Posted: Sun Dec 06, 2009 5:59 pm
Eeeew! Vaccine made in bugs?
http://online.wsj.com/article/SB125911113742763271.html
Vaccine Makers Struggle to Speed Output
Cell-Culture Technology Hastens the Process, but Slow-Growing Virus Remains a Problem, and U.S. Production Is Years Away
By BETSY MCKAY and JEANNE WHALEN
A new Novartis AG vaccine plant in North Carolina is supposed to boost the U.S.'s ability to fight pandemics like the current swine-flu virus. But despite a ribbon-cutting Tuesday, it won't be pumping out flu shots for at least another two years.
Nor will the plant's cutting-edge technology do much to solve one of the biggest problems vaccine makers have faced in churning out this year's swine-flu vaccine: a slow-growing virus. High-speed techniques that bypass the lengthy and onerous process of incubating viruses to make vaccine are years away.
View Full Image
Reuters
Novartis employees clean equipment at the Novartis flu vaccine facility in Holly Springs, N.C., on Tuesday.
After more than five years and about $2 billion in government spending, the U.S. is still struggling to modernize and speed up production of vaccinations against deadly pandemics like swine flu. The system is undermined by a lack of manufacturing plants and by decades-old technology that takes six to nine months to make flu vaccine.
The new Novartis plant, heavily financed by the U.S. government, represents one of the biggest steps in 60 years toward modernizing flu-vaccine manufacturing in the U.S. It uses new technology to grow flu viruses in vats of cells derived from dog kidneys, and uses these viruses to make vaccine. The decades-old process involves growing the virus in chicken eggs.
Novartis says the new approach could shave four to six weeks off the time needed to make each shot. The plant has other advantages: If a deadly avian-flu virus hit, it could kill scores of chickens and endanger the supply of eggs needed to make vaccine the old-fashioned way. Cell-culture technology removes that risk.
Novartis's new plant is just one element of a bigger modernization strategy that will take years to unfold. It has taken the Swiss pharmaceutical giant more than three years to build the plant and fine-tune the technology. And the company must carry out more tests on its equipment and vaccine before it can start mass producing the shots in the U.S., even though it already has a cell-culture factory in Germany.
Even when the new Novartis plant is up and running, flu viruses that grow slowly in eggs, as does the current H1N1 virus, may also grow slowly in cells, meaning production may not be much faster, scientists warn.
Cell-culture technology "is not the end game for us," said Anthony Fauci, director of the U.S. government's National Institute of Allergy and Infectious Diseases. His institute is spending $262 million this year on influenza research, including research on a new generation of vaccines that can be made without having to grow a virus.
Protein Sciences Corp., of Meriden, Conn., received a $35 million contract from the Department of Health and Human Services in June to develop a next-generation flu vaccine that doesn't depend on growing the virus, but inserts genetic material from a flu virus into another virus that infects insect cells. The infected insect cells produce proteins that are then used to create a vaccine for humans. Such a shot is "a year or two [away] at the most," Dr. Fauci said. A Food and Drug Administration advisory panel narrowly voted last week against approval of the vaccine, asking for more studies.
The government began investing heavily in flu vaccine after the outbreak of avian flu in 2003, and then a shortage of seasonal-flu vaccine in 2004 when a large manufacturer suffered a contamination problem. HHS has put $1.56 billion into cell-based projects like the new Novartis plant.
But when the new H1N1 virus emerged in April, none of those technologies had yet been licensed. The government had no choice but to turn to its slow, but tried-and-true egg-based system. Then, the new H1N1 virus proved uncooperative, growing slowly in the eggs and yielding only a quarter to a third of the antigen—the main ingredient in vaccine—that manufacturers had been expecting.
The slow pace of modernization underscores a deeper, fundamental problem with the U.S. market for flu vaccines: uncertain demand and slim profit margins. The government is trying to build a pandemic vaccine manufacturing system on the back of a fickle market for seasonal-flu vaccine.
The majority of Americans routinely ignore public health officials' pleas to get an annual flu shot.
An oversupply of flu vaccine on the U.S. market in the past three years has pushed prices down 30% to 40%, "creating a strong disincentive for manufacturers to maximize or even maintain current production capacity for the U.S. market," Vas Narasimhan, president of Novartis Vaccines USA, said in written testimony submitted for a congressional hearing last week.
It isn't clear how many benefits cell-culture technology will offer. A spokeswoman for Illinois-based Baxter International Inc. said the company's cell-culture plant in the Czech Republic—one of the first large-scale cell-culture facilities—initially experienced the same difficulty growing the H1N1 virus that egg-based plants did. Like other drug makers, Baxter managed to improve the yield, she said, though she declined to say by how much. Baxter is supplying 80 million doses of H1N1 vaccine to countries including Austria, the U.K., Ireland, Germany and France. Its flu vaccine isn't licensed for sale in the U.S.
Other companies have had mixed results with cells. GlaxoSmithKline PLC of the U.K. received a $274 million HHS contract in 2007 to develop cell-culture vaccine and to build manufacturing capacity for it, but in an interview in September, the head of the company's vaccine business said the technology is about a decade away from being "mature" enough for use. "GSK will be in cell-culture technology perhaps in ten years, but not today," Jean Stephenne, the Glaxo official, said.
France's Sanofi-Aventis, the world's largest flu-vaccine maker, has also cast doubt on the immediate usefulness of cell-culture technology. In an interview in April, Sanofi's chief executive said the sticking point was designing the right kind of cells. "We just haven't actually found the right cell lines that do what we need them to do," he said."We're still several years away from cell-based flu vaccines," he said.
HHS gave Sanofi a $97 million grant in 2005 to carry out work in the area. A Sanofi spokeswoman said Tuesday that the company did develop a cell-based flu vaccine, but found that it provided only a "modest" reduction in production time and would be "considerably" more expensive to produce.
The "ultimate end game" is a universal flu vaccine that would protect people against all flu strains by targeting a component of the influenza virus that remains constant from season to season, said Dr. Fauci. That would eliminate the need for a flu shot every year. Novartis and other companies are at an early stage of researching such a vaccine, but such a shot is at least 10 years away, he said.
http://online.wsj.com/article/SB125911113742763271.html
Vaccine Makers Struggle to Speed Output
Cell-Culture Technology Hastens the Process, but Slow-Growing Virus Remains a Problem, and U.S. Production Is Years Away
By BETSY MCKAY and JEANNE WHALEN
A new Novartis AG vaccine plant in North Carolina is supposed to boost the U.S.'s ability to fight pandemics like the current swine-flu virus. But despite a ribbon-cutting Tuesday, it won't be pumping out flu shots for at least another two years.
Nor will the plant's cutting-edge technology do much to solve one of the biggest problems vaccine makers have faced in churning out this year's swine-flu vaccine: a slow-growing virus. High-speed techniques that bypass the lengthy and onerous process of incubating viruses to make vaccine are years away.
View Full Image
Reuters
Novartis employees clean equipment at the Novartis flu vaccine facility in Holly Springs, N.C., on Tuesday.
After more than five years and about $2 billion in government spending, the U.S. is still struggling to modernize and speed up production of vaccinations against deadly pandemics like swine flu. The system is undermined by a lack of manufacturing plants and by decades-old technology that takes six to nine months to make flu vaccine.
The new Novartis plant, heavily financed by the U.S. government, represents one of the biggest steps in 60 years toward modernizing flu-vaccine manufacturing in the U.S. It uses new technology to grow flu viruses in vats of cells derived from dog kidneys, and uses these viruses to make vaccine. The decades-old process involves growing the virus in chicken eggs.
Novartis says the new approach could shave four to six weeks off the time needed to make each shot. The plant has other advantages: If a deadly avian-flu virus hit, it could kill scores of chickens and endanger the supply of eggs needed to make vaccine the old-fashioned way. Cell-culture technology removes that risk.
Novartis's new plant is just one element of a bigger modernization strategy that will take years to unfold. It has taken the Swiss pharmaceutical giant more than three years to build the plant and fine-tune the technology. And the company must carry out more tests on its equipment and vaccine before it can start mass producing the shots in the U.S., even though it already has a cell-culture factory in Germany.
Even when the new Novartis plant is up and running, flu viruses that grow slowly in eggs, as does the current H1N1 virus, may also grow slowly in cells, meaning production may not be much faster, scientists warn.
Cell-culture technology "is not the end game for us," said Anthony Fauci, director of the U.S. government's National Institute of Allergy and Infectious Diseases. His institute is spending $262 million this year on influenza research, including research on a new generation of vaccines that can be made without having to grow a virus.
Protein Sciences Corp., of Meriden, Conn., received a $35 million contract from the Department of Health and Human Services in June to develop a next-generation flu vaccine that doesn't depend on growing the virus, but inserts genetic material from a flu virus into another virus that infects insect cells. The infected insect cells produce proteins that are then used to create a vaccine for humans. Such a shot is "a year or two [away] at the most," Dr. Fauci said. A Food and Drug Administration advisory panel narrowly voted last week against approval of the vaccine, asking for more studies.
The government began investing heavily in flu vaccine after the outbreak of avian flu in 2003, and then a shortage of seasonal-flu vaccine in 2004 when a large manufacturer suffered a contamination problem. HHS has put $1.56 billion into cell-based projects like the new Novartis plant.
But when the new H1N1 virus emerged in April, none of those technologies had yet been licensed. The government had no choice but to turn to its slow, but tried-and-true egg-based system. Then, the new H1N1 virus proved uncooperative, growing slowly in the eggs and yielding only a quarter to a third of the antigen—the main ingredient in vaccine—that manufacturers had been expecting.
The slow pace of modernization underscores a deeper, fundamental problem with the U.S. market for flu vaccines: uncertain demand and slim profit margins. The government is trying to build a pandemic vaccine manufacturing system on the back of a fickle market for seasonal-flu vaccine.
The majority of Americans routinely ignore public health officials' pleas to get an annual flu shot.
An oversupply of flu vaccine on the U.S. market in the past three years has pushed prices down 30% to 40%, "creating a strong disincentive for manufacturers to maximize or even maintain current production capacity for the U.S. market," Vas Narasimhan, president of Novartis Vaccines USA, said in written testimony submitted for a congressional hearing last week.
It isn't clear how many benefits cell-culture technology will offer. A spokeswoman for Illinois-based Baxter International Inc. said the company's cell-culture plant in the Czech Republic—one of the first large-scale cell-culture facilities—initially experienced the same difficulty growing the H1N1 virus that egg-based plants did. Like other drug makers, Baxter managed to improve the yield, she said, though she declined to say by how much. Baxter is supplying 80 million doses of H1N1 vaccine to countries including Austria, the U.K., Ireland, Germany and France. Its flu vaccine isn't licensed for sale in the U.S.
Other companies have had mixed results with cells. GlaxoSmithKline PLC of the U.K. received a $274 million HHS contract in 2007 to develop cell-culture vaccine and to build manufacturing capacity for it, but in an interview in September, the head of the company's vaccine business said the technology is about a decade away from being "mature" enough for use. "GSK will be in cell-culture technology perhaps in ten years, but not today," Jean Stephenne, the Glaxo official, said.
France's Sanofi-Aventis, the world's largest flu-vaccine maker, has also cast doubt on the immediate usefulness of cell-culture technology. In an interview in April, Sanofi's chief executive said the sticking point was designing the right kind of cells. "We just haven't actually found the right cell lines that do what we need them to do," he said."We're still several years away from cell-based flu vaccines," he said.
HHS gave Sanofi a $97 million grant in 2005 to carry out work in the area. A Sanofi spokeswoman said Tuesday that the company did develop a cell-based flu vaccine, but found that it provided only a "modest" reduction in production time and would be "considerably" more expensive to produce.
The "ultimate end game" is a universal flu vaccine that would protect people against all flu strains by targeting a component of the influenza virus that remains constant from season to season, said Dr. Fauci. That would eliminate the need for a flu shot every year. Novartis and other companies are at an early stage of researching such a vaccine, but such a shot is at least 10 years away, he said.