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Pandemic (H1N1) 2009 Influenza Vaccine Manufacturing Considerations

Pandemic (H1N1) 2009 Influenza Vaccine Manufacturing Considerations. Vaccines and Related Biological Products Advisory Committee (7/23/2009) Jerry P. Weir, Ph.D., Director Division of Viral Products/OVRR/CBER/FDA. Emergence of the Pandemic (H1N1) 2009 Virus and Vaccine Recommendation.

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Pandemic (H1N1) 2009 Influenza Vaccine Manufacturing Considerations

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  1. Pandemic (H1N1) 2009 Influenza VaccineManufacturing Considerations Vaccines and Related Biological Products Advisory Committee (7/23/2009) Jerry P. Weir, Ph.D., Director Division of Viral Products/OVRR/CBER/FDA

  2. Emergence of the Pandemic (H1N1) 2009 Virus and Vaccine Recommendation • On May 26 2009, WHO released a recommendation for development of vaccines against the pandemic (H1N1) 2009 virus “The majority of the novel influenza A (H1N1) isolates are antigenically and genetically related to the A/California/7/2009 (H1N1)v virus. Should vaccines be prepared against the novel influenza A (H1N1) virus, it is therefore recommended that vaccines contain the following: - An A/California/7/2009 (H1N1)v -like virus”

  3. Reference Strains for Pandemic (H1N1) 2009 Vaccine Development • Currently available reference strains • Classical reassortants - NYMC X-179A & CSL IVR-153 • RG reassortants - A/Texas/05/2009-IDCDC-RG15, A/California/07/2009-NIBRG121) and A/California/04/2009 (H1N1)v-PR8-CBER-RG2 • The ferret safety testing for X-179A, IVR-153, RG15 and NIBRG121 has been completed. Tests on other reassortants not needed per WHO guidance • Reassortants for LAIV produced by manufacturers • All reference strains are A/California/7/2009 (H1N1) –like • Both classical and reverse genetic reassortants are acceptable for vaccine production

  4. Virus Yields from Pandemic (H1N1) 2009 Reference Strains • Development work has indicated that existing reference strains have an expected yield of around 30% of H1N1 seasonal vaccine strains • Potential reduction in current global vaccine production capacity estimates • Manufacturers have expressed a need for better yielding vaccine strains • Additional reassortants in preparation, some being derived from other wild type strains (e.g., A/England/195/2009, A/New York/18/2009) • Reference strains under development are A/California/7/2009 (H1N1) –like • No expectation that significantly better yields will result • If higher yielding strains are found, additional clinical trials likely not to be needed

  5. Potency Reagents for Pandemic (H1N1) 2009 Influenza Inactivated Vaccines • Potency of inactivated influenza vaccines (μg/dose of hemagglutinin (HA) determined by SRID and standardized using reagents supplied by regulatory agencies • Reference antiserum is strain-specific • Production begins when the new HA is prepared for immunization; high titer antiserum requires multiple injections • Pandemic (H1N1) 2009 HA for injection difficult to isolate • Reference antigen is inactivated whole virus to which an HA value is determined by the collaborating WHO Essential Reference Laboratories (CBER, NIBSC, TGA, NIID) • Production is at industrial scale and requires manufacturers to be in production using a candidate vaccine reference strain

  6. Timelines for Availability of Pandemic (H1N1) 2009 Potency Reagents • Reference antiserum available from NIBSC (UK) and sent to other WHO ERLs (CBER, TGA, NIID) early July • Reference antigen available from TGA (Australia) and sent to other ECLs (NIBSC, CBER, NIID) early July • Calibration and assignment of antigen value for the initial reference antigen ongoing • Target date – end of July • Can be used to evaluate clinical trial material • Reference antigen for US manufacturers end of July • Will be bridged to TGA antigen by SRID in-house and with small set of collaborating laboratories (not WHO ECL network) • Preparation of reference antiserum for US manufacturers underway • Specificity and optimization being evaluated

  7. Availability of Pandemic (H1N1) 2009 Potency Reagents and the Initiation of Clinical Trials • Due to the urgency of the pandemic situation, formulation of vaccine for clinical trials is needed before potency reagent calibration is finalized • Flexible approach is being taken to allow the use of alternative methods (e.g., HPLC) for potency determination of initial vaccine lots used in clinical trials • Manufacturers will test all vaccine lots by SRID when reference standards become available • Vaccine lots will undergo usual testing and lot release procedures

  8. Summary • Emergence of Pandemic (H1N1) 2009 influenza virus has presented numerous challenges for vaccine manufacturing • Some challenges expected as a result of extensive pandemic preparedness planning (e.g., switchover and scale-up; development of reference strains and reagents, biocontainment procedures) • Some challenges unique to the Pandemic (H1N1) 2009 influenza virus (e.g., low yields even after reassortant, difficulty in isolation of HA for antiserum production) • Extraordinary interaction and cooperation among manufacturers, public health agencies and national regulatory authorities to address difficulties encountered

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