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Influenza A (H1N1) Vaccine

Influenza A (H1N1) Vaccine. Vaccines and Related Biological Products Advisory Committee Meeting, 23 July 2009 Raburn Mallory, M.D. Proprietary. Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD. Overview.

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Influenza A (H1N1) Vaccine

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  1. Influenza A (H1N1) Vaccine Vaccines and Related Biological Products Advisory Committee Meeting, 23 July 2009 Raburn Mallory, M.D. Proprietary Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD

  2. Overview • Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal • Clinical studies planned and data availability • Manufacturing plans and vaccine availability Proprietary 2 Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD eSlide - P4815 - MedImmune Template

  3. MedImmune’s 2009monovalent live influenza A (H1N1) vaccine • Intranasal delivery using a pre-filled single dose AccuSpray™device • 0.2 mL/dose (0.1 mL in each nostril) • Contains no preservative or adjuvants • Dose is fixed at 107±0.5 FFU/strain • Clinical efficacy studies conducted with trivalent seasonal vaccine, FluMist, used to establish dose for H1N1monovalent vaccine • FluMist replicates intranasally to generate a broad immune response • Cellular • Humoral • Mucosal • High levels of efficacy seen in studies with trivalent FluMist • HAI titers not correlated with protection Proprietary 3 Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD eSlide - P4815 - MedImmune Template

  4. Clinical studies of our H1N1 vaccine are based on annual strain change procedure • 7 previous annual clinical studies conducted in adults to incorporate new strains into trivalent seasonal vaccine, FluMist • Safety from studies used to allow strain change to proceed • Two concurrent placebo-controlled clinical studies planned • MI-CP215: Healthy adults 18-49 years of age (n = 300) • MI-CP217: Healthy children 2-17 years of age (n = 300) • Design and randomization • 2 dose schedule (107±0.5 FFU/dose) delivered 1 month apart • Subjects randomized 4:1 (vaccine:placebo) • Subjects randomized 1:1 to have blood drawn 14 or 28 days after first dose • Objectives • Demonstrate attenuation by evaluating fever rates • Evaluate solicited symptoms and adverse events • Evaluate serum immune responses after each dose Proprietary 4 Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD eSlide - P4815 - MedImmune Template

  5. Timing of data availability from studies* * Timing reflects best case scenario of first subject in on August 17th and no unexpected events occurring during study conduct or data analysis Proprietary 5 Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD 04/14/2008 – 6:00pm eSlide - P4815 - MedImmune Template

  6. Manufacturing progress and key regulatory milestones • A 6:2 reassortant virus made using reverse genetics 11 May 2009 • 23 separate variants evaluated • Master virus seed selected for commercial manufacture 25 June 2009 • Yields appear consistent with normal seasonal strains • Antigenically similar to CDC recommended strain • Commercial scale manufacturing initiated 03 July 2009 • Key regulatory milestones • Submission of strain change supplement • Review and release of H1N1 lots • Review and approval of second high speed fill line

  7. Bulk doses released Filled doses released Timing of vaccine availability from manufacturing* Projected availability of influenza A (H1N1) bulk and filled doses by month Millions of doses, cumulative Aug Sept Oct Nov Dec Jan Feb Mar Fill line 2 approval Vaccine availability limited by delivery device supply constraints • Finished product capacity = ~40M filled doses • Limitation is availability of sprayers (from now until March 2010) • Bulk capacity at current growth rates = ~200M doses * Availability of doses is based on current manufacturing schedule for having QC released doses available and is not linked to FDA release

  8. Acknowledgements • This project has been funded in whole or in part with Federal Funds from the HHS/ASPR/BARDA, under Contract No. HHSO100200900002I • The content of this publication does not necessarily reflect the view or policies of the Department of Health and Human Services, nor does the mention of the trade names, commercial products or organizations imply endorsement by the U.S. Government. Proprietary 8 Vaccines and Related Biological Products Advisory Committee meeting, 23July 2009, Gaithersburg MD eSlide - P4815 - MedImmune Template

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