1 Vaccines and Related Biological Products Advisory Committee Meeting FluBlok ® : Influenza Vaccine, Recombinant Hemagglutinin Applicant: Protein Sciences.

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Presentation transcript:

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 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 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 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 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 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 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