Posted on 12/11/2004 9:35:01 AM PST by neverdem
The Chiron Corporation said yesterday that it had received a warning letter from the Food and Drug Administration demanding more information about the company's plans to fix widespread sanitary problems at its flu vaccine factory in Liverpool, England.
The letter comes after an inspection of the plant by the F.D.A. in October, during which the agency found many problems, including bacterial contamination and lax quality-control procedures.
Citing similar findings, British regulators suspended Chiron's manufacturing license for three months in early October, eliminating half of the United States' expected supply of flu shots for this winter.
This week, the British regulators extended that suspension for another three months, until early April, though they said that was not because new problems had been found. Analysts said the extension would make it harder for Chiron to resume supplying vaccine next year because the company had said it would need to begin production by early spring.
Alison Marquiss, a spokeswoman for Chiron, said it still expected to supply vaccine next year and that the suspension could be lifted earlier if the company satisfied regulators that it had fixed the problems at the factory.
She said the warning letter would not affect the company's timetable. She characterized the letter as a formality, and said that it did not bring up any problems that the F.D.A. had not already mentioned in a report it gave to Chiron right after the inspection. The company, which is based in Emeryville, Calif., has already responded to most of the concerns in a plan it submitted to the F.D.A. last month, she said.
Still, in the letter, the F.D.A. gave Chiron 15 days to provide more details on the steps it would take. That could indicate that the agency was not totally satisfied with the company's plans for fixing the problems.
An F.D.A. spokeswoman said warning letters were standard procedure after serious violations were found in an inspection. She said the agency would make the letter public on Tuesday, when it normally posts warning letters on its Web site.
The F.D.A. was harshly criticized last month at a Congressional hearing for not issuing such a warning letter the last time it found problems at the Liverpool factory, after an inspection in June 2003. Instead of taking official enforcement action, the agency permitted Chiron to fix the problems voluntarily.
Representative Henry A. Waxman, the California Democrat who is the ranking minority member on the House Committee on Government Reform, asserted that the failure to issue a warning letter and undertake a follow-up inspection permitted the problems to fest, leading to the shutdown of the factory this year.
Lester M. Crawford, the acting F.D.A. commissioner, replied that an official action had not been needed because Chiron had been fixing the problems. He said the problems found in 2003 were not related to those that led to the license suspension this year.
Even if Chiron resumes production next year, many analysts say, its sales will be sharply limited because new suppliers will enter the market, which has been dominated by just two companies, Chiron and Aventis.
Chiron "may become the vaccine supplier of last resort, given its manufacturing problems and tarnished reputation," Eric Ende of Merrill Lynch wrote on Dec. 2, when he downgraded the stock to sell from neutral. Yesterday, Chiron shares rose 25 cents, to close at $31.29.
GlaxoSmithKline, which sells flu vaccine in 70 other countries, has indicated it might enter the United States market as early as next year.
The government said this week that it would buy up to four million doses from Glaxo to help with this year's shortage. Since the vaccine has not been approved in this country, those who receive it will have to give informed consent, as if they were participating in a clinical trial.
ID Biomedical, a Canadian supplier, said this week that 1.2 million doses it had considered supplying to the United States this year would instead remain in Canada. However, the company said it still planned to enter the United States market after approval of its vaccine, possibly as early as next year. It said it had signed long-term agreements to supply three American distributors, including Henry Schein, the Melville, N.Y., company that had been the main wholesaler for Chiron.
But in a possible setback to future supplies, Baxter International said Thursday that it had halted a late-stage clinical trial of a vaccine in Europe because of a higher-than-expected rate of mild fever in people who received the shots. Baxter planned to begin testing the vaccine in the United States next year, with possible market entry in 2007 or 2008, but those plans are up in the air while it tries to fathom the reasons for the fevers.
Baxter has been a leader in developing a manufacturing technique that is potentially faster and more sanitary than the standard process, thereby reducing the chances of future shortages. In that process, the viruses that are killed to make the vaccine are grown in vats of animal cells rather than in chicken eggs, the traditional method.
Deborah Spak, a spokeswoman, said Baxter did not know whether the side effects resulted from the production method. But she said that successful vaccines for diseases other than flu were already made by the same process, called cell culture.
FReepmail me if you want on or off my health and science ping list.
We are at the mercy of the British. How lovely. Tea anyone?
Spot on, old chap...
I never take a flu vaccine...I'm allergic to them.
Chiron bought the facility in England from a previous manufacturer of vaccines, IIRC. They thought they had a bargain. The vaccine that was quarantined was contaminated with Serratia, a type of bacteria.
I believe that Serratia is a water-borne bacteria; is that correct?
Serratia marcescens
a species found in water, soil, milk, foods, and silkworms and other insects; a significant cause of hospital-acquired infection, especially in patients with impaired immunity; it is the type species of the genus Serratia.
bttt
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.