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U.S. jump-starts flu effort
Baxter and five other firms share $1 billion to help them develop and produce vaccine
By Bruce Japsen
Tribune staff reporter
Published May 5, 2006
Worried that the 1940s-era egg-based flu vaccine technology still in use won't stand up to bird flu, the federal government on Thursday awarded Baxter International Inc. and five other vaccine makers more than $1 billion to advance a new technology that eliminates the need for chicken eggs.
The contracts are a vote of support for new cell-based flu vaccine production technologies being pursued by Deerfield-based Baxter and others. They are also a boost for vaccine makers in an era when the United States and other countries lack sufficient capacity to make vaccines against both seasonal flu and pandemic bird flu.
The money is aimed at helping companies modernize processes and make the right vaccine quickly, in large quantities.
Currently, vaccine makers hand-process millions of chicken eggs in their labs, shining a light through each shell to find the embryo, into which a strain of influenza virus is injected and incubated in a months-long process.
The United States and other countries worry that the egg supply itself could one day be threatened since thousands of birds of all kinds are dying in Europe, Asia and elsewhere.
"Egg supplies are vulnerable to Avian infections," U.S. Health and Human Services Secretary Mike Leavitt told reporters during a press briefing and conference call from Washington Thursday. "These steps will make America better prepared, not just for a single terrible event but for a decade of emergencies."
More than $1 billion was awarded Thursday by the government as part of a $3.3 billion proposal by President Bush.
The money was appropriated this year by Congress to help the nation prepare for a pandemic.
A joint award of $41 million went to Deerfield-based Baxter and Computer Sciences Corp. subsidiary DVC, which will manage the project and clinical trials from DVC headquarters in Frederick, Md. Baxter will manufacture the vaccine and serve as the U.S. license holder.
Baxter and DVC will develop cell culture-derived influenza vaccines for seasonal and pandemic influenza.
The pandemic vaccine candidate that is being developed under the contract will be designed to protect against H5N1 avian influenza.
Pending future congressional approval, the contract could be worth more than $240 million to Baxter and DVC. Baxter would not specify how much of the money it would get of the total contract awards that will be used to develop and help pay for clinical trials.
Four other vaccine makers, including GlaxoSmithKline PLC, Medimmune Inc., Novartis AG and Solvay SA were awarded contracts to assist in research, development and equipment purchases in the pursuit of cell-based bird flu vaccines.
The production of flu vaccines today, while considered effective, is done with the 1940s method that requires technicians to inject a strain into millions of chicken eggs.
In times of seasonal flu vaccine shortages, the egg-based approach has caused difficulty. It can take several months to ramp up capacity when even one seasonal flu vaccine maker has a production problem. With the cell-based method, analysts say, production is more consistent and can generate higher yields in as little as nine to 12 weeks, compared with the smaller yields that take several months in egg-based manufacturing. Baxter said they could deliver a pandemic vaccine "three months earlier" than egg-based manufacturers.
"Our current capacity of egg-based influenza vaccine production is not sufficient to meet increased demands during an emergency," Leavitt said. "Accelerating the development of this vaccine technology and creating domestic capacity are critical to our preparedness efforts. We have the opportunity to be the first generation that prepares for pandemic."
Though cell-based flu vaccines are possible they are not considered ready for prime time.
Baxter does not have a vaccine produced in cell cultures that is commercially available, but the company landed a U.S. contract after Sept. 11, 2001, to produce a U.S. government stockpile of smallpox vaccine, which is undergoing human clinical trials.
Baxter sees the government's cash infusion as a major endorsement of its technology, one that could eventually lead to a contract to stockpile avian flu vaccine down the road, pending Food and Drug Administration clearance of its product.
Earlier this year the UK ordered two million doses of a cell-based avian flu vaccine to stockpile as a preventive for front-line health-care workers.
Baxter is in discussions with the UK and other countries it would not name for potential stockpile contracts.
"It is one of the most promising solutions for providing efficacious pandemic flu vaccine in the shortest possible time," said Joy Amundson, Baxter corporate vice president and president of the company's biosciences business.
The Health and Human Services Department has yet to order stockpile dosages of cell-based vaccine but is working toward a "short-term goal" of a stockpile of 20 million dosages, based on previously announced contracts with egg-based manufacturers. The ultimate goal is to produce 300 million dosages within six months of a pandemic virus being isolated, HHS said.
The U.S. government has a long way to go to reach 300 million dosages but believes the $1 billion allocation will spur companies to increase capacity, a huge international need.
Analysts believe Baxter's already existing cell-based production facility, which is located in the Czech Republic, gives it the most capacity of cell-based manufacturers.
Should its avian flu vaccine due for testing in humans later this spring show efficacy, Baxter executives say they will be off to the races to land contracts to stockpile product.
"We do have a full-scale commercial facility," Amundson said. "Once we show clinical efficacy . . . we can supply immediately. We do not have to construct a facility."
Baxter stock closed up 2.6 percent Thursday to $38.12 in trading on the New York Stock Exchange.
- - -
Egg came first, but cell better
Using methods from the 1940s, it can take 20 to 28 weeks to produce needed vaccines with the egg-based method. With the cell-based method, vaccine can be made in as little as 9 to 12 weeks.
http://www.chicagotribune.com/business/chi-0605050088may05,1,6686670.story?coll=chi-business-hed
Baxter and five other firms share $1 billion to help them develop and produce vaccine
By Bruce Japsen
Tribune staff reporter
Published May 5, 2006
Worried that the 1940s-era egg-based flu vaccine technology still in use won't stand up to bird flu, the federal government on Thursday awarded Baxter International Inc. and five other vaccine makers more than $1 billion to advance a new technology that eliminates the need for chicken eggs.
The contracts are a vote of support for new cell-based flu vaccine production technologies being pursued by Deerfield-based Baxter and others. They are also a boost for vaccine makers in an era when the United States and other countries lack sufficient capacity to make vaccines against both seasonal flu and pandemic bird flu.
The money is aimed at helping companies modernize processes and make the right vaccine quickly, in large quantities.
Currently, vaccine makers hand-process millions of chicken eggs in their labs, shining a light through each shell to find the embryo, into which a strain of influenza virus is injected and incubated in a months-long process.
The United States and other countries worry that the egg supply itself could one day be threatened since thousands of birds of all kinds are dying in Europe, Asia and elsewhere.
"Egg supplies are vulnerable to Avian infections," U.S. Health and Human Services Secretary Mike Leavitt told reporters during a press briefing and conference call from Washington Thursday. "These steps will make America better prepared, not just for a single terrible event but for a decade of emergencies."
More than $1 billion was awarded Thursday by the government as part of a $3.3 billion proposal by President Bush.
The money was appropriated this year by Congress to help the nation prepare for a pandemic.
A joint award of $41 million went to Deerfield-based Baxter and Computer Sciences Corp. subsidiary DVC, which will manage the project and clinical trials from DVC headquarters in Frederick, Md. Baxter will manufacture the vaccine and serve as the U.S. license holder.
Baxter and DVC will develop cell culture-derived influenza vaccines for seasonal and pandemic influenza.
The pandemic vaccine candidate that is being developed under the contract will be designed to protect against H5N1 avian influenza.
Pending future congressional approval, the contract could be worth more than $240 million to Baxter and DVC. Baxter would not specify how much of the money it would get of the total contract awards that will be used to develop and help pay for clinical trials.
Four other vaccine makers, including GlaxoSmithKline PLC, Medimmune Inc., Novartis AG and Solvay SA were awarded contracts to assist in research, development and equipment purchases in the pursuit of cell-based bird flu vaccines.
The production of flu vaccines today, while considered effective, is done with the 1940s method that requires technicians to inject a strain into millions of chicken eggs.
In times of seasonal flu vaccine shortages, the egg-based approach has caused difficulty. It can take several months to ramp up capacity when even one seasonal flu vaccine maker has a production problem. With the cell-based method, analysts say, production is more consistent and can generate higher yields in as little as nine to 12 weeks, compared with the smaller yields that take several months in egg-based manufacturing. Baxter said they could deliver a pandemic vaccine "three months earlier" than egg-based manufacturers.
"Our current capacity of egg-based influenza vaccine production is not sufficient to meet increased demands during an emergency," Leavitt said. "Accelerating the development of this vaccine technology and creating domestic capacity are critical to our preparedness efforts. We have the opportunity to be the first generation that prepares for pandemic."
Though cell-based flu vaccines are possible they are not considered ready for prime time.
Baxter does not have a vaccine produced in cell cultures that is commercially available, but the company landed a U.S. contract after Sept. 11, 2001, to produce a U.S. government stockpile of smallpox vaccine, which is undergoing human clinical trials.
Baxter sees the government's cash infusion as a major endorsement of its technology, one that could eventually lead to a contract to stockpile avian flu vaccine down the road, pending Food and Drug Administration clearance of its product.
Earlier this year the UK ordered two million doses of a cell-based avian flu vaccine to stockpile as a preventive for front-line health-care workers.
Baxter is in discussions with the UK and other countries it would not name for potential stockpile contracts.
"It is one of the most promising solutions for providing efficacious pandemic flu vaccine in the shortest possible time," said Joy Amundson, Baxter corporate vice president and president of the company's biosciences business.
The Health and Human Services Department has yet to order stockpile dosages of cell-based vaccine but is working toward a "short-term goal" of a stockpile of 20 million dosages, based on previously announced contracts with egg-based manufacturers. The ultimate goal is to produce 300 million dosages within six months of a pandemic virus being isolated, HHS said.
The U.S. government has a long way to go to reach 300 million dosages but believes the $1 billion allocation will spur companies to increase capacity, a huge international need.
Analysts believe Baxter's already existing cell-based production facility, which is located in the Czech Republic, gives it the most capacity of cell-based manufacturers.
Should its avian flu vaccine due for testing in humans later this spring show efficacy, Baxter executives say they will be off to the races to land contracts to stockpile product.
"We do have a full-scale commercial facility," Amundson said. "Once we show clinical efficacy . . . we can supply immediately. We do not have to construct a facility."
Baxter stock closed up 2.6 percent Thursday to $38.12 in trading on the New York Stock Exchange.
- - -
Egg came first, but cell better
Using methods from the 1940s, it can take 20 to 28 weeks to produce needed vaccines with the egg-based method. With the cell-based method, vaccine can be made in as little as 9 to 12 weeks.
http://www.chicagotribune.com/business/chi-0605050088may05,1,6686670.story?coll=chi-business-hed