【甲流H1N1精品课件】 CBER Regulatory Approaches.ppt

INES AND RELATEDBIOLOGICAL PRODUCTS MITTEE
CBER Regulatory Approaches & Activities
To Support Licensure of
Pandemic (H1N1) 2009 ine
Wellington Sun, MD
Director, Division of ines and Related Products Applications
CBER/FDA
July 23, 2009
Presentation Outline
Background
ine licensure pathways
Clinical trial design
Emergency use authorization (EUA)
Summary
Pandemic (H1N1) 2009 ine Considerations
New triple human, swine, avian reassortant
Sustained transmission outside normal flu season
Low antibody level and higher attack rate among children/adolescents
Cross-reactive antibody in >60 yo suggesting the older population may be primed
Recent seasonal ines unlikely to afford protection
Multiple ine options available
Currently Licensed Influenza ines in .
Seasonal Afluria (CSL) Inactivated ≥ 18 yo
Fluarix (GSK) Inactivated ≥ 18 yo
FluLaval (ID Biomed) Inactivated ≥ 18 yo
Fluvirin (Novartis) Inactivated ≥ 4 yo
Fluzone (SP) Inactivated ≥ 6 mo FluMist (MedImmune) LAIV 2-49 yo
Pandemic H5N1 (SP) (Inactivated) 18-64 yo
Available Regulatory Pathways for use of Pandemic (H1N1) 2009 Influenza ine
New BLA
Supplement to seasonal license
Emergency Use Authorization (EUA)
Treatment IND
Licensure of Unadjuvanted Monovalent Pandemic (H1N1) 2009 ines Made by Licensed Process
Manufacturers will submit a supplement to their seasonal influenza biologics license for the pandemic (H1N1) 2009 ine analogous to seasonal strain change supplement.
Licensure of Unadjuvanted Monovalent Pandemic (H1N1) 2009 ines Made by Licensed Process
Strain change supplement without new clinical data at the time of licensure relies on:
Nonclinical, CMC information
Clinical data in the BLA for seasonal influenza ine
Age range, dose and dosing regimen for the pandemic (H1N1) 2009 ine will be the same as for each licensed seasonal ine
ine will be formulated at 15 mcg/dose of HA for inactivated, - FFU/dose for LAIV
Applicable to non-adjuvanted ines only, when manufactured by the