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USA: Flu Shot Surpluses/Supply

MHSC

Senior Moderator
Too Much Medicine

Flu Shot Surpluses Across Nation Could End Up in Trash

By STEVE GROVE

Jan. 19, 2007? - Last year at this time, Dr. James Nordin had run out of flu vaccines. This year, the Health Partners Medical Group in St. Paul, Minn., where Nordin is a pediatrician has 3,000 unused doses that are headed to the Dumpster if more patients don't take them.
And Minnesota isn't the only place overstocked with the shots. Though the flu season has yet to hit many parts of the country, doctors at several clinics in the U.S. are struggling to get people to take the vaccine.
"Once Christmas comes, people no longer think about flu shots," says Nordin.
Public health officials say that a delay in production, problems in the distribution system and good old fashioned psychology are to blame for the excess vaccines. And if the problems persist, it could mean a shortage of vaccines next winter.

Serious Problems

The flu shot isn't your typical vaccine. Its formula is changed every year by officials who try to predict which strain of the virus will hit next, and its distribution is handled mainly by private companies who earn comparatively low profits for their efforts. And each year, the Center for Disease Control releases recommendations for which segments of the population should take the shot.
All these moving variables make finding the balance between surplus and shortage each year very difficult. And the problem is serious: an estimated 36,000 Americans die every year from the flu, and 200,000 are hospitalized.
Two years ago, a flu shot shortage caused Sen. John Kerry to comment during his presidential campaign that he would not be taking the shot, leaving one of the only 54 million U.S. doses available for someone else more at-risk. This year, almost twice the numbers of shots are available, and doctors are having trouble even giving them away.
And because the flu shot costs clinics $11 to $20 per dose, that could mean big financial losses nationwide.
The surplus problem started last fall, when production of the flu vaccine was delayed by a month due to sterilization issues with some manufacturers. Because most people who get flu shots do so in the early fall, many patients were turned away from their clinics.
<!-- page --> "Everybody comes in September [to get the shot]" says Dr. Mark Siegel, a New York University doctor who writes often on flu issues. Siegel had to turn away several patients because he didn't have the vaccine in the early fall.
Matthew Rowan, the President and CEO of the Health Industry Distributors Association, said flu vaccine distributors got calls from doctors wondering when the vaccine would come in.
"Anything that would help manufacturers safely produce vaccine in a more timely way is important," Rowan tells ABCNews.com. The vaccine is currently produced using 11-day old fertilized chicken eggs as incubators; a process experts agree is too time-consuming and costly. But the government has recently begun supporting new cell-based technology -- in which the vaccine is made in the cells extracted from caterpillar ovaries -- that scientists hope will produce the vaccine more quickly, and cheaply.
"We think that's a good thing," Rowan says. But it wasn't just a late production cycle that caused excess flu shots this year. After the flu season last year, the CDC widened its recommendations on who should be vaccinated -- chief among them was the that all children under five should get the shot. This season, manufacturers distributed a record 102 million doses, according to government estimates.
"That's 20 million more than we've ever had," says Christine Pearson, a spokesperson for the CDC. She added that at the national level, the CDC does run such campaigns as "National Influenza Vaccination Week."
"There's a lot of work that goes every year into getting people to take the shots," says Pearson.
Siegel believes that the problems of distribution could be solved if the government exercised more direct control over the flu shot, buying more doses and taking a bigger hand in distribution.
"The problem with flu shots is that it's not a profitable business," Siegel explains. "The last thing [drug companies] want is to have a bunch of surplus." Siegel says that means that if there's a surplus this year; the market might correct and produce fewer vaccines next year.
<!-- page --> That leaves it up to local clinics to market the extra doses to their patients -- a problem made difficult by public psychology about the flu shot.
Shot Psychology

Despite the market challenges of the flu shot, good old fashioned psychology also plays a big role in how many people get the shot.
"The warm weather had probably got a lot of people to stop thinking about the flu," says Siegal. While studies have shown that the flu virus lives better in the low-humidity conditions that come with cold winters, Siegal said that temperatures are dropping in the Northeast and Midwest -- regions of the country where flu season has yet to hit -- and that more people need to start getting the shot.
World events also have an effect. Nordin, the Minnesota doctor, remember that in 2003 there were many reports in the media of flu deaths happening in the Southwest, causing and increased demand for the shots. But then an event took place that almost completely halted his patients' demand for the shot: the capture of Sadaam Hussein.
"People have a short attention span," says Nordin. He agrees that clinics need to do a better job of marketing the vaccine to patients, as public psychology hasn't caught up yet to the increased CDC recommendations. He hopes that changes soon.
"The vaccine doesn't do any good sitting on a shelf."

Copyright ? 2007 ABC News Internet Ventures



http://abcnews.go.com/Health/print?id=2805486
 
USA Flu Shot Supply

USA Flu Shot Supply

http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/jul2707vaccine.html
Flu vaccine distributor group reports on supply and delivery delays

Jul 27, 2007 (CIDRAP News) ? The Health Industry Distributors Association (HIDA), a group that includes 600 companies that distribute half of the United States' flu vaccine supply, released a report yesterday to help shed light on the some of the supply chain obstacles have delayed vaccine shipments to doctors' offices.
During the 2006-07 season, influenza vaccine producers made a record 120.9 million flu vaccine doses, but 18.4 million of them went unsold amid complaints from many physicians that they received their supplies too late.
Earlier this year, public health officials said the vaccine glut was caused by a combination of record production, distribution delays, and a mild flu season. Sanofi, the largest producer of flu vaccines for the US market, had attributed some of the delay to a slow-growing influenza (H3N2) strain. Two other companies?GlaxoSmithKline and Novartis?also said they had problems growing the strain.
"The supply came later than expected or arrived in several staggered and/or partial shipments during peak periods of demand," the HIDA report says. Last season manufacturers shipped 50% of the flu vaccine supply to customers; distributors delivered the other half, which was up from the 35% they supplied the 2005-06 season, the report states.
Curtis Allen, a spokesperson for the National Immunization Program at the US Centers for Disease Control and Prevention (CDC) said in a previous CIDRAP report that in 2006 no vaccine doses shipped in August, compared with the previous 7 years when millions of flu vaccine doses began shipping in August.
The vaccine manufacturing process is a 5- to 8-month process that incorporates at least 15 weeks of lot testing by the US Food and Drug Administration (FDA), the HIDA report says. Scientists must test the safety and potency of each lot of vaccine, both at the monovalent and trivalent stages.
Over the course of the most recent influenza season, the FDA's lot-release process ranged from 21 lots for MedImmune to 85 lots for Sanofi, the group says.
This season, vaccine manufacturers have projected they will make 127 million to 132 million doses for the US market for the 2007-08 flu season, another record, according to the Centers for Disease Control and Prevention (CDC).
Production for 2007-08 could be even higher if the FDA approves a seasonal flu vaccine from a fifth manufacturer, CSL Biotherapies, the US branch of an Australian company. CSL announced Apr 3 it had applied for FDA approval for its vaccine.
The CDC and other healthcare experts have pushed for later flu vaccination clinics to help providers and their patients better adjust when vaccine supplies are delayed. Though many flu vaccination efforts focus on early autumn, the CDC says administering the flu vaccine in November, December, January, and beyond is consistent with the recommendations from the federal Advisory Committee on Immunization Practices.
See also:
Jul 27 HIDA press release
http://www.hida.org/press_room/display.asp?document_id=10312
HIDA vaccine production and distribution report
http://www.hida.org/attachment.asp?attachment_id=10509
Jan 30 CIDRAP News story "Winter glut of flu vaccine worries officials"
Apr 24 CIDRAP News story "Record flu vaccine expected for next season"
Nov 13, 2006, CIDRAP News story "CDC launches late-season immunization push"
 
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