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Originally posted by joey
In the past, I've been a major proponent of the flu shot. Having spent most of my life in the college school system, I took my vaccines religiously. However, last week, when we heard of the shortage, we rushed my 97 year old MIL to the doctor for a vaccine. She was healthy when she took the shot. Monday morning, she was admitted to the hospital with pneumonia and is being given very slim chances of making it . I found it very interesting that the first question by the ER was : " Has she had a flu shot?" When we answered "yes". The question was "how long ago...less than a week?" Normally, I would think that they were just ensuring she'd been vaccinated and didn't have the flu which led to the pneumonia. However,since we have NO reported flu cases in our state, I'm very suspicious over the questions about the vaccine. Perhaps I'm overly suspicious (I Am overy suspicious or I wouldn't be lurking around here LOL),but I do wonder if some of the "tainted" vaccine has gotten into the population. Not trying to resort to scare tactics here,but I have had my complacency about the flu shot shatttered.
Apparently, her infection is bacterial and systemic.
Keep us posted on what you find out.
We were trying to do the right thing in vaccinating her and it would be a tragic irony if we actually did exactly the wrong thing.
joey
I wouldnt take it if you paid me to.
Originally posted by Nerdling
There is no flu crisis.
This time last year only 8 states had confirmed outbreaks. Right now it's sitting at 9 I believe.
Theres plenty to go around too, they stockpile 100,000,000 (yes thats 100 million) doses.
FDA Rejects British Flu Vaccine
VOA News
16 Oct 2004, 17:20 UTC
The U.S. Food and Drug Administration has confirmed that none of the flu vaccine quarantined by British officials is safe for use.
An FDA spokeswoman says agency personnel have inspected and rejected all 46 million doses at a Liverpool, England, factory of the Chiron Corporation, which manufactured the vaccine. She said the company violated good manufacturing processes, and that all the vaccines are suspected to be contaminated.
Last week, British officials shut down the plant, causing a huge shortfall of flu vaccine in the United States.
The vaccine shortfall - roughly half the U.S. supply - means there will not be enough to protect vulnerable children and elderly people.
Flu and its complications, such as pneumonia, kill 36,000 Americans and cause 200,000 hospitalizations per year. [/qoute]
news.google.com...
[edit on 16-10-2004 by psilocin]
Originally posted by moxyone
Has there been any thought given to the possibility that the flu vaccine was DELIBERATELY tampered with in an effort to wipe out a large portion of the US population?
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.
It was a partner with the Maryland biotech company MedImmune in making what it 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.
6 million doses of suspect vaccine in U.S. warehouses
Quarantined since August pending tests
Sabin Russell, Chronicle Medical Writer
Thursday, October 7, 2004
Under U.S. Food and Drug Administration rules that place much of the responsibility for product safety in the hands of manufacturers, Chiron Corp. shipped 6 million doses of its now-suspect flu vaccine from its British plant to the United States before the company's own tests uncovered evidence of bacterial contamination.
The Chronicle has learned that vaccine shipped across the Atlantic has been sitting since August in the warehouses of American drug distributors, under a Chiron-imposed "quarantine,'' but outside the direct control of the company or U.S. regulators.
Now, Chiron's entire production of at least 48 million doses of flu vaccine has been rendered useless after British regulators abruptly suspended the license of the Emeryville-based company's Liverpool factory Tuesday, cutting the U.S. supply of flu shots in half.
In this case, Chiron employed the little-known quarantine process under which drugmakers can ship products to distributors before final safety tests are completed.
Norman Baylor, deputy director for the FDA's vaccine unit, said it was not unusual for manufacturers to ship vaccine under quarantine. The quarantine is lifted by the manufacturer when the company's final tests confirm that the product is safe and the distributor is free to sell it.
"I think the system works,'' Baylor said in an interview in September shortly after Chiron's contamination problem first surfaced. "The system did what it was supposed to do.''
Baylor also confirmed that 27 bulk lots -- nearly half of the 60 produced by the Chiron plant -- had been "released" by the FDA prior to the company's discovery that some finished product was contaminated. The actual number of doses that can be produced from each lot varies.
Although the federal agency does not conduct tests on the final product, companies are liable for the safety of their medicines and have powerful incentive to test them thoroughly before releasing them from quarantine, Baylor explained.
Chiron shipped its first million doses of vaccine to distributors in late July, trumpeting its first-to-market achievement in a July 23 press release. At that time, the company explained that "in the coming days," it would "complete its internal release procedures, allowing distributors to begin shipping vaccines to customers.''
Any optimism at Chiron evaporated with Tuesday's ruling. "We consider the Fluvirin season to be over, for all intents and purposes,'' Chiron spokesman John Gallagher said Wednesday.
He also confirmed that the initial crisis had been triggered when tests detected serratia bacteria in a small number of lots. Serratia bacteria are often implicated in episodes of hospital-acquired infection and can be deadly in the bloodstream.
The company has yet to reveal when it discovered the contaminated lots, but having found a problem, Chiron never lifted its quarantine.
Although no Chiron vaccine was shipped to clinics, some drug industry experts acknowledge that its presence at multiple U.S. distributor warehouses poses a potential security problem.
"Because of the shortage, the spot market for flu vaccines is going to go through the roof,'' said David Webster, a health care consultant in Lehigh Valley, Penn. "Any time there is an extremely valuable commodity, the potential exists that it will work its way on to the black market. It is a legitimate cause for concern.''
Chiron chief executive Howard Pien said Tuesday that all of the Fluvirin doses "would be destroyed in due course.''
Top FDA officials are meeting in Britain today in an attempt to learn why their British counterparts suddenly and unexpectedly pulled the license for the Liverpool plant, where Chiron had brewed nearly 50 million doses of flu vaccine.
American distributors had been gearing up to ship their stocks of Chiron vaccine after the company and U.S. health officials expressed optimism last week that the cause of the contamination had been found and that the problem was confined to a small amount of vaccine.
Secretary of Health and Human Services Tommy Thompson said Tuesday he was surprised by the British decision. "We were assured by Chiron that everything was OK,'' he said, adding that U.S. officials had been in contact with British regulators, who had made no indication as recently as last weekend that Chiron's license was in jeopardy.
He said FDA regulators would be visiting the Liverpool plant this weekend and would try to determine whether some of the Chiron vaccine could be released.
"It does not look promising at this point,'' Thompson said Wednesday.
Tuesday's British action not only cut the U.S. flu vaccine supply in half, it raises serious concerns about whether drug safety regulation in Britain is overly cautious -- or whether American oversight is too lax.
When British regulators suspended the license of Chiron's Liverpool factory Tuesday, they shut down a facility that had been cleared by U.S. inspectors one year earlier, and they apparently have blocked for good the sale of 27 lots of vaccine that had already been released by the FDA.
According to FDA spokeswoman Lenore Gelb, the agency's direct role in the testing of flu shots ends with the production of bulk quantities of vaccine. The final manufacturing steps, such as filling vials and syringes, are regulated through bi-annual inspections to assure that companies are adhering to "good manufacturing practices" that are the basis of their licensure.
Manufacturers are required to conduct their own tests for sterility, and it was one of these quality-control tests by Chiron that spotted the serratia in August.
The current crisis was triggered when British regulators re-inspected the Chiron plant and concluded that it did not meet British standards for good manufacturing practices.
U.S. health officials, meanwhile, continued to counsel calm about the instant shortage of flu vaccine, calling on the public to cooperate with efforts to steer vaccine toward those most in need.
Thompson said vaccine maker Aventis Pasteur would be able to produce 1 million more doses than initially predicted, bringing its total production this year to 55 million.
Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention in Atlanta, said it was "not a realistic strategy" for the federal government to seize the vaccine produced by Aventis and direct its distribution.
She said the CDC was in the process of establishing a toll-free hot line for consumers to report shortages, so the agency can steer privately held surpluses of vaccine to regions that need it. She described it as a collaborative process.
The newly revised guidelines no longer recommend vaccine for healthy adults. Programs that provide flu shots to that population -- and had purchased large quantities of Aventis vaccine -- are likely to find they have too much on hand. The CDC will facilitate the sale of that vaccine to needier clients.
The current flu vaccine shortage, Gerberding added, underscores the need for "a comprehensive national strategy" to build up America's domestic flu shot manufacturing capacity.
"Our entire vaccine production system is fragile in this country,'' she said.
www.sfgate.com.../c/a/2004/10/07/MNG31952VC1.DTL&type=printable
[edit on 19-10-2004 by psilocin]