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Influenza Vaccine Manufacturing. Industry Perspective for 2011-2012 Vaccine Supply. 2010-2011 Influenza Vaccines. Highly successful manufacturing campaign More doses distributed than ever before Mid-season indications of significantly increased uptake Timely strain selection by VRBPAC

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Influenza Vaccine Manufacturing

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Influenza vaccine manufacturing l.jpg

Influenza Vaccine Manufacturing

Industry Perspective for 2011-2012 Vaccine Supply

VRBPAC 25 February 2011


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2010-2011 Influenza Vaccines

  • Highly successful manufacturing campaign

    • More doses distributed than ever before

    • Mid-season indications of significantly increased uptake

  • Timely strain selection by VRBPAC

    • Strong production numbers despite moderate yields

  • Challenges

    • Completion of pandemic influenza vaccine production

    • Delayed release for some manufacturers due to late information regarding tip caps

    • Inconsistent SRID potency values for some manufacturers when using reagents from different sources

VRBPAC 25 February 2011


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Significant Immunization Growth in 2010-11 to 19% Overall

  • Pediatric immunization had ~18% growth

  • Adult immunization had ~24% growth

  • 65+ immunization had ~14% growth after 20% decrease in 2009 as a result of H1N1 prioritization

With supply now far exceeding demand, opportunity for immunization growth is greatly improved

Sources: Surveillance Data Inc., CDC Distribution and Vaccination Data, and internal supply estimates

VRBPAC 25 February 2011


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Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Strain Selection

FDA

Annual

License

Approval

Surveillance &

Reassortants

Vaccination

WHO

Production

(at risk)

Strain

Balancing

Production

(may be at risk)

Formulation

Production

Filling &

Packaging

Distribution

Influenza Vaccine Manufacturing Timeline

Produce &

Standardize Reagents

Production

Produce

Working

Seed

VRBPAC 25 February 2011


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Influenza Vaccine ManufacturingCritical Factors

  • Objective: Distribution & Administration of influenza vaccines prior to peak season

  • Global timing of strain selection

    • Ensures timely availability of very large quantities of vaccines while manufacturers accept some risk by starting production early

    • Requires consideration of strain surveillance, selection timing, and impact to vaccine availability

    • Allows final development of working seeds that require a minimum of 4 weeks from receipt of a viable candidate virus through release prior to use in large-scale manufacturing

    • Minimizes impact of constraints imposed by the least productive monovalent strain candidate

  • Availability of Potency Test Reagents

    • Lengthy process of preparation and standardization

    • Linked to global timing of strain selection for new strains

    • Constrains start of formulation of finished vaccine

VRBPAC 25 February 2011


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2011-12 NH Current Manufacturing Status

  • Production initiated by most manufacturers “at risk” to ensure timely supply

  • H1N1: A/California/7/2009–like

    • A/California/7/2009 X-179A

    • A/California/7/2009 X-181

    • A/Christ Church/16/2010 NIB-74

  • H3N2: A/Perth/16/2009–like

    • A/Victoria/210/09 X-187

VRBPAC 25 February 2011


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B-Strain Candidates for TIV & LAIV

  • B Victoria-lineage candidates

    • B/Brisbane/60/2008 (CBER reagents)

    • B/Brisbane/60/2008 BX-35 (NIBSC reagents)

  • B Yamagata-lineage candidates

    • B/Hubei-Wujiagang/158/2009 BX-39 (no reagents available)

  • Some manufacturers are developing a quadrivalent influenza vaccine that includes a second B-Strain

VRBPAC 25 February 2011


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Industry Agency Shared Responsibility is necessary for Successful Influenza Vaccine Production & Supply

  • Communication

    • Continued timely sharing of surveillance and candidate virus information

  • Strain selection

    • Timely review and selection of the appropriate viral strains

    • Balanced consideration of strain surveillance, selection timing, and impact to vaccine availability

  • Virus availability: rapid availability of wild-type viruses and reassortants

    • Access to wild-type viruses to reassortant labs (NYMC, NIBSC, CSL, MedImmune, etc) is rate-limiting step

    • Opportunity for manufacturers to evaluate growth characteristics of potential strain candidates

    • Availability of potency test reagents for new strains by June

  • Vaccine approval and release

    • Timely approval of Annual License Supplement

    • In-Season Lot review and release process

VRBPAC 25 February 2011


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