1 / 7

Candidate Vaccine Strains and Potency Reagents for 2012-13 Influenza Season

Candidate Vaccine Strains and Potency Reagents for 2012-13 Influenza Season. Rajesh K. Gupta, Ph.D. Deputy Director, Division of Biological Standards & Quality Control Lab Chief, Lab of Biochemistry, Virology & Immunochemistry OCBQ, CBER, FDA Prepared for

lyn
Download Presentation

Candidate Vaccine Strains and Potency Reagents for 2012-13 Influenza Season

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Candidate Vaccine Strains and Potency Reagents for 2012-13 Influenza Season Rajesh K. Gupta, Ph.D. Deputy Director, Division of Biological Standards & Quality Control Lab Chief, Lab of Biochemistry, Virology & Immunochemistry OCBQ, CBER, FDA Preparedfor Vaccines and Related Biological Products Advisory Committee 28 February 2012

  2. Influenza A (H1N1) • Current Vaccine (2011–12 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 2012–13: No Change from 2011–12 Strain

  3. CBER Authorized Reagents for H1N1 • Continue with Reagents from 2011–12 Season • Antibodies from NIBSC & CBER • X-179A Ref Antigen from CBER • X-181 Ref Antigen from CBER and TGA • NIB-74 Ref Antigen from NIBSC

  4. Influenza A (H3N2) • Current Vaccine (2011–12 Season) Strain: A/Perth/16/2009 like Virus • A/Wisconsin/15/2009 (NYMC 183); A/Victoria/210/2009 (NYMC 187) • Reagents Available from CBER, NIBSC • WHO Recommended Strain for 2012–13: A/Victoria/361/2011 like Virus • A/Victoria/361/2011 (IVR-165) • CBER Plans to Generate Reagents, if this Strain is Selected, Target Availability June 2012

  5. Influenza B • Current Vaccine (2011–12 Season) Strain: B/Brisbane/60/2008 like Virus (B/Victoria/2/87-lineage) • Vaccine Made from B/Brisbane/60/2008 • Reagents available from CBER • WHO Recommended Strain for 2012–13: B/Yamagata/16/88-lineage, B/Wisconsin/1/2010 like Virus • B/Hubei Wujiagang/158/09 (Wt, BX-39), B/Wisconsin/1/2010 (Wt, BX-41A), B/Texas/6/2011 (Wt), B/Stockholm/12/2011 (Wt) • Reagents for B/Hubei Wujiagang/158/09, BX-39, Available from CBER (Generated for Quadrivalent Formulations) • CBER Plans to Generate Homologous Ref Antigen, if this Strain is selected & Manufacturers Plan to Use Other Strains (e.g. B/Texas) • Target Availability June 2012

  6. Influenza B (Victoria Lineage) for Quadrivalent Formulations • WHO Recommended Second B Strain (B/Victoria/2/87-lineage) • B/Brisbane/60/2008 like Virus – Current B Strain • Reagents available from CBER, NIBSC, TGA • Use of Monospecific Antibodies Recommended • Significant Cross-Reactivity in CBER Generated Antibodies • Use of TGA/NIBSC Antibodies for B/Brisbane/60 • Efforts are Ongoing to Prepare Mono-specific sera for B/Brisbane/60 • Use of Reference Antigen • Use of Mixture of Reference Antigens for Both B Strains • Correction Factors are Not Recommended with Use of Specific Reference Antigen

  7. 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 Calibration of Adopted Reagents • CBER will Verify Availability and Acceptable Performance of Compatible Authorized Reagents with Manufacturer’s Vaccine Product • CBER will Make Every Effort to Assure Availability of Reagents Appropriate for all Strains Selected for Production of Vaccine

More Related