Few companies willing to make flu vaccines
submited by kickingbird at Oct, 17, 2004 22:42 PM from The Washington Post
Few companies willing to make flu vaccines
Unprofitable: The shortage of shots exposes a troubling industrywide trend
Wyeth Pharmaceuticals doesn磘 make flu shots anymore, and it doesn磘 miss them one bit.
For two decades, Wyeth made injectable influenza vaccine at a plant in Marietta, Pa. For the winter of 2002-03, it made 21 million doses in a labor-intensive, time-crunched process and shipped them to clinics and doctors?offices early in the fall.
But it turned out a lot fewer people wanted it. Flu vaccine can磘 be saved from year to year. So, sometime the next spring Wyeth threw away 7 million unsold doses, for a loss of $30 million. It then quit making flu shots. It eventually closed the Marietta plant, which once employed 800 people. And after a failed attempt at marketing a new 创live创 virus vaccine, Wyeth got out of the flu vaccine business for good.
Wyeth´s decisions go a long way toward explaining why the United States finds itself with only half the amount of vaccine needed to protect its population against a disease that may contribute to more than 50,000 deaths this year.
The company´s exit is part of a long, slow industrywide flight from flu vaccine, which has simply become more trouble than it´s worth.
创It shouldn磘 be surprising to anybody,创 said Gregory Poland, director of the vaccine research group at the Mayo Clinic, in Minnesota. 创In fact, I marvel that there are companies willing to stay in the business.创
Even under the best circumstances, vaccines have never been very attractive investments. The global market for them is about $6 billion a year, compared with $340 billion for drugs. Thirty years ago, more than a dozen companies made flu shots. Five years ago, the number was down to four.
This year, there were two - until Oct. 5, when one, Chiron Corp., announced it would not be able to deliver 48 million doses bound for the U.S. market. The British government´s drug-regulatory agency had impounded all doses made at Chiron´s plant in Liverpool, England, because of bacterial contamination of some lots.
Now there is one left: Aventis Pasteur. Every flu shot that goes into an American arm this season will come from the French company´s plant in Swiftwater, Pa.
Wyeth has no second thoughts about being out of the market, even now that the flu shot is the most sought-after medical commodity in the country.
创It was the right decision for us,创 Peter Paradiso, vice president for scientific affairs, said Friday.
The Centers for Disease Control and Prevention is scrambling to help reapportion what remains of Aventis?55 million doses of flu vaccine - about half the 100 million shots that were supposed to be on the market.
CDC director Julie Louise Gerberding has repeatedly described the vaccine-production industry in the United States as 创extremely fragile - and getting more so.创 Several childhood vaccines have been in dangerously short supply, too.
But the current scarcity of flu shots also reflects forces unique to this vaccine.
Every year, hundreds of millions of people around the world contract influenza and hundreds of thousands die.
In the 1990s, the infection contributed to about 51,000 deaths each year in the United States, about 8,000 of them directly traceable to the virus, the CDC estimates.
Besides being contagious and deadly, flu virus mutates easily. Each winter gives the microbe a new opportunity to infect humans with slightly different versions of itself. These opportunities are augmented by the fact that two influenza A strains and one B strain are circulating to one degree or another at all times.
The vaccine is made of a weakened strain of virus of each type. Generally, atleast one strain each year undergoes so much mutation that it needs to bereplaced by an 创updated创 version. Consequently, a new flu vaccine formula has to be drawn up each year.
There are other reasons flu vaccine isn磘 very popular with vaccine makers.
For more than 40 years, flu vaccine has been made by injecting virus into fertilized chicken eggs. It´s no accident that Wyeth´s shuttered plant, and Aventis´s operating one, are both in Pennsylvania, the state with the third-largest egg production in the United States. Each egg must be hand-inspected and hand-injected. One egg grows enough virus for 4 or 5 doses of vaccine. Millions are needed. The final shot is actually three vaccines packaged as one: two strains of influenza A and one of B.
Each round of production using this old-fashioned technology is known as a 创campaign;创 they have some of the risk, time-pressure and uncertainty of political races and military attacks.
In 1999, supply and demand were evenly matched - only 400,000 doses of 77 million went to waste. The next year, though, 8 million were thrown out. In 2001-02, 10 million doses were pitched. The next year (Wyeth´s last) the number was 13 million. Last winter, despite a run on vaccine in an earlier-than-usual flu season, 4 million doses, out of 87 million made, were discarded.
The waste is particularly hard for vaccine makers to stomach because their profit margin is small. Because much of the vaccine is bought in huge orders by government agencies, the price is low.
Over three seasons, Wyeth lost $50 million from unsold flu vaccine. It was also facing millions of dollars in improvements to keep its plant up to Food and Drug Administration standards.
Getting out of the business 创certainly wasn磘 a no-brainer - we do not make decisions like that lightly,创 Wyeth´s Paradiso said. But, he added, 创We were finding that there was not, in fact, a market for our product.创
Chiron, which wouldn磘 discuss its business strategy for this article, apparently had a different view.
Experts say the California-based company saw an opportunity to make money, which it could funnel into its main work of developing biotech products, if it could acquire an existing plant, which it did - in Liverpool.
The strategy might have paid off handsomely - if the company hadn磘 run into the contamination problems - because the market for flu vaccine is big, and growing.
This year, for the first time, the CDC recommended universal flu vaccination for all children 6 to 23 months old. For several years, it has had a huge campaign to vaccinate the elderly and chronically ill, only half of whom typically get a flu shot. Some experts believe it´s only a matter of time before the agency advises every American to get a flu shot each year.
Even that prospect isn磘 likely to lure companies back immediately.
Nobody wants to invest hundreds of millions of dollars and five to seven years in building an egg-based vaccine plant when the industry is on the verge of switching to a radically new way of making the product.
Sometime in the next decade, flu vaccine will start to be grown in cell cultures. That technology is far more clean, predictable and expandable than the egg-based method.
See Also:
Unprofitable: The shortage of shots exposes a troubling industrywide trend
For two decades, Wyeth made injectable influenza vaccine at a plant in Marietta, Pa. For the winter of 2002-03, it made 21 million doses in a labor-intensive, time-crunched process and shipped them to clinics and doctors?offices early in the fall.
But it turned out a lot fewer people wanted it. Flu vaccine can磘 be saved from year to year. So, sometime the next spring Wyeth threw away 7 million unsold doses, for a loss of $30 million. It then quit making flu shots. It eventually closed the Marietta plant, which once employed 800 people. And after a failed attempt at marketing a new 创live创 virus vaccine, Wyeth got out of the flu vaccine business for good.
Wyeth´s decisions go a long way toward explaining why the United States finds itself with only half the amount of vaccine needed to protect its population against a disease that may contribute to more than 50,000 deaths this year.
The company´s exit is part of a long, slow industrywide flight from flu vaccine, which has simply become more trouble than it´s worth.
创It shouldn磘 be surprising to anybody,创 said Gregory Poland, director of the vaccine research group at the Mayo Clinic, in Minnesota. 创In fact, I marvel that there are companies willing to stay in the business.创
Even under the best circumstances, vaccines have never been very attractive investments. The global market for them is about $6 billion a year, compared with $340 billion for drugs. Thirty years ago, more than a dozen companies made flu shots. Five years ago, the number was down to four.
This year, there were two - until Oct. 5, when one, Chiron Corp., announced it would not be able to deliver 48 million doses bound for the U.S. market. The British government´s drug-regulatory agency had impounded all doses made at Chiron´s plant in Liverpool, England, because of bacterial contamination of some lots.
Now there is one left: Aventis Pasteur. Every flu shot that goes into an American arm this season will come from the French company´s plant in Swiftwater, Pa.
Wyeth has no second thoughts about being out of the market, even now that the flu shot is the most sought-after medical commodity in the country.
创It was the right decision for us,创 Peter Paradiso, vice president for scientific affairs, said Friday.
The Centers for Disease Control and Prevention is scrambling to help reapportion what remains of Aventis?55 million doses of flu vaccine - about half the 100 million shots that were supposed to be on the market.
CDC director Julie Louise Gerberding has repeatedly described the vaccine-production industry in the United States as 创extremely fragile - and getting more so.创 Several childhood vaccines have been in dangerously short supply, too.
But the current scarcity of flu shots also reflects forces unique to this vaccine.
Every year, hundreds of millions of people around the world contract influenza and hundreds of thousands die.
In the 1990s, the infection contributed to about 51,000 deaths each year in the United States, about 8,000 of them directly traceable to the virus, the CDC estimates.
Besides being contagious and deadly, flu virus mutates easily. Each winter gives the microbe a new opportunity to infect humans with slightly different versions of itself. These opportunities are augmented by the fact that two influenza A strains and one B strain are circulating to one degree or another at all times.
The vaccine is made of a weakened strain of virus of each type. Generally, atleast one strain each year undergoes so much mutation that it needs to bereplaced by an 创updated创 version. Consequently, a new flu vaccine formula has to be drawn up each year.
There are other reasons flu vaccine isn磘 very popular with vaccine makers.
For more than 40 years, flu vaccine has been made by injecting virus into fertilized chicken eggs. It´s no accident that Wyeth´s shuttered plant, and Aventis´s operating one, are both in Pennsylvania, the state with the third-largest egg production in the United States. Each egg must be hand-inspected and hand-injected. One egg grows enough virus for 4 or 5 doses of vaccine. Millions are needed. The final shot is actually three vaccines packaged as one: two strains of influenza A and one of B.
Each round of production using this old-fashioned technology is known as a 创campaign;创 they have some of the risk, time-pressure and uncertainty of political races and military attacks.
In 1999, supply and demand were evenly matched - only 400,000 doses of 77 million went to waste. The next year, though, 8 million were thrown out. In 2001-02, 10 million doses were pitched. The next year (Wyeth´s last) the number was 13 million. Last winter, despite a run on vaccine in an earlier-than-usual flu season, 4 million doses, out of 87 million made, were discarded.
The waste is particularly hard for vaccine makers to stomach because their profit margin is small. Because much of the vaccine is bought in huge orders by government agencies, the price is low.
Over three seasons, Wyeth lost $50 million from unsold flu vaccine. It was also facing millions of dollars in improvements to keep its plant up to Food and Drug Administration standards.
Getting out of the business 创certainly wasn磘 a no-brainer - we do not make decisions like that lightly,创 Wyeth´s Paradiso said. But, he added, 创We were finding that there was not, in fact, a market for our product.创
Chiron, which wouldn磘 discuss its business strategy for this article, apparently had a different view.
Experts say the California-based company saw an opportunity to make money, which it could funnel into its main work of developing biotech products, if it could acquire an existing plant, which it did - in Liverpool.
The strategy might have paid off handsomely - if the company hadn磘 run into the contamination problems - because the market for flu vaccine is big, and growing.
This year, for the first time, the CDC recommended universal flu vaccination for all children 6 to 23 months old. For several years, it has had a huge campaign to vaccinate the elderly and chronically ill, only half of whom typically get a flu shot. Some experts believe it´s only a matter of time before the agency advises every American to get a flu shot each year.
Even that prospect isn磘 likely to lure companies back immediately.
Nobody wants to invest hundreds of millions of dollars and five to seven years in building an egg-based vaccine plant when the industry is on the verge of switching to a radically new way of making the product.
Sometime in the next decade, flu vaccine will start to be grown in cell cultures. That technology is far more clean, predictable and expandable than the egg-based method.
See Also:
- GISAID: H5N1 Bird Flu continues to take its toll in the United States 10 hours ago
- US: Wisconsin human HPAI case confirmed by CDC 5 days ago
- US: Iowa HHS Reports First Human Case of Highly Pathogenic Avian Influenza (HPAI) in Iowa 5 days ago
- Canada: Highly pathogenic avian influenza subtype H5N1 in Ontario, December 19, 2024 5 days ago
- GISAID: H5N1 Bird Flu continues to take its toll in the United States 6 days ago
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