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