FDA Presentations

• The Public Health Need for Pandemic Influenza Vaccines (PPT - 1.2MB)
  Jesse L. Goodman, M.D., M.P.H.
• Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (Q-Pan H5N1 Vaccine) Manufactured by GlaxoSmithKline (PPT - 1.2MB)
  Carmen M. Collazo-Custodio, Ph.D.
• Vaccine Adjuvants & Mode of Action for GSK’s AS03 Adjuvanted Influenza A (H5N1) Virus Monovalent Vaccine (PPT - 1.9MB)
  Hana Golding, Ph.D.
• Clinical Review of Data Supporting the Immunogenicity, Safety and Effectiveness of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (PPT - 1.5MB)
  Andrea James, M.D.
• Hepatitis B Vaccine (Recombinant), Adjuvanted (HBV Surface Antigen (HBsAg) Protein with 1018 ISS (CpGs))(HEPLISAV (PPT - 224KB)
  Marian Major, Ph.D.
• Hepatitis B Vaccine (Recombinant), Adjuvanted (HEPLISAV): Review of Immunogenicity (PPT - 519KB)
  Alexandra S. Worobec, M.D., M.S.
• Hepatitis B Vaccine (Recombinant), Adjuvanted (HEPLISAV): Review of Safety (PPT - 1.1MB)
  Lorie Smith, M.D., M.H.S.

Non-FDA Presentations

Persons with disabilities having problems accessing the any file below may call 301-827-0314 for assistance.

• Topic I: GSK Presentation and Backup Slides Presented (PPTX - 1.9MB)
  Donna Boyce, Head North America, Global Regulatory Affairs, GlaxoSmithKline Vaccines
• Topic II: Dynavax Presentation and Backup Slides Presented (PDF - 839KB)
  Dynavax Technologies Corporation, November 15, 2012, White Oak
• US Government Programs and Goals for Antigen-Sparing Pandemic Monovalent Vaccines (PPTX - 1.4MB)
  Robin Robinson, Ph.D., BARDA/HHS
• Pandemic Vaccine Effectiveness; Experience during H1N1 Pandemic (PPT - 7.9MB)
  Joseph Bresee, M.D., CDC