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Candidate Vaccine Strains and Potency Reagents for 2013-14 Influenza Season

Candidate Vaccine Strains and Potency Reagents for 2013-14 Influenza Season. Division of Biological Standards & Quality Control Laboratory of Biochemistry, Virology & Immunochemistry OCBQ, CBER, FDA Dr. Manju Joshi Prepared for Vaccines and Related Biological Products

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Candidate Vaccine Strains and Potency Reagents for 2013-14 Influenza Season

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  1. Candidate Vaccine Strains and Potency Reagents for 2013-14 Influenza Season Division of Biological Standards & Quality Control Laboratory of Biochemistry, Virology & Immunochemistry OCBQ, CBER, FDA Dr. Manju Joshi Prepared for Vaccines and Related Biological Products Advisory Committee 27 February 2013

  2. Influenza A (H1N1) • Current Vaccine (2012–13 Season) Strain: A/California/07/2009 like virus • X179A (classical), X181 (classical), NIBRG-121XP (RG) • A/Christchurch/16/2010, NIB-74 (classical) • WHO Recommended Strain for 2013–14: No change from 2012–13 Strain

  3. CBER Authorized Reagents for H1N1 • Continue with Reagents from 2012–13 Season • Antibodies from NIBSC & CBER • X-179A Reference Antigen from CBER, • X-181 Reference Antigen from CBER and TGA • NIB-74 Reference Antigen from NIBSC

  4. Influenza A (H3N2) • Current Vaccine (2012–13 Season) Strain: A/Victoria/361/2011-like Virus • A/Victoria/361/2011(IVR-165) • Reagents available from CBER, TGA • WHO Recommended Strain for 2013–14: A(H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011 • A/Texas/50/2012 (reassortants X-223 and X-223 A) • CBER plans to generate homologous reagents, if this strain is selected. Target availability June 2013

  5. Influenza B • Current Vaccine (2012–13 Season) Strain: B/Yamagata/16/88-lineage, B/Wisconsin/1/2010-like Virus • B/Hubei Wujiagang/158/09, B/Texas/6/2011 • Reagents available from CBER, NIBSC, TGA (Note: Anti B/Texas/6/2011 antiserum is now available from CBER) • WHO Recommended Strain for 2013–14: B/Yamagata/16/88-lineage, B/Massachusetts/2/2012-like Virus • CBER plans to generate homologous reagents, if this strain is selected. Target availability June 2013

  6. Influenza B (Victoria Lineage) for Quadrivalent Formulations • WHO Recommended Second B Strain (2012-13 Season): B/Victoria-lineage • B/Brisbane/60/2008-like Viruses • Reagents available from CBER, NIBSC, TGA, • WHO Recommended Second B Strain: B/Victoria-lineage • No Change from 2012-13 Season • Use of Reference Antigen • Use of mixture of Reference Antigens for Both B Strains • Correction Factors with use of Specific Reference Antigen are Not Recommended

  7. CBER Influenza Potency ReagentsSummary….1 • CBER authorized reagents should be used to test potency of vaccines marketed in the US. • Authorized reagents will either be produced by CBER or adopted by CBER for use. • CBER will collaborate with other ERLs in calibration of adopted reagents. • CBER will verify availability and acceptable performance of compatible authorized reagents.

  8. CBER Influenza Potency ReagentsSummary….2 • The use of reference antigen and reference antiserum (as a calibrated pair) from same source is desirable to avoid discrepancies. • Use of same reagents for Monovalent, Trivalent/ Quadrivalent formulations (and follow-up stability studies) for a particular lot is desirable. • CBER will make every effort to assure timely availability of reagents appropriate for all strains selected for production of vaccine.

  9. Challenges in Production of SRID Reagents • Generation of multiple reagent sets due to availability and selection from multiple strains and/or reassortants (e.g. H1N1, B) • Vaccines made in different substrates (Eggs, Cell Cultures or Recombinant) • Suitability of Egg based reagents needs to be evaluated for alternative production processes

  10. Use of Heterologous Reagents in SRID • Homologous Reagents for SRID Preferred • Homologous Reference Antigen - optimal • Heterologous Antibodies – May be acceptable • Homologous Reagents – Not Always Available • Takes 2 – 3 Months to generate & calibrate Ref Antigen • If Homologous Reference Antigen unavailable then heterologous reagents may be an option under the following conditions: • If performance evaluated (i.e. generates Parallel Lines with test sample and Re-calibrated, if necessary) • And Performance has been verified and authorized by CBER

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