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The bottleneck in producing ample pandemic vaccine for the US, and the world, was caused in large part because we rely on the 50-year-old technology of growing antigen in chicken eggs.
There are newer cell-based technologies on the horizon, but production facilities must be built, manufacturing problems solved, and these novel vaccines approved for use by the FDA.
Maggie Fox, Health & Science Editor for Reuters brings us word of a new factory in Holly Springs, North Carolina, that in a few years will hopefully be capable of producing as much as 150 million doses of adjuvanted cell-based vaccine within 6 months of a pandemic virus being isolated.
The problems aren’t all technical or logistical, however.
This cell technology is new, unfamiliar to most Americans, and the use of adjuvants in this country is currently viewed with suspicion.
The hope is, that we’ll come out of this pandemic season with a lot more safety data on the use of adjuvants.
Tens of millions of adjuvanted vaccines have already been delivered to the arms of people in Canada and Europe without apparent problems, and by the time this factory is ready to produce, it is hoped Americans may be more inclined to accept the product.
Next-generation flu vaccine plant to open in U.S.
Mon Nov 23, 2009 11:53am EST
* New factory first in U.S. to use cells to make flu shots
* Novartis hopes U.S. market will accept boosted vaccines
* First dose won't come before 2011
By Maggie Fox, Health and Science Editor
WASHINGTON, Nov 23 (Reuters) - Novartis (NOVN.VX) will officially open the first next-generation flu vaccine plant in the United States on Tuesday, but it will be years before it makes its first vaccine.
The factory in Holly Springs, North Carolina, will use batches of dog cells to grow influenza vaccine, instead of the chicken eggs widely used now. While the cell method is only slightly faster, it can be scaled up more quickly.
Federal advisers to the U.S. Food and Drug Administration last week asked for more safety data on another cell-based vaccine, one made by privately held Protein Sciences Corp. But U.S. officials said the new Novartis shot is not as experimental.
"I see them as totally different. The whole point of pushing on cell culture was increasing capacity and surge capacity," Dr. Bruce Gellin, head of the U.S. Health and Human Services Department's National Vaccine Program Office, said in an interview.
HHS spent $487 million helping Novartis build the plant, which was planned before the current pandemic of H1N1 swine flu.
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