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  • 3. Influenza in Humansepidemiology and control by vaccinationSam Lee, PhDSr. Director, Pandemic Influenza StrategyFranchise & Global Marketing StrategySanofi Pasteur
  • 4. Airborne Transmission of RespiratoryPathogens Steinhoff, Johns Hopkins School of Public Health, EID_lect13_Steinhoff.pdf
  • 5. InfluenzaHighly contagious respiratory illness caused by frequently changing virus
  • 6. Antigenic Drift vs. Antigenic Shift
  • 7.
  • 8. Influenza Virus Antigenic & Genetic Drift
  • 9. Annual Impact of Seasonal Influenza in theUnited States Deaths Hospitalizations 36,0001 114,0002 Physician visits 25 million3 Infections and illnesses 50–60 million3 Direct medical costs >$10 billion4 In-Direct medical costs >$50 billion5 1 Thompson WW et al. JAMA. 2003;289:179-186. 2 CDC. MMWR Recomm Rep. 2003;58(RR-8):1-34. 3 Chow A, et al. Emerg Infect Dis. 2006 Jan;12(1):114-21. 4 Molinari NA, et al. Vaccine. Jun 28 2007;25(27):5086-5096. 5 Szucs T. J Antimicrob Chemother. Nov 1999;44 Suppl B:11-15.
  • 10. Goals for Influenza Vaccination Primary Goal: Prevent severe disease and complications, and to prevent death Secondary Goal: Prevent any mild form of the disease or mild complications Public Health Goal: Reduce disease burden and medical costs for society 10
  • 11. Vaccination provides effective protection against flu at all ages In the Elderly Flu vaccination among the elderly has been shown to reduce severe illness and complications by up to 60%, and deaths by up to 80% 1 In Children Vaccination reduces influenza illness in children by 60 to 90% 2 Vaccination of children reduces disease transmission  Demonstrated 61% indirect protection (herd effect) of non- vaccinated persons 3 In Healthy Adults Influenza vaccination prevents influenza illness in 70 – 90% of healthy adults aged < 65 years 4 Vaccination of healthy working adults was shown to reduce work absenteeism by up to 78% 5 1 July 2, 2010.*Influenza vaccination is most effective when circulating viruses are well-matched with vaccine viruses 2 Nichol K. Vaccine ,2003;21(16):1769-75. 3 Loeb M, et al.. JAMA, 2010;303(10):943-50. 4 CDC. MMWR, 2009;58(RR8). 5 Samad AH, et al. J Occup Health, 2006;48(1):1-10.
  • 12. Influenza Vaccine Strain ChangesWHO Recommendations 1969-2012
  • 13. Seasonal Occurrence of Influenza Northern hemisphere Tropical Southern hemisphereJ F M A M J J A S O N D Reichelderfer PS, et al. Influenza surveillance in the pacific basin. In: Current topics in medical virology 1988:412-38
  • 14. Potential Benefit of Quadrivalent Vaccines B lineage circulation in Europe (2003-2011) 100% 9% 8% 6% 90% 31% 80% 70% 56% 60% 80% 50% 99% Yamagata 91% 92% 94% 40% Victoria 69% 30% 20% 44% 10% 20% 1% 0% 2003-2004 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2010-2011Vaccine Victoria Yamagata Yamagata Yamagata Yamagata Yamagata VictoriaMatch withdominantcirculating lineage X P X X P X P
  • 15. Human-Animal Interface
  • 16. SANOFI PASTEUR WORLDWIDE LEADER IN HUMAN VACCINES● Our Vision ● A world in which no one suffers or dies from a vaccine preventable disease● Our Mission ● To protect and improve human health worldwide by providing superior, innovative vaccines for the prevention and treatment of disease and by playing an active role in the immunization community to maximize vaccination
  • 17. 17SANOFI PASTEURGLOBAL PRODUCTION FOR GLOBAL HEALTH● To produce vaccines in large quantities, meeting the highest quality standards, to help fulfill public health needs 10 sites plus 3 under construction Val de Reuil Marcy-l’Etoile More than Toronto 50% of total staff in industrial operations Shenzhen More than 1 billion doses Swiftwater (PA) of vaccine produced each Canton (MA) year Rockville (MD) Nearly 2 billion invested in Hyderabad production infrastructures Chachoengsao over the Pilar past 5 yearsSites under construction: Ocoyoacac (Mexico), Neuville (France), Shenzhen (China)
  • 18. SANOFI PASTEURTHE BROADEST RANGE OF VACCINES WORLDWIDE Viral diseases Bacterial diseases 20 diseases Yellow fever Pertussis Mumps Diphtheria Poliomyelitis Haemophilus influenzae type b infections Measles Meningococcal meningitis Rubella Pneumococcal infections Influenza Tetanus Hepatitis A Tuberculosis Hepatitis B Typhoid fever Rabies Cholera Japanese encephalitis and against one eradicated disease (*) This vaccine is produced in response to the Chickenpox Smallpox (*) threat of bioterrorism using strains of the smallpox virus.
  • 19. Creating VaccinesProtecting Life
  • 20. Back-up Slides
  • 21. Influenza Vaccine Manufacturing Timeline Northern HemisphereDec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Strain Selection Annual License FDA Produce & Approval Standardize Reagents Vaccination WHO Surveillance & Reassortants Production Strain Production (at risk) Balancing Production (may be at risk) Formulation Produce Production Working Seed Filling & Packaging Distribution
  • 22. The A(H1N1) 2009 Pandemic: Key dates 250 14000 12000 200 First case in Europe Epidemic 10000 150 27 New influenza A virus First case in Africa 8000 identified by CDC in samples from Mexico 02 6000 100 and USA First case in Asia 208 countries and territories 24 02 reported cases 4000 50 11 2000 Apr 09 May 09 Jun 09 Jul 09 Aug 09 Sep 09 Oct 09 Nov 09 Dec 09 Jan 10 Who / CDC / ECDC 26 26 WHO: Level of influenza pandemic alert WHO: recommended WHO, CDC, ECDC 24 strain for any vaccine Stop reporting the WHO: A/California/7/2009 (H1N1)-like virus from phase 3 to 4 A/California/7/2009 (H1N1)v number of cases recommended for 2010 southern 27 11 07 hemisphere seasonal influenza vaccines WHO: Level of influenza WHO: Level of influenza WHO, ACIP, ECDC pandemic alert pandemic alert List of priority groups from phase 4 to 5 from phase 5 to 6 for pandemic vaccinationVaccine Manufacturing 23 13 and registration 26 15 European Medicines Agency recommends 3 A(H1N1) French Afssaps licensed Sanofi Pasteurs Sanofi Pasteur began large-scale production US FDA licensed Sanofi Pasteurs 2009 pandemic vaccines pandemic influenza non-adjuvanted vaccine of the novel H1N1 vaccine in the US and France pandemic influenza vaccine for an EU-wide marketing 29 1-8 Sanofi Pasteur announced preliminary results Sanofi Pasteur begins shipping from US and European clinical trials in adults pandemic influenza vaccine in US following one dose of influenza A (H1N1) 2009 vaccine Vaccination campaign 09 21 Vaccination campaign China: first country to start 20 began in Russia pandemic vaccine immunization, in students Vaccination campaign began in France and UK 30 05 Vaccinatiion campaign Vaccination campaign began in Australia began in the USA
  • 23. Public Health Impact of Influenza Disease Numbers of Excess Pneumonia & Influenza Virus Epidemics Hospitalizations (US, 1969-95) A/H1N1 2 35,000-49,000 A/H3N2 12 85,000-220,000 B 4 56,000-114,000 Mean Annual Numbers of Deaths (US, 1976-99) Pneumonia & Respiratory & Virus All Causes Influenza Circulatory A/H1N1 381 1960 2836 A/H3N2 6613 28940 40017 B 1103 5255 8349 Simonsen, et al., JID 2000;181:831 Thompson, et al., JAMA 2003;289:179