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2006 Contract Awards for Cell-based Pandemic Vax

 
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Mixin



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PostPosted: Sun Jul 13, 2008 12:28 am    Post subject: 2006 Contract Awards for Cell-based Pandemic Vax Reply with quote

This is likely old news (except for the newer flubies).
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Contractor Awardee:
HHSO100200600010C, MedImmune, Gaithersburg, MD, $169,462,231;
HHSO100200600011C, GlaxoSmithKline, Phila., PA, $274,752,168;
HHSO100200600012C, Novartis, Emeryville, CA, $220,507,491;
HHSO100200600013C, DynPort Vaccine, Frederick, MD, $242,582,756
HHSO100200600014C, Solvay, Marietta, Georgia, $298,594,057

Also on this site is the soliticitation, 61 pdf. The awardees agree to perform the following activities over a 3 to 5 year period:
To conduct advanced stage development of cell- or recombinant-based seasonal and pandemic influenza vaccines with the aim of FDA licensure
To plan the establishment of a U.S. based influenza vaccine manufacturing facility with a surge capacity of at least 150 million monovalent vaccine doses using this technology

Then we have the milestones:
Milestone 1: Within six (6) months of contract award, the Contractor shall provide to the USG a master product development plan...

Milestone 2: Within six (6) months of contract award, the Contractor shall submit for review and approval a comprehensive product development protocol...

Milestone 3: Within twelve (12) months of contract award, the Contractor shall provide the USG with a plan to establish a U.S- based production facility...

Milestone 4: Within twelve (12) months of contract award, the Contractor shall provide a feasibility plan to manufacture, formulate, fill, and finish at least 150 million doses of monovalent influenza vaccine (assuming that a dose includes 15ug HA antigen alone) on an annualized basis when operating at full capacity. The routine level of operation and production of seasonal trivalent influenza vaccine for annual influenza outbreaks may be less. If the facility is designed as a multi-use facility, describe in detail, plans and timelines for production change to influenza vaccine manufacturing at full capacity on an emergency basis at any time of year.

Milestone 5: Within twelve (12) months of the contract award, the Contractor shall submit for approval a pandemic influenza vaccine plan, and upon approval shall commence manufacturing and clinical trials...

Milestone 6: Contractor defined milestones.
https://www.fbo.gov/index?id=814c73e0fd4a1d4eac1d6f166e743154
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If just these 5 companies are able to meet the 150 million dose capacity, that should be sufficient for just about all Americans to be vaxed. But it's a ways off; they have until 2011 to just have a plan for building if I'm reading this correctly. Probably several more years for the actual construction.
Then we can include Sanofi's production in their new facility.
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