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Candidate Vaccine Strains and Potency Reagents 2011-12 Season

Candidate Vaccine Strains and Potency Reagents 2011-12 Season. William M. McCormick, Ph.D. Director, Division of Product Quality OCBQ, CBER, FDA Prepared for Vaccines and Related Biological Products Advisory Committee 25 February 2011. WHO Recommended Strains for 2011-12.

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Candidate Vaccine Strains and Potency Reagents 2011-12 Season

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  1. Candidate Vaccine Strains and Potency Reagents2011-12 Season William M. McCormick, Ph.D. Director, Division of Product Quality OCBQ, CBER, FDA Prepared for Vaccines and Related Biological Products Advisory Committee 25 February 2011

  2. WHO Recommended Strains for 2011-12 WHO Recommended Strain for 2011-2012: [No change from 2010-2011 NH season] • H1N1 A/California/07/2009 like virus • H3N2 A/Perth/16/2009 like virus • B B/Brisbane/60/2008 like virus

  3. H1N1 Candidate Vaccine Viruses A/California/07/2009 - like

  4. CBER Reagents for Influenza A (H1N1)

  5. H3N2 Candidate Vaccine Viruses A/Perth/16/2009 - like

  6. CBER Reagents for Influenza A (H3N2)

  7. B Candidate Vaccine Viruses B/Brisbane/60/2008 -like

  8. CBER Reagents for Influenza B

  9. CBER Influenza Potency Reagents • Only CBER Authorized Reagents shall be Used to test potency of Vaccines Marketed in the US. • Authorized Reagents will be produced by CBER or adopted by CBER for use. CBER will collaborate in the calibration of adopted reagents. • CBER will verify availability and acceptable performance of compatible authorized reagents with each manufacturer’s vaccine product. • CBER will make every effort to assure availability of reagents appropriate for all strains selected for production of vaccine.

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