Same bacteria was used in 1950 Bay Area germ-warfare test -- and high-risk groups for shots would be most vulnerable
Tainted flu vaccine story here (or below)
Again, the best defense against things like this is your own immune system.
"There are two obstacles to vibrant health and longevity:
ignorance and complacency"
- World Health Organization
--------------------------------
Bernadette Tansey, Chronicle Staff Writer
Sunday, October 31, 2004 now part of stylesheet -->
Americans may never know how close a Bay Area company came to distributing a bacteria-tainted flu vaccine, or how much of that vaccine was contaminated.
What is known is that the bacteria that ruined the stockpile of vaccine produced by Chiron Corp. was used in a secret germ-warfare experiment in the Bay Area conducted by the Army and was tied to three deaths in Contra Costa County in 2001.
The bacteria -- which tainted about half of the nation's flu vaccine supply -- was once considered a harmless microbe. But a 1950 experiment, in which a ship off the San Francisco coast let loose clouds of Serratia marcescens to test whether an enemy could launch a biological warfare attack from a distance, is now suspected of causing a cluster of hard-to-treat infections.
Experts say the serratia bacteria can trigger a cascade of life- threatening illnesses, including heart-valve infections, pneumonia and septic shock when injected into vulnerable patients.
The bacterium was blamed for a deadly outbreak of meningitis in Contra Costa County in 2001, which was traced to injected drugs legally mixed by a Walnut Creek pharmacy.
British regulators pulled the license of Chiron's factory in Liverpool on Oct. 5 after discovering vaccine tainted with serratia. There had been problems with sterility at the plant, which Chiron insisted were confined to a small fraction of the vaccine's inventory. The company was preparing to ship at least 46 million doses of its product, Fluvirin, to U.S. distributors.
Officials at Chiron, which is based in Emeryville, and the Food and Drug Administration have yet to provide details about how the bacteria infiltrated the vaccine at Chiron's British manufacturing plant. Nor have they revealed how much of the live bacteria or its dangerous toxins were found in the huge inventory of vaccine doses.
What is known is that serratia can be deadly.
If distributed nationwide, a flu vaccine contaminated with serratia would become a highly efficient vehicle to deliver the dangerous microbe into the bodies of people most susceptible to its effects -- the old, the sick, those with weakened immune systems and small children. That's the very population most strongly urged by health authorities to get a flu shot.
"If you injected it, you'd get bacteremia and sepsis," especially in the people most likely to get the vaccine, said Mary York, a Walnut Creek consultant and former director of microbiology at UCSF. "It would be horrible."
People exposed to the bacteria in the air or water are unlikely to become ill. But injecting it into fragile patients is a different matter.
The illnesses that could result would be hard to treat because serratia has a genetic knack for quickly developing resistance to antibiotics, said Dr. Lee Riley, a professor of infectious disease at UC Berkeley.
The organism is now known to be a frequent culprit behind outbreaks of infection in hospital patients, who often undergo invasive procedures such as surgery, intravenous fluid drips and injections, which could help microbes penetrate the bloodstream.
How long it would take to discover that a flu vaccine nationally administered to millions of people was contaminated with serratia -- and how many would become infected and sickened before the program was stopped -- is a question that, fortunately, remains unanswered.
If the contaminated vaccine had been shipped and injected, doctors might start to pick up signs like swelling and redness at the site of the flu shot, said Dr. Suzanne Bradley, an infectious disease specialist at the University of Michigan Medical School.
"For most of us, we'd probably fight it off and say, 'I'm never going to get this vaccine again,' " she said.
But in the more vulnerable patients, like the elderly with underlying medical problems, serratia could multiply in the heart valves and spread to the lungs, causing pneumonia, said UC Berkeley's Riley.
"Such a person could potentially die," said Riley. "Even if you had one single case like that, it could be devastating."
The aggressive treatment often needed to control a serratia infection also has its risks, said Riley.
"As a treatment of last resort, you have to use multiple drugs," Riley said. But a prolonged course of combined antibiotics would expose patients to the further danger of infection by fungal growths, he said. "Treatment becomes very, very difficult."
How serious and how widespread the health damage might be from such a contaminated flu vaccine would depend on how many of the live germs, or the toxins from its cell walls, had managed to infiltrate each vaccine dose, said the University of Michigan's Dr. Bradley. A sole bacterium might cause no harm.
However, one of serratia's other tricks is that it can keep multiplying, even if the solution containing it is chilled.
"It grows in the refrigerator," said Mary York.
Flu shot shortage
The American health care system had planned to inoculate a record 100 million people against flu when British drug regulators blocked the release of the 46 million flu vaccine doses made at the Liverpool plant of Chiron Corp.
U.S. officials have replaced some of the lost vaccine, boosting available doses to 61 million, and have attempted to reserve supplies for the most vulnerable people -- the elderly, the ill and young children. The flu kills 36,000 people a year in the United States, primarily among high-risk groups.
Congress is investigating the quality of oversight of the Chiron plant by the Food and Drug Administration. The Securities and Exchange Commission and federal prosecutors also are investigating whether Chiron downplayed its problem in public statements.
CDC medical ethicists are drafting guidelines for the fair allocation of crucial drug supplies in case of future shortages -- decisions now handled by local health officials.
Sunday, October 31, 2004 now part of stylesheet -->
Americans may never know how close a Bay Area company came to distributing a bacteria-tainted flu vaccine, or how much of that vaccine was contaminated.
What is known is that the bacteria that ruined the stockpile of vaccine produced by Chiron Corp. was used in a secret germ-warfare experiment in the Bay Area conducted by the Army and was tied to three deaths in Contra Costa County in 2001.
The bacteria -- which tainted about half of the nation's flu vaccine supply -- was once considered a harmless microbe. But a 1950 experiment, in which a ship off the San Francisco coast let loose clouds of Serratia marcescens to test whether an enemy could launch a biological warfare attack from a distance, is now suspected of causing a cluster of hard-to-treat infections.
Experts say the serratia bacteria can trigger a cascade of life- threatening illnesses, including heart-valve infections, pneumonia and septic shock when injected into vulnerable patients.
The bacterium was blamed for a deadly outbreak of meningitis in Contra Costa County in 2001, which was traced to injected drugs legally mixed by a Walnut Creek pharmacy.
British regulators pulled the license of Chiron's factory in Liverpool on Oct. 5 after discovering vaccine tainted with serratia. There had been problems with sterility at the plant, which Chiron insisted were confined to a small fraction of the vaccine's inventory. The company was preparing to ship at least 46 million doses of its product, Fluvirin, to U.S. distributors.
Officials at Chiron, which is based in Emeryville, and the Food and Drug Administration have yet to provide details about how the bacteria infiltrated the vaccine at Chiron's British manufacturing plant. Nor have they revealed how much of the live bacteria or its dangerous toxins were found in the huge inventory of vaccine doses.
What is known is that serratia can be deadly.
If distributed nationwide, a flu vaccine contaminated with serratia would become a highly efficient vehicle to deliver the dangerous microbe into the bodies of people most susceptible to its effects -- the old, the sick, those with weakened immune systems and small children. That's the very population most strongly urged by health authorities to get a flu shot.
"If you injected it, you'd get bacteremia and sepsis," especially in the people most likely to get the vaccine, said Mary York, a Walnut Creek consultant and former director of microbiology at UCSF. "It would be horrible."
People exposed to the bacteria in the air or water are unlikely to become ill. But injecting it into fragile patients is a different matter.
The illnesses that could result would be hard to treat because serratia has a genetic knack for quickly developing resistance to antibiotics, said Dr. Lee Riley, a professor of infectious disease at UC Berkeley.
The organism is now known to be a frequent culprit behind outbreaks of infection in hospital patients, who often undergo invasive procedures such as surgery, intravenous fluid drips and injections, which could help microbes penetrate the bloodstream.
How long it would take to discover that a flu vaccine nationally administered to millions of people was contaminated with serratia -- and how many would become infected and sickened before the program was stopped -- is a question that, fortunately, remains unanswered.
If the contaminated vaccine had been shipped and injected, doctors might start to pick up signs like swelling and redness at the site of the flu shot, said Dr. Suzanne Bradley, an infectious disease specialist at the University of Michigan Medical School.
"For most of us, we'd probably fight it off and say, 'I'm never going to get this vaccine again,' " she said.
But in the more vulnerable patients, like the elderly with underlying medical problems, serratia could multiply in the heart valves and spread to the lungs, causing pneumonia, said UC Berkeley's Riley.
"Such a person could potentially die," said Riley. "Even if you had one single case like that, it could be devastating."
The aggressive treatment often needed to control a serratia infection also has its risks, said Riley.
"As a treatment of last resort, you have to use multiple drugs," Riley said. But a prolonged course of combined antibiotics would expose patients to the further danger of infection by fungal growths, he said. "Treatment becomes very, very difficult."
How serious and how widespread the health damage might be from such a contaminated flu vaccine would depend on how many of the live germs, or the toxins from its cell walls, had managed to infiltrate each vaccine dose, said the University of Michigan's Dr. Bradley. A sole bacterium might cause no harm.
However, one of serratia's other tricks is that it can keep multiplying, even if the solution containing it is chilled.
"It grows in the refrigerator," said Mary York.
Flu shot shortage
The American health care system had planned to inoculate a record 100 million people against flu when British drug regulators blocked the release of the 46 million flu vaccine doses made at the Liverpool plant of Chiron Corp.
U.S. officials have replaced some of the lost vaccine, boosting available doses to 61 million, and have attempted to reserve supplies for the most vulnerable people -- the elderly, the ill and young children. The flu kills 36,000 people a year in the United States, primarily among high-risk groups.
Congress is investigating the quality of oversight of the Chiron plant by the Food and Drug Administration. The Securities and Exchange Commission and federal prosecutors also are investigating whether Chiron downplayed its problem in public statements.
CDC medical ethicists are drafting guidelines for the fair allocation of crucial drug supplies in case of future shortages -- decisions now handled by local health officials.