Midthun noted that once a vaccine is contaminated it can raise issues about the production process...'For a sterile product, you routinely do sterility testing," she said. 'If there is contamination you know those lots are not sterile. The question is whatever it was that predisposed those lots to become contaminated'...There could be low-level contamination of all the product, she said -- too low to detect by conventional testing."


Saturday, October 9, 2004

Britain says U.S. told of vaccine shortage

By Glenn Frankel and Glenda Cooper / The Washington Post

LONDON -- British health officials said Friday that their American counterparts were informed in mid-September that problems at a drug-manufacturing plant in northwest England could disrupt influenza vaccine supplies to the United States.

Records at Britain’s Department of Health show that the plant’s owner, Chiron Corp., on Sept. 13 warned officials of the U.S. Food and Drug Administration and the British Medicines and Healthcare Products Regulatory Agency that potential contamination problems remained unresolved at the plant, according to Alison Langley, a senior spokeswoman at the department.

Health officials in Britain responded to the warning by seeking other possible sources for the vaccine, Langley said. “That’s when we started making our contingency plans by contacting other manufacturers.”

The British account is at odds with statements by U.S. health officials that they were caught by surprise by the British regulatory agency’s decision this week to suspend vaccine manufacturing for three months at the Liverpool plant. It had been expected to provide 48 million doses of flu vaccine to the United States, about half of the U.S. supply this year.

In Washington Friday, federal health officials told an emergency hearing in the House Committee on Government Reform that the system for procuring vaccines for the American public has been getting increasingly “fragile” for years, but none of the proposed solutions are likely to fix the problem quickly.

British officials said there had been regular communication with U.S. public health officials at the FDA and Centers for Disease Control and Prevention since Aug. 26, when Chiron announced it would delay releasing supplies of the vaccine because about 4 million doses had been tainted.

Jason Brodsky, an FDA spokesman, provided an agency statement disputing the British account, saying that “none of the Center for Biologics Evaluation and Research (CBER) staff who were in regular communication with Chiron since August 25, 2004, were notified by Chiron that there was an increased level of concern regarding the company’s investigation of the bacterial contamination.”

Furthermore, the statement said, there had been no communication between CBER and the British agency until that agency suspended Chiron’s license. That decision was reached last weekend, and Chiron was informed on Tuesday, according to congressional testimony this week.

Britain had been scheduled to receive about 2 million doses, or 10 to 20 percent of its total need, of the vaccine, known as Fluvirin. A British Department of Heath statement said officials had already arranged for an additional 1.2 million doses from some of its five other suppliers by the end of the month, with an additional 1 million due to arrive by mid-November.

U.S. officials, by contrast, have said they might not be able to make up the shortfall and urged doctors to give the vaccine only to people who are at highest risk. Influenza kills about 36,000 Americans each year, and as many as 500,000 people worldwide.

A senior British official disclosed this week that the initial cause of the contamination was serratia marcescens, a potentially dangerous bacterium.

A microbe with a distinctive red pigment, serratia marcescens is spread by contact with contaminated hands or equipment and was once considered harmless, according to Melanie Scourfield of the Society of Microbiologists here.

“It’s an opportunistic pathogen that lives in soil and water and has been linked to hospital-acquired infections, dialysis infections and pneumonia,” she said.

The Liverpool plant, which Chiron purchased last year, has gone through a series of owners and technical problems in recent years, according to British news reports. In 1999, FDA inspectors accused a previous owner, Medeva, of failing to ensure that the plant’s systems and equipment for producing Fluvirin were free from contamination.

The following year, British health officials ordered polio vaccines manufactured in 1996 at the plant to be withdrawn because of possible contamination with the misformed proteins that cause mad cow disease. In 2002, Irish officials suspended sales of BCG, a tuberculosis vaccine made at the plant, because of concerns that it was below required strength.

Medeva was bought in January 2000 by Celltech, which later sold its vaccine business to PowderJect Pharmaceuticals, a British-based firm that in turn sold the plant to Chiron.

“This plant has been well known in the industry,” said a British pharmaceutical executive who spoke on condition of anonymity. “It’s passed through a lot of companies’ hands very quickly. ... One or two companies who have owned this plant -- perhaps they haven’t spent the money on it they should have done, while milking it pretty hard.”

Chiron’s corporate communications headquarters in Emeryville, Emeryville, Calif., did not return a reporter’s phone calls Friday. Company officials previously have denied that they sought to expand the plant’s production capacity too rapidly and said they spent $75 million to upgrade the facility.

British health experts said U.S. officials should have realized the potential scale of the plant’s problems and taken steps to find other suppliers.

“The American policy has been cruelly exposed -- their decision to put all their eggs in one basket, so to speak,” said John Oxford, an international expert on influenza at Queen Mary’s College in London. “But perhaps this will be a good wake-up call and an encouragement to the American government to think again about how they are going to manage flu. It is urgent that we increase production, because there will be a flu pandemic some time in future years.”

Michael Langman, chairman of the Joint Committee on Vaccination and Immunization, an independent expert advisory committee, said Britain was wise to line up a half dozen suppliers. “You have to take the approach that it is always possible that something could go wrong with a company’s vaccine,” he said. “The probability is that it won’t, but the possibility is there.”


A Biotech Company's Aggressive Move Backfires

Howard Pien, the chief executive of Chiron, said he wanted to help meet America's need for more flu vaccine, while expanding the business of his company. So Mr. Pien has been sharply increasing the production of flu vaccine at a British factory Chiron acquired in 2003.

The company had expected that plant to supply about 50 million vaccine doses to the United States this year, up from 26 million in 2002, when the plant was owned by another vaccine maker.

But now Mr. Pien's aggressive plan has backfired. Finding contamination problems, British regulators suspended the license for vaccine production at the factory on Tuesday, a move that will deprive the United States of nearly half the flu vaccine it expected for this winter. The suspension has cost Chiron not only three-quarters of the profit it expected this year, but also some of its credibility with investors and customers.

Some analysts downgraded Chiron's stock, and Moody's Investor Services said it was looking at lowering the company's debt rating. Mark Augustine, an analyst at Credit Suisse First Boston, called Chiron a "broken" biotechnology stock. Shares of Chiron plummeted 16 percent on Tuesday, rebounding very modestly yesterday to close at $38.32, up 34 cents.
Vaccines accounted for about $700 million of the company's $1.75 billion in revenue last year. Fluvirin, the flu vaccine, alone accounted for $219 million. With the big increase in production, analysts had expected more than $300 million in revenue from Fluvirin this year.

Chiron, anticipating increased revenue, had increased spending in research and development and other areas of its business. It is also building a new office for its vaccine business in Philadelphia. Now the company may have to scale back plans. And prospects for its future flu vaccine business are clouded.

Mr. Pien has said that the company remains committed to being a major flu vaccine supplier next year. But he conceded in a news conference Tuesday that addressing the problems at the factory might extend past next February or March, when production would have to begin for next winter.

Mr. Pien, who rose quickly in the management ranks in several major pharmaceutical companies before becoming chief executive of Chiron in April 2003, did not make himself available for an interview yesterday. He said on Tuesday that the British regulatory decision was "disappointing and unexpected, but we respect the regulatory authority's judgment because it is based on concerns over safety."

One question is whether the contamination problems may have been a consequence of Mr. Pien's push to increase vaccine production quickly at the aging factory.

"The problem was they really stressed the system this year to get to that 50, 52 million doses," said Geoffrey C. Porges, an analyst at Sanford C. Bernstein & Company who formerly worked in the vaccines business at Merck.  David V. Smith, Chiron's chief financial officer, said yesterday that the company had not expanded its production too fast. About $75 million has been spent to upgrade the factory in the last five years, the company said. Chiron said it is committed to spending another $100 million to replace part of the plant.

The plant, located in Liverpool, dates back to the 1970's and has had a series of owners and problems in the last decade as pharmaceutical companies merged and divested assets.

Chiron acquired the owner of the Liverpool plant, PowderJect Pharmaceuticals, in July 2003 to expand its vaccine business. That merger was completed shortly after Mr. Pien took over, though the deal had been planned before he arrived. PowderJect, in turn, had acquired the factory in 2000 from Celltech, which owned it for about seven months.

Contamination problems were not new. Polio vaccines manufactured by Medeva, another previous owner, at the plant before 1996 were recalled in October 2000 after British authorities said they might be contaminated with BSE, or mad cow disease. In 1999, the Food and Drug Administration notified Medeva that there were risks of contamination in the flu vaccine produced at the plant.

Production issues at the plant when it was owned by Medeva also caused delays for Aviron, the developer of the nasal spray flu vaccine. The manufacturing of the spray vaccine, called FluMist, is still done partly on the same Liverpool campus but that production is now under the control of MedImmune, which acquired Aviron.

"It's an old facility that was sold by Glaxo to Medeva, who spent some money on it, though probably not in the right spot, then to Celltech, who didn't give a toss," said one British pharmaceutical executive.

Still, J. Leighton Read, the former chief executive of Aviron, said that he would not necessarily blame the age of the factory for Chiron's problems. "Every vaccine plant that's more than a year old that I'm aware of has a history of challenges in complying with the regulatory regime," said Dr. Read, now a venture capitalist. "In our extreme concern for safety, which is largely appropriate, we have evolved systems that are too rigid and brittle to adapt to circumstances such as this."

Chiron, based in Emeryville, Calif., is one of the nation's oldest biotech companies, founded in 1981 by three scientists from the University of California campuses in San Francisco and Berkeley. Perhaps its biggest claim to fame is the discovery of the hepatitis C virus.

But Chiron has not had as much success in developing biotech drugs as some of its competitors like Amgen and Genentech. The company has grown in large part through acquisitions and now has three businesses - drugs, the testing of donated blood for viruses like H.I.V. and hepatitis C, and vaccines.

The shutdown of its vaccine production could damage Chiron's business beyond the immediate loss of revenue. Hospitals, clinics and distributors might be more wary of ordering from Chiron in the future.

The federal government could become more aggressive in acquiring flu vaccine from additional suppliers next year, or encourage other companies to enter the business, which would cut Chiron's market share in the future. Chiron is currently one of two major suppliers of flu vaccine in the United States this year, the other being Aventis.

It is also possible the government will become more cautious in expanding its recommendations on who should get flu shots. "I took down my flu vaccine forecast right through 2012 because of this," said Mr. Porges of Sanford C. Bernstein.

Investors might also become less trusting of Chiron management. Mr. Pien gave public assurances, including in Senate testimony last week, that although the company had detected a limited contamination problem in the Liverpool factory, it was close to correcting the problem and would be shipping flu shots early in October.
"It certainly raises eyebrows in the investment community," said Mr. Augustine of Credit Suisse.

Argeris N. Karabelas, known as Jerry, who was Mr. Pien's boss at SmithKline Beecham in the 1990's, defended his credibility. "I can tell you there is nobody more credible that I've ever worked with than Howard Pien," said Dr. Karabelas, now a venture capitalist in Princeton, N.J. "This guy, if he said it, he believed it totally."

Mr. Pien, who was born in Taiwan and has an engineering degree from the Massachusetts Institute of Technology and an M.B.A. from Carnegie-Mellon, worked at Merck, Abbott Laboratories and SmithKline Beecham, which later became GlaxoSmithKline.

He became head of most of the SmithKline pharmaceutical business at the age of 40. His last position before joining Chiron was president of international pharmaceuticals at GlaxoSmithKline when the company, along with others, dropped a lawsuit aimed at keeping cheap copies of AIDS drugs out of South Africa.

Heather Timmons contributed reporting from London for this article.

Chiron Corporation, a leading biotechnology company headquartered in Emeryville, California, faced an urgent need to expand its R & D and administrative facilities, and wanted to remain in its existing urban setting rather than move to a new suburban location. 

The Chiron site was severely impacted by soil and groundwater contamination resulting from 75 years of past industrial uses. As an EPA Brownfields Grant Site, Chiron worked with California environmental regulatory officials to address volatile organics, arsenic, PCBs and petroleum contamination. 60,000 cubic yards of contamination were removed from the site. On and off site groundwater plumes were addressed.

OCTOBER 12, 2004. Reporter Jon Eisen, at Scoop Media, runs down another Chiron tale. He has the audacity to actually read the Chiron package insert that goes along with the vaccine. Surely he is breaking some law. It's not fair to examine company literature too closely.

I confess I visited the Chiron website. And I found this reassuring statement: "Every second, 25 people across more than 70 countries are immunized with a Chiron vaccine."  Also, beneath a very long list of Chiron vaccines, I encountered a remark that was puzzling. The FDA has not approved any of the vaccines. They are not sold in the US. Call me crazy, but I'd think Chiron would want to peddle these shots in the richest nation in the world.

Here is an excerpt from the bracing Eisen piece:

Maker Admits Meningococcal Vax May Be Dangerous
Monday, 23 August 2004, 9:26 amPress Release: Jon Eisen (full article)

Vaccine Maker Admits NZ Meningococcal Vaccine May Not Work, and Could Be

The manufacturer of the new meningococcal vaccine currently being introduced into New Zealand has admitted that ”complete protection against  infection caused by the New Zealand strain (of the bacteria) cannot be guaranteed.”  In the “package insert” designed to provide guidelines for doctors and nurses administering the vaccine, the CHIRON company also states that the vaccine has a high rate of possible side effects. Moreover, it says that much crucial data about the performance of the
vaccine, as well as data on “contraindications” (where it should not be used) are incomplete.

• While the insert says that “the population at risk should be vaccinated with MeNZB [company name for the vaccine] to prevent serious systemic disease” it concedes that “data on concomitant use of other vaccines are not yet available.” This means that if a person gets one or more other vaccines at or around the same time as the MeNZB vaccine, there are no data on possible adverse outcomes.  • The vaccine also “has not been evaluated in persons with thrombocytopenia (low blood platelet count) or bleeding disorders.”

• ”As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the rare case of an anaphylactic event (life threatening allergic reaction) following
administration of a vaccine.” The company neglects to provide any data on these kinds of events.

• “MeNZB has not been specifically evaluated in the immunocompromised. Individuals with complement deficiencies and individuals with functional or anatomical asplenia (problems with or absence of a spleen) may mount an immune response to MeNZB; however, the degree of protection that would be afforded is unknown.” [Understand that far more than a BILLION people in
this world have compromised immune systems---JR]

• “Any acute infection and febrile illness (an illness with an associated fever) is reason for delaying the use of MeNZB except when, in the opinion of the physician,withholding the vaccine entails a greater risk.” In other words, inasmuch as the manufacturer does not actually have any meaningful data on risks and benefits, it’s up to the doctor’s “educated guess” as to whether or not to vaccinate a sick child or infant. More: “A minor illness such a temperature of less than 38.5 detgrees such as a minor upper respiratory infection, is not usually reason to postpone immunisation.” However, in that such an infection may or may not be an indication of someone who is “immunocompromised” (a contraindication for the vaccine; remember that there is “no data” on this) the reader is left wondering about this apparent contradiction in the directions.

• “There are no adequate data from the use of MeNZB in pregnant women.”

• “Information on the safety of the vaccine during lactation is not available.”

• “The degree and quality of the cellular immune response is not yet established.”

• “Clinical efficacy (whether it works or not): No prospective efficacy trials have been performed with MeNZB.” In other words, the company has no idea as to whether or not the vaccine actually does what they say it should do.

End of Scoop excerpt


Full Article
Maker Admits Meningococcal Vax May Be Dangerous
Monday, 23 August 2004, 9:26 am
Press Release: Jon Eisen 

Vaccine Maker Admits NZ Meningococcal Vaccine May Not Work, and Could Be Dangerous

The manufacturer of the new meningococcal vaccine currently being introduced into New Zealand has admitted that ”complete protection against infection caused by the New Zealand strain (of the bacteria) cannot be guaranteed.”  In the “package insert” designed to provide guidelines for doctors and nurses administering the vaccine, the CHIRON company also states that the vaccine has a high rate of possible side effects.

Moreover, it says that much crucial data about the performance of the vaccine, as well as data on “contraindications” (where it should not be used) are incomplete.


• While the insert says that “the population at risk should be vaccinated with MeNZB to prevent serious systemic disease” it concedes that “data on concomitant use of other vaccines are not yet available.” This means that if a person gets one or more other vaccines at or around the same time as the MeNZB vaccine, there are no data on possible adverse outcomes.

• The vaccine also “has not been evaluated in persons with thrombocytopenia (low blood platelet count) or bleeding disorders.”

• ”As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the rare case of an anaphylactic event (life threatening allergic reaction) following
administration of a vaccine.” The company neglects to provide any data on these kinds of events.

• “MeNZB has not been specifically evaluated in the immunocompromised. Individuals with complement deficiencies and individuals with functional or anatomical asplenia (problems with or absence of a spleen) may mount an immune response to MeNZB; however, the degree of protection that would be afforded is unknown.”

• “Any acute infection and febrile illness (an illness with an associated fever) is reason for delaying the use of MeNZB except when, in the opinion of the physician,withholding the vaccine entails a greater risk.” In other words, inasmuch as the manufacturer does not actually have any meaningful data on risks and benefits, it’s up to the doctor’s “educated guess” as to whether or not to vaccinate a sick child or infant. More: “A minor illness such a temperature of less than 38.5 detgrees such as a minor upper respiratory infection, is not usually reason to postpone immunisation.” However, in that such an infection may or may not be an indication of someone who is “immunocompromised” (a contraindication for the vaccine; remember that there is “no data” on this) the reader is left wondering about this apparent contradiction in the directions.

• “There are no adequate data from the use of MeNZB in pregnant women.”

• “Information on the safety of the vaccine during lactation is not available.”

• “The degree and quality of the cellular immune response is not yet established.”

• “Clinical efficacy (whether it works or not): No prospective efficacy trials have been performed with MeNZB.” In other words, the company has no idea as to whether or not the vaccine actually does what they say it should do.

• “Adverse Reactions from Clinical Studies with the Norwegian parent vaccine, Menbvac, an OMV vaccine manufactured with a strain from a different sero-(sub)type (B:15:P1.7,16)  For MenBvac further adverse events were reported including anaphylactic reactions, flu-like symptoms, haematuria (blood in the urine), Guillain-Barre Syndrome (neurological disorder that may include paralysis), myalgic encephalomyelitis/chronic fatigue syndrome(aka ME). All these reactions were very rare (no data supplied) and occured in adolescents and/or adults. Additional information: Although MenBvac is the parent vaccine of MeNZB the above mentioned adverse events of MenBvac may not necessarily be expected to happen with MeNZB (no reason or data specified).

TRANSLATION: These are some of the adverse reactions to the parent strain (Norwegian vaccine) from which the New Zealand vaccine was developed. We don’t know what the reactions to the NZ strain will be, and this is the reason:

“Adverse reactions (to the vaccine in the trial period) were collected on the day of vaccination and each day following for up to 7 days.” This means is that the NZ vaccine, which is related to the Norwegian vaccine, may or may not have a similar adverse reaction profile nobody knows yet and the Ministry of Health is not waiting to find out before it releases the vaccine for use in New Zealand.

Moreover, the company followed up the trial subjects ) only about 1000 people) for only about a week, even though some “adverse reactions” don’t begin to show up until many weeks or months later (or even years with some vaccines, like the cancer connection to the polio vaccine).

Finally, we come to aluminium hydroxide, an “adjuvant” in the vaccine. This was shown as far back as 1975 to be a possible carcinogen (cancer-causing agent) by US Bureau of Biologics and the US Food and Drug Administration). 

The fact is that the MeNZB vaccine is still highly experimental, despite what the Ministry of Health is telling the people of New Zealand, which is that the vaccine will prevent meningoccocal meningitis, is safe and well trialled.  “This vaccine has been safely used in clinical trials in Auckland with a range of age groups, including babies and adults.”

The MoH is not telling the people of New Zealand that we are paying a vaccine company $200 million to experiment on our children with the possibility of long lasting “adverse consequences” like cancer, diabetes and other serious illnesses down the track.

A Precedent

With the bandwagon rolling along on the new meningitis vaccine, it may be instructive to consider the following, which links an earlier vaccine for meningitis to a marked increase in diabetes.

The prestigious peer reviewed journal Autoimmunity (August 2002 Vol. 35 (4), pp. 247-253} recently published an article by Dr. J. Bart Classen, an immunologist at Classen Immunotherapies, and David Carey Classen, an infectious disease specialist at the University of Utah, proving a causal relationship between the hemophilus vaccine and the development of insulin dependent diabetes. The data is particularly disturbing because it indicates the risks of the vaccine exceeds the benefit. The findings are expected to allow many diabetics to receive compensation for their injuries.

The study followed over 100,000 children who had been randomized in a large clinical trial to receive 1 or 4 doses of the hemophilus vaccine and over 100,000 unvaccinated children. After 7 years the group receiving 4 doses of the vaccine had a statistically significant, 26% elevated rate of diabetes,
or an extra 54 cases/100,000 children, compared to children who did not receive the vaccine.

By contrast immunization against hemophilus is expected to prevent only 7 deaths and 7 to 26 cases of permanent disability per 100,000 children immunized. The study showed that almost all of the extra cases of diabetes caused by the vaccine occurred between 3-4 years after vaccination. Furthermore the paper provides new data proving the vaccine causes diabetes in mice and reviews data from 3 smaller human studies, which all had similar results to the current study, but were too small to reach statistical significance.

"Our results conclusively prove there is a causal relationship between immunization schedules and diabetes. We believe immunization schedules can be made safer," stated Dr. Bart Classen.  The Classens' research is already becoming widely accepted. An independent group of researchers working at a prestigious Swedish medical center recently published a paper (Annals. N.Y. Acad Sci. 958: 293-296, 2002) supporting their findings. Last year doctors attending a conference of the American College for Advancement in Medicine overwhelmingly agreed that vaccines can cause chronic diseases such as diabetes.

In the December 1994 Medical Post, Canadian author of the best-seller Medical Mafia, Guylaine Lanctot, MD, stated, "The medical authorities keep  lying. Vaccination has been a disaster on the immune system. It actually causes a lot of illnesses. We are actually changing our genetic code through vaccination...100 years from now we will know that the biggest crime against humanity was vaccines."

After critically analyzing literally ten's of thousands of pages of the vaccine medical literature, Dr. Viera Scheibner concluded that "there is no evidence whatsoever of the ability of vaccines to prevent any diseases.

To the contrary, there is a great wealth of evidence that they cause serious side effects." Dr. Classen has stated, "My data proves that the studies used to support immunization are so flawed that it is impossible to say if immunization provides a net benefit to anyone or to society in general.

"This question can only be determined by proper studies which have never been performed. The flaw of previous studies is that there was no long-term follow up and chronic toxicity was not looked at.

The continued denial and suppression of the evidence against vaccines only perpetuates the "myths" of their "success" and, more importantly, their negative consequences on our children and society. Aggressive and comprehensive scientific investigation into adverse vaccine events and is clearly warranted, yet immunization programs continue to expand in the absence of such research.
Concerns over vaccine adverse effects and conflicts of interest led the American Society of Physicians and Surgeons to issue a Resolution to Congress calling for a "moratorium on vaccine mandates and for physicians to insist upon truly informed consent for the use of vaccines."

Approved by unanimous vote at the AAPS October 2000 annual meeting, the resolution made references to the "increasing numbers of mandatory childhood vaccines, to which children are subjected without information about potential adverse side effects"; the fact that "safety testing of
many vaccines is limited and the data are unavailable for independent scrutiny, so that mass vaccination is equivalent to human experimentation and subject to the Nuremberg Code, which requires voluntary informed consent"; and the fact that "the process of approving and 'recommending' vaccines is tainted with conflicts of interest."

In an October 1999 statement to Congress, Bart Classen, M.D., M.B.A., founder and CEO of Classen Immunotherapies and developer of vaccine technologies, stated, "It is clear that the government's immunization policies are driven by politics and not by science."

FACT: In The New England Journal of Medicine (July 1994) a study found that over 80% of children under 5 years of age who had contracted whooping cough had been fully vaccinated (immunised).

FACT: The death rate from common infectious diseases such as tuberculosis, whooping cough, measles and diptheria had declined by over 90% BEFORE the introduction of vaccination. (1)

FACT: A 1992 study published in The American Journal of Epidemiology shows that children die at a rate 8 times greater than normal within three days after getting a DPT vaccination.

FACT: Many children develop serious conditions as a result of vaccination. How many? Unfortunately, it is impossible to know for sure because only a small fraction (less than 10%) of all "adverse reactions" are ever reported. (2)

Long-term adverse reactions to vaccines may include:

Arthritis: This is a known risk of the rubella portion of the MMR vaccine. The risk is higher in and women and adolescent girls.(3)

Diabetes: According to the NZ Medical Journal (24/05/96), Insulin Dependent Diabetes increased by 60% in NZ children after a mass vaccination campaign using a genetically engineered Hepatitis B vaccine.

Autism: This once rare (but now common) brain disorder has been linked to the MMR vaccine by several independent researchers and doctors and published in peer-reviewed medical journals like The Lancet and The Journal of Adverse Drug Reactions. Dr Mary Megson and others have also linked the DPT vaccine to this distressing condition. Autism can ruin a child’s ability to learn and develop normal relationships.

Asthma:British researcher Dr Michael Odent found that children who were vaccinated with the DPT vaccine were four times more likely to develop asthma than children who were not injected with this vaccine.

Cancer: The polio vaccine has been implicated in some brain cancers where the presence of a cancer-causing virus (SV-40) contaminating the vaccine has been confirmed. (Surprisingly there has never been a study comparing the health of vaccinated vs unvaccinated people, and the medical establishment refuses to conduct one on “ethical” grounds.)

FACT: Some vaccines such as the rubella (MMR) (4), the Hepatitis A vaccine(5) among others, are cultured on cells from aborted human foetuses.

FACT: Many vaccines do not prevent disease very effectively, despite what you’ve been told. In the USA where 98% of children are vaccinated, children (and adults) still develop measles, whooping cough and other "vaccine preventable" diseases. A massive outbreak of whooping cough occurred in Holland in 1998, despite the fact that over 90% of the population had been vaccinated against it.

New Zealand vaccinations are not compulsory. Children DO NOT have to be vaccinated in order to go to daycare or school. Know your rights. Inform yourself about the pros and cons of any and all vaccines before you decide. It is your decision.

Positive Outcome of Phase I DNA Influenza Study

PowderMed Announces First Clinical Trial Results

OXFORD, England, November 18 /PRNewswire/ -- PowderMed Ltd (PowderMed), a company focusing on the development of therapeutic DNA vaccines has announced positive results in a Phase I clinical trial of a proprietary prophylactic DNA influenza vaccine.

The trial examined three doses of the DNA influenza vaccine (1, 2 and 4 micrograms), in 12 volunteers per arm, making 36 volunteers in total. Each was administered as a single dose to healthy adult volunteers. The immune response was assessed according to the criteria laid down by the Committee for Proprietary Medicinal Products (CPMP) for the approval of annual flu vaccines in the European Union. All three doses passed the CPMP criteria at 56 days and the maximum dose (4 micrograms) passed the criteria at 21 days and was well tolerated. At the maximum dose (4 micrograms) 100% of the subjects achieved a seroprotective level of antibodies demonstrating that this DNA vaccine is a viable candidate for further trials to develop a vaccine against influenza or pandemic flu. Dr Clive Dix, CEO of PowderMed commented: "We are very encouraged by this positive clinical data generated with PowderMed technology. I am convinced  that a PowderMed DNA flu vaccine could become a viable solution for the current threat from pandemic flu."

This DNA influenza vaccine can be readily commercialised using PowderMed's proprietary PowderJect(TM) Particle Mediated Epidermal Delivery (PMED(TM)) technology. DNA vaccines using PMED are highly versatile in that they rely on powdered DNA and can be stored at room temperature and have much longer shelf-lives than traditional vaccines.

Notes for Editors

About PowderMed Ltd - PowderMed Ltd, based in Oxford, United Kingdom, is a leader in the development of therapeutic DNA Vaccines. The Company was created through a spin-out of the powder injection DNA Vaccines technology from Chiron Vaccines, a business unit of Chiron Corporation (NASDAQ: CHIR). PowderMed has acquired the rights to the PowderJect(TM) Particle Mediated Epidermal Delivery (PMED(TM)) technology which it plans to use, in the first instance, in the development of therapeutic DNA vaccines targeting chronic viral diseases and cancer. PowderMed has a proprietary therapeutic vaccine for the treatment of genital herpes in Phase I trials and also two partnered Phase I programmes in Cancer (Ludwig Institute) and HIV/AIDS (GlaxoSmithKline). In addition the Company has two proprietary preclinical lead programmes targeting genital warts and, hepatitis B. The Company will seek to further its technology in areas outside of its strategic focus through partnerships and collaborations.

Early hints of flu-shot crisis revealed
Chiron waited nearly 2 months to tell officials vaccine was failing sterility tests
Sabin Russell, Chronicle Staff Writer

Sunday, November 21, 2004

Chiron Corp. was wrestling with bacterial contamination of flu vaccine at its Liverpool plant as early as March, and its finished vials began failing sterility tests nearly two months before the company warned regulators it had a problem, newly surfaced documents show.

Details emerging from Wednesday's Capitol Hill hearing on the flu shot shortage -- and the release of hundreds of pages of Food and Drug Administration inspection reports, notes and e-mail correspondence -- paint a disturbing picture of how things went wrong at the British factory responsible for half the U.S. influenza vaccine supply.

The Emeryville biotechnology company first revealed on Aug. 26 that eight lots of its Fluvirin vaccine had been contaminated by bacteria, condemning 4 million of a planned production run of 52 million doses.

However, documents obtained by the House Government Reform Committee probing the flu shot shortage disclose the sterility test failures actually began on July 8 and continued through Aug. 2 -- well before the company informed the FDA, British regulators or the public of the problem.

Reports released by Rep. Henry Waxman, D-Los Angeles, ranking minority member of the committee, show that plant operators were struggling with excessive amounts of bacteria even in the early phases of this year's production.

Problems on March 2

One document shows that British regulators traced the problem as far back as March 2, when high levels of bacteria were found in pools of vaccine that had not been fully processed. While low levels of bacteria are expected and tolerated before final filtration steps are taken, high levels in bulk vaccine are a sign that something is wrong with the process. Contamination of finished product is a potential disaster.

"Considering the history of failure in that plant, both the FDA and the CDC (Centers for Disease Control and Prevention) should have been informed of the filled vial sterility failures. They should have been on a plane to England on July 8,'' said Sarah Sellers, an expert on pharmaceutical regulation and a consultant to the FDA.

Chiron officials were unavailable for comment on the documents released by the committee, but company chairman Howard Pien testified on Wednesday that the company thought "the scope of the problem did not appear to threaten any supplies.''

Chiron announced shipment

Despite the discovery of potentially lethal Serratia bacteria in some of its filled vials, Chiron announced on July 23 that it had shipped 1 million doses of its Fluvirin vaccine to distributors in the United States -- a marketing coup for the Emeryville biotech company that had purchased the British plant one year earlier.

An eager new player in the U.S. flu vaccine market in 2003, Chiron hoped to boost production by 35 percent this year.

Chiron eventually shipped 6 million doses over the summer to its seven U.S. distributors under a privately enforced quarantine that forbade them from selling it to customers until the company conducted final tests. That clearance never came, and the vaccine remains at distributors pending a Chiron "remediation" plan to destroy it, the company has said.

Despite assurances that the FDA was in close and frequent contact with Chiron after it acknowledged the contamination in August, the records unearthed by the congressional committee portray a federal agency caught unaware of the scope of problem at the plant its own inspectors found serious fault with a year earlier.

In one telling set of handwritten notes, the FDA official in charge of manufacturing quality recounts a teleconference with Chiron and British drug regulators on Oct. 5, the day the plant was shut down. One entry, from Jay Eltermann, director of manufacturing and product quality, makes clear that key FDA officials had no idea Chiron was struggling with high levels of bacteria in the earliest phases of production. It says, "... company aware of the problem since April!"

The handwritten exclamation is accompanied by a doodle of a sinking ship.

Following the telephone briefing, British regulators concluded that the first contamination problem in the plant was identified by Chiron operators on March 2.  Documents provided to the Government Reform Committee show that bacterial contamination in the early phase of production has been a long-running problem at the Liverpool plant, which has changed ownership three times in recent years.

In 1999, the FDA issued a warning letter to Medeva Pharma Ltd., which owned the Liverpool plant at the time, threatening to suspend its license if it did not correct numerous flaws in its quality control processes. The company eventually met the requirements demanded of it. FDA officials had considered taking a similarly tough stand following an inspection of the Liverpool plant, operated by Powderject Pharmaceuticals, shortly before Chiron acquired it in June 2003.

High levels of bacteria in the early stages of production were once again a problem. Congressional investigators concluded that, in some cases, the levels "were more than 1,000 times higher than expected.'' Serratia bacteria, the same potentially lethal microbe that turned up in Chiron lots this summer, was detected 14 times in Powderject tests of vaccine after it had passed through a process known as "ultrafiltration'' in 2001 and 2002.

Told to find 'root cause'

As the new owner of the plant, Chiron was directed to find the "root cause" of the bacterial contamination. But the FDA report detailing what needed to be done was not delivered to the company until June 2004, nearly nine months after the federal agency downgraded its enforcement action from mandatory to voluntary.

British regulators, who visited the Liverpool plant shortly after they were told of the contamination in late August, informed Chiron on Sept. 24 that they would be conducting one more inspection "for cause," and barred the company from selling any vaccine until it was concluded. Chiron did not tell the FDA of the impending inspection by British regulators, who had the power to shut down the plant.

Documents indicate that the plant operators were not aware that their license to run the plant was in serious jeopardy. The British regulators ultimate found 19 "serious issues related to microbial contamination or a potential for microbial contamination,'' and on Oct. 5 suspended the plant's operations for three months.  When the FDA conducted its own inspection Oct. 10-15, it affirmed the British regulators' findings, and found the plant had failed to take corrective actions noted in its inspection in 2003.


 Rocky Mountain News

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U.K. extends suspension of Chiron flu vaccine license
By Marni Leff Kottle, Bloomberg News
December 9, 2004

Chiron Corp. said United Kingdom regulators extended a suspension of the company's license to make flu shots until April, possibly jeopardizing next year's U.S. supply. The company produces all of its U.S. flu vaccines at a plant in Liverpool, England, that U.K. regulators shut in October because of contamination.

The closing caused a shortage of shots in the U.S. The initial suspension, scheduled to end Jan. 4, was extended by three months, Emeryville, Calif.-based Chiron said. Chiron, the world's second-largest maker of influenza vaccines, needs to begin making shots for next year by March to be ready in time for the 2005-2006 flu season, the company said in a U.S. regulatory filing last month.

The plant's closing created an opening for GlaxoSmithKline PLC to enter the U.S. market this year, and other drugmakers may follow in 2005, investors said. "The whole franchise may be in trouble," said Steven Lampe, who helps manage about $8 billion in assets at Delaware Investments in Philadelphia and sold Chiron shares after the factory was closed. "I'd be lying if I said I thought it was going to get this bad." Chiron is working with U.S. and U.K. regulators to reopen the plant in time to manufacture vaccines for the 2005-2006 flu season, company spokeswoman Alison Marquiss said.

Chiron's stock, which closed at $30.91 on Wednesday, has dropped more than 30 percent since Oct. 4, the day before the company announced the license suspension. GlaxoSmithKline, based in Brentford, England, won U.S. Food and Drug Administration approval Tuesday to provide as many as 4 million flu vaccines for this year's season.

Copyright 2004, Rocky Mountain News. All Rights Reserved.


USA got improperly made flu vaccine
By Julie Schmit, USA TODAY
The British plant responsible for the recent flu vaccine shortage sent some improperly made vaccine, by mistake, to U.S. consumers three years ago, according to a 2003 government inspection report recently given to Congress. Whether that vaccine stayed potent and sterile through its expiration date could be questioned, USA TODAY found. That was because the plant first deviated from approved manufacturing methods, then failed to document whether that would harm the vaccine's quality over time.

The report doesn't say how many doses were involved, and there's no proof the vaccine harmed anyone. But the mistake — along with other deficiencies in vaccine production at the Liverpool plant — is likely to increase skepticism about the Food and Drug Administration's oversight of the plant and the vaccine industry.

The FDA discovered the mistakenly released vaccine during a plant inspection in mid-2003, more than a year after millions of people got flu shots for the 2001-2002 season and a month before the plant's current owner, Chiron, bought it from PowderJect Pharmaceuticals. The FDA's report became public last fall during Congress' probe of the vaccine shortage. A close examination reveals many unreported details about the plant's vaccine, most of which was for the U.S. market:

•Four out of five batches of tested vaccine made for the 2001-2002 flu season lost potency too soon.

•PowderJect managers considered — but decided against — recalling flu vaccine in 2002 because of concerns about its potency.

•Some required quality-control tests before 2003 were "simply overlooked," the company told FDA inspectors, and it didn't do others on time. In two unspecified years before 2004, the company sent the FDA test vaccine samples labeled as one kind of flu strain when they were actually another.

•Plant operators repeatedly failed to fully and properly investigate problems.

Despite these failings, the FDA largely accepted the company's word that it would correct deficiencies, even though the plant had received a bad FDA review in 1999, and was being relied upon for more of the USA's flu vaccine.

Last year, the plant's 48 million doses, half the USA's expected flu-shot supply, were scrapped after British regulators suspended the plant's license when about 8% of its vaccine turned up contaminated. British officials cited deficient manufacturing conditions. The FDA then said it couldn't be sure any of the vaccine was safe.

Chiron is upgrading the plant and hopes to provide flu shots to the United States this fall.

The story of the Liverpool plant is one of lax FDA oversight of an industry in which millions of Americans put their trust every year, FDA critics and some pharmaceutical industry experts say. If the FDA had done more to ensure plant upgrades after the 2003 inspection, this season's shortage might have been prevented, says Rep. Henry Waxman, D-Calif., an FDA critic. The FDA disputes that.

The 2003 report, which focuses on the 2001-2002 vaccine, also "raises serious questions" about the quality of vaccine the plant produced three years ago, Waxman says: "I see no clear evidence that individuals were harmed, but it is certainly a situation we do not want to repeat."

The FDA says the plant's vaccine that flu season — and in others except for 2004 — met its requirements for safety and effectiveness. No vaccine was distributed that didn't pass the manufacturer's and FDA's tests, the agency says.

But three drug-industry experts, including a former FDA investigator, who reviewed the report for USA TODAY say they cannot be sure that all the 2001-2002 vaccine met government standards. They don't think the FDA can say for certain, either. That's because the way the vaccine was made and tested was deficient in too many ways for anyone to be certain all of it met federal potency and safety standards through its expiration date, they say. None of them would have felt comfortable taking it themselves.

"I don't feel confident that the plant's vaccine was safe and effective based on its non-compliance with good manufacturing practices," says Sarah Sellers, a drug safety consultant and FDA adviser who reviewed the report.

Flu vaccine problems

FDA concerns: 17
Warning letter: Yes
Concerns included:

High levels of microorganisms found in partially processed vaccine, requiring refiltering.

No data proving refiltering didn't harm vaccine's quality.

Inadequate probe into why some vaccines flunked sterility tests.

FDA concerns: 31
Warning letter: No

FDA concerns: 20
Warning letter: No
Concerns included:

High levels of microorganisms found in partially processed vaccine, requiring refiltering.

No data proved refiltering didn't harm vaccine's quality.

No formal probe into root cause of high levels of microorganisms going back to 2000.

Inadequate probe into why some vaccine flunked sterility tests.

FDA concerns: 14
Warning letter: Yes
Concerns included:

Some vaccine is likely contaminated because of inadequate condtions as it moves from one part of the process to another - a weakness noted in 2003 inspection that wasn't adequately corrected.

Company's probe into why some vaccine flunked sterility tests was inaccurate.

High levels of microorganisms are found in partially processed vaccine, same as for vaccine produced in 2000 and 2001.

Source: FDA

Testing misses some problems

Testing of vaccine is just one check to ensure that it's safe and effective. But it isn't a fail-safe method, because only samples of vaccine are tested, and problems can be missed, says Denise Dion, a former 18-year FDA investigator now with consulting firm EduQuest. She also reviewed the report.

That's why regulators also check to make sure vaccines are made using good manufacturing practices, as defined by the government. Those include everything from having proven procedures to strong quality control, testing and record-keeping. Drugs made without good practices can be declared adulterated even if tests show samples are fine. Without good manufacturing practices, the World Health Organization says, it "is impossible to be sure that every unit of a medicine is of the same quality as the units ... tested in the laboratory."

In mistakenly releasing the improperly made vaccine three years ago, the plant violated good manufacturing practices, the FDA says.

"If you look at what's in FDA's own documents, it's stunning they didn't get a warning letter or something worse" after the 2003 inspection, says Gordon Richman, a former director of quality strategy for GlaxoSmithKline's manufacturing. He is now an FDA-regulatory consultant at EduQuest. He reviewed the report separately from colleague Dion.

Warning letters demand fixes under threat of further action, such as license suspension. Instead, the FDA let the plant make fixes voluntarily, Waxman says, even though its own investigators recommended official action against the plant, he says. His office reviewed several thousand pages of documents, not all of which have been released to the public. The House Committee on Government Reform, which includes Waxman, plansa hearing todayon the flu-shot shortage and future challenges.

The FDA says it allowed the plant to make voluntary fixes because it had made some corrections and planned others. In an e-mail response to USA TODAY, it also said the vaccine-making process includes safeguards, such as testing at various stages. Because of that, "violations in certain good manufacturing practices do not necessarily or routinely translate into unsafe products," it says.

The FDA declined requests for interviews with FDA officials and didn't answer all questions via e-mail. Chiron declined comment on vaccines made at the plant before it owned the plant.

Longtime supplier

The plant has provided Fluvirin flu vaccine to the USA since 1988, the FDA says. In 1999, the FDA gave the owner then, U.K.-based Medeva Pharmaceuticals, a warning letter for violating good manufacturing practices. Among the FDA's concerns: Some of the plant's partially processed vaccine contained unusuallyhigh levels of bioburden — bacteria and other microorganisms. It had to be refiltered to remove the organisms.

All flu vaccine starts out with bacteria in it because it's made using eggs, which contain bacteria. The manufacturing process is supposed to get rid of all detectable bacteria. Refiltering is discouraged because it can harm a vaccine's quality and might indicate something is wrong with the plant's system that needs to be fixed.

Medeva took issue with some of the FDA's findings but promised many fixes, FDA documents show.

In March 2001, when the FDA re-inspected the plant, PowderJect owned it. That inspection report was not made public. But the 2003 report says FDA inspectors in 2001 told plant operators that refiltering and reprocessing were not appropriate for U.S. vaccine.

Yet, when FDA investigators returned in 2003, they found just that: Batches of vaccine during the summer of 2001 had been refiltered to successfully lower bacteria levels. They were mixed with other batches to make the final vaccine.

The report says refiltered vaccine went into three lots sent to U.S. consumers. A vaccine lot typically has hundreds of thousands of doses, industry experts say.

In addition to violating FDA rules, the plant lacked sufficient data to show that the reworking didn't harm the vaccine's stability, the 2003 report indicates, which would include its ability to stay potent and sterile through its expiration date and use by consumers.

"Since there was no supporting data, it (the vaccine) may be OK but we don't know," says Lina Patel, a former Bayer AG scientist who is now a stability expert at Diosynth Biotechnology.

When an FDA investigator asked about the reworked vaccine in 2003, PowderJect's head of quality first said refiltered vaccine wasn't sent to the USA. When the investigator found otherwise, the quality chief said the plant had FDA approval to do so, the 2003 report says. When the plant couldn't produce a letter to that effect, officials said they assumed they could, because they'd given the FDA a new operating procedure that included refiltering. Finally, plant executives said the shipment of that vaccine to the USA was a mistake, the report says. The company promised corrective actions. In 2001-2002, the plant supplied about one-quarter of the USA's flu vaccine.

Potent problems

In addition to mistakenly releasing vaccine, the plant struggled with potency.

That might have been especially true for the 2001-2002 flu season. Then, four out of five lots of final vaccine predesignated for testing failed potency checks.A failure rate that high "is not typical" of drugmaking plants, says consultant Patel. "It's not good," she adds.

Failure in a test lot could be important, because it might indicate problems with others. In 2002, for instance, vaccine maker Aventis Pasteur, now Sanofi Pasteur, voluntarily recalled some vaccine protecting against meningococcal disease after samples from four lots failed routine potency tests.

The 2003 inspection report doesn't indicate consumers got subpotent vaccine. But PowderJect was sufficiently concerned to consider a recall. The company's report justifying its decision has not been released to the public.

The FDA inspectors said the plant's investigation into the potency failures was incomplete, partly because even in 2003 it had failed to identify the cause of the problem. In addition, the FDA says the plant didn't do some required tests and didn't tell the FDA soon enough about others. In one instance, that meant in time to protect consumers, if needed.

FDA investigator Robert Jennings noted that some "potency failure information that was likely to impact ... the current flu season, was not reported to the FDA."

The report notes several testing and reporting mishaps. It's not clear which one he was referring to.

In one, the plant was supposed to test a lot one, two, three and six months after it was manufactured. It didn't. That wasn't reported to the FDA. When FDA inspectors asked in June 2003 why the tests weren't done, the company's response "was that they were simply overlooked," wrote FDA biologist Jonathan McInnis. When the vaccine was tested at the seven-month point in May 2002, it failed.

In another case, one lot of vaccine failed a potency test in February 2002. But the FDA didn't learn of it until four months later. It was supposed to be reported within 45 days. The test result was close to passing, and according to the FDA report, the plant "reportedly did not consider" it a failure.

Three FDA officials who wrote the 2003 report declined comment or did not return telephone calls. The fourth could not be reached.

New leadership

Chiron has replaced several of the plant's top managers since last fall. Two of them were at the plant in 2003, and one dating back to at least 1999.

The FDA is working to approve other flu-shot vaccine suppliers, but the Chiron plant is crucial. It was one of only two plants, along with one owned by Sanofi Pasteur, fully licensed last year to make flu-shot vaccine for U.S. consumers.

That was also true at the time of the 2003 inspection — a factor that might have influenced the FDA not to come down too hard on the plant for fear of losing a key supplier, several industry consultants say.

"I'm sure the FDA had that in mind," says David Webster, pharmaceutical consultant with Webster Consulting Group.

He says the FDA constantly struggles to balance the need for vaccine against ensuring manufacturers meet high standards. "It is not an easy decision," he says.

Nor is it an easy task. The Liverpool plant became one of two U.S. flu-shot vaccine makers after two others, in 2000 and 2002, quit the U.S. market. One had its U.S. plant shut by the FDA after repeated problems. The other said it got out because the business did not justify costly plant upgrades needed to meet FDA requirements.

Chiron Foundation Awards Five Grants to Support Public Awareness Initiatives for Global Infectious Disease Prevention
March 24, 2005 08:00:00 AM ET

Chiron Corporation CHIR announced today that it has awarded $400,000 to four organizations for five projects addressing public health issues in the United Stated and abroad. The recipients are the CDC Foundation, Every Child by Two, Immunization Action Coalition and the National Foundation for Infectious Disease. The grants, provided by the Chiron Foundation, will assist each organization in the development of specific programs to create long-term, sustainable change and improvement in immunization practices and the prevention of infectious disease.

"The global reach of the programs made possible by these grants brings to the forefront our dedication to disease prevention and improving lives worldwide," said Jay Grover, president of the Chiron Foundation. "It is our privilege to support organizations that play a vital role in raising public awareness around the importance of vaccination by devoting resources to educating health professionals and facilitating the delivery of immunization services to those at risk."

Chiron's grant to the CDC Foundation, located in Atlanta, Ga., will provide funding for an immunization program at Rabia-Balkhi Women's Hospital in Kabul, Afghanistan. Rabia-Balkhi is one of the most important centers for maternal and child healthcare in the country. In an effort to assist in rebuilding the healthcare infrastructure at the Rabia-Balkhi Women's Hospital, Chiron's grant will provide funding for a program that will provide hospital healthcare workers with the recommended adult series of immunizations, including tetanus/diphtheria, pnuemococcal, hepatitis A and B, measles/mumps/rubella, Varicella, and meningococcal. Additionally, hospital workers will be trained in administering vaccinations to patients seeking care. Overall, the program will protect not only the hospital's healthcare workers; it also will help prevent the spread of disease in the immediate area and establish a sustainable framework for larger immunization efforts throughout the country.

Chiron also has awarded a separate grant to the CDC Foundation for its International Emerging Infectious Diseases (IEID) fellowship program. The grant will provide funding for three one-year fellowships for non-U.S. doctoral-level scientists to attend the IEID laboratory training program. Each fellow will gain skills in the latest laboratory techniques and technology and thereby build the laboratory capacity for addressing diseases endemic to their home countries.

Chiron's grant to Every Child by Two (ECBT), located in Washington, D.C., will fund an outreach campaign to all U.S. Department of Agriculture (USDA) Women, Infant and Children (WIC) staff agencies to promote new vaccine recommendations for children 6-23 months of age and pregnant women. Approximately seven million children, nearly half of all children in the United States, participate in WIC programs. ECBT strives to protect all children from vaccine-preventable diseases by raising parental awareness of the critical need for timely immunization by age two.

Chiron's grant to Immunization Action Coalition (IAC), located in St. Paul, Minn., will provide funding to distribute a comprehensive guide to adult vaccination to immunization leaders and physician training programs throughout the country. IAC strives to increase immunization rates, prevent disease, and enhance the delivery of safe and effective immunization services. It also facilitates communication about the safety, efficacy and use of vaccines within the broad immunization community of patients, parents, healthcare organizations and government health agencies.

"With generous support from the Chiron Foundation, Immunization Action Coalition is able to distribute its new adult immunization kit titled 'Adults-Only Vaccination: A Step-by-Step Guide' to every internal medicine and family medicine residency program in the United States," said Deborah Wexler, M.D., executive director of IAC. "By providing this critical information to U.S. residency programs that deliver healthcare services to adults, we anticipate that more patients will receive vaccinations and those administering vaccinations will be better trained."

Chiron's grant to the National Foundation for Infectious Diseases (NFID), located in Bethesda, Md., will support the organization's Traveling Professorship in Rural Areas program. The goal of the professorship is to conduct educational outreach to physicians in rural areas about infectious disease, including influenza and other vaccine-preventable diseases.

About the Chiron Foundation

Established in 2004, the Chiron Foundation is an independent, nonprofit organization committed to improving lives through better healthcare, empowering lives through better education and enriching lives through better communities. The foundation awards grants in three major focus areas: health and medicine, education, and community. For further information about the Chiron Foundation, please visit

About Chiron

Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information about Chiron, please visit

This news release contains forward-looking statements that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-Q for the quarter ended September 30, 2004, and the form 10-K for the year ended December 31, 2004, and will be contained in all subsequent periodic filings made with the SEC.

We do not undertake an obligation to update the forward-looking information we are giving today.

Contact Information: Chiron Corporate Communications & Investor Relations Media: 510-923-6500 Investors: 510-923-2300

© 2005 BusinessWire

Chiron clears an FDA hurdle
Flu vaccine-maker corrects problems
- Bernadette Tansey, Chronicle Staff Writer
Thursday, September 1, 2005

Chiron Corp.'s efforts to correct manufacturing flaws that ruined its entire U.S. flu vaccine supply last year and caused a nationwide shortage have won conditional approval from the FDA.

Chiron of Emeryville still faces other regulatory hurdles before it can resume sales of its product, Fluvirin. It announced the favorable inspection results Wednesday as the Food and Drug Administration also approved a competing flu vaccine made by drug giant GlaxoSmithKline.

Rivals have been jumping into the market since contamination at Chiron's plant in Liverpool, England, sidelined all 50 million of Chiron's doses in October, forcing the government to ration the vaccine.

The tougher competition for Chiron is good news for public health officials, who relied in the past on Chiron and one other firm, Sanofi-Aventis SA, to provide the bulk of the U.S. flu vaccine supply. After a July inspection of the plant, FDA officials found Chiron's improvements "generally acceptable,'' the firm said. But how many doses Chiron will provide this year is still uncertain. Chiron did not update its earlier estimate that it could produce 18 million to 26 million shots. The company must gain the FDA's formal approval of changes to its manufacturing processes, and score passing grades on tests of vaccine batches before Fluvirin can be sold in the United States.

"We are pleased that the Chiron Corp. has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season," said Dr. Jesse Goodman, FDA director of the Center for Biologics Evaluation and Research. "However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season.''

Meanwhile, other suppliers are increasing production. Sanofi, which boosted production last year to 58 million doses, will produce 60 million for the coming winter, said spokesman John Abrams. Capacity at the French firm's U. S. plant will double to as much as 120 million doses by 2009, Abrams said.

Glaxo will supply 8 million doses of its vaccine, Fluarix, just approved by the FDA for adults, in the coming winter. The company, based in London, plans to double its worldwide capacity of 30 million doses, spokeswoman Amanda Foley said. Medimmune Inc. of Maryland already makes limited supplies of an inhaled vaccine, FluMist, which is FDA-approved only for people ages 5 to 49 who have no underlying health problems. And Canadian flu vaccine supplier ID Biomedical Corp. hopes to win FDA approval for its product, Fluviral, which was granted a fast-track review by the agency. The firm could provide up to 25 million U.S. doses next year and 38 million the following flu season, said spokesman Dean Linden.

Chiron welcomes the entry of competitors to the market, said spokeswoman Alison Marquiss. As the total supply of flu vaccine increases, she said, public health officials can feel free to recommend vaccination to everyone who can benefit -- as many as 150 million U.S. residents -- without running short of shots for people most at risk.

"The more supply that's available, the more you can promote demand,'' Marquiss said. The FDA said an estimated 200,000 people are hospitalized due to complications of influenza, and 36,000 die each year.

Deutsche Bank analyst Jennifer Chao said Chiron's long-term competition will be significant. She estimates that Chiron will sell 22 million doses of Fluvirin in 2005 worth $160 million, representing about 8 percent of Chiron's total revenues. Fluvirin sales had contributed 12 percent of the company's total revenue of $1.8 billion in 2003. Deutsche Bank solicits business in the biotech sector.

After the FDA inspection results were announced, Chiron shares gained 31 cents or 0.86 percent to close at $36.44. Chiron shares have dropped nearly 20 percent since its 2004 flu vaccine supply was condemned in October.

E-mail Bernadette Tansey at

Page C - 1

Makers of vaccines sit down with Bush Concerns aired over possible global bird flu pandemic
- Bernadette Tansey, Chronicle Staff Writer
Saturday, October 8, 2005

A much-heralded conclave between President Bush and vaccinemakers on preparations for a global bird flu pandemic ended after brief presentations by the companies Friday, and without solutions to their concerns such as liability exposure. In the 45-minute White House meeting, Bush asked the manufacturers to detail their capacity to respond if a potentially deadly flu virus in birds starts to spread widely among the human population.

"The president was very interested in hearing what the manufacturers could do,'' said Nancy Pekarek, a spokeswoman for GlaxoSmithKline, which is developing one of the experimental vaccines for the avian flu.  But the short meeting didn't address issues that have discouraged participation in the vaccine market -- the threat of lawsuits by people who react badly to the shots, and the risk that unused vaccine will go unsold.

However, Bush drew praise for his administration's heightened focus on the danger that the virulent bird flu could gain the ability to spread from human to human.  Chiron Corp. of Emeryville, one of the six manufacturers invited to the meeting, is developing two bird flu vaccines under contracts with the government.

"Chiron applauds the president's leadership in pandemic preparedness,'' the company said in a statement. "We look forward to working closely with the administration and Congress on this issue and bringing our innovative science to bear to help protect the American people against a potential pandemic."

Chiron, which won its bird flu contracts in 2004, is playing catch-up with rival Sanofi pasteur to contribute to the U.S. stockpile of vaccines against the disease. Sanofi pasteur's experimental vaccine has already proved effective in stimulating an immune response in clinical trials, and the French company is beginning mass production this month of $100 million worth of inoculations. Trial results on one of Chiron's vaccines, made in Italy, are due shortly, said spokeswoman Alison Marquiss. But she said the other
vaccine's development has been delayed by manufacturing problems at the Liverpool, England, plant where Chiron makes its Fluvirin shot for ordinary seasonal influenza.

Contamination discovered at that plant in 2004 sidelined Chiron's entire inventory of 50 million doses of Fluvirin last winter, throwing the market open to Sanofi and other competitors. In addition, the plant's overhaul drew resources away from the bird flu product made partially at that plant and at another Liverpool facility. Chiron expects to deliver the second bird flu vaccine to the government late this fall for clinical trials, Marquiss said.

Meanwhile, Chiron is still waiting for clearance from the Food and Drug Administration to release this year's doses of Fluvirin from its improved plant. Chiron, which once produced half the nation's flu vaccine supply, has said it will make at most 18 million to 26 million doses for this winter. After the White House meeting, Sanofi said its ordinary flu shots have a role to play in preventing a bird flu pandemic.  "The best preparation for a possible influenza pandemic is to help ensure the public is aware of the current, annual threat of seasonal influenza and the need for vaccination -- starting with this season -- with a goal toward universal immunization before a pandemic arrives,'' the company said. "Increased annual influenza immunization rates mean more and more will become believers in prevention, and we can achieve universal immunization ahead of a potential pandemic."

E-mail Bernadette Tansey at



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Centeon L.L.C.  [successor entity for Armour Pharmaceutical Company (ARM); abbreviation and/or name superseded, see AVB]



Cutter Laboratories  [inactive] [see BAY]


Cytos Biotechnology AG



Dow Chemical Company  [inactive]



DynPort Vaccine Company LLC



Eisai Co., Ltd  [manufacturing collaboration with Biken (BIK)]



Elan Pharmaceuticals 



Evans Vaccines Ltd. (wholly owned subsidiary of PowderJect Pharmaceuticals Plc) [formerly Evans Medical, Ltd., which acquired vaccine business of Wellcome (WEL); Evans was acquired by and renamed to Medeva (MDV); MDV vaccine business subsequently acquired by PowderJect and Evans name restored]



FFF Enterprises



Government Pharmaceutical Organization (Thailand)



GlaxoSmithKline plc  [merger of Glaxo Wellcome plc (GLX, which absorbed Wellcome (WEL)) and SmithKline Beecham plc (SBB and SB), which earlier absorbed Recherche et Industrie Thérapeutiques (RIT)] 



Greer Laboratories



HUMAN Serum Production and Medicine Manufacturing Company Limited (Hungary)



INRS-Institut Armand-Frappier, Institut National de la Recherche Scientifique, Université du Québec



Immuno AG, Immuno International AG [abbreviation and/or name superseded, absorbed into Baxter Healthcare Corporation (BAX)]



ID Biomedical Corporation


Impfstoffwerk Dessau-Tornau GmbH (Germany)



Inex Pharmaceuticals Corporation



Institute of Immunology (Zagreb, Croatia)



Institut Mérieux  [inactive; formed Pasteur Vaccins (PV) joint venture with Institut Pasteur; later became Pasteur Mérieux Sérums et Vaccins (PMSV), then Pasteur Mérieux Connaught (PMC) subsidiary of Rhône-Poulenc, then Aventis Pasteur (AVP)] 



Immune Response Corporation





Intercell AG, CISTEM Biotechnologies GmbH



InterVax Biologicals Limited



Iomai Corporation



Institute of Poliomyelitis and Viral Encephalitis (Russia)



Intellivax, Inc., Intellivax International, Inc. [became wholly owned subsidiary of ID Biomedical Corporation (IDBE)]



Immuno-U.S., Inc. [abbreviation and/or name superseded, see BAX]



Korea Green Cross Corporation (South Korea)



Lederle Laboratories Division American Cyanamid Company [absorbed into Wyeth (WYE)]



Laboratorios Leti (Grupo Farmacéutico Leti) (Spain)



Lucky Goldstar Chemical, Ltd. (Pharmaceutical Division) (South Korea)



Eli Lilly and Company  [inactive]



Massachusetts Biologic Laboratories, University of Massachusetts  [formerly Massachusetts Public Health Biologic Laboratories]



MediGene AG



Medeva plc and Celltech Medeva Pharma [inactive] [successor entity for vaccine line of Evans Medical, Ltd. (EVN); line subsequently sold; abbreviation and name superseded, see EVN



MedImmune, Inc. [purchased Aviron (AVIR)]



Mead Johnson [inactive] [subsidiary of Bristol-Myers Squibb BMY]



Microscience Ltd



Miles Laboratories  [abbreviation and/or name superseded; see BAY]



Michigan Biologic Products Institute (formerly Michigan Department of Public Health) [abbreviation and/or name superseded; see BP]



Merck and Co., Inc.  [successor name for Merck, Sharpe, and Dohme, Inc. (MSD)]



Merrell National Laboratories, Division of Richardson Merrell  [inactive, see AVP]



Merck, Sharpe, and Dohme, Inc.  [abbreviation and/or name superseded; see MRK]



NABI  [successor entity for North American Biologicals, Inc.]



North American Vaccine, Inc.  [absorbed into Baxter Healthcare Corporation (BAX)]



National Cancer Institute, National Institutes of Health (USA)



National Center of Infectious and Parasitic Diseases (Sofia, Bulgaria)



Novartis [formerly Sandoz (SAN) and Ciba-Geigy]


Nederlands Vaccin Instituut (Netherlands Vaccine Institute) [see RIVM and SVM]



Northwest Biotherapeutics, Inc. 



New York Blood Center



OraVax, Inc.  [abbreviation and/or name superseded: subsidiary of Peptide Therapeutics Group, plc; see PTE]



Ortho-Clinical Diagnostics  [a Johnson & Johnson company; successor entity for Ortho Diagnostic Systems, Inc.]



Organon Teknika Corporation, Organon Teknika, B.V.  [successor entity for Bionetics Research, Inc. (BIR)]



Parke Davis  [inactive, traqnsferred influenza vaccine production to Parkedale Pharmaceuticals (PDL)] 



Parkedale Pharmaceuticals, Inc. (subsidiary of King Pharmaceuticals, Inc.) [inactive; successor entity for Parke Davis influenza vaccine production]



Pfizer, Ltd.  [inactive]


Pharmexa A/S



Philips Roxane, Inc. [inactive name; became Solvay Pharmaceuticals (SOL)]



PowderJect Pharmaceuticals plc  [wholly owned subsidiary of Chiron Corporation (CHIR). Includes PowderJect Vaccines, Inc.; PowderJect earlier acquired SBL Vaccin AB (SBL) and the vaccine business of Medeva (MDV), restoring the Evans name to the wholly-owned subsidiary, Evans Vaccines, Ltd. (see EVN)]



Pasteur Mérieux Connaught [abbreviation and name superseded; see AVP]



Pasteur Mérieux Sérums et Vaccins [formerly Pasteur Vaccines (PV) joint venture of Institut Pasteur and Institut Mérieux (IMER); became Pasteur Mérieux Connaught (PMC) subsidiary of Rhône-Poulenc, then Aventis Pasteur (AVP)]


Groupe Pierre Fabre: Centre d'Immunologie Pierre Fabre



Praxis Biologics  [absorbed into Wyeth (WYE)]


Peptide Therapeutics Group, plc



Pitman-Moore, Inc., Pitman-Moore Pharmaceuticals, Ltd. [inactive; absorbed into International Minerals and Chemical Corporation]



Pasteur Vaccins  [inactive; joint venture of Institut Pasteur and Institut Mérieux (IMER); later became Pasteur Mérieux Sérums et Vaccins (PMSV), then Pasteur Mérieux Connaught (PMC) subsidiary of Rhône-Poulenc, then Aventis Pasteur (AVP)]



Quad Pharmaceuticals, Inc. [inactive]  [absorbed into Par Pharmaceuticals, Inc., Pharmaceutical Resources, Inc.] 



Recherche et Industrie Thérapeutiques  [inactive; antecedent company of GlaxoSmithKline (GSK)]



Rijksinstituut voor Volksgezondheid en Milieu  [National Institute of Public Health and the Environment] (as of 2003, vaccine activities reorganized into the Stichting ter bevordering van de Volksgezondheid en Milieuhygiëne (SVM) [Foundation for the Promotion of Public Health and Environmental Hygiene] and the Netherlands Vaccine Institute (NVI)



Sandoz [inactive, see Novartis (NOV)]



SmithKline Beecham Biologicals [component of former SmithKline Beecham Pharmaceuticals (SB); merged into GlaxoSmithKline; see GSK



SBL Vaccin AB (Sweden) [absorbed into PowderJect Pharmaceuticals plc (PJP)] 



Schering AG (Germany)



Sclavo, S.p.A  [vaccine business absorbed into former Biocine joint venture of Chiron and Ciba-Geigy, and later into Chiron Corporation (CHIR)]



Schering-Plough Corporation (USA)



Shire Biologics, a wholly-owned subsidiary of Shire Pharmaceuticals Group plc  [absorbed BioChem Pharma (BCH) through merger]



Serum Institute of India, Ltd.



SmithKline Beecham  [abbreviation and/or name superseded; see SBB]



Solvay Pharmaceuticals [influenza product] [successor company to Philips Roxane, Inc. (PHR)]



StressGen Biotechnologies Corporation



Statens Serum Institut (Denmark)



Swiss Serum and Vaccine Institute (Berne, Switzerland)  [abbreviation and/or name superseded; see BER]


Stichting ter bevordering van de Volksgezondheid en Milieuhygiëne (Foundation for the Promotion of Public Health and Environmental Hygiene, the Netherlands; see RIVM and NVI]



Texas Department of Health Resources  [inactive]



Torlak Immunology and Virology Institute (Serbia)



Transgene S.A.



The Salk Institute - Government Services Division [inactive; formerly a division of The Salk Institute for Biological Studies; absorbed into Aventis Pasteur, Inc. (AVP)]



University of Illinois  [inactive]



Universiteit Leiden 



University of Queensland



United States Army Medical Research and Materiel Command



Virax Holdings Limited



VaxGen, Inc.



Wyeth-Ayerst  [abbreviation/name superseded; see WYE]



Wyeth-Ayerst Laboratories [abbreviation/name superseded; see WYE]



Wellcome; Burroughs Wellcome; Wellcome plc  [inactive] [merged into Glaxo Wellcome, but its vaccine business acquired by Evans Medical, Ltd. (EVN)]



The Wistar Institute (University of Pennsylvania)



Wyeth-Lederle Vaccines (and Pediatrics)  [abbreviation/name superseded; see WYE]



Wyeth Pharmaceuticals, division of Wyeth [renamed from American Home Products, encompassing former Wyeth-Ayerst Laboratories (WAL); Wyeth-Ayerst (WA), Wyeth-Lederle Vaccines (and Pediatrics) (WLV), Wyeth Laboratories, Inc. (WYL), Lederle Laboratories Division American Cyanamid Company (LED), and Praxis Biologics (PRX)] 



Wyeth Laboratories, Inc.  [abbreviation/name superseded; see WYE