FLU SHOTS Vaccine leads to problems for companies

Companies say the vaccine has become more trouble than it's worth.
WASHINGTON POST
Wyeth Pharmaceuticals doesn't make flu shots anymore, and it doesn't 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't 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.
But Wyeth wasn't out of the flu vaccine business -- yet.
It was a partner with the Maryland biotech company, MedImmune, in making what they considered the flu shot of the future -- a "live" virus vaccine squirted up the nose. They made 5 million doses of FluMist for last winter, the product's inaugural season. But FluMist never found its market. Only 450,000 doses were sold; the rest were thrown away.
Last April, Wyeth pulled out. It was done with flu vaccine.
Wyeth's decisions go a long way toward explaining why the United States -- the world's richest market for medical products -- 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 industry-wide flight from flu vaccine, which has simply become more trouble than it's worth.
"It shouldn't be surprising to anybody," said Gregory A. Poland, director of the vaccine research group at the Mayo Clinic, in Minnesota. "In fact, I marvel that there are companies willing to stay in the business."
On the market
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.
"It was the right decision for us," Peter Paradiso, vice president for scientific affairs, said Friday. The company is concentrating on vaccines -- such as for meningitis and pneumonia -- that have fewer competitors and don't need to be remade every year, he said.
Distribution
The Centers for Disease Control and Prevention is scrambling to help reapportion what remains of Aventis's 55 million doses of flu vaccine -- about half the 100 million shots that were supposed to be on the market. (There are about 2 million doses of FluMist as well, but it can only be used by healthy people from age 5 to 49.)
CDC director Julie Louise Gerberding has repeatedly described the vaccine-production industry in the United States as "extremely fragile -- and getting more so." Several childhood vaccines have been in dangerously short supply, too.
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.