Current needs for Vaccine R & D and Implementation in Developing Countries : Norwegian & Intl. Partners Contribution

Size: px
Start display at page:

Download "Current needs for Vaccine R & D and Implementation in Developing Countries : Norwegian & Intl. Partners Contribution"

Transcription

1 Current needs for Vaccine R & D and Implementation in Developing Countries : Norwegian & Intl. Partners Contribution by DR.SURESH S. JADHAV Executive Director Serum Institute of India Ltd/Pune & President - DCVMN 1

2 OVER THE YEARS, SIIL HAS BEEN ABLE TO PRODUCE THE MOST IMPORTANT VACCINES REQUIRED FOR BASIC NATIONAL & INTERNATIONAL HEALTH PROGRAMS SUCH AS : BCG VACCINE DTP GROUP OF VACCINES. MMR GROUP OF VACCINES. RECOMBINANT HEPATITIS-B B VACCINE. HEMOPHILUS INFLUENZA TYPE B VACCINE. AMONGST OTHER NEEDED VACCINES : HUMAN DIPLOID RABIES VACCINE. COMBINATION VACCINES. DTP + Hep.. B Vaccine DTP + Hib Vaccine DTP + Hep.. B + Hib Vaccine 2

3 SOME OF THE MILESTONES CROSSED IN ITS DECADES OF EXISTANCE ARE OPERATION STARTED, WITH TETANUS ANTITOXIN & TETANUS TOXOID LARGE-SCALE MANUFACTURE OF ADSORBED TETANUS TOXOID UNDERTAKEN TRIPLE ANTIGEN DTP PRODUCTION COMMENCED AUTONOMOUS SCIENTIFIC WING, SERUM INSTITUTE OF INDIA RESEARCH FOUNDATION ESTABLISHED. 3

4 1980 FIRST-TIME TIME-IN-THE-WORLD COLLECTION OF EQUINE SERUM BY SIMULTANEOUS AND CONTINUOUS PLASMAPHERESIS USING IBM COMPUTERISED CELL SEPARATOR MANUFACTURE OF LIFE-SAVING POLYVALENT ANTI-SNAKE VENOM SERUM EFFECTIVE AGAINST FOUR POISONOUS SNAKES COMMONLY ENCOUNTERED IN INDIA COMMENCED MANUFACTURE OF MEASLES VACCINE MANUFACTURE OF RUBELLA VACCINE PRODUCTION OF MR AND MMR VACCINES COMMENCEMENT OF EXPORTS TO UN AGENCIES. 4

5 1997 EXPORT OF ANTICANCER PRODUCTS EXPORT OF VACCINES CROSSED OVER 100 COUNTRIES AND TODAY IT IS MORE THAN 130 COUNTRIES SERUM INSTITUTE RECOGNIZED AS THE LARGEST PRODUCER OF MEASLES AND DTP VACCINE IN THE WORLD ONE OUT OF EVERY TWO CHILDREN IN THE WORLD IS VACCINATED BY SERUM INSTITUTE S VACCINE LAUNCH OF GENEVAC-B RECOMBINANT HEPATITIS B VACCINE. 5

6 2002 LAUNCH OF BCG VACCINE LAUNCH OF HUMAN DIPLOID RABIES VACCINE (ADSORBED). DEVELOPMENT OF POLYSACCHARIDE CONJUGATE VACCINE (Hib AND MEN-A) 2005 LAUNCH OF DIPHTHERIA, TETANUS, PERTUSSIS AND HEPATITIS-B VACCINE (COMBINATION VACCINE) LAUNCH OF ONCO-BCG VACCINE LAUNCH OF HAEMOPHILUS INFLUENZA TYPE B (HIB) CONJUGATE VACCINE LAUNCH OF DTP HEP-B + HIB VACCINE (PENTAVALENT) 6

7 Agencies who helped in this growth : CRI, Kasauli. USAID. RIVM (NVI). Wistar Institute and Dr.Stanley Plotkin MVP, PATH, USFDA, WHO, NIH & CDC NIBSC 7

8 THE KEY ISSUES FOR THIS SUCCESS WERE : CREATING A cgmp COMPLIANT FACILITY. DEVELOPING SKILLED AND DILIGENT MANPOWER CREATING A CAPABILITY OF MANUFACTURING HUGE QUANTITIES AND THUS REDUCING OPERATING COSTS. IMPROVING YIELDS OVERCOMING ONE BY ONE SHORTCOMINGS WITH TOTAL DEDICATION AND CLEAR FUTURE VISION. 8

9 THE KEY ISSUES FOR THIS SUCCESS WERE (CONTD ) : LIMITING EXPENSES ON OVERHEADS AND COST OVERRUNS LIMITING EXPENDITURE ON PUBLICITY AND ADVERTISEMENT AND USING THESE FUNDS FOR SCIENTIFIC DEVELOPMENT AND UP-GRADATION GETTING HELP FROM PROACTIVE INSTITUTIONS. USING MATERIALS FROM REPUTED VENDORS. DEVELOPING AN EFFICIENT TEAM FOR DISTRIBUTION OF VACCINES. 9

10 R&D THRUST USING THE TECHNICAL SUPPORT AND KNOW-HOW FROM PROACTIVE INSTITUTIONS WITHOUT HAVING TO PAY EXORBITANT ROYALTIES. HAVING SUCCESSFULLY MANUFACTURED AND DELIVERED THE BASIC VACCINES. THE SIIL NOW LOOKS AT THE COMBINATION VACCINES AND THE CONJUGATE VACCINES AS THRUST AREA. THIS WOULD REQUIRE TO IDENTIFY ADVANCE TECHNOLOGIES AND PROPER TRAINING TO MANUFACTURE WITH SUCCESSFUL DOWN STREAM PROCESS TO PRODUCE A ECONOMIC AND QUALITY PRODUCT. 10

11 NEW PRODUCTS IN PIPELINE : 1. RECOMBINANT PRODUCTS 2. PEGYLATED RECOMBINANT PRODUCTS 3. POLYSIALATED RECOMBINANT PRODUCTS 4. LIPOSOMAL ANTICANCER PRODUCTS 5. LIPOSOMAL VACCINES 6. AEROSOL MEASLES VACCINE 7. DTP-Hib & DTP-Hep.B-Hib IN LIQUID FORM 8. MENINGOCOCCAL A POLYSACCHARIDE/CONJUGATE VACCINE 9. PANDEMIC INFLUENZA VACCINE 10. RABIES HUMAN MONOCLONAL ANTIBODIES 11. PNUMOCOCCAL POLYSACCHARIDE/CONJUGATE VACCINE 12. HEPATITIS A VACCINE 13. ROTAVIRUS VACCINE 14. ACELLULAR PERTUSSIS VACCINE 15. MEN A, C, Y, W 11

12 DEVELOPING COUNTRIES VACCINE MANUFACTURERS NETWORK - an overview Formed in November members Steering Committee. Full members of DCVMN are members with WHO pre-qualification located in countries with a fully functional National Regulatory Authority (NRA). Prospective Full (PF) members of DCVMN are vaccine manufacturers located in countries with a fully functional National Regulatory Authority working towards attaining the status of pre-qualification. Associate members of DCVMN are members who are committed to becoming viable and do not have a fully functional NRA but have the viability to supply to UN Agencies. Vaccinology Institutions (IVI, RIVM/NVI) are resources for technical support. WHO helps with coordination of our network. 12

13 DCVMN MEMBERS 1) Bharat Immunologicals & Biologicals Corp n, India 2) Bharat Biotech Intl. Ltd., India 3) Bio Farma, Indonesia * 4) Biological E. Ltd., India 5) BIRMEX, Mexico 6) China National Biotec Corp n, China 7) CGEB, Cuba* 8) Fiocruz/BioManguinhos, Brazil * 9) Finlay Institute, Cuba 10) Haffkine Bio-Pharmaceutical Corp n Ltd., India 11) Indian Immunologicals Ltd., India 12) Instituto Butantan, Brazil 13) Institut Pasteur d Iran, Iran 14) Institut Pasteur de, Dakar, Senegal* 15) Institut Pasteur de Tunis, Tunisia 16) Institute of Virology, Belgrade, Yugoslavia 17) Queen Saovabha Memorial Institute (QSMI), Thailand * 18. LG LifeSciences/Korea* 19. National Inst. of Vaccines & Biologicals (IVAC), Vietnam 20. Panacea Biotech Ltd., India * 21. Razi Institute for Serums & Vaccines, Iran 22. Serum Institute of India Ltd.,* India 23. Vabiotech, Natl. Inst. of Hygiene & Epidemiology (NIIHE), Vietnam 24. VACSERA, Egypt 25. Zhengzhou Kangtai Pharmaceutical Co. Ltd., China 26. Zydus Cadila, India 27. The Biovac, South Africa 28. Xiamen YST Biotech/China Resource Institutes a) RIVM/NVI e) PATH b) IVI f) NIH c) WHO g) USAID d) SVI h) PneumoADIP WHO Pre-qualified Vaccine Manufacturers 13

14 Members Collaborations BioFarma / Indonesia NVI for Hib Vaccine NIH for Typhoid Vaccine IVI for Cholera Vaccine Japan Poliomyelitis Research Institute (JPRI) for SIPV Murdoch Children Research Institute (MCRI), Australia for Rotavirus Cape biological, Belgium for Hib Vaccine Biological-E / India NVI for Hib Vaccine NIH for Rotavirus Vaccine Intercell AG ICDDR/Bangladesh for Cholera Vaccine 14

15 Members Collaborations contd Bio-Manguinhos Merieux Institute for Men. A + C JPRI for Poliomyelitis Oral Butantan Institute/Brazil for DTP + Hib Chembio for Rapid Test HIV diagnostic Heber Biotec for Interferon alfa 2b Cimab for Eritropoyetin Rockefeller Foundation for Yellow Fever Vaccine Biken Institute for Measles Glaxo Smithkline for MMR & Hib vaccine Instituto Butantan / Brazil George Washington University for Hook Worm Childrens Hospital Harvard for Whole cell pneumococcus NIH for Dengue Vaccine Infectious Disease Research Institute for Leishmania/Rabies Aventis for Influenza (Seasonal) WHO for Pandemic Influenza 15

16 Lipoxen Technology, UK University of Uppsala, Organization Dept. of Pharmaceuticals, Sweden Rijksinstiuut Voor volksgezondheid en Milieu (RIVM) (Now, Netherlands Vaccine Institute, NVI), Netherlands National Institute of Health, USA University of Pune, Pune/India Agharkar Research Institute, Pune/India Biosyneus, USA BIOCAM, UK Sun Bio, South Korea National Institute of Virology, Pune/India WHO / NIH Activ-Dry / USA Intl Consultant Vaccine & Biologicals SPRL / Belgium SIIL COLLABORATIONS Description of Partnership Liposomal delivery technology for vaccines Oral Vaccine Delivery Bacterial vaccines Typhoid, Rotavirus & Aerosol Measles Vaccine Recom. Human Chorionic Gonadotropin Hormone. Dev.of New Adjuvant from Natural Resources Actionkinase Polyvalent Conjugate Pnumococcal Vaccine Recombinant Therapeutics Pegylation Technology JE Vaccine, Hepatitis A Vaccine Aerosol Measles, Pandemic Influenza & Meningococcal A Con. Vaccine Stable Measles Vaccine Acellular Pertussis Vaccine CDC / Atlanta Massachusetts Biologic Laboratories (MBL) / USA Instituto Butantan / Brazil Analysis method for Acellular Pertussis and Pneumococcal Vaccine Rabies Monoclonal Antibodies Anti-Rabies Serum 16

17 EXPECTATION FROM NORWEGIAN & INTERNATIONAL PARTNERS Financial support in terms of donations / soft loans for infrastructure development Support to conduct clinical trial as per International norms (GCP) Full support to fight immoral patents 17

18 EXPECTATION FROM NORWEGIAN & INTERNATIONAL PARTNERS (Contd ) Financial support to buy Patents Rights for newer technologies Legal support to counteract litigations in developed world. Financial support for setting up Inhouse Power Plant using Green Technology to reduce their carbon footprint on the earth & to minimize waste 18

19 DCVMN s COMMITMENTS Making vaccines available in quantity & quality at affordable prices for the underprivileged children from the developing & also to the developed world. Meet the emerging vaccine needs in the developing world by continuation of R&D research and development efforts by our members 19

20 20

Vaccine Development in the Developing World; past, present and future: SEAR Perspective

Vaccine Development in the Developing World; past, present and future: SEAR Perspective Speech by Dr Samlee Plianbangchang Regional Director, WHO South-East Asia Vaccine Development in the Developing World; past, present and future: SEAR Perspective 15 June 2010 Bangkok, Thailand Vaccine

More information

How and Why Vaccines Are Developed by Industry. Stanley A. Plotkin

How and Why Vaccines Are Developed by Industry. Stanley A. Plotkin How and Why Vaccines Are Developed by Industry Stanley A. Plotkin Merieux 2012 1 Why Vaccines are Different than Drugs 1) Given to healthy people, high safety required 2) Larger governmental role 3) Low

More information

DCVMN AND VACCINE SECURITY IN ASEAN REGION. ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014.

DCVMN AND VACCINE SECURITY IN ASEAN REGION. ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014. DCVMN AND VACCINE SECURITY IN ASEAN REGION ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014. Phuket - Thailand Developing Countries Vaccine Manufacturers Network (DCVMN)

More information

Intellectual Property Rights & Vaccines in Developing Countries

Intellectual Property Rights & Vaccines in Developing Countries Intellectual Property Rights & Vaccines in Developing Countries by Dr. S.S.Jadhav President DCVMN Developing Country Vaccine Manufacturers Network DCVMN Formed in November 2000. 7 members steering committee.

More information

Prospective Models of Vaccine Security Collaborations in Research and Development

Prospective Models of Vaccine Security Collaborations in Research and Development Prospective Models of Vaccine Security Collaborations in Research and Development Georges Thiry, PhD IVI (International Vaccine Institute) Phuket, Oct 01, 2014 Content R&D Examples of collaborations from

More information

Pneumococcal Symposium

Pneumococcal Symposium 3 rd Regional Pneumococcal Symposium 13-14 14 February 2008 Istanbul, Turkey Dr. Akira Homma Bio-Manguinhos, Fiocruz DCVMN Developing Countries Vaccine Manufacturers Network -DCVMN- Formed in 2000, Bandung,

More information

Role of Partnerships in Developing Innovative Vaccines: Brazil

Role of Partnerships in Developing Innovative Vaccines: Brazil Role of Partnerships in Developing Innovative Vaccines: Brazil SAGE Meeting, October 2010 Reinaldo Guimarães, M.D, MSc. Secretary of Science, Technology and Strategic Inputs Ministry of Health of Brazil

More information

Outline. Role of Developing Country Vaccine Industry For Meeting Global Vaccine Needs. Immunization Landscape ADVAC 2013

Outline. Role of Developing Country Vaccine Industry For Meeting Global Vaccine Needs. Immunization Landscape ADVAC 2013 Role of Developing Country Vaccine Industry For Meeting Global Vaccine Needs ADVAC 2013 Dr. Suresh Jadhav Executive Director Serum Institute of Limited Maharashtra,, 411028 ssj@seruminstitute.com France,

More information

Summaries of Complementary Presentations on Agenda Item:

Summaries of Complementary Presentations on Agenda Item: Summaries of Complementary Presentations on Agenda Item: WHO s Role in Supporting Emerging Vaccine Manufacturers To inform the SAGE discussion on this agenda item, four presentations have been solicited

More information

CHAPTER ONE: EXECUTIVE SUMMARY. The Global Vaccine Industry CHAPTER TWO: INTRODUCTION TO VACCINES

CHAPTER ONE: EXECUTIVE SUMMARY. The Global Vaccine Industry CHAPTER TWO: INTRODUCTION TO VACCINES CHAPTER ONE: EXECUTIVE SUMMARY The Global Vaccine Industry o Scope and Methodology o Overview o Pediatric Preventative Vaccines o The Market o Adult Preventative Vaccines o The Market o Total Market o

More information

The RIVM as knowledge and training centre

The RIVM as knowledge and training centre The RIVM as knowledge and training centre Belgrade, Serbia March 2012 Marit Holleman 1 Content: 1. Training and Technology Transfer at RIVM 2. Training on influenza vaccines 3. New courses 2 Training and

More information

Stanley A. Plotkin ADVAC /10/2010 2:35 PM

Stanley A. Plotkin ADVAC /10/2010 2:35 PM How and dwh Why Vaccines are Made Stanley A. Plotkin ADVAC 1 2010 5/10/2010 2:35 PM 1 Vaccines 1. History of vaccination 2. The vaccine industry 3. Why vaccines are developed 4. The current problems of

More information

Table Of Contents Executive Summary Introduction to Vaccines Pediatric Preventive Vaccines

Table Of Contents Executive Summary Introduction to Vaccines Pediatric Preventive Vaccines Table Of Contents Executive Summary THE GLOBAL VACCINES INDUSTRY Scope and Methodology Overview Pediatric Preventative Vaccines THE MARKET Adult Preventative Vaccines THE MARKET TOTAL MARKET ISSUES AND

More information

Programme update. Prequalification of Vaccines

Programme update. Prequalification of Vaccines Programme update Prequalification of Vaccines UN Prequalification of Medicines, Diagnostics and Vaccines 6th Consultative Stakeholder Meeting 4 April 2011 David Wood, WHO/IVB/QSS Outline Good news - A

More information

TABLE 7 ADVANTAGES AND DISADVANTAGES OF TOXOID VACCINES SUBUNIT VACCINES Applications of Subunit Vaccines TABLE 8 APPLICATIONS OF

TABLE 7 ADVANTAGES AND DISADVANTAGES OF TOXOID VACCINES SUBUNIT VACCINES Applications of Subunit Vaccines TABLE 8 APPLICATIONS OF CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED

More information

Technology Transfer from the Perspective of IFPMA vaccine members

Technology Transfer from the Perspective of IFPMA vaccine members Technology Transfer from the Perspective of IFPMA vaccine members WHO Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines Michael Watson (Sanofi Pasteur) Chair of IFPMA Biologicals

More information

ECONOMICS OF THE VACCINE MARKET: SIZE, GROWTH AND REVENUES

ECONOMICS OF THE VACCINE MARKET: SIZE, GROWTH AND REVENUES ECONOMICS OF THE VACCINE MARKET: SIZE, GROWTH AND REVENUES 1 Relationship between research funding and burden of disease Source: Global Forum for Health Research Monitoring Financial Flows for Health Research

More information

Managing cost considerations and access to technology for cost effective vaccine manufacture in developing countries.

Managing cost considerations and access to technology for cost effective vaccine manufacture in developing countries. Managing cost considerations and access to technology for cost effective vaccine manufacture in developing countries. Amol R. Dindokar Serum Institute of India ltd. Overview Disease Control Priorities

More information

Establishing human vaccine manufacturing in Southern Africa

Establishing human vaccine manufacturing in Southern Africa Engineering Conferences International ECI Digital Archives Vaccine Technology IV Proceedings Spring 5-21-2012 Establishing human vaccine manufacturing in Southern Africa Morena Makhoana The Biovac Institue

More information

NVI Experience and Concept of Central Technology Hub

NVI Experience and Concept of Central Technology Hub NVI Experience and Concept of Central Technology Hub Jan Hendriks Netherlands Vaccine Institute (NVI) MSF/Oxfam Consultation improving access and stimulating vaccine development for use in resource pour

More information

Modern Drug House.

Modern Drug House. +91-8048941768 Modern Drug House https://www.moderndrughouse.in/ We are one of the leading suppliers and traders of a wide range of Vaccine and Pharmaceutical Products. Owing to its effectiveness, purity

More information

Annex 1. WHO Recommendations, Guidelines and other documents related to the manufacture and quality control of biological substances used in medicine

Annex 1. WHO Recommendations, Guidelines and other documents related to the manufacture and quality control of biological substances used in medicine WHO related to the manufacture and quality control of biological substances used in medicine WHO are intended to provide guidance to those responsible for the production of biological substances as well

More information

Michel BAIJOT Vice President, WW Business Development & Strategic Alliances

Michel BAIJOT Vice President, WW Business Development & Strategic Alliances Technology Transfer and Vaccines: The GSK Experience WHO Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines Geneva, November 30th, 2010 Michel BAIJOT Vice President, WW Business

More information

GAVI ALLIANCE: UPDATE AND FUTURE DIRECTIONS FOR GLOBAL VACCINES AND IMMUNISATIONS

GAVI ALLIANCE: UPDATE AND FUTURE DIRECTIONS FOR GLOBAL VACCINES AND IMMUNISATIONS GAVI ALLIANCE: UPDATE AND FUTURE DIRECTIONS FOR GLOBAL VACCINES AND IMMUNISATIONS Ranjana Kumar International Rotavirus Symposium Istanbul, 3 4 June 2008 The GAVI Alliance Public-private partnership bringing

More information

How and Why Vaccines are Made. Stanley A. Plotkin

How and Why Vaccines are Made. Stanley A. Plotkin How and Why Vaccines are Made Stanley A. Plotkin Levine 2017 January 23, 2017 Vaccinology A combination of: Microbiology Immunology Epidemiology Public Health and Pharmacy 2 The impact of vaccination on

More information

Sanofi Pasteur: A partner in eradicating vaccine preventable diseases and improving access to vaccines

Sanofi Pasteur: A partner in eradicating vaccine preventable diseases and improving access to vaccines Sanofi Pasteur: A partner in eradicating vaccine preventable diseases and improving access to vaccines 1 Vaccines: the single most effective medical intervention 2 Vaccines save lives Millions of cases

More information

Safety monitoring of vaccines. Jeremy Labadie MD vaccine safety specialist

Safety monitoring of vaccines. Jeremy Labadie MD vaccine safety specialist Safety monitoring of vaccines Jeremy Labadie MD vaccine safety specialist vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and

More information

Quality assurance for essential medicines and health products: moving towards an harmonized approach

Quality assurance for essential medicines and health products: moving towards an harmonized approach Quality assurance for essential medicines and health products: moving towards an harmonized approach Prequalification of vaccines David Wood QSS/EMP/WHO 12 December 2012 A growing portion of vaccines procured

More information

Vaccines and other immunological antimicrobial therapy 1

Vaccines and other immunological antimicrobial therapy 1 Vaccines and other immunological antimicrobial therapy 1 Vaccines Vaccine: a biological preparation that provides active acquired immunity to a particular disease. Vaccine typically contains an agent that

More information

Vaccine Technologies and Global Markets

Vaccine Technologies and Global Markets A BCC Research Pharmaceutical Report and Global Markets PHM014D Use this report to: Learn about the strengths and weaknesses of each category of human and veterinary vaccine to prevent or treat infectious

More information

Progress under GAP Pillar 2 "Increase Production Capacity" Contribution of the WHO Technology Transfer Programme. Martin Friede

Progress under GAP Pillar 2 Increase Production Capacity Contribution of the WHO Technology Transfer Programme. Martin Friede Progress under GAP Pillar 2 "Increase Production Capacity" Contribution of the WHO Technology Transfer Programme Martin Friede Global influenza vaccine production capacity since 2006 Cantacuzino Romania

More information

Practical Applications of Immunology. Chapter 18

Practical Applications of Immunology. Chapter 18 Practical Applications of Immunology Chapter 18 I. Vaccines A. Definition A suspension of organisms or fractions of organisms that is used to induce immunity (immunologic memory). The mechanism of memory

More information

V3P: Region Fact Sheet

V3P: Region Fact Sheet V3P: Region Fact Sheet Highlights The 1 region market is 15% of the global market in volume and 63% in value. The regional vaccine procurement habits are different from the rest of the world in several

More information

Overall presentation of IVR Strategy

Overall presentation of IVR Strategy Annex 3 Overall presentation of IVR Strategy Presentation to the IVR Advisory committee (IVAC) April 2007 Outline Why does WHO invest in Research & Development? What is the Initiative for Vaccine Research

More information

Evaluating the acceptability of vaccine and vaccination programmes: an individual and public health perspective

Evaluating the acceptability of vaccine and vaccination programmes: an individual and public health perspective The regulatory process Evaluating the acceptability of vaccine and vaccination programmes: an individual and public health perspective Annecy, Les Pensières July 7-9, 2008 Dr. Nora Dellepiane, Scientist

More information

Adolescent vaccination strategies

Adolescent vaccination strategies Adolescent vaccination strategies Gregory Hussey Vaccines for Africa Initiative Institute of Infectious Diseases & Molecular Medicine University of Cape Town www.vacfa.uct.ac.za gregory.hussey@uct.ac.za

More information

Heat and Freeze Sensitivity of Vaccines

Heat and Freeze Sensitivity of Vaccines Heat and Freeze Sensitivity of Vaccines DCVMN Workshop "Vaccine quality management systems for manufacturing excellence" Michael Rush, MBA Executive Director - Global Health Policy October 24-25, 2013

More information

V3P: Region Fact Sheet

V3P: Region Fact Sheet V3P: Region Fact Sheet Highlights The 1 region market is 4% of the global market in volume and 5% in value. The regional vaccine procurement habits are different from the rest of the world in several ways,

More information

Healthy People 2020 objectives were released in 2010, with a 10-year horizon to achieve the goals by 2020.

Healthy People 2020 objectives were released in 2010, with a 10-year horizon to achieve the goals by 2020. Appendix 1: Healthy People 2020 Immunization-related Objectives Healthy People provides science-based, 10-year national objectives for improving the health of all Americans. For three decades, Healthy

More information

Public Statement: Medical Policy. Effective Date: 01/01/2012 Revision Date: 03/24/2014 Code(s): Many. Document: ARB0454:04.

Public Statement: Medical Policy. Effective Date: 01/01/2012 Revision Date: 03/24/2014 Code(s): Many. Document: ARB0454:04. ARBenefits Approval: 01/01/2012 Effective Date: 01/01/2012 Revision Date: 03/24/2014 Code(s): Many Medical Policy Title: Immunization Coverage Document: ARB0454:04 Administered by: Public Statement: 1.

More information

Development of Vaccine Security at the Regional Level

Development of Vaccine Security at the Regional Level Workshop among ASEAN countries on Opportunities for Regional Vaccine Security September 30 to October 3, 2014, Cape Panwa, Phuket, Thailand Development of Vaccine Security at the Regional Level Stephane

More information

Last mile vaccine distribution to rural health centres. Faheem Merchant

Last mile vaccine distribution to rural health centres. Faheem Merchant Last mile vaccine distribution to rural health centres Faheem Merchant New Global Immunization Goals 2000 - Millennium Development Goal # 4 Reduce under 5 child mortality by 2/3 between 1990 and 2015.

More information

Developing a novel Group B Streptococcus (GBS) Vaccine. Patrick Tippoo

Developing a novel Group B Streptococcus (GBS) Vaccine. Patrick Tippoo Developing a novel Group B Streptococcus (GBS) Vaccine Patrick Tippoo Presentation 1. Overview of Biovac 2. GBS Project Overview 3. African Significance Biovac Overview A Centre of Excellence rooted in

More information

Live attenuated Influenza vaccine

Live attenuated Influenza vaccine Serum Institute of India Pvt. Ltd. Live attenuated Influenza vaccine Parikshit Tyagi, MSc, PhD Sr. Manager, Quality Control Introduction founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing

More information

Immunization Update & focus on meningococcal vaccine PART 1

Immunization Update & focus on meningococcal vaccine PART 1 Immunization Update & focus on meningococcal vaccine PART 1 Gregory Hussey Vaccines for Africa Initiative Institute of Infectious Diseases University of Cape Town www.vacfa.uct.ac.za Disclosures Received

More information

Principles of Vaccination

Principles of Vaccination Immunology and Vaccine-Preventable Diseases Immunology is a complicated subject, and a detailed discussion of it is beyond the scope of this text. However, an understanding of the basic function of the

More information

1. Executive Summary 2. Worldwide Pediatric Vaccines Market and Forecast ( ) 3. Worldwide Pediatric Vaccines Market Share & Forecast (Sector

1. Executive Summary 2. Worldwide Pediatric Vaccines Market and Forecast ( ) 3. Worldwide Pediatric Vaccines Market Share & Forecast (Sector 1. Executive Summary 2. Worldwide Pediatric Vaccines Market and Forecast (2006 ) 3. Worldwide Pediatric Vaccines Market Share & Forecast (Sector wise) (2005 ) 4. Worldwide Pediatric Vaccines Market Share

More information

Procedure/Product Code Description

Procedure/Product Code Description Proc. Type Code Procedure/Product Code Description ACA Primary Care Services Fees VFC 90585 TB $23.14 VFC 90632 Hep A $23.14 VFC 90633 Hep A $23.14 VFC 90634 Hep A $23.14 VFC 90636 Hep A - Hep B $23.14

More information

Creating VaCCines, ProteCting Life

Creating VaCCines, ProteCting Life Creating VaCCines, ProteCting Life PreVenting Disease through VaCCination a Constant BattLe Immunization has been a great public health success story. The lives of millions of children have been saved,

More information

History and aims of immunisation. Dr Anna Clarke Department of Public Health Dr. Steevens Hospital Dublin 8

History and aims of immunisation. Dr Anna Clarke Department of Public Health Dr. Steevens Hospital Dublin 8 History and aims of immunisation Dr Anna Clarke Department of Public Health Dr. Steevens Hospital Dublin 8 Objectives To examine the history of immunisation To explain the aim of immunisation To develop

More information

Protecting people against known and emerging infectious diseases globally

Protecting people against known and emerging infectious diseases globally Protecting people against known and emerging infectious diseases globally 18 October 2017 SAGE Geneva By Mahima Datla President, DCVMN 1 Agenda Introduction to DCVMN DCVMN s contributions Suggested areas

More information

Stainless-steel vs Single-use: The Vaccines Perspective

Stainless-steel vs Single-use: The Vaccines Perspective Stainless-steel vs Single-use: The Vaccines Perspective CMO-Biomanufacturer Panel Tue 21 April, Noon-1:30pm, Exhibit Hall Daniel C.Vellom, PhD Sr. Director Global Technology Innovation 2015 INTERPHEX 1

More information

Prequalification Team WHO PUBLIC INSPECTION REPORT Vaccine Manufacturer

Prequalification Team WHO PUBLIC INSPECTION REPORT Vaccine Manufacturer 20, avenue Appia CH-1211 Geneva 27 Switzerland Tel central +41 22 791 2111 Fax central +41 22 791 3111 www.who.int Part 1: General information Name of Manufacturer Prequalification Team WHO PUBLIC INSPECTION

More information

Crucell a compelling investment case

Crucell a compelling investment case Crucell a compelling investment case Investor Presentation March 2008 Disclaimer The presentation contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain

More information

Global Vaccine Market Features and Trends

Global Vaccine Market Features and Trends Global Vaccine Market Features and Trends Miloud Kaddar Senior Adviser, Health Economist 1 WHO, IVB, Geneva GLOBAL VACCINE MARKET MAIN FEATURES OF THE VACCINE MARKET? NEW TRENDS SINCE 2000? IMPLICATIONS?

More information

Economics of Vaccine Development A Vaccine Manufacturer s Perspective

Economics of Vaccine Development A Vaccine Manufacturer s Perspective Economics of Vaccine Development A Vaccine Manufacturer s Perspective Gerald Voss The Value of Vaccines 2 29 diseases are currently preventable by vaccination Global public health Cervical cancer 1 Diphtheria

More information

9/10/2018. Principles of Vaccination. Immunity. Antigen. September 2018

9/10/2018. Principles of Vaccination. Immunity. Antigen. September 2018 Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Principles of Vaccination September 2018 Chapter 1 September 2018 Photographs and images included in

More information

Jan Hendriks & Claire Boog Netherlands Vaccine Institute (NVI)

Jan Hendriks & Claire Boog Netherlands Vaccine Institute (NVI) Influenza Technology Hub a WHO Vaccinology Centre of Excellence Bilthoven, the Netherlands WHO Technology Transfer Workshop 30 November-1 December 2010 Jan Hendriks & Claire Boog Netherlands Vaccine Institute

More information

Immunizations are among the most cost effective and widely used public health interventions.

Immunizations are among the most cost effective and widely used public health interventions. Focused Issue of This Month Recommended by the Korean Pediatric Society, 2008 Hoan Jong Lee, MD Department of Pediatrics, Seoul National University College of Medicine E mail : hoanlee@snu.ac.kr J Korean

More information

Keynote Address: The Challenge of Achieving Universal Access to Vaccines

Keynote Address: The Challenge of Achieving Universal Access to Vaccines Keynote Address: The Challenge of Achieving Universal Access to Vaccines & AMF Seth Berkley M.D, CEO www.gavi.org 1 Vaccine landscape The world before vaccines Examples of major disease outbreaks Yellow

More information

The administration of covered immunizations and vaccines also is covered.

The administration of covered immunizations and vaccines also is covered. Covered Benefit: Vaccines & Immunization Definitions: CMP Published: Yes No CMP Link: CPG Link: Pediatric, Adolescent and Adult Routine Preventative Services Immunizations and vaccinations for treatment

More information

Bharat Biotech. Hyderabad. Type of PAC (Supplement and Notifiable / Permission Granted by CDSCO) S. No Product

Bharat Biotech. Hyderabad. Type of PAC (Supplement and Notifiable / Permission Granted by CDSCO) S. No Product Bharat Biotech Hyderabad S. No Product Type of PAC (Supplement and / Permission Granted by CDSCO) PAC Details Date of NOC in manufacturing process of Oral Polio F.No. 12-63/BHARAT/(PACOPV)/13-BD 30.08.2013

More information

Detailed cost of vaccination/ Immunization in India (Birth to 10 years of age)

Detailed cost of vaccination/ Immunization in India (Birth to 10 years of age) Detailed cost of vaccination/ Immunization in India (Birth to 10 years of age) Glossary: IPV= Injectable Polio vaccine OPV= Oral polio vaccine (these are oral drops, which is also given in "Pulse Polio

More information

A. Children born in 1942 B. Children born in 1982 C. Children born in 2000 D. Children born in 2010

A. Children born in 1942 B. Children born in 1982 C. Children born in 2000 D. Children born in 2010 Who do you think received the most immunologic components in vaccines? Development of which vaccine slowed after the invention of antibiotics? A. Children born in 1942 B. Children born in 1982 C. Children

More information

The Financial Sustainability of New Vaccine Introduction in the Poorest Countries :

The Financial Sustainability of New Vaccine Introduction in the Poorest Countries : The Financial Sustainability of New Vaccine Introduction in the Poorest Countries : Evidence from the First Phase of GAVI (Global Alliance for Vaccines and Immunization) Patrick Lydon lydonp@who.int Session:

More information

Global Health Policy: Vaccines

Global Health Policy: Vaccines Global Health Policy: Vaccines Edwin J. Asturias Senior Investigator Colorado School of Public Health Department of Pediatrics Children s Hospital Colorado UNIVERSITY OF COLORADO COLORADO STATE UNIVERSITY

More information

Journal Club 3/4/2011

Journal Club 3/4/2011 Journal Club 3/4/2011 Maternal HIV Infection and Antibody Responses Against Vaccine-Preventable Diseases in Uninfected Infants JAMA. 2011 Feb 9;305(6):576-84. Jones et al Dept of Pediatrics, Imperial College,

More information

Assessment of Influenza Vaccine Production Compatibilities

Assessment of Influenza Vaccine Production Compatibilities United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Assessment of Influenza Vaccine Production Compatibilities Joshua Speidel, PhD Influenza

More information

Vaccine Innovation: Challenges and Opportunities to Protect Health. Julie Louise Gerberding, M.D., M.P.H President, Merck Vaccines

Vaccine Innovation: Challenges and Opportunities to Protect Health. Julie Louise Gerberding, M.D., M.P.H President, Merck Vaccines Vaccine Innovation: Challenges and Opportunities to Protect Health Julie Louise Gerberding, M.D., M.P.H President, Merck Vaccines Protecting Health with Vaccines HEALTH IMPROVEMENT Population Impact Guidelines

More information

The Gates Challenge. Bill Gates Commencement Address Harvard University Class of 2007

The Gates Challenge. Bill Gates Commencement Address Harvard University Class of 2007 History & Future of the Expanded Programme on Immunization Supplier Meeting, Copenhagen, 3-4 April 2008 Dr Osman David Mansoor Senior Adviser EPI (New Vaccines) UNICEF New York The Gates Challenge If we

More information

SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World

SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World MIT OpenCourseWare http://ocw.mit.edu SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World Spring 2009 For information about citing these materials or our

More information

Vaccines: Poised To Deliver Significant Growth in Emerging Markets

Vaccines: Poised To Deliver Significant Growth in Emerging Markets Vaccines: Poised To Deliver Significant Growth in Emerging Markets 4 th DVFA Symposium Life Science Pierre Morgon Vice-President, Franchise & Global Marketing Operations, Sanofi Pasteur Frankfurt, May

More information

New Vaccines in SA. Regulatory Perspectives James Southern 2015

New Vaccines in SA. Regulatory Perspectives James Southern 2015 New Vaccines in SA Regulatory Perspectives James Southern 2015 Outline Regulatory Environment of new vaccines Clinical Trials Application procedures HIV Vaccines Other new vaccines in development Ongoing

More information

Outline. World Health Organization 14 July, Strengthening for capacity to regulate influenza vaccines

Outline. World Health Organization 14 July, Strengthening for capacity to regulate influenza vaccines Strengthening for capacity to regulate influenza vaccines Outline WHO reorganization and Regulatory Systems Strengthening (RSS) Team WHO Regulatory Systems Strengthening Department of Essential Medicines

More information

V3P: Region Fact Sheet

V3P: Region Fact Sheet V3P: Region Fact Sheet Highlights The 1 region market is 6% of the world market in volume and 6% in value. The regional vaccine procurement habits are different from the rest of the world in several ways,

More information

GAVI S VACCINE INVESTMENT STRATEGY

GAVI S VACCINE INVESTMENT STRATEGY GAVI S VACCINE INVESTMENT STRATEGY Judith Kallenberg, Head of Policy PDVAC 22 June 2017, Geneva Reach every child www.gavi.org Gavi finances vaccines and immunisation through three routes ($9 Billion in

More information

Access to vaccination in GAVI countries and at global level

Access to vaccination in GAVI countries and at global level Access to vaccination in GAVI countries and at global level Stefano Malvolti Director, Vaccine Implementation GAVI Alliance 15th ADVANCED COURSE OF VACCINOLOGY May 12, 2014 Global progress to MDG 4 for

More information

Update on Transition: the case of Honduras. Minister Dra Yolani Batres AMRO/EURO Gavi Constituency Representative Geneva June 2016

Update on Transition: the case of Honduras. Minister Dra Yolani Batres AMRO/EURO Gavi Constituency Representative Geneva June 2016 Update on Transition: the case of Honduras Minister Dra Yolani Batres AMRO/EURO Gavi Constituency Representative Geneva June 2016 GAVI Support for Honduras Content Honduras EPI Situation 2011-2016 Vaccination

More information

Progress and Challenges of Enteric Vaccines. Dr. Tajul Islam A Bari icddr,b Bangladesh

Progress and Challenges of Enteric Vaccines. Dr. Tajul Islam A Bari icddr,b Bangladesh Progress and Challenges of Enteric Vaccines Dr. Tajul Islam A Bari icddr,b Bangladesh New enteric vaccines in use Cholera Rotavirus Typhoid Cholera- History During the 19th century, cholera spread across

More information

VACCINE MANAGEMENT. Recommendations for Handling and Storage of Selected Biologicals. January 2001 DEPARTMENT OF HEALTH AND HUMAN SERVICES

VACCINE MANAGEMENT. Recommendations for Handling and Storage of Selected Biologicals. January 2001 DEPARTMENT OF HEALTH AND HUMAN SERVICES VACCINE MANAGEMENT Recommendations for Handling and Storage of Selected Biologicals January 2001 DEPARTMENT OF HEALTH AND HUMAN SERVICES DTaP: Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine

More information

CPT 2016 Code Changes

CPT 2016 Code Changes CPT 2016 Code Changes Code Changes - Medicine New CPT 2016 New Codes Code Description 69209 Removal impacted cerumen using irrigation/lavage, unilateral 90620 Meningococcal recombinant protein and outer

More information

Centers for Disease Control and Prevention. Final Revised Vaccine Information Materials for MMR

Centers for Disease Control and Prevention. Final Revised Vaccine Information Materials for MMR This document is scheduled to be published in the Federal Register on 03/15/2018 and available online at https://federalregister.gov/d/2018-05299, and on FDsys.gov BILLING CODE: 4163-18-P DEPARTMENT OF

More information

Approaches to Pandemic Influenza Vaccine Preparedness

Approaches to Pandemic Influenza Vaccine Preparedness United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Approaches to Pandemic Influenza Vaccine Preparedness Julie Schafer, MPH, MS Influenza

More information

The administration of covered immunizations and vaccines also is covered.

The administration of covered immunizations and vaccines also is covered. Covered Benefit: Immunization & Vaccines Definitions: CMP Published: Yes No CMP Link: CPG Link: Pediatric, Adolescent and Adult Routine Preventative Services Immunizations and vaccinations for treatment

More information

Immunizations for Children and Teens with Suppressed Immune Systems

Immunizations for Children and Teens with Suppressed Immune Systems Immunizations for Children and Teens with Suppressed Immune Systems Your child is starting treatment that will suppress the immune system. This will affect how your child s body responds to routine immunizations

More information

Cigna Drug and Biologic Coverage Policy

Cigna Drug and Biologic Coverage Policy Cigna Drug and Biologic Coverage Policy Subject Routine Immunizations Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 3 References... 7 Effective Date... 4/15/2018

More information

Coverage of Vaccines Medicaid and Child Health Plus Members

Coverage of Vaccines Medicaid and Child Health Plus Members Coverage of Vaccines Medicaid and Child Health Plus Members For children between the ages 0-18, routine recommended vaccinations are covered through Vaccines for Children program [VFC]. Fidelis Care will

More information

Armed Services Blood Program Immunization List

Armed Services Blood Program Immunization List Immunization List NOTICE: The Department of Defense (DoD) assumes no risk for the use of this information by non-dod personnel, blood programs, or individual medical institutions. The use of this information

More information

Copyright regulations Warning

Copyright regulations Warning COMMONWEALTH OF AUSTRALIA Copyright regulations 1969 Warning This material has been reproduced and communicated to you by or on behalf of the University of Melbourne pursuant to part VB of the Copyright

More information

1 Principles of Vaccination Immunology and Vaccine-Preventable Diseases... 1 Classification of Vaccines... 4 Selected References...

1 Principles of Vaccination Immunology and Vaccine-Preventable Diseases... 1 Classification of Vaccines... 4 Selected References... 1 Principles of Vaccination Immunology and Vaccine-Preventable Diseases... 1 Classification of Vaccines... 4 Selected References... 7 2 General Recommendations on Immunization Timing and Spacing of Vaccines...

More information

The Crisis in. Vaccine Development

The Crisis in. Vaccine Development The Crisis in Vaccine Development Stanley A. Plotkin 1 Annecy 2015 The Evolution of the Vaccine Industry 1. 18 th -19 th Centuries Pioneers 2. 1900-1950 National Producers 3. 1960-1980 Globalization 4.

More information

Sustaining Immunization in Developing Countries: The Future We Make

Sustaining Immunization in Developing Countries: The Future We Make Sustaining Immunization in Developing Countries: The Future We Make Global Health Summit Denver, CO 29 April 211 Jon Kim Andrus, MD Deputy Director Umbrella of protection in the Americas Measles eradication

More information

Syrian Programme Refugees Advice on assessment of immunisation status and recommendations for additional immunisation

Syrian Programme Refugees Advice on assessment of immunisation status and recommendations for additional immunisation Syrian Programme Refugees Advice on assessment of immunisation status and recommendations for additional immunisation Background Information Immunisation services in Syria Syria had good immunisation services,

More information

Inaugural Keynote Lecture: Contributions of Gavi and DCVMN to the global vaccine markets

Inaugural Keynote Lecture: Contributions of Gavi and DCVMN to the global vaccine markets Inaugural Keynote Lecture: Contributions of Gavi and DCVMN to the global vaccine markets Seth Berkley M.D, CEO, Seoul www.gavi.org 1 Gavi s mission, model and achievements to date Gavi s mission Saving

More information

Central Inspection Plan Using Risk Based Approach Of Vaccine Manufacturing Units for 2017

Central Inspection Plan Using Risk Based Approach Of Vaccine Manufacturing Units for 2017 , follow-up, failure A NORTH ZONE 1 M/s Biomed Pvt. Ltd, C-96, Site I, Bulandshahar Road, Ind. Area, Ghaziabad. 1. Oral Polio Vaccine IP, 2. Vi Typhoid Vaccine (Bio Typh TM ) IP, 3. Haemophilus Type-B

More information

Benefit Interpretation

Benefit Interpretation Benefit Interpretation Subject: Part B vs. Part D Vaccines Issue Number: BI-039 Applies to: Medicare Advantage Effective Date: May 1, 2017 Attachments: Part B Vaccines Diagnosis Code Limits Table of Contents

More information

Industry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine. since 2006

Industry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine. since 2006 Industry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine use from high to low income countries since 2006 Dr. Michael Watson, sanofi-pasteur on behalf of WHO GAP

More information

Pentabio Vaccine (DTP-HB-Hib)

Pentabio Vaccine (DTP-HB-Hib) SUMMARY OF PRODUCT CHARACTERISTICS Product Name Pharmaceutical Form Strength Presentation : Pentabio : Suspension for injection : 1, 5 and 10 doses : Box of 10 vials @ 0.5 ml Box of 10 vials @ 2.5 ml Box

More information

Global health and vaccination: TB & beyond. Dr Mary Moran Executive Director

Global health and vaccination: TB & beyond. Dr Mary Moran Executive Director Global health and vaccination: TB & beyond Dr Mary Moran Executive Director mmoran@policycures.org Outline About Policy Cures 3 reasons to focus on vaccine innovation Where are we today? The pipeline Where

More information

Please read Chapters 5, 6 and 7 of your vaccine text for next Wednesday s lecture. Chapters 9, 17 and 8 for next Friday s lectures

Please read Chapters 5, 6 and 7 of your vaccine text for next Wednesday s lecture. Chapters 9, 17 and 8 for next Friday s lectures Valerie Daggett Please read Chapters 5, 6 and 7 of your vaccine text for next Wednesday s lecture Chapters 9, 17 and 8 for next Friday s lectures ppt files for first 2 lectures Past exams Principles of

More information