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Influenza Vaccine Manufacturing

Influenza Vaccine Manufacturing. Industry perspective for 2013-2014 influenza vaccine supply.

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Influenza Vaccine Manufacturing

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  1. Influenza Vaccine Manufacturing Industry perspective for 2013-2014 influenza vaccine supply The FDA CBER requested this annual summary of information from influenza vaccine manufacturers supplying the U.S., for purposes of a general presentation to the VRBPAC. This summary has been prepared  from a variety of public sources, and was reviewed by GSK, Sanofi-Pasteur, Novartis, CSL, and MedImmune.   VRBPAC, 27 February 2013

  2. Northern Hemisphere Influenza Vaccine Strain Changes VRBPAC, 27 February 2013

  3. 2012-2013 Influenza Vaccine Production • Successful manufacturing campaign • Timely strain recommendation by VRBPAC for the 2012-13 season: • Trivalent commercial vaccines should contain two new strains • A/Victoria/361/2011 (H3N2)-like and B/Wisconsin/1/2010-like (Yamagata lineage) • Quadrivalent investigational vaccines should contain the additional B/Brisbane/60/2008-like strain (Victoria lineage) strain • Challenges • Late identification of new H3N2 strain (late flu season, H3N2 strains increasingly difficult to isolate in eggs) • At the time of the 2012 VRBPAC meeting IIV manufacturers had not received the H3N2 Victoria IIV reassortant, and LAIV manufacturer had not received the wild-type strain for reassortant production • Manufacturing seeds not available • No opportuity to evaluate/optimize vaccine strain in manufacturing processes • Manufacturing of 3rd strain started later than usual • H3N2 antigen and calibrated reagents were available later than usual • CBER commitment to providing reagents and transparency regarding timing of reagent availability facilitated planning of manufacturing activities VRBPAC, 27 February 2013

  4. Influenza Manufacturing Cycle Produce Reassortants Produce & Standardize Reagents Annual License Approval Select Vaccine Strain(s) WHO-FDA Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Produce Working Seeds (3 strains) Formulation, Fill, Packaging of Trivalent Vaccine Manufacture Strain 1 Strain Balancing Manufacture Strain 2 Strain Balancing Manufacture Strain 3 Strain Balancing Distribution

  5. Influenza Vaccine ManufacturingCritical Factors • Global timing of strain selection ensures large vaccine supply • Available time to manufacture influenza vaccine is determined by • Need to distribute & administer vaccine before the peak season • Availability of last vaccine strain • To ensure timely availability of influenza vaccine, manufacturing of one strain starts at risk before final strain composition is made • Productivity of the least productive monovalent strain determines supply quantity • Availability of Potency Test Reagents • Complex process to prepare and standardize potency reagents for new strains • Linked to global timing of strain selection for new strains • Availability of calibrated reagents determines start of influenza vaccine formulation VRBPAC, 27 February 2013

  6. Examples of Vaccine Strains under Consideration/Evaluation for 2013-2014 NH Vaccine • H1N1: A/California/7/2009-like • *A/California/7/2009 and reassortants (IIV and LAIV) • A/Christchurch/16/2010 and reassortants (IIV) • H3N2: *A/Victoria/361/2011-like • A/Texas/50/2012 and reassortants (IIV and LAIV) * Indicates most recent H1N1pdm and H3N2 vaccine strains VRBPAC, 27 February 2013

  7. Examples of Vaccine Strains under Consideration/Evaluation for 2013-2014 NH Vaccine • B Yamagata lineage: • B/Massachusetts/2/2012 and reassortants (IIV and LAIV) • B Victoria lineage (for quadrivalent vaccines): • *B/Brisbane/60/2008 and reassortants (IIV and LAIV) • B/Nevada/3/2011 and reassortants (IIV and LAIV) • B/Hong Kong/259/2010 and reassortants (IIV) • *Indicates most recent Victoria lineage vaccine strain VRBPAC, 27 February 2013

  8. Influenza Manufacturing Cycle Produce Reassortants Produce & Standardize Reagents Annual License Approval Select Vaccine Strain(s) WHO-FDA Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Produce Working Seeds (3 strains) Formulation, Fill, Packaging of Trivalent Vaccine Manufacture Strain 1 Strain Balancing Manufacture Strain 2 Strain Balancing Manufacture Strain 3 Strain Balancing Distribution

  9. Shared Responsibility of Public and Private Sectors • Timely communication of surveillance data and new candidate viruses • Timely selection of vaccine strains, considering antigenic match and growth potential • Early access of all reassortant labs (NYMC, NIBSC, CSL, MedImmune, others) to wild-type viruses for reassortant production • Opportunity for manufacturers to evaluate growth potential of candidate strains • Time for CDC to certify antigenic properties of new candidate strains • Availability of potency test reagents for new strains by May/June • Timely approval of Annual License Supplement • Lot review and release • Collaboration on key initiatives (e.g., improved SRID assay, alternative potency assays, cell culture isolates, synthetic seeds) • Information sharing during telephone conferences, chaired by ERL or WHO, between WHO CCs, ERLs, reassortant producers and manufacturers has been key in challenging situations (e.g. 3 strain changes in one season) VRBPAC, 27 February 2013

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