1. 1 Vaccines and Related Biological Products Advisory Committee Meeting FluBlok ® : Influenza Vaccine, Recombinant Hemagglutinin Applicant: Protein Sciences Corporation (PSC) Rakesh Pandey, Ph.D. November 19, 2009

2. 2 FluBlok  Each 0.5 ml dose contains: 45 μg of each rHA antigen in sterile phosphate buffered saline (PBS) containing 0.005% Tween 20, without preservative, adjuvant, or antibiotics. The vaccine is stored at 2°C to 8°C.  Proposed Indication: for active immunization of adults 18 years of age and older against seasonal influenza disease caused by influenza virus subtypes A and type B represented in the vaccine.

3. 3 Clinical Overview Data from four clinical trials (1 phase II, 3 phase III) submitted in support of approval of the 45μg/strain dose. Two placebo-controlled and two active-controlled trials. Safety population: 3233 FluBlok recipients 23% ≥ 50 years of age; 13% ≥ 65 years of age. Vaccine efficacy population: 2344 FluBlok recipients 100% 18 to 49 years of age. Immunogenicity population: 1323 FluBlok recipients 55% ≥ 50 years of age; 32% ≥ 65 years of age.

4. 4 Regulatory History October 23, 2004 IND submitted December 11, 2006Fast track request granted September 21, 2007Pre-BLA meeting with PSC April 18, 2008Original BLA submitted requesting accelerated approval. August 29, 2008Complete Response letter (CRL) April 28, 2009Response to CRL submitted with additional data on Clinical Efficacy

5. 5 Today’s Agenda 9:15 a.m.FDA IntroductionRakesh Pandey, Ph.D., CBER 9:30Sponsor PresentationManon Cox, Ph.D. M.B.A. John Treanor, M.D. 11:00Break 11:10FDA PresentationCynthia Nolletti, M.D., CBER 12:30 p.m.Lunch 1:30Open Public Hearing 2:00FDA Presentation of Questions Rakesh Pandey, Ph.D., CBER 2:15Committee Discussion and Recommendations

6. 6 1.Do the available clinical data support an indication for FluBlok in the prevention of influenza disease caused by influenza subtypes A and type B included in the vaccine in adults:  a. 18 to 49 years of age;  b. 50 to 64 years of age;  c. 65 years of age and older? Questions for the Committee

7. 7 2. Do the available safety data support the safety of FluBlok in adults 18 years and older? 3.Please comment on what additional studies, if any, should be requested post-licensure. Questions for the Committee