6 million doses of suspect vaccine in U.S. warehouses Quarantined since August pending tests by UserX ..... News Forum
Date: 10/7/2004 7:51:00 AM ( 20 y ago)
Hits: 1,268
URL: https://www.curezone.org/forums/fm.asp?i=586391
1 readers agree with this message. Hide votes What is this?
Why does the FDA trust Pharma with safety but they aggressively go after herbal stores?
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.
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/10/07/MNG31952VC1.DTL
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/10/07/MNG31952VC1.DTL
<< Return to the standard message view
fetched in 0.01 sec, referred by http://www.curezone.org/forums/fmp.asp?i=586391