1,3*, Woradee Lurchachaiwong2, Zhiwen Zhang1,3 Temitayo Awoyomi1,3, Chien-Chung Chao1,3 and Anthony Schuster2 1Viral and Rickettsial Diseases Department, Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, USA 2Entomology Department, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand 3Uniformed Services University of the Health Sciences, Bethesda, USA *Corresponding author: Wei-Mei Ching, PhD, Viral and Rickettsial Diseases Department, Infectious Diseases Directorate, Naval Medical Research Center, 503 Robert Grant Ave, RM3N71, Silver Spring, MD 20910, USA, Tel: 301 319 7438; Fax: 301 319 7451; E-mail: [email protected] Received date: 15 Sep 2014; Accepted date: 24 Oct 2014; Published date: 27 Oct 2014 Copyright: © 2014 Ching WM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Scrub typhus, an acute, febrile disease is transmitted by the bite of an Orientia infected chigger. We evaluated the protective potential of a recombinant 56 kDa antigen in a chigger challenge mouse model which mimics the natural transmission of Orientia. Chiggers from an L.
    [Show full text]
  • Vaccination and Anaphylaxis
    14 FORENSIC SCIENCE Croat Med J. 2017;58:14-25 https://doi.org/10.3325/cmj.2017.58.14 Vaccination and anaphylaxis: a Cristian Palmiere1, Camilla Tettamanti2, Maria Pia forensic perspective Scarpelli1 1CURML, University Center of Legal Medicine, Lausanne 25, Switzerland 2Department of Legal Medicine, Aim To review the available literature pertaining to fatali- University of Genova, Genova, Italy ties following vaccine administration and, in particular, cas- es of vaccine-related fatal anaphylaxis. Method The MEDLINE database was systematically searched up to March 2016 to identify all relevant articles pertaining to fatal cases of anaphylaxis following vaccine administration. Results Six papers pertaining to fatal anaphylaxis following vaccination were found relevant. Mast cell tryptase and to- tal IgE concentration was assessed exclusively in one case. Laryngeal edema was not detected in any of these cases, whereas eosinophil or mast cell infiltration was observed in lymphoid organs. In one case, immunohistochemical in- vestigations using anti-tryptase antibodies allowed pulmo- nary mast cells and degranulating mast cells with tryptase- positive material outside to be identified. Conclusion In any suspected IgE-mediated fatal anaphy- lactic cases, biochemical investigations should be system- atically performed for forensic purposes. Splenic tissue should be routinely sampled for immunohistochemical investigations in all suspected anaphylaxis-related deaths and mast cell/eosinophil infiltrations should be systemati- cally sought out in
    [Show full text]
  • India: the World's Pharmacy Expands Its Reach in Global Health
    New York | New Delhi | Rio de Janeiro Nairobi | Johannesburg | London India: The World’s Pharmacy Expands Its Reach in Global Health March 2021 This white paper was last updated on 1 March 2021 Global Health Strategies 18/1, 2nd Floor Shaheed Bhawan, Aruna Asaf Ali Marg, New Delhi, 110 067 www.globalhealthstrategies.com Twitter: @GHS Contents Executive Summary 02 India’s response to COVID-19 03 ∙ Pharmaceuticals and Biosimilars 04 ∙ Vaccines 05 ∙ Diagnostics 06 Evolution of India’s pharmaceutical industry 07 ∙ Milestones 08 Case Studies ∙ Hepatitis B Vaccine 10 ∙ Anti-retroviral Drugs 11 ∙ MenAfriVac 12 ∙ Complex Generics 13 ∙ Insulin 14 ∙ Monoclonal Antibodies 15 ∙ Vaccine for Rotavirus 16 ∙ Typhoid Conjugate Vaccine 17 Conclusion: Looking Forward 18 Executive Summary India’s pharmaceutical industry is already playing a pivotal role in the scale-up of pharmaceuticals and diagnostics to combat the global COVID-19 pandemic. It is poised to play an even more dominant role as biological products – preventive vaccines and cutting-edge biotechnology such as monoclonal antibodies– come to the fore. Even before the pandemic, Indian manufacturers produced vast quantities of generic antiviral drugs that turned HIV from a death sentence to a chronic manageable condition in developing countries. India’s global dominance in generic drugs and vaccine manufacturing has earned it the label “Pharmacy of the World”. COVID-19 only strengthens the case for this moniker. So far, India has supplied medicines to 133 countries to fight the pandemic. Six Indian manufacturers have been granted royalty-free licenses by Gilead to manufacture the first antiviral drug approved by the U.S.
    [Show full text]
  • Contributions of Native Americans to the Global Control of Infectious Diseases Mathuram Santosham A,∗, Raymond Reid A, Aruna Chandran A, Eugene V
    Vaccine 25 (2007) 2366–2374 Contributions of Native Americans to the global control of infectious diseases Mathuram Santosham a,∗, Raymond Reid a, Aruna Chandran a, Eugene V. Millar a, James P. Watt a, Robert Weatherholtz a, Connie Donaldson a, Janne´ Croll a, Lawrence H. Moulton a, Claudette M. Thompson b, George R. Siber c, Katherine L. O’Brien a a Center for American Indian Health, Department of International Health, Johns Hopkins University, 621 N. Washington Street, Baltimore, MD 21205, United States b Department of Epidemiology, Harvard School of Public Health, 665 Huntington Avenue, Boston, MA 02115, United States c Wyeth Vaccines, 401 North Middletown Road, BH 21101, Pearl River, NY 10965, United States Available online 18 September 2006 Abstract For over a half of a century, Native American populations have participated in numerous studies regarding the epidemiology, prevention and treatment of infectious diseases. These studies have resulted in measures to prevent morbidity and mortality from many infectious diseases. The lessons learned from these studies and their resultant prevention or treatment interventions have been applied around the world, and have had a major impact in the reduction of global childhood morbidity and mortality. © 2006 Elsevier Ltd. All rights reserved. Keywords: Native Americans; Infectious diseases; Clinical trials; Pneumococcus; H. influenzae type b (Hib); Rotavirus; Trachoma; Tuberculosis; BCG Key messages from these studies has been applied in many populations around the world and has met with great success. This In the keynote address (The Robert Austrian Lecture) paper reviews the major achievements in Native Amer- for the 5th International Symposium on Pneumococci and ican health that have been made to date.
    [Show full text]
  • Production Flow Sheet
    (Refer SOP No. QA-INS-010) Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Central Inspection Plan Using Risk Based Approach Of Vaccine Manufacturing Units for 2019 Sl. Name and Vaccines manufactured (category Dt. of last Purpose of last Major Compliance AEFI reported/ Proposed time of No. address of the wise list) inspection inspection (grant deficiencies met till date, changes/ Inspection manufacturing with no of /renewal /post-approval detected if any Product site days & team changes, AEFI, follow- complaints, up, routine) failure if any A NORTH ZONE 1 M/s Biomed Pvt. 1.Oral Polio Vaccine IP, 03.10.2018 to To find out the root As per report Observations NSQ Reported 1st Quarter Ltd, 2. Vi olysaccharide Typhoid Vaccine 06.10.2018 & cause for the NSQ communicate Annual Inspection C-96, Site –I, (Bio TyphTM) IP, 3. Haemophilus Type- 08.10.2018 Reported d to the firm Bulandshahar B Conjugate Vaccine (PedaHib) for 2nd Quarter 4. Meningococal Polysaccharide Vaccine ADC(I) and compliance. Follow-up Road, Ind. Area, (Group A,C,Y,W 135) QuadriMeningo Ghaziabad. 5. Meningococal Polysaccharide Vaccine DIs of Inspection (Group A&C) Bivalent CDSCO, , and (if any) 6. Vi Conjugate Typhoid Vaccine (Peda DI, Uttar Typh), Pradesh 3rd Quarter 7. Vi Conjugate Typhoid Vaccine (Bio Annual Inspection TyphTM), 8. Haemophilus Type-B Conjugate 4th Quarter Vaccine (PedaHib) IP Follow-up 9. Meningococal Inspection Polysaccharide Vaccine (Group A,C,Y,W 135) IP QuadriMeningo (if any) 10.
    [Show full text]
  • Requirements for Diphtheria. Tetanus. Pertussis and Combined Vaccines
    0World Health Organization World Health Or_panizatior?. Technics; Rsporr Series. Xo . S0.l . 1990 Annex 2 REQUIREMENTS FOR DIPHTHERIA. TETANUS. PERTUSSIS AND COMBINED VACCINES (Requirements for Biological Substances Nos. 8 and 10) (Revised 1989) Page Introduction ....................................................................................................... 88 Requirements for diphtheria vaccine (adsorbed) ............................................ 91 General considerations ........................................................................... 91 Part A . Manufacturing requirements .......................................................... A .1 Definit~ons............................................................................. A.2 General manufacturing requirements .................................... A.3 Production control ................................................................ A.4 Filling and containers ........................................................... A.5 Control of final product ........................................................ A.6 Records ................................................................................. A.7 Samples ................................................................................. A.8 Labelling ................................................................................ A.9 Distribution and transport .................................................... A.10 Stability . storage and expir>-date ..................................... Part B . Kational control
    [Show full text]
  • WHO Expert Committee on Biological Standardization of Publications
    WHOWHOWHO Technical Technical Technical Report Report Report Series Series Series 941941941 BIOLOGICAL BIOLOGICAL BIOLOGICAL ThisThisThis report report report presents presents presents the the recommendationsthe recommendations recommendations of ofa ofWHOa WHOa WHO Expert Expert Expert WHOWHOWHO EXPERT EXPERT EXPERT COMMITTEE COMMITTEE COMMITTEE CommitteeCommitteeCommittee commissioned commissioned commissioned to tocoordinate tocoordinate coordinate activities activities activities leading leading leading to tothe tothe adoptionthe adoption adoption of ofinternational ofinternational international recommendations recommendations recommendations for for the for the the ONONON BIOLOGICAL BIOLOGICAL BIOLOGICAL productionproductionproduction and and andcontrol control control of ofvaccines ofvaccines vaccines and and andother other other biologicals biologicals biologicals STANDARDIZATION STANDARDIZATION STANDARDIZATION andand andthe the establishmentthe establishment establishment of ofinternational ofinternational international biological biological biological reference reference reference STANDARDIZATIONSTANDARDIZATIONSTANDARDIZATION materials.materials.materials. TheThe Thereport report report starts starts starts with with with a discussiona discussiona discussion of ofgeneral ofgeneral general issues issues issues brought brought brought to tothe tothe attentionthe attention attention of ofthe ofthe Committeethe Committee Committee and and andprovides provides provides information information information onon theon the statusthe
    [Show full text]
  • The Historical Impact of Epidemic Typhus
    THE HISTORICAL IMPACT OF EPIDEMIC TYPHUS by JOSEPH M. CONLON LCDR, MSC, USN [email protected] INTRODUCTION Louse-borne Typhus Fever is undoubtedly one of the oldest pestilential diseases of mankind. Called by many names and confused with other fevers, it is not until the late fifteenth century that it can be recognized with certainty as causing devastating epidemics. With Plague, Typhoid, and Dysentery, it was the scourge of armies and civilian populations throughout the Middle Ages and frequently played a decisive role in wars conducted in Europe from the 15th through the 20th centuries. The manner in which the course of European history has been affected by Typhus epidemics has been graphically portrayed by a number of authors. This paper will attempt a further analysis of the historical impact of Louse-borne Typhus and how its epidemic propagation has led many to regard Pediculus humanus corporis as having a more profound effect on human history than any other animal. EPIDEMIC TYPHUS FEVER (TABARILLO, CLASSIC OR EUROPEAN TYPHUS, JAIL FEVER, WAR FEVER) Causative Agent. Typhus fever is an acute specific infection caused by Rickettsia prowazeki as isolated and identified by DaRocha-Lima in 1916. Named in honor of H. T. Ricketts and L. von Prowazek, both of whom contracted typhus in the course of their investigations and died, R. prowazeki was originally believed to be a virus because of its minute size and difficulty of cultivation. R. prowazeki is now recognized as being morphologically and biochemically a type of bacterium. A rod-shaped microorganism, R. prowazeki is an obligate intracellular parasite whose cell wall contains muramic acid, diaminopimelic acid, and other components similar to those of the gram-negative bacteria.
    [Show full text]
  • Vaccine Information Table UPDATED FEBRUARY 28, 2020
    Vaccine Information Table UPDATED FEBRUARY 28, 2020 VACCINE INFORMATION TABLE Florida SHOTS Vaccine Brand Name Manufacturer (Code) ADENOVIRUS Adenovirus, type 4 and type 7, live, oral Adenovirus Types 4 and 7 TEVA Pharmaceuticals USA (TVA) ANTHRAX Anthrax Biothrax Emergent BioSolutions (MIP) ANTHRAX IG Anthrax immune globulin * * BCG Bacillus Calmette-Guerin Tice BCG Organon Teknika Corp. (OTC) BOTULINUM Botulinum Antitoxin * * CHOLERA LIVE Cholera, live attenuated Vaxchora PaxVax CHOLERA UNK Cholera, unspecified * * CMVIG Cytomegalovirus immune globulin * * DAPTACEL DTaP, 5 pertussis antigens Daptacel Sanofi Pasteur (PMC) DENGVAXIA Dengue Fever Dengvaxia Sanofi Pasteur (PMC) DIPTHERIA ANTITOXIN Diphtheria antitoxin * * DT Diphtheria and Tetanus - pediatric DT (generic) Sanofi Pasteur (PMC) DT-IPV (NON-US) Diptheria, Tetanus, Polio adsorbed * * Infanrix GlaxoSmithKline (SKB) DTAP Diphtheria, Tetanus, acellular Pertussis Tripedia Sanofi Pasteur (PMC) Diphtheria, Tetanus, acellular DTAP UNK * * Pertussis - unspecified DTAP-HIB DTaP-Hib Trihibit Sanofi Pasteur (PMC) Kinrix GlaxoSmithKline (SKB) DTAP-IPV DTaP-IPV Quadracel Sanofi Pasteur (PMC) DTP Diphtheria, Tetanus, Pertussis * * Diphtheria, tetanux toxoids, whole cell DTP-HIB Tetramune * pertussis, and Hemophilus influenza B FLU HIDOSE Influenza, high dose, seasonal Fluzone-High Dose Sanofi Pasteur (PMC) Afluria, quadrivalent Seqiris (SEQ) FLU QUAD P Influenza, injectable, quadrivalent Flulaval, quadrivalent ID Biomedical (IDB) Fluzone, quadrivalent Sanofi Pasteur (PMC) Afluria, quad, pf
    [Show full text]
  • A Century of Pneumococcal Vaccination Research in Humans
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector REVIEW 10.1111/j.1469-0691.2012.03943.x A century of pneumococcal vaccination research in humans J. D. Grabenstein1 and K. P. Klugman2,3 1) Merck Vaccines, West Point, PA USA, 2) Rollins School of Public Health and Division of Infectious Diseases, School of Medicine, Emory University, Atlanta, GA, USA and 3) Medical Research Council, National Institute for Communicable Diseases Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa Abstract Sir Almroth Wright coordinated the first trial of a whole-cell pneumococcal vaccine in South Africa from 1911 to 1912. Wright started a chain of events that delivered pneumococcal vaccines of increasing clinical and public-health value, as medicine advanced from a vague understanding of the germ theory of disease to today’s rational vaccine design. Early whole-cell pneumococcal vaccines mimicked early typhoid vaccines, as early pneumococcal antisera mimicked the first diphtheria antitoxins. Pneumococcal typing systems developed by Franz Neufeld and others led to serotype-specific whole-cell vaccines. Pivotally, Alphonse Dochez and Oswald Avery isolated pneumo- coccal capsular polysaccharides in 1916–17. Serial refinements permitted Colin MacLeod and Michael Heidelberger to conduct a 1944– 45 clinical trial of quadrivalent pneumococcal polysaccharide vaccine (PPV), demonstrating a high degree of efficacy in soldiers against pneumococcal pneumonia. Two hexavalent PPVs were licensed in 1947, but were little used as clinicians preferred therapy with new antibiotics, rather than pneumococcal disease prevention. Robert Austrian’s recognition of high pneumococcal case-fatality rates, even with antibiotic therapy, led to additional trials in South Africa, the USA and Papua New Guinea, with 14-valent and 23-valent PPVs licensed in 1977 and 1983 for adults and older children.
    [Show full text]