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HHS Awards $1 Billion in Contracts to Speed Cell-Based Vaccine Development
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.
The US Department of Health and HumanServices (HHS, Washington, DC, www.hhs.gov) willdistribute more than $1 billion in contracts to accelerate thedevelopment of cell-based production technologies for influenzavaccines. This technique employs cell cultures rather than chicken eggs(as do most vaccine manufacturing techniques) for primary production,which greatly shortens the production time (see Pharmaceutical Technology's April2006 Special Report, "Process Considerations for Cell-Based InfluenzaVaccines").
The funds, which were part of President Bush's $3.3-billion plan toprotect the United States against pandemics, were divided into fivecontracts that will be distributed over the next five years:
- GlaxoSmithKline (GSK,Philadelphia, PA, www.gsk.com)will receive $274.75 million to carry out clinical programs to supportthe filing of a biologics license application for a cell culture-basedtrivalent seasonal flu vaccine. GSK also will complete Phase II studiesof an H5N1 cell culture-based pandemic influenza vaccine.
- MedImmune (Gaithersburg,MD, www.medimmune.com),maker of the "FluMist" intranasal flu vaccine, was awarded $169.46million to develop a live, attenuated, needle-free flu vaccine usingcell-based technology. The company is currently in Phase III trialswith a cold-adapted trivalent influenza vaccine, a next-generation formof FluMist.
- HHS committed $220 million to Novartis(East Hanover, NJ, www.novartis.com)to support cell-based vaccine development and facility and equipmentdesign and validation. The company also plans to invest additionalresources into its US vaccine manufacturing facility.
- DVC LLC, a CSC Company(Frederick, MD, www.dynport.com)will use its $242.5-million award to collaborate with Baxter Healthcare Corporation(Deerfield, IL, www.baxter.com) to develop a cell-culture-derived,split-virus vaccine for seasonal flu and a modified whole-virus vaccineto protect against H5N1 avian flu. DVC will manage the project andclinical trials, and Baxter will manufacture the vaccines and serve asthe FDA license-holder.
- As part of its $298-million award, Solvay Pharmaceuticals (Marietta,GA, www.solvaypharmaceuticals-us.com)plans to establish a state-of-the-art, cell-based manufacturing facilityin the United States.
