Vaccines: All things considered

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Importance of Vaccines and how the 9/11 change the face of vaccine field. A glimpse of world/Indian vaccine industry

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<ul><li> 1. Life or death for a young child too often depends on whether he is born in a country where vaccines are available or not </li></ul> <p> 2. accines: All the things considered 3. The Spanish FLU 1918-1919 more than 50million people 4. G O O D 5. ARI HIV Diarrhoeal diseases Tuberculosis Malaria Measles, Hepatitis B virus The infectious diseases 6. The World Health Organisation 7. Vaccination is probably the most beneficial therapy that a physician can provide a patient Vaccines are an excellent, technically feasible defense against these threats with the potential to limit disease spread Prevention is better than cure 8. Success stories of vaccines Small pox Polio, by 99.9% from 3,50,000 cases in 1998 to 800 in 2002 39% decrease in mortality because of Measles End of 2003 78% of world population got immunized with DTP 9. Biological basis for immune response to a vaccine ? 10. Late 20th Century T cell 21st Century Dendritic Cell Controller of immune response Dendritic cell T cell 11. Unfortunately the DC biology is still very confusingUnfortunately the DC biology is still very confusing Immature DC Pathogens DC Cytokines APC APC T-Cell Cytokines Activated Cells 12. Conserved microbial molecules shared by many pathogens Bacterial lipopolysaccharides TLR4 Peptidoglycan TLR2 Flagellin TLR5 Nucleic acids Pathogen-associated molecular patterns (PAMPS) Pattern Recognition Receptors (PRR) Toll like receptors 13. Toll-like receptors &amp; Host-Pathogen Interaction 14. What decides Th1 or Th2 response ? IL-12, IFN-, Controll Intra cellular pathogens Combination of both antibody and CMI Th1 Th2 Predominantly antibody response Th1 Th2 Antagonistic 15. Need to look for new adjuvants What is the role of adjuvants ? Alum based adjuvants are only approved and Problem with Alum ? IL-12 cytokines and antigen loaded dendritic cells as adjuvants are in pipeline 16. MPL (monophosphoryl lipid A) Montanide ISA51 (seppic) MF59 Mix of different adjuvants (Alum+MPL) also used in few vaccines ex. Human papillomavirus , Herplex simplex virus (GlaxoSmithkline) LEAPS (Ligand epitope antigen presentation system) ICBL (Immune cell binding ligands) Newer adjuvants Problems with small peptide vaccines 17. Reason for these Studies Increased understanding of the immune response Technology advances in Proteomics Genomics Structural biology Instrumentation New developments in vaccine designNew developments in vaccine design 18. Hurdles to the development and licensing of new vaccines 19. Difficulty in preparing 100% safe and effective Almost unavoidable minor adverse event The high cost of testing Long time to get through phase III trials Profit margin is 1/10 or less than that of a successful drug that must be taken daily Target for lawsuits HurdlesContd. 20. Beyond that Vaccine program's are expensive Vaccines are perishable Administration by professionals People may not accept without a defined urgent microbial threat 21. Produce an immune response ? Protect after challenge? Safe ? Immune response ? Best dose? Safe ? How much of an immune response ? Does it work ? Preclinical Phase I Phase II Phase III Animals 30-50 people 200-400 people 3000-5000 people Goals of vaccine Trial process 22. Fails if it is effective only in a subgroup of patients or if a subgroup experiences extreme side effects Failure on the way to success Variable outcomes caused by the particular genetic makeup of the individuals ex. Worlds first AIDS vaccine AIDSVAX 23. ex. In 2000 Rotashield vaccine was withdrawn from the US market due to safety concerns Risk benefit ratio must be reasonable Vaccines also have some undesired side effects A safety evaluation must ask not only what are the bad things that can happen if this vaccine is used? It must also ask, what bad things can happen if this vaccine is NOT used? 24. Bitter truth Clinically not proven in preventing disease Simple reason that no researcher has directly exposed test subjects to diseases Go to doctor and you get a toxic additive than the viral component ex. Thimerosal - Autism BSA - Prion diseases 25. Drive for Vaccine development Benefit to mankind Profit 26. The big Three vs neglected diseases HIV Malaria TB Hookworm disease Schistosomiasis 27. Money Time Success Profit Worries with vaccines 231million $ in 1987 to 802 million$ in 2000 Vaccine is expensive to develop, licensure, and marketing As a result funds are always from Government 28. Drive for vaccine funding by Government Fear : Fear of Bioterrorism Fear of being blamed for inaction Concern over lost revenue due to illness Fear of bioterrorism elevates infectious diseases to the status of a military weapon and changes the definition of vaccine program in to military deterrent Fear of bioterrorism elevates infectious diseases to the status of a military weapon and changes the definition of vaccine program in to military deterrent 29. Bioterrorism Boom in the Vaccine development 30. Project Bioshield Goals of Project Bioshield Accelerate the R &amp; D on vaccines Purchase Availability of priority medical countermeasures to protect the US population 31. Change in Vaccine industry after Bioshield Contracts since 2001 to pileup 80 million doses of Anthrax vaccine Botulin antitoxin Smallpox vaccine Plague Ebola fever Change the future of vaccine developmentChange the future of vaccine development 32. To improve child health in poorest countries GAVI ALLIANCE 33. Innovative partnership for benefit of mankind 34. Bill and Melinda Gates foundation The largest transparently operated charitable foundation in the world Malaria Vac I Childrens Vac I HIV 35. WARREN BUFFET 36. Global vaccine industry US$ 11.42 Billion in 2006 US$ 21.05 Billion by 2010 After decades of malaise vaccine industry is getting injection But remains small piece 3% of drug industry 37. 24.3 22.6 21.3 17.8 8.1 5.9 Novartis/ Chiron* GSK Wyeth Merck** Sanofi- Aventis** Other Growing market with a restricted number of mostly US-prone vaccine players 38. Vaccine industry in India Shanta is first to indigenously produce a rec Hep B vaccine Shantha and Serum institute are working on pentavalent vaccine ( DPT, HepB, influ B) Bharath biotech working on malaria &amp; rotavirus (Bill &amp; melinda) 39. Contd Indian immunologicals Biological E Panacea biotech Serum Institute of India Shanta supplies 40% of UNICEF global requirement for Hep B Serum institute highest exporter-138 countries Surprising facts 40. Summary More R&amp;D on immunology and host pathogen interaction is required Government can enrich the funding for vaccine R&amp;D NIH remains primary funding source for most vaccine projects Database of NIH for past 10 years indicate more funding for pharmacy 3% 17.5% NIH 41. Vaccine research shouldnt stop there 42. Thank you We cannot be a strong nation unless we are a healthy nation </p>