FDA Presentations: Day 1, Topic 1

• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (PPT - 125KB)
  Julienne Vaillancourt, R.Ph., M.P.H.
• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Primary Immunogenicity Endpoints for New Infant Pneumococcal Conjugate Vaccines (PPT - 199KB)
  Lucia H. Lee, M.D.
• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (PPT - 978KB)
  Tina Khoie, M.D., M.P.H
• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Pneumococcal 13-valent Conjugate Vaccine Post Licensure Pharmacovigilance and Vaccine Effectiveness Plans (PPT - 150KB)
  Robert Wise, MD, MPH
• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Questions for the Committee (PPT - 109KB)

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• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diptheria CRM197 Protein) (PPT - 17.8MB)
  Wyeth
• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Epidemiology of Pneumococcal Disease in the U.S. in the Conjugate Vaccine Era (PPT - 316KB)
  Matthew R. Moore, MD, MPH CDR, USPHS

FDA Presentations: Day 1, Topic 2

• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Safety Monitoring of 2009 Pandemic H1N1 Influenza Vaccines (PPT - 716KB)
  Hector Izurieta

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• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Enhanced Surveillance of Novel H1N1 Vaccines Among Military Personnel (PPT - 1MB)
  LTC Patrick Garman, PharmD, PhD
• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: The PRISM (Post-Licensure Rapid Immunization Safety Monitoring) System for H1N1 Vaccine (PPT - 227KB)
  Richard Platt, MD, MS
• November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Monitoring the Safety of Influenza A (H1N1) 2009 Monovaler Vaccines (PPT - 2.4MB)
  Claudia Vellozzi, MD, MPH

FDA Presentations: Day 2

• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: FluBlok®: Influenza Vaccine, Recombinant Hemagglutinin (PPT - 120KB)
  Rakesh Pandey, Ph.D.
• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Influenza Vaccine, Recombinant Hemagglutinin FluBlok Protein Sciences Corporation (PPT - 7.7MB)
  Cynthia Nolletti, MD
• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Influenza Vaccine, Recombinant Hemagglutinin FluBlok Protein Sciences Corporation (PPT - 2.1MB)
  Cynthia Nolletti, MD

Sponsor: Day 2

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• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: FluBlok® Protein Sciences Corporation Presentation (PPT - 4.5MB)
  Protein Sciences
• November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Advax Enhances Response to Pandemic Avian Influenza Vaccine (PPT - 253KB)
  Nickolai Petrovsky