1. Candidate Vaccine Strains and Potency Reagents, 2009-2010 Season Rajesh K. Gupta, Ph.D. Deputy Director, Division of Product Quality OVRR, CBER, FDA Prepared for Prepared for Vaccines and Related Biological Products Advisory Committee Advisory Committee 18 February 2009

2. Influenza A (H1N1) Current vaccine (2008-09 season) strain: A/Brisbane/59/ 2007-like virusCurrent vaccine (2008-09 season) strain: A/Brisbane/59/ 2007-like virus –IVR-148 Reassortant –Reagents available from CBER, NIBSC, TGA WHO Recommended strain for 2009-10: No Change, A/Brisbane/59/2007 like virusWHO Recommended strain for 2009-10: No Change, A/Brisbane/59/2007 like virus –Continue with 2008-09 Season Reagents (Limited Amounts Available) –Calibrate New Lots against 2008-09 Season Reagents to maintain Continuity

3. Influenza A (H3N2) Current vaccine (2008 – 09 season )strain: A/Brisbane/10/2007-like virusCurrent vaccine (2008 – 09 season )strain: A/Brisbane/10/2007-like virus –A/Uruguay/716/2007, Reassortant NYMC X175C used in vaccine –Reagents available from CBER, NIBSC WHO Recommended strain for 2009-10: No Change, A/Brisbane/10/2007 like virusWHO Recommended strain for 2009-10: No Change, A/Brisbane/10/2007 like virus –Reagents for A/Uruguay/716/2007 & A/Brisbane/10 Available from 2008-09 Season (Limited Amounts) –Calibrate New Lots of A/Uruguay against 2008-09 Season Reagents to maintain Continuity

4. Influenza B Current vaccine (2008-09 season) strain: B/Florida/4/2006-like virusCurrent vaccine (2008-09 season) strain: B/Florida/4/2006-like virus –B/Brisbane/3/2007 & B/Florida/4 used in vaccine –Reagents available from CBER, NIBSC WHO Recommended strain for 2009-10: B/Brisbane/60/2008 -like virusWHO Recommended strain for 2009-10: B/Brisbane/60/2008 -like virus –Possible candidates: B/Brisbane/60/2008; B/Brisbane/33/2008 –Potency Reagents: Available from CBER – May 2009