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Flu Vaccine Preparedness
Press Kit | Drug Safety News
Chiron's Contaminated Vaccine Production Facility
Company consistently downplayed what was a life-threatening risk;
under proposed bill, if the bad batch hadn't been caught, there would
be no compensation for injured first responders and others.
In 2004, Chiron, a California-based company that manufactures flu
vaccine in Great Britain, almost sold 48 million contaminated doses
in the United States. The Serratia bacteria contaminating the vaccine
was especially dangerous for the very people who need protection the
most—seniors, very young children, and others with weakened immune
systems. What if that vaccine had hit the market and millions of people
became sick or even died? According to one proposal, absolutely nothing
would have happened to Chiron executives despite their chronic mismanagement.
A bill being pushed by some Members of Congress would provide complete
legal immunity for vaccine makers if a public health emergency is
declared. If an unsafe vaccine is sold, even if the company knew the
production process was flawed, there would be no accountability in
the courts and no compensation for those injured or killed.
Asking Americans to put full faith in the pharmaceutical industry
and then eliminating any accountability or justice system is dangerous.
After repeated missteps at Chiron and other scandals, how can Americans
be asked to trust them with our lives?
Timeline of Chiron's Mismanagement: Pressure to Cut Costs and Failure
to Follow Best Practices Led to Unsafe Vaccine
After Chiron discovered contamination, executives not to call
the FDA. In October 2004, an FDA official on a conference call
with British counterparts and Chiron executives writes “company
aware of the problem since April!” His handwritten note is accompanied
by a doodle of a sinking ship. The full story follows:
| 1999 |
The Food and Drug Administration (FDA) issues a
warning letter to Medeva Pharma Ltd., warning that their Liverpool,
England plant has numerous flaws in its quality control processes,
including unusually high levels of bacteria. This is the plant
that Chiron will eventually acquire to produce flu vaccines. |
| 2000 |
British regulators tell Celltech, the new owners
of the same Liverpool plant, that it must withdraw its polio vaccine
because of contamination concerns. |
| 2002 |
The Liverpool plant, now owned by Powderject Pharmaceuticals,
deviates from approved manufacturing methods, which results
in a flu vaccine with questionable potency and sterility. Tests
reveal four out of five batches lose potency too soon. Powderject
managers consider recalling the vaccine. Instead the improperly
made flu vaccine is shipped to the U.S.
Separately, the Irish Medicines Board announces it is dissatisfied
with plant procedures and suspends the company’s license
to supply a tuberculosis vaccine.
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| June 2003 |
FDA inspectors find bacteria contaminations a thousand
times the expected levels at the Liverpool plant. Chiron, which
is in talks to buy Powderject, will not receive the FDA report
for a further nine months. At that time the inspectors recommend
a formal warning, but agency managers overrule them and instead
ask the company to correct the problem voluntarily. |
| September 2003 |
Chiron buys Powderject, and the Liverpool plant,
for nearly $1 billion. Company executives say they anticipate
raising its productivity by as much as 35%. Analysts later will
say the plant was victim of “long under-investment,”
but Chiron goes on to spend only $6.3 million of the $97 million
that its board approves for improvements. |
| March 2, 2004 |
Unexpectedly high levels of bacteria are found in
pools of vaccine that had not yet been fully processed. It is
184 days before Chiron will eventually notify the FDA of a problem.
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| July 8, 2004 |
Finished vials begin failing sterility tests. It
is 56 days before Chiron will notify the FDA. |
| July 23, 2004 |
Despite finding potentially lethal Serratia bacteria
in finished vials, Chiron announces the shipment of one million
doses of flu vaccine to the United States. |
| August 26, 2004 |
Chiron announces that it has detected a contamination
problem in its UK plant. Chiron Chief Executive Howard Pien says
four million doses of influenza vaccine will be destroyed, but
that the company will release the rest of its full complement
of 46-48 million doses within two months. |
| August 27, 2004 |
One day after revealing the contamination in the
UK, Chiron confirms it is investigating an unexpectedly high number
of allergic reactions in connection with a different vaccine in
Brazil. The reactions, ranging from rashes to potentially fatal
anaphylactic shock, had affected at least 125 children who had
been administered the MMR vaccine. |
| October 2004 |
Chiron executives claim they have found the source
of the contamination and isolated infected lots. The company produces
a 100-page report of its investigation to reassure inspectors.
Far from being reassured, the inspectors see the report as a red
flag. They conclude the company has failed to consider all sources
of possible contamination. |
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October 5, 2004
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Chiron announces that it will not be able to sell
any of its planned 48 million vaccine doses. British regulators
suspend the company’s license and order a three month investigation.
An FDA official on a conference call with British counterparts
and Chiron executives writes “company aware of the problem
since April!” His handwritten note is accompanied by a doodle
of a sinking ship. |
| October 15, 2004 |
Despite Chiron’s assurances that the contamination
problem has been corrected, a team of FDA inspectors confirms
the British determination that all of the vaccine doses are suspect.
|
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December 7, 2004
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British regulators extend Chiron’s suspension,
blocking the company from resuming operations until at least April.
|
| February 11, 2005 |
The Securities and Exchange Commission (SEC) begins
a formal investigation into whether Chiron violated securities
laws. The agency had previously begun an informal investigation
after the contamination problem had forced the suspension of the
company’s license. |
Sources:
- USA got improperly made flu vaccine, USA Today, February 9, 2005.
- Was Chiron a victim of too-lofty goals?, USA Today, October 11,
2004.
Schmit.
- Officials Found Earlier Contamination at Flu Vaccine Plant, Associated
Press, November 18, 2004.
- Early flu-shot contamination revealed Chiron knew sometime in
July that vaccine was failing sterility tests, San Francisco Chronicle,
November 21, 2004.
- A Big Maker of Flu Shots Finds Some Contaminated, The New York
Times, August 27, 2004.
- Tainted Vaccine Is Unsalvageable, F.D.A. Says, The New York Times,
October 16, 2004.
- Half of U.S. Flu Vaccine Withheld; Supply Due From British Firm
Tainted, The Washington Post, October 6, 2004.
- British Flu Vaccine Is Unusable, FDA Says; Factory Inspection
Finds None Is Safe, The Washington Post, October 16, 2004.
- Chiron's Suspension Extended; MedImmune Among Firms Rushing to
Fill Vaccine Void, The Washington Post, December 9, 2004.
- Chiron Facing Formal S.E.C. Investigation¸ Reuters, February
12, 2005.
December 9, 2005
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