Bacteria Causes U.S. Flu Vaccine Shortage
UPDATED - Saturday October 09, 2004 12:54pm
Washington (AP) - The reddish bacterium to blame for this year's shortage of flu vaccine has a colorful history.
Until the 1960s, Serratia marcescens was considered harmless - so safe, in fact, that the military secretly dispersed it across U.S. cities in germ warfare studies. Today, Serratia is blamed for urinary tract infections, infected surgical wounds and pneumonia, usually spread among hospital patients.
The germ that tainted the flu vaccine at a British factory is a common contaminant in labs - and lots of other places. Serratia is found in people's intestines, and possibly growing as pinkish scum in the shower, too. "Most of us carry it every day of our lives," said Martin Blaser, chairman of medicine at the New York University School of Medicine. "A great paradox of life and health is we have all these bad organisms we carry around OK in our intestinal tracts, and if we move them over one inch to our bladder, for example, they make us sick."
During one such test in 1950 - "Operation Sea-Spray" - Navy vessels cruised the San Francisco coast, spewing huge amounts of the bacterium into the air over the city. At least one hospital noticed an increase in pneumonia patients. In the 1970s, when the military disclosed the tests, a San Francisco family sued over a pneumonia death they blamed on Serratia. Courts ruled the government was immune from such lawsuits.
Is this the only time our government has sprays its people with toxic substances? Here is another time .....New controversy over army germ
FDA officials said that a bacteria called serratia had apparently
contaminated some vaccine.
More on Serratia
Members of the Serratia genus, the contaminants found in the flu vaccine, were once known as harmless organisms that produced a characteristic red pigment. Today, Serratia marcescens is considered a harmful human pathogen which has been known to cause urinary tract infections, wound infections, and pneumonia. Serratia bacteria also have many antibiotic resistance properties which may become important if the incidence of Serratia infections dramatically increases. Serratia can be distinguished from other genera belonging to Enterobacteriaceae by its production of three special enzymes: DNase, lipase, and gelatinase.
Serratia is normally not harmful to healthy people but it is what is known as an opportunistic pathogen. Given the opportunity, Serratia can spell trouble. In people with a compromised (weakened) immune system, Serratia can cause infection of the blood (sepsis), wound infections, and infections of the endocardium (of the heart) and the urinary and respiratory tracts.
And part of the problem is that the high-risk groups for the flu who most need the flu vaccine are precisely those with a weakened immune system. Another part of the problem is that the finding of Serratia in the vaccine is a red flag, It is a warning that who knows what else may be contaminating the vaccine.
October 7, 2004
Contact: Jane Rohman, (413) 848-1407; email@example.com
David Kirby is also available at (718) 230-4250; firstname.lastname@example.org
FLU VACCINE SHORTAGE – THIMEROSAL TO BLAME?
NEW YORK - "Everyone is asking how the Chiron shut-down will affect vaccination rates, but few are asking how this could have happened," says David Kirby, author of the forthcoming book Evidence of Harm – Mercury in Vaccines and the Autism Epidemic: A Medical Controversy, from St. Martin’s Press. Kirby is also a contributor to the health and science pages of The New York Times and other publications.
This week, Chiron’s Fluvirin vaccine was pulled after the potentially dangerous serratia bacteria was found in some lots. "Chiron used the mercury-based preservative thimerosal as a sterilizing agent in making Fluvirin, to prevent exactly this type of contamination,” says Kirby, whose book explores the
possibility that thimerosal could have contributed to the rising numbers of cases of autism, ADD and other childhood disorders. “Thimerosal is also used as a preservative in multi-dose vials. By definition, no thimerosal-containing solution should have live bacteria present in its final formula.”
Thimerosal, Kirby adds, “has never been proven to be 100% safe, and now we see again that it is not 100% effective either.” A law to ban thimerosal in childhood vaccines was just signed by California Governor Arnold Schwarzenegger.
Vaccine making is nasty business, and microorganisms thrive in the warm egg-based brew used to produce the flu shot. The microbe-rich solution is treated with thimerosal, as a sterilizing agent, to kill all the bugs. Most mercury is removed before packaging, though 25 micrograms-per-dose remain in each 10-dose vial, to avoid contamination from repeated puncture of the seal by syringes.
This vaccine was contaminated with serratia at the company’s factory in Liverpool, England. “But with so much thimerosal in the mix, how was the bacteria able to survive?” Kirby asks. Thimerosal, it seems, is not a perfect preservative. In 1982, an FDA panel reported that thimerosal only prevents the growth of new bacteria rather than killing all the organisms altogether. It said mercury-based preservatives should be removed from topical products, and proposed that thimerosal was “not generally recognized as safe and effective.”
In fact, thimerosal was singled out as being “no better than water in protecting mice from fatal streptococcal infection.” And it was 35.3 times more toxic for embryonic chick heart tissue than for Staphylococcus aureus. Other studies found that up to 26 percent of the population was hypersensitive to thimerosal. Fluvirin’s package insert warns that it should not be given to “ anyone with a history of hypersensitivity to any component of the vaccine, including thimerosal.”
“This raises some troubling questions,” Kirby says. “If thimerosal doesn’t work, why are we using it? And why did it take the British Government to intervene on behalf of the safety of Americans? Now we face an imminent flu season with only half the vaccine needed. Millions will go unvaccinated and
people could die because thimerosal failed to perform its job. Government and industry must work to develop a safe AND effective way of making flu vaccine.”
CONTACT: Stephen Lee, St. Martin’s Press: 212-674-5151
NEW BOOK EXPLORES LINKS BETWEEN MERCURY IN VACCINES AND AUTISM, ADHD AND OTHER CHILDHOOD DISORDERS
NEW YORK – Did mercury in vaccines cause an epidemic of autism, ADD, ADHD, speech delay and other childhood disorders? A new book, to be released by St. Martin’s Press in Winter, 2005, explores this chilling possibility -- and the heated controversy swirling around it. The book, Evidence of Harm, Mercury in Vaccines and the Autism Epidemic: A Medical Controversy, was written by New York Times contributor David Kirby.
By most accounts, autism is now epidemic in the United States. In the 1990’ s reported autism cases among American children began spiking, from about 1 in 10,000 children in 1987 to a shocking 1 in 166 today. In this period, new shots containing a mercury-based preservative called Thimerosal were added to the nation’s already crowded vaccination schedule. Meanwhile, some parents noticed that their healthy children were descending into silent, disturbed, and physically ill behavior after receiving vaccinations. In 1999, the FDA announced that children were being exposed to mercury at very young ages at levels far exceeding federal regulations, but the public health establishment failed to take parental concerns about the impact seriously.
Evidence of Harm explores both sides of this controversy, which has pitted families and their allies against the federal government, public health agencies, medical academies, and powerful pharmaceutical giants. It examines:
Story of Thimerosal: a mercury-based additive approved by the FDA in the 1930’s as a vaccine preservative and never subsequently tested by the Agency Increase in reported autism cases and apparent parallel to the increase in number and frequency of Thimerosal-containing vaccinations in the 1990s. Private meeting at which FDA, CDC, medical and pharmaceutical company representatives discussed data on neurological childhood disorders related to mercury in vaccines
Mysterious rider to the 2002 Homeland Security bill which would free drug companies of liability in lawsuits regarding Thimerosal State and federal lawsuits filed by families against the drug makers
seeking compensation for the lifelong care of their ill children New biological research indicating a direct link between Thimerosal exposure and neurological disorders Preliminary Federal investigations currently underway into allegations of fraud, malfeasance, and conflict of interest at pharmaceutical companies and among officials at the FDA and CDC Recently discovered CDC data showing a shockingly high correlation between Thimerosal exposure and autism, ADD and other childhood disorders This disturbing, important book examines both the personal stories of families and the unfolding political drama in the courts and halls of Congress.
DAVID KIRBY has been a contributor to The New York Times for seven years, where he writes science and health articles for Science Times, among other things, and has been a writer in this field for over fifteen years. He lives in Brooklyn, New York.
Tainted flu vaccine could have been a health nightmare Bacteria used in 1950 germ-warfare test in Bay Area can be deadly --and target groups for shots would be most susceptible
Bernadette Tansey, Chronicle Staff Writer
Sunday, October 31, 2004
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 1950experiment, 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 oflife-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 withserratia would become a highly efficient vehicle to deliver thedangerous microbe into the bodies of people most susceptible to itseffects -- the old, the sick, those with weakened immune systems andsmall children. That's the very population most strongly urged byhealth 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 behindoutbreaks of infection in hospital patients, who often undergo invasiveprocedures 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 exposepatients 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 shortageThe American health care system had planned to inoculate a record100 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.
http://news.xinhuanet.com/english/2004-11/27/content_2268088.htm State Council passes lab safety regulations to prevent new outbreaks www.chinaview.cn 2004-11-27 21:26:10
BEIJING, Nov. 27 (Xinhuanet) -- A new set of regulations taking effect Saturday will prohibit Chinese lab directors from allowing experiments on risky pathogenic microbes without approval. The Chinese cabinet passed the 32-page and 72-item regulations in response to the incident in March when two people were infected by severe acute respiratory syndrome (SARS) virus at a lab of the Chinese Center for Disease Control and Prevention. China will grade its pathogenic microbe labs by four levels. The first and second grades are labs forbidden to conduct experiments on risky pathogenic microbes, which can cause severe diseases in human and animals and easily spread, the regulations said.
The third and fourth grade of labs are off limits for experiments without special certificates from the health and veterinary medicine administrations, the regulations said. These labs also must get approval from the administration when they plan to take up the experiments on risky pathogenic microbe and report the result when the research ends, the document added.
Early this year, the Diarrhea Virus Laboratory under the Institute of Virus Diseases of the center did experiments with the SARS virus without proper qualification and facilities to prevent the virus from spreading. The administration found that the lab researchers used an untested method to kill the SARS virus and did not test the result of the process. This was later confirmed as the source of SARS outbreak in China this year. The 2004 recurrence of SARS caused nine people to fall ill and one death.
The director and deputy director of the center resigned. The head and deputy head of the center's Institute of Virus Diseases as well as director of the lab were dismissed in July. Now, according to the regulations, the head of the institution that owns a lab and head of the lab will be dismissed if a mistake like this happens again. The biosafety regulations were the first and most authoritative one in China for medical labs, said an official with the Ministry of Health Saturday.
"The ministries of Health, of Agriculture and of Science and Technology all issued relevant documents and rules on this aspect but no standardized one was issued," he said, "We are working on an plan to implement the regulations." Gao Qiang, executive vice-minister of health, said early July that strengthening lab biosafety is an important and urgent task for the national health system. "The March outbreak sounds the alarm for the nation's lab safety management," Gao said. "The necessary punishment for some cadres is to help consolidate the responsibility awareness for relevant officials and establish a responsibility system for majoraccidents."
The regulations also ask medical labs to set up special departments or personnel to supervise the facilities. The labs must report to the superior administration if an accident takes place, the regulations said. The first outbreak of SARS happened in early spring 2003 and a total of 5,327 cases were reported that year in 24 provincial areas on the mainland. Nearly 350 people died of the disease. The Ministry of Health issued a plan to prevent SARS and bird flu this winder and next spring early this month, promising to send out experts within 24 hours after the first suspected case is found.
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