MastrVrusSed Pep Vrus Reference Sain Pep Clinical InvestigationalLotMf ClinicalIsolatonSmple Vaccine Distribution Administration C o m m e r c i a l S c a l e B u l k A n t i g e n M anufactur ID: 848886
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1 U.S. 2009-H1N1 Vaccine StrategyVer 20_05
U.S. 2009-H1N1 Vaccine StrategyVer 20_05-18-09 MastrVrusSed Pep. Vrus Reference Sain Pep. Clinical InvestigationalLotMf ClinicalIsolatonSmple Vaccine Distribution & Administration C o m m e r c i a l S c a l e B u l k A n t i g e n M anufacturing With Adjuvant Ptncy Assay Reagentep.andCalibraton Sasonal Flu Vccine Formulaton/Fill Finish anufctring – NH Clinical dies Antigen and Adjuvant Seasonal FluNorthernHemisphere2009-10 SeasonSeasonal FluSouthern Hemisphere2009U.S. Congressional Summer Recess H1N1 2nd Wave VACCINE DEVELOPMENT Immunization Planning Determination of virus severity and transmissibility in populationsJan 10FebSept 9Oct 9Nov9Aug9Jun9Apr9Mar9 Bulk Adjuvant Manufacturing H1N1 1st Wave Monitoring Effectiveness & Safety Vccine Manufacturing Commercial Scale Syringe/Needles Vccine Formulaton ill-inish Manufctring – SHSasonal Flu Vccine Commercial Sale ulk Antgen Manufacturing Without Adjuvant D e c is io n 2 - est. Sept 15th Procurement Procurement of bulk antigen for stockpile started (5/09) and decision to Decision to Decision to start the v Decision to Decision 3 8 7a 6 7b 4b 5 4a 2 1 6 4a 6 7aDecisio 1: $6.9 B- Procurement of bulk adjuvant, bulk antigen, and syringes/needles ($6.4 B)- Letters of intent to manufacturers - Phase one of vaccine immunization planningPrior Decisions: $800M- Vaccine Development ($150M) Production of clinical investigational vaccine lots, clinical studies, and potency assay reagent production- Commercial Scale Up ($650M)D e c i s i o n 3 - est. Oct 15th Decision 3: $3.9 - $4.3B- Fund immunization program ($3.9B -$4.3B)- Initiate immunization programD e c i s i o n 1 - June 1st Ver 20_05-18-09 Decision 2 - est. Sept 15thDecision 2: $1.6B1. Develop a H1N1 vaccine Virus Reference Strain/Clinical Studies 2. 3. Procurement of bulk adjuvant for stockpile started and decision to purchase4a. Procurement of bulk antigen for stockpile started (5/09) and decision to4b. Seasonal flu vaccine bulk manufacturing will finish ~Aug 1st 5. Decision to procure mass quantities of syringes/needles decision by June 1st6. Decision to start the vaccine formulation, upon completion of clinical studies 7a. Decision to move forward with vaccine formulation/fill-finish manufacturing (? Oct 15th)7b. Seasonal flu vaccine fill-finish manufacturing campaign will finish ~ Oct 31st8. Decision to Immunize the nation (? Sept 15th)Decision 1: $6.9 BDecision 3 - est. Oct 15thDecision 3: $3.9 - $4.3BDecision 1 - June 1st Isolation U.S. 2009-H1N1 Vaccine Strategy Determination of virus severity and transmissibility in populations Epidemiology of the Virus VACCINE DEVELOPMENT U.S. Clinical Virus Congressional Sample Reference Summer Recess Strain Prep. MasterVirus Seed Prep. ClinicaLot Mfg. Clinical Studies Antigen and Adjuvant Vaccine Manufacturing Potency Assay Reagents Prep. and Calibration Commercial Scale Bulk Antigen Manufacturing Without Adjuvant Commercial Scale Bulk Antigen Manufacturing With Adjuvant H1N1 2nd Wave Bulk Adjuvant Manufacturing Vaccine Formulation Fill-Finish Commercial Scale Syringe/Needles H1N1 1st Wave Vaccine Distribution & Administration ? Immunization Planning Monitoring Effectiveness & Safety Seasonal Flu Vaccine Seasonal Flu Vaccine Manufacturing – SH Seasonal Flu Vaccine Formulation/Fill Finish Manufacturing – NH Bulk Antigen M Seasonal Flu Northern Seasonal Flu Hemisphere Southern Hemisphere 2009-10 Season 2009 Mar 09 Apr 09 May 09 Jun 09 Jul 09 Aug 09 Sept 09 Oct 09 Nov 09 Dec 09 Jan 10 Feb 10