Candidate Vaccine Strains and Potency Reagents, 2009-2010 Season Rajesh K. Gupta, Ph.D. Deputy Director, Division of Product Quality OVRR, CBER, FDA Prepared.

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Candidate Vaccine Strains and Potency Reagents, 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

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

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 : No Change, A/Brisbane/10/2007 like virusWHO Recommended strain for : No Change, A/Brisbane/10/2007 like virus –Reagents for A/Uruguay/716/2007 & A/Brisbane/10 Available from Season (Limited Amounts) –Calibrate New Lots of A/Uruguay against Season Reagents to maintain Continuity

Influenza B Current vaccine ( season) strain: B/Florida/4/2006-like virusCurrent vaccine ( 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 : B/Brisbane/60/2008 -like virusWHO Recommended strain for : B/Brisbane/60/2008 -like virus –Possible candidates: B/Brisbane/60/2008; B/Brisbane/33/2008 –Potency Reagents: Available from CBER – May 2009