Just in time or too late?
Things must be even worse than we thought. The Bush Administration is now taking meaningful (although tardy) steps that recognize a bird flu pandemic is a real possibility. The most dramatic, although the least important, was Bush's Friday signing of an Executive Order adding "pandemic influenza" to the list of diseases allowing isolation of any passenger coming into the US from abroad who refuses to cede to a voluntary request (which I guess abolishes the ability to do so "voluntarily").
A more important development was the announcement that the Department of Health and Human Services had awarded a $97 million contract to pharma giant Sanofi-Pasteur to accelerate its transition from egg-based to cell culture influenza vaccine system. Teams are being assembled at facilities in Swiftwater, PA and Marcy L'Etoile, France to increase vaccine manufacturing capacity in the event of a pandemic. It is a five year plan with most of the work to be done in three years. Three years. I hope we have that long. Anyway, here's the plan.
The company is already in clinical trials with a conventional egg-based H5N1 vaccine. Healthy volunteers ages 18 to 64 are being recruited in Central New York State, Baltimore and Los Angeles to determine safety and dosage. Each will receive two injections four weeks apart and be compensated $35 per visit. If shown safe, as expected, a new round of volunteers will be recruited to examine a greater range of doses and the vaccine's ability to raise antibodies will be examined. But to produce an egg-based vaccine the eggs must first be adapted to viral strains and then incubated for months. Each egg makes a single dose.
The new cell-based vaccine will employ culture techniques licensed from the Dutch company Crucell N.V. It will shorten the production process by several months and allow banking frozen cells for later use. Phase 1 and 2 clinical studies (safety and dose range finding studies, tests of efficacy) will be followed within three years with Phase 3 trials (larger scale pre-marketing tests of safety and efficacy). Sanofi-Pasteur will also design a full-scale manufacturing process for large quantities of vaccine by refitting an existing facility and provide engineering plans for the US construction of a cell-culture vaccine manufacturing facility to supply up to 300 million doses of a monovalent (single strain) influenza vaccine. The contract, however, does not cover constructing such a facility. (Infection Control)
Sanofi-Pasteur will use Crucell's PER.C6(R) cell-line to grow cells in a nutritive medium in bottles or bioreactors rather than eggs. Usually the cells have been "immortalized" so the culture line can grow indefinitely. Here's how the company website describes the technology:
Still, considering what hasn't been done so far, I suppose this is good news. So why does it make my blood boil? Maybe because of what hasn't been done so far?
White House spokesman Trent Duffy called the directive a precautionary measure.Jeez. Why do I feel like the South Koreans when North Korea admits to having bird flu: if they're admitting it, it must really be bad.
"There's no evidence of any risk of avian flu to the American people at this time. But in an abundance of caution, this is a pragmatic step to ensure the government has the authority it needs to protect the American people as best it can," Duffy said. (New York Times).
A more important development was the announcement that the Department of Health and Human Services had awarded a $97 million contract to pharma giant Sanofi-Pasteur to accelerate its transition from egg-based to cell culture influenza vaccine system. Teams are being assembled at facilities in Swiftwater, PA and Marcy L'Etoile, France to increase vaccine manufacturing capacity in the event of a pandemic. It is a five year plan with most of the work to be done in three years. Three years. I hope we have that long. Anyway, here's the plan.
The company is already in clinical trials with a conventional egg-based H5N1 vaccine. Healthy volunteers ages 18 to 64 are being recruited in Central New York State, Baltimore and Los Angeles to determine safety and dosage. Each will receive two injections four weeks apart and be compensated $35 per visit. If shown safe, as expected, a new round of volunteers will be recruited to examine a greater range of doses and the vaccine's ability to raise antibodies will be examined. But to produce an egg-based vaccine the eggs must first be adapted to viral strains and then incubated for months. Each egg makes a single dose.
The new cell-based vaccine will employ culture techniques licensed from the Dutch company Crucell N.V. It will shorten the production process by several months and allow banking frozen cells for later use. Phase 1 and 2 clinical studies (safety and dose range finding studies, tests of efficacy) will be followed within three years with Phase 3 trials (larger scale pre-marketing tests of safety and efficacy). Sanofi-Pasteur will also design a full-scale manufacturing process for large quantities of vaccine by refitting an existing facility and provide engineering plans for the US construction of a cell-culture vaccine manufacturing facility to supply up to 300 million doses of a monovalent (single strain) influenza vaccine. The contract, however, does not cover constructing such a facility. (Infection Control)
Sanofi-Pasteur will use Crucell's PER.C6(R) cell-line to grow cells in a nutritive medium in bottles or bioreactors rather than eggs. Usually the cells have been "immortalized" so the culture line can grow indefinitely. Here's how the company website describes the technology:
Crucell's PER.C6® technology, which is currently licensed to numerous organizations and biopharmaceutical firms, is a production technology that is derived from a single healthy, human retinal cell. The original cell was immortalized using recombinant DNA technology, allowing it to replicate indefinitely. This feature enables the cell line to produce biologics [vaccines and similar products] in sufficient quantities for commercial distribution.This is a welcome development, but one wonders why it is coming so late. And what about licensing, pricing, availability to the rest of the world? In three years we will have a plan for a facility. But in 6 months we could be in the midst of a pandemic.
Many of today's vaccines are produced on animal-derived substrates, including fertilized chicken eggs and mouse brains. To overcome limitations in production capacity, processing time, and potential safety risks associated with the use of animal-derived substrates, Crucell's PER.C6® technology is an attractive alternative production technology for the manufacturing of inactivated whole virus, live-attenuated, live-vector and subunit vaccines.
PER.C6® technology supports the growth of a wide variety of human disease causing viruses that can subsequently be processed into vaccines suitable for administration to humans. Many viruses have been demonstrated to efficiently replicate on PER.C6® cells including influenza, Japanese encephalitis, respiratory syncytial and parainfluenza viruses. Crucell continues to identify additional virus strains that grow efficiently on PER.C6® cells. In addition, Crucell's PER.C6® technology allows for efficient production of recombinant vaccines.
Still, considering what hasn't been done so far, I suppose this is good news. So why does it make my blood boil? Maybe because of what hasn't been done so far?
posted by Revere at
4/04/2005 01:55:00 PM
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