November 29, 2006

Marine from area can't walk after reaction to smallpox vaccine

Go to the link for video clip., by Michelle Sherwood, KY3 News

SPRINGFIELD -- Josef Lopez had only been serving in Iraq for one week when he suddenly lost all ability to move. Now he's in physical therapy at St. John's Hospital, where he's been since mid-November.

"I didn't know sit ups would be so hard," said Lopez as he worked with a therapist recently. "Every day, I can feel myself getting a little bit better."

The things that used to be second nature to him now take serious concentration. His left leg drags as he walks across the floor with a walker.

"It doesn't want to get straight," he told his therapist.

Lopez says it's frustrating.

"You're thinking, 'I should be able to do this.' But I can't," he said.

Lopez got his vaccinations in California about a week before leaving for Iraq. When he got there, he started training and learning about the locale. However, on the last day in September, he says he noticed something was wrong with his body as he walked or ran.

"Overnight I couldn't go to sleep," said Lopez. "Things just got worse, and by the morning I couldn't move my legs at all."

Lopez was rushed to a hospital in Germany. His mother and older brother met up with him a few days later. His mother, Barbara, couldn't believe her eyes.

"I knew he was going to look pretty bad," she said. "And he did."

Doctors in Germany told her they had only seen Lopez open his eyes before her arrival. She says her son responded to her voice right away.

The doctors didn't immediately know the cause of Lopez's paralysis --they only knew it was moving quickly. It had moved from his toes to his brain stem before they realized that he had a reaction to the smallpox vaccine.

"It made my body attack itself," Lopez said.

Doctors told him that the vaccine basically made his antibodies attack one another. It took several blood transfusions to start reversing the problem.

After a few days, Lopez and his family flew to Bethesda, Md., to undergo more treatment at a naval hospital. Doctors there told them they had only seen three other cases like his in 10 years. In fact, the Centers for Disease Control and Prevention reports, out of a million people, less than 55 will have a serious reaction to the vaccine.

As tough as this is for Lopez, he believes it happened for a good reason -- so he could see his dad, who died on Thanksgiving Day from Alzheimer's disease.

"He was in the hospital the day I got here, so I got to see him that day," he said. "When I left for Iraq, I thought I'd never get to see him again, so I did get to see him one last time. It's kind of weird how this smallpox thing brought me home."

Lopez has lost a lot in a short amount of time, but he says he's gained a new perspective on things.

"It's made me realize how stupid little things are," he said.

He hopes to get on crutches by Christmas and, by the progress he's had so far, he just might make it.

November 28, 2006

Government Sets New Deadline for VaxGen to Begin Next Clinical Trial

Press Release Source: VaxGen, Inc.

BRISBANE, Calif., Nov. 27 /PRNewswire-FirstCall/ -- VaxGen (Pink Sheets: VXGN.PK - News) announced today that the Office of Public Health Emergency Preparedness within the Department of Health and Human Services (HHS) has unilaterally imposed December 18, 2006 as the new deadline for the company to initiate its next Phase II clinical trial under the contract for the next-generation anthrax vaccine.

HHS's decision is the latest in a series of government directives that began early in November when the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research imposed a clinical hold on VaxGen's forthcoming clinical trial. The hold was imposed on the grounds that data submitted at that point by the company were insufficient to determine that the vaccine candidate was stable enough to resume clinical testing.

Prior to December 18, VaxGen and FDA are scheduled to discuss approaches to satisfying the agency's requirements with the goal of determining the appropriate development pathway, including the resumption of clinical studies.

HHS also unilaterally established new contractual deadlines for the demonstration of human safety and immunogenicity of the vaccine (November 26, 2007); demonstration of human safety and immunogenicity to support Emergency Use Authorization (EUA) of Contingency Use of the vaccine (November 26, 2008); and IND amendment to support EUA or Contingency Use (January 3, 2009).

About VaxGen

VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax and smallpox. VaxGen has been awarded an $877.5 million contract by the U.S. Department of Health and Human Services to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. Based in Brisbane, Calif., VaxGen operates a wholly owned manufacturing facility in California and owns a minority interest in Celltrion, Inc., a company in the Republic of Korea established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company's web site at

Note: This press release contains "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the Company's ability to meet with the FDA prior to December 18, 2006; and the Company's ability to determine a development pathway, including the resumption of clinical trials, for its anthrax vaccine candidate. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 8.01 of the company's Current Report on Form 8-K filed by VaxGen on February 16, 2006 under the heading "Risk Factors" for a more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Fowl raisers oppose bird flu vaccine plan

PIYAPORN WONGRUANG - Representatives of chicken raisers yesterday asked the Agriculture and Cooperatives Ministry to drop its plan to use the anti-bird flu vaccine in fowl for fear this would harm both human health and the broiler, or young chicken, industry.

Nathsak Pattanakulchai, vice-president of the Broiler Raisers for Exporting Association, submitted the request to Agriculture and Cooperatives Minister Thira Sutabutra through his secretary. Mr Nathsak said vaccinating poultry was not a practical means to curb the virus, which can mutate, and at one point there would be no effective vaccine to deal with it.

The vaccine could also speed up virus mutations and trigger a human pandemic, he said. The vaccination of chickens and ducks would also hurt the poultry trade, which had only recently picked up and is valued at 40 billion baht a year, he said. He said the nation has won recognition from the international community for refraining from the use of the vaccine. ''We can assume that our control measures against the disease are already good enough. So I can't see why we should go for a vaccine,'' said Mr Nathasak.

The idea of introducing the use of a bird flu vaccine was floated by the ministry last week. Experts from both the state and private sectors plan to hold a meeting this week to discuss the pros and cons of using the vaccine, and the results of the meeting will be forwarded to the cabinet for consideration. If approved, this would be a U-turn in the country's bird flu control policy, which had banned the use of the vaccine ever since the virus first emerged in early 2004. The use of vaccine in fowl has been fiercely debated as poultry raisers and experts are divided over the issue.

Traditional fowl raisers, including those who raise free range ducks, favour the vaccine, claiming it would help prevent their poultry from dying of avian flu. But most virologists from leading academic institutions said the vaccine would speed up virus mutations to a point that triggers a pandemic.

November 26, 2006

Less sun, more sneezing - Theory suggests that a shortage of vitamin D triggers outbreaks of flu,0,3590649.story?coll=bal-nationworld-headlines
The Baltimore Sun, By Michael Stroh

As the annual flu season looms, some scientists have this question on their minds: Why now?

For more than a century, physicians have recognized that influenza sweeps the Northern Hemisphere during the winter months, typically peaking here between late December and March.

Over the years they've floated numerous theories to explain the seasonal flu spike - blaming everything from the flood of frigid air to the wintertime tendency of people to huddle indoors.

Yet these explanations "remain astonishingly superficial and full of inconsistencies," says Dr. Scott Dowell, director of the Global Disease Protection Program at the Centers for Disease Control and Prevention in Atlanta.

Now Dowell and other researchers are focusing on a provocative new hypothesis that blames annual flu epidemics on something most people don't get enough of this time of year: sunshine. In a paper scheduled for publication next month in the journal Epidemiology and Infection, a Harvard University-led team proposes that a vitamin D deficiency caused by inadequate winter sun exposure may predispose people to infection. If this theory proves correct, it would not only solve a long-standing
mystery, but could also have major public health consequences.

Influenza kills an average 36,000 people in the U.S. each winter, mostly the very old and very young. If scientists could pinpoint the secret behind its seasonal recurrence and somehow alter it, "the potential impact would be far greater than the current influenza vaccine," says Dowell.

Hippocrates, the Greek physician widely regarded as the father of medicine, was the first to recognize that certain diseases ebb and flow with the calendar. "Whoever wishes to investigate medicine properly," he wrote around 400 B.C., "should ... consider the seasons of the year."

Epidemiologists, however, have found that this is easier said than done.

"You look at the environment around you and say, 'What's the difference between winter and summer?'" says Dr. David Fisman of the Ontario Provincial Public Health Laboratory in Canada. "There are so many things that are seasonal, it's really hard to tease them apart."

One obvious answer is that it's colder in winter. And for as long as parents have bundled up their babies, there's been an unshakable belief that catching a chill makes a person more susceptible to cold or flu.

Cold flunks tests

Since World War II, scientists have devised numerous teeth-chattering tests of this stubborn wives' tale, dunking volunteers in cold baths or confining them to refrigerated meat lockers while squirting virus-spiked mucus up their noses.

"All attempts at demonstrating some relationship between cold exposure and susceptibility to infection have proved negative," Ron Eccles, director of the Common Cold Centre at Cardiff University in Wales, concluded in a recent published review of such studies.

Experiments on the influenza virus have hinted that the flu bug is more stable in the cool, dry air of winter. But that doesn't solve the mystery, says Fisman, whose summary of efforts to understand seasonal influenza is scheduled for publication next year in the Annual Review of Public Health.

One reason: Influenza surveillance efforts in Southeast Asia and other steamy tropical locales reveal that flu is not only common there but also exhibits seasonal patterns akin to those in colder climates.

"If you go back to the hypothesis about cold temperature and flu, it doesn't hold for the tropics," says epidemiologist Cecile Viboud of the National Institutes of Health's Fogarty International Center in Bethesda.

Then there's the crowding theory.

Because scientists think that the flu spreads only from person to person, most have assumed that the disease ravages in winter because people are cooped up in close quarters.

But even Sir Christopher Andrewes, the British virologist who co-discovered the influenza virus in 1933, once observed, "I have always had my doubts about this."
Andrewes, who died in 1988, argued that the winter crowding explanation defies common sense, since office and factory workers are stuck indoors year-round. And summertime flu epidemics remain rare despite the prevalence of cruise ships, airplanes, and subways packed with international travelers, other skeptics of the theory note. "There are plenty of things that don't fit," says the CDC's Dowell.

The latest theory to generate a buzz centers on sunlight.

In 1981, a British general practitioner named R. Edgar Hope-Simpson published the first paper documenting a link between influenza epidemics in the northern hemisphere and the winter solstice. The solstice - which arrives on Dec. 21 this year - is commonly identified with the start of winter and is the shortest day of the year.

Hope-Simpson, who had no formal training in epidemiology, realized that influenza infections tended to jump just before and after the solstice. Solar radiation, he surmised, triggered some sort of "seasonal stimulus" that affected the flu virus, its human host or both. Although he had no idea what that seasonal stimulus was, Hope-Simpson believed that solving the mystery "would provide the key to understanding most of the influenza problems confronting us."

"His work was basically ignored," says Dr. John Cannell, a psychiatrist at the Atascadero State Hospital in California. In their forthcoming paper in Epidemiology and Infection, Cannell and colleagues from Harvard University, the National Institutes of Health and Boston University propose that Hope-Simpson's seasonal stimulus could be vitamin D.

The tip-off, says Cannell, came in April 2005, when an outbreak of influenza swept through Atascadero, a maximum-security facility for the criminally insane 200 miles south of San Francisco. "The ward below me got it, then the ward to my right, to my left and the one across the hall," he recalls. Cannell's 32 patients, however, were spared. As far as he could tell, there was only one glaring difference between his
patients and those who came down with flu: Cannell's patients were taking high daily doses of vitamin D.

Manufactured by the skin in response to solar ultraviolet B radiation (UVB), vitamin D is the only vitamin made naturally in the body. On sunny days, a fair-skinned person can crank out the equivalent of 20,000 international units (IU) of the vitamin in 15 minutes, says Cannell. One cup of fortified milk, by contrast, contains fewer than 100 IU.

But vitamin D production plummets during winter because people spend less time outdoors and because UVB radiation has a harder time penetrating the atmosphere in that season, especially at middle to high latitudes.

As a result, health experts in recent years have warned that many Americans may not be getting as much vitamin D as they need. One ominous sign: a recent resurgence in cases of rickets, a bone disorder caused by a lack of the vitamin.

In their new paper, which draws together strands from more than seven decades of vitamin and flu research, Cannell and his colleagues argue that vitamin D stimulates production of a natural infection-fighting substance in the body called cathelicidin.

Although cathelicidin has yet to be studied directly on influenza, recent research has shown that it attacks a variety of fungi, viruses, and bacteria - including the bug that causes tuberculosis, researchers reported last March in Science.

There's also indirect evidence of the sun's role in seasonal flu, Cannell and his colleagues argue. In the late 1970s, Soviet scientists inoculated nearly 835 young men in St. Petersburg with a weakened form of the influenza virus during different seasons of the year. The men, they discovered, were eight times more likely to develop fever and other signs of flu infection in winter than in summer. Repeating the experiment in another city yielded similar results.

And what of the sun-drenched tropics?

Cannell and his colleagues point to a scattering of studies showing vitamin D deficiencies even in Hong Kong and other equatorial spots. Another important clue: A 2003 review of tropical influenza infections found the virus strikes mainly during the rainy season, presumably a time of reduced sun exposure.

Maybe yes, maybe no

Some researchers find the Vitamin D theory tantalizing. "It's a wonderful story, and I think there's considerable substance behind it," says immunologist Dr. Michael A. Zasloff, a professor at Georgetown University.

Others, however, wonder whether this is just another vitamin fad - just as vitamin C was once promoted by double Nobel laureate Linus Pauling as a cure for the common cold. "They have manipulated the literature (some of it very bad literature) to
prove their points," Dr. James Cherry, a pediatric infectious disease specialist at UCLA's David Geffen School of Medicine, wrote in an e-mail.

However, "The hypothesis should be easy to prove or disprove with a controlled, blinded study," he added.

Vitamin D isn't the only substance being kicked around as a seasonal stimulus candidate. The CDC's Scott Dowell favors melatonin, a naturally occurring hormone whose production is tied to the daily light-dark cycle. Preliminary research suggests that the hormone might help regulate the body's immune response. "I don't know where it's going to lead," he concedes.

Cannell, meanwhile, says he takes 5,000 IU of vitamin D during the winter months, more than twice the maximum daily recommended dose. He says he rarely gets sick anymore.

November 24, 2006

Genetic breakthrough that reveals the differences between humans

Scientists hail genetic discovery that will change human understanding
By Steve Connor, Science Editor

Scientists have discovered a dramatic variation in the genetic make-up of humans that could lead to a fundamental reappraisal of what causes incurable diseases and could provide a greater understanding of mankind.

The discovery has astonished scientists studying the human genome - the genetic recipe of man. Until now it was believed the variation between people was due largely to differences in the sequences of the individual " letters" of the genome.

It now appears much of the variation is explained instead by people having multiple copies of some key genes that make up the human genome.

Until now it was assumed that the human genome, or "book of life", is largely the same for everyone, save for a few spelling differences in some of the words. Instead, the findings suggest that the book contains entire sentences, paragraphs or even whole pages that are repeated any number of times.

The findings mean that instead of humanity being 99.9 per cent identical, as previously believed, we are at least 10 times more different between one another than once thought - which could explain why some people are prone to serious diseases.

The studies published today have found that instead of having just two copies of each gene - one from each parent - people can carry many copies, but just how many can vary between one person and the next.

The studies suggest variations in the number of copies of genes is normal and healthy. But the scientists also believe many diseases may be triggered by an abnormal loss or gain in the copies of some key genes.

Another implication of the finding is that we are more different to our closest living relative, the chimpanzee, than previously assumed from earlier studies. Instead of being 99 per cent similar, we are more likely to be about 96 per cent similar.

The findings, published simultaneously in three leading science journals by scientists from 13 different research centres in Britain and America, were described as ground-breaking by leading scientists.

"I believe this research will change for ever the field of human genetics," said Professor James Lupski, a world authority on medical genetics at the Baylor College of Medicine in Houston, Texas.

Professor Lupski said the findings superseded the basic principles of human genetics that have been built up since the days of Gregor Mendel, the 19th century "father" of Mendelian genetics, and of Jim Watson and Francis Crick, who discovered the DNA double helix in 1953.

"One can no longer consider human traits as resulting primarily from [simple DNA] changes... With all respect to Watson and Crick, many Mendelian and complex traits, as well as sporadic diseases, may indeed result from structural variation of the genome," Professor Lupski said.

Deciphering the three billion letters in the sequence of the human genome was once likened to landing on the Moon. Having now arrived, scientists have found the "lunar landscape" of the genome is very different from what they expected.

Matthew Hurles, one of the project's leaders at the Wellcome Trust Sanger Institute in Cambridge, said the findings show each one of us has a unique pattern of gains and losses of entire sections of our DNA.

"One of the real surprises of these results was just how much of our DNA varies in copy number. We estimate this to be at least 12 per cent of the genome - that has never been shown before," Dr Hurles said.

Scientists have detected variation in the "copy number" of genes in some individuals before but the sheer scale of the variation now being discovered is dramatic.

"The copy number variation that researchers had seen before was simply the tip of the iceberg, while the bulk lay submerged, undetected," Dr Hurles said.

"We now appreciate the immense contribution of this phenomenon to genetic differences between individuals," he said.

The studies involved a detailed and sophisticated analysis of the genomes of 270 people with Asian, African or European ancestry. It was important to include as wide a sample of the human gene pool as possible.

They found that 2,900 genes could vary in the number of copies possessed by the individuals. The genes involved multiple copies of stretches of DNA up to a million letters of the genetic code long.

"We used to think that if you had big changes like this, then they must be involved in disease. But we are showing that we can all have these changes," said Stephen Scherer of the Howard Hughes Medical Institute in Chevy Chase, Maryland.

But it is also becoming apparent that many diseases appear to be influenced by the number of copies of certain key genes, said Charles Lee, another of the project's leaders at the Brigham and Women's Hospital and Harvard Medical School in Boston, Massachusetts.

"Many examples of diseases resulting from changes in copy number are emerging. A recent review lists 17 conditions of the nervous system alone, including Parkinson's disease and Alzheimer's, that can result from such copy number changes," Professor Lee said.

"Indeed, medical research will benefit enormously from this map, which provides new ways for identifying genes involved in common diseases," he said.

Mark Walport, director of the Wellcome Trust, the medical charity that funded much of the research, said: "This important work will help to identify genetic causes of many diseases."

The key questions answered

What have scientists discovered today?

They have found that each of us is more different genetically than we previously believed. Instead of being 99.9 per cent identical, it may turn out to be more like 99 per cent identical - enough of a difference to explain many variations in human traits. Instead of having just two copies of every gene - one from each parent - we have some genes that are multiplied several times. Furthermore these "multiple copy numbers" differ from one person to another, which could explain human physical and even mental variation.

Why does this matter?

One practical benefit is that it could lead to a new understanding of some of the most difficult, incurable diseases. Although it adds an extra layer of complexity to our understanding of the human genome, the discovery could lead eventually to new insights and medical treatments of conditions ranging from childhood disorders to senile dementia. Scientists are predicting for instance that the knowledge could lead to new diagnostic tests for such diseases as cancer.

How was this discovery made?

Scientists have developed sophisticated methods of analysing large segments of DNA over recent years. "In some ways the methods we have used are 'molecular microscopes', which have transformed the techniques used since the foundation of clinical genetics where researchers used microscopes to look for visible deletions and rearrangements in chromosomes," explained Nigel Carter of the Sanger Institute in Cambridge.

What genes are copied many times and why?

There are just under 30,000 genes in the human genome, which consists of about 3 billion "letters" of the DNA code. The scientists found that more than 10 per cent of these genes appear to be multiplied in the 270 people who took part in the study. They do not know why some genes are copied and some are not. One gene, called CCL3L1, which is copied many times in people of African descent, appears to confer resistance to HIV. Another gene involved in making a blood protein is copied many times in people from south-east Asia and seems to help against malaria. Other research has shown that variation in the number of copies of some genes is involved in Alzheimer's and Parkinson's disease.

Are there any other practical applications?

The scientists looked at people from three broad racial groups - African, Asian and European. Although there was an underlying similarity in terms of how common it was for genes to be copied, there were enough racial differences to assign every person bar one to their correct ethnic origin. This might help forensic scientists wishing to know more about the race of a suspect.

Who made the discovery and where can we read more about it?

Scientists from 13 research centres were involved, including Britain's Sanger Institute in Cambridge, which also took a lead role in deciphering the human genome. The research is published in Nature, Nature Genetics and Genome Research.

Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice

Thu Nov 23, 2006 7:27 pm (PST)
1: Neuromolecular Med. 2007;9(1):83- 100. Links
Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice.
Petrik MS, Wong MC, Tabata RC, Garry RF, Shaw CA.
Department of Ophthalmology and Program in Neuroscience, University of British Columbia, Vancouver, British Columbia, Canada.

Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene.

To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behaviora l tests over a 6-mo period post injections.

Following sacrifice, central nervous system tissues were examined using immunohistochemistr y for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk.

Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord.

The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants. PMID: 17114826 [PubMed - in process]

November 22, 2006

Another 1918?

Despite preparations, a flu pandemic could still kill millions of Americans.

ON MONDAY, the Department of Health and Human Services released a progress report on its preparations for a flu pandemic in the United States. Not stressed, but nevertheless clear, was how much the country would rely on antiviral drugs such as Tamiflu, a drug that can reduce the severity of flu symptoms, to treat Americans while new vaccines were developed. Public health authorities are frantically stockpiling Tamiflu, and they hope to have more than 50 million courses of antiviral medication on hand by the end of 2008 to administer in the event of an outbreak.

But a report released by the World Health Organization earlier this month said that strains of the H5N1 "bird flu" virus -- a likely candidate for mutation into a pandemic flu -- might be developing resistance to Tamiflu and other antivirals. The influenza virus is unpredictable and quick to mutate. No one knows how, or how fast, the bird flu virus will change, so no one knows if the reported cases of Tamiflu resistance will remain isolated or if the virus will become increasingly more resistant to standard antivirals -- as it has with other drugs. But the country faces the possibility that its reserve of Tamiflu might not do much to counter a pandemic flu.

The federal government is also collecting doses of vaccines that protect against existing strains of the bird flu virus, though on a much smaller scale than its purchase of Tamiflu. These shots, the HHS report said, might eliminate or ease symptoms caused by new forms of the virus. But the WHO report was pessimistic about the effectiveness of the vaccines against strains of the virus they were not designed to fight.

In other words, if a pandemic flu began spreading tomorrow, the government's most effective strategies for saving lives could be old-fashioned quarantine and public education, techniques akin to those used during the great flu pandemic of 1918. It is not surprising, then, that the federal government currently estimates that as many as 2 million people could die if a virulent and contagious strain of flu hit the United States.

Given the capriciousness of the virus, says Columbia epidemiologist Stephen S. Morse, the government has "no silver bullet" in its arsenal. But HHS should consider investing heavily in technologies such as the reverse genetic engineering of flu vaccines, a process that promises to speed up vaccine production dramatically. The federal government should also focus more on aiding the World Health Organization's efforts to monitor avian flu and to improve the health infrastructure in Southeast Asia. Added American assistance to the understaffed WHO in Indonesia, Thailand and Vietnam could save many more American lives than 50 million courses of antivirals.

November 21, 2006

US boosts bird flu vaccine stocks

This story is from our network Source: AFP,20867,20794591-1702,00.html
From correspondents in Washington

THE US announced today nearly $US200 million ($A260 million) in deals to boost strategic stocks of bird flu vaccine to be used at the onset of an influenza pandemic.

The US Department of Health and Human Services awarded three contracts to major drug companies to produce 5.3 million, 90-microgram doses of vaccine designed to protect against the H5N1 influenza virus strain.

The deals included a $US117.9 million ($A153.6 million) contract with Sanofi Pasteur for 3.7 million doses; a $US40.95 million ($A53.3 million) contract to Novartis for 800,000 doses and a $US40.6 million ($A52.9 million) deal with GlaxoSmithKline for 800,000 doses.

At two apiece, the doses would be enough to vaccinate 2.7 million people at the outbreak of a flue pandemic.

"Having a stockpile of influenza vaccine that may offer protection against the H5N1 virus is an important part of our pandemic influenza preparedness plan," Health Secretary Mike Leavitt said.

"These contracts are a continuation of our aggressive multi-pronged approach to a potentially critical public health challenge."

The US is looking to build up enough supplies of a vaccine against the H5N1 avian influenza strain to immunise a 20 million-strong workforce at the threat of a widespread outbreak. It already has on hand 5.9 million doses.

The H5N1 virus erupted in poultry flocks in Asia in 2003 and has since killed more than 150 people worldwide.

Scientists fear the virus could mutate so that it could pass from human to human and trigger a deadly pandemic.

U.S. Suspects Several Nations of Seeking Bioweapons

Global Security Newswire

Iran, North Korea and Syria have all taken steps toward developing biological weapons banned under an international treaty, a senior U.S. official said yesterday (see GSN. Nov. 20).

Assistant Secretary of State John Rood told delegates at the sixth review conference of the Biological Weapons Convention that the three countries — of concern due to their “support for terrorism” — all skirted the controls of the ban on bioweapons, Reuters reported.

“We believe that Iran probably has an offensive biological weapons program in violation of the BWC,” Rood said. “We also believe North Korea has a biological weapons capability and may have developed, produced and weaponized for use.

“Finally, we remain seriously concerned that Syria … has conducted research and development for an offensive BW program,” Rood said.

Iran and North Korea are full treaty states. Syria has signed but not ratified the pact. All three nations have previously denied seeking biological weapons.

“I categorically reject what the U.S. delegation has said about my country,” said Iranian envoy Alireza Moaiyeri. “Their baseless allegations are contrary to the spirit of the review conference.”

Syrian and North Korean diplomats had no immediate response to Rood’s comments, according to Reuters.

Representatives from treaty nations meet every five years to review the convention. At the last meeting in 2001 the United States successfully led opposition to a verification protocol for the convention. Measures such as spot checks on biological laboratories could encourage industrial espionage, Washington contended.

The 155 treaty states instead agreed to work on other areas, such as improved cooperation in international disease surveillance and codes of conduct for scientists.

Moving forward from 2006, Rood said the United States wants to see enforcement of national laws addressed to prevent biological weapons from falling into the possession of terrorist groups (Richard Waddington/Reuters, Nov. 20).

Rood said it would be irresponsible to take steps to strengthen the convention, “yet turn a blind eye to the problems with the foundation itself,” he said according to a U.S. government release. The U.S. government is anxious to bring all countries into the 155-member treaty, he said.

Noncompliance with the ban is best dealt with directly, he said, adding that the international community must “root out violators that undermine the integrity of the convention” (Jacqui Porth/Washington File, Nov. 20).

Emergent BioSolutions Celebrates Initial Public Offering; CEO To Ring Opening Bell on the NYSE

Emergent BioSolutions Inc. (NYSE:EBS), a biopharmaceutical company that develops vaccines and therapeutics for biodefense and commercial applications and manufactures the only anthrax vaccine approved by the U.S. Food and Drug Administration (FDA), today announced it will be celebrating the Company's recently completed initial public offering with the ringing of the opening bell of the New York Stock Exchange by Fuad El-Hibri, chairman and chief executive officer, on Wednesday November 22, 2006.

"Throughout the Company's history, our people, science and technology have contributed significantly to safeguarding millions of military personnel and the general population through the delivery of a safe and effective countermeasure against the threat of anthrax infection," said Mr. El-Hibri. "Tomorrow's ringing of the opening bell is an opportunity to celebrate our Company and our achievements thus far, while acknowledging the commitment and support of our employees, customers and, now, investors who continue to drive our success."

Emergent BioSolutions' common stock began trading on November 15, 2006 under the symbol EBS. Emergent is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and immune globulins, that induce or assist the body's immune system to prevent or treat disease. The Company operates in two business segments: biodefense and commercial. In its biodefense business, the Company develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the Company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs.

The Company's marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the FDA for the prevention of anthrax infection. For more information about BioThrax, please review the package insert located on the Company's website In addition to BioThrax(R), the Company's biodefense product portfolio includes three biodefense product candidates in preclinical development and a next generation anthrax vaccine program with product candidates in preclinical and Phase I clinical development. The Company's commercial product portfolio includes a typhoid vaccine candidate and a hepatitis B therapeutic vaccine candidate, both of which are in Phase II clinical development, one vaccine candidate in Phase I clinical development and two vaccine candidates in preclinical development.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions are forward-looking statements. There are a number of important factors that could cause Emergent's actual results to differ materially from those indicated by such forward-looking statements, including our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs; preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company's Registration Statement on Form S-1 and subsequent reports filed with the SEC. The Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

November 20, 2006

Bird Flu Vaccines Lose Their Strength

The initial doses of bird flu vaccines that were stockpiled by US authorities are less effective now - they lose their strength over time. As the vaccines have a shorter 'shelf-life' than was first expected, it is possible that the US stockpile would now cover one million fewer people than previously thought.

In other words - as the vaccines have a shorter shelf-life than we had previously thought, many of the first ones that were bought may now not be so good.

(Shelf life = How long a drug can be kept/stored before it has to be thrown away. A bit like 'expiry date' on foods. If a drug has a two-year shelf life and was made on 1 January, 2007, it must be discarded by the end of 2008.)

Authorities may have to re-think their contingency plans. It was first thought that by having large stocks of H5N1 vaccines, a nation would be better prepared against a possible pandemic by vaccinating health workers, key personnel and other high-risk groups.

Even so, authorities stressed that the loss of strength is gradual, not total. It does not mean that the strength of the oldest vaccines in stock have gone down from 100 to zero.

Novartis Wins Contract To Top Up USA H5N1 Vaccine Stockpile

Novartis has been awarded a $40.95 million contract to top up the USA's bird flu vaccine stockpile. US authorities aim to have enough vaccines to cover 20 million people. Last year Novartis was awarded a $62.5 million contract.

The pre-pandemic egg-based vaccine will be manufactured by Novartis in 2007 in Liverpool, UK.

Written by: Christian Nordqvist
Editor: Medical News Today

Neurologic adverse events associated with smallpox vaccination in the United States – response and comment on reporting of headaches as adverse events

Originally published 10 Nov. 06
By Walter R. Schumm
(Note: Go to the above link for references and tables)



Accurate reporting of adverse events occurring after vaccination is an important component of determining risk-benefit ratios for vaccinations. Controversy has developed over alleged underreporting of adverse events within U.S. military samples. This report examines the accuracy of adverse event rates recently published for headaches, and examines the issue of underreporting of headaches as a function of civilian or military sources and as a function of passive versus active surveillance.


A report by Sejvar et al was examined closely for accuracy with respect to the reporting of neurologic adverse events associated with smallpox vaccination in the United States. Rates for headaches were reported by several scholarly sources, in addition to Sejvar et al, permitting a comparison of reporting rates as a function of source and type of surveillance.


Several major errors or omissions were identified in Sejvar et al. The count of civilian subjects vaccinated and the totals of both civilians and military personnel vaccinated were reported incorrectly by Sejvar et al. Counts of headaches reported in VAERS were lower (n = 95) for Sejvar et al than for Casey et al (n = 111) even though the former allegedly used 665,000 subjects while the latter used fewer than 40,000 subjects, with both using approximately the same civilian sources.

Consequently, rates of nearly 20 neurologic adverse events reported by Sejvar et al were also incorrectly calculated. Underreporting of headaches after smallpox vaccination appears to increase for military samples and for passive adverse event reporting systems.


Until revised or corrected, the rates of neurologic adverse events after smallpox vaccinated reported by Sejvar et al must be deemed invalid. The concept of determining overall rates of adverse events by combining small civilian samples with large military samples appears to be invalid. Reports of headaches as adverse events after smallpox vaccination appear to be have occurred much less frequently using passive surveillance systems and by members of the U.S. military compared to civilians, especially those employed in healthcare occupations. Such concerns impact risk-benefit ratios associated with vaccines and weigh against making vaccinations mandatory, without informed consent, even among military members. Because of the issues raised here, adverse event rates derived solely or primarily from U.S. Department of Defense reporting systems, especially passive surveillance systems, should not be used, given better alternatives, for making public health policy decisions.


Recently, Sejvar et al [1] reviewed the U.S. Vaccine Adverse Event Reporting System (VAERS) reports from 64,600 civilians, mostly health care workers, and from 590,400 Department of Defense (DoD) employees who had been vaccinated against smallpox. Their stated objective was "To determine rates and describe the clinical features of neurologic events associated with smallpox vaccination." The civilians had been vaccinated by the Department of Health and Human Services (DHHS) while the DoD employees had been vaccinated within the U.S. military medical system. The VAERS reports had been submitted between December 2002 and March 2004. VAERS reports involving neurologic symptoms for 214 individuals were analyzed, 111 for DHHS vaccinees and 103 for DoD vaccinees. The most common neurologic symptom reported was headache, in 95 (44%) of the 214 cases. They concluded that "During the 2002–2004 smallpox vaccination campaign, neurologic events were generally mild and self-limited, and no neurologic syndrome was identified at a rate above baseline estimates."

Reviewing Sejvar et al [1], it is clear that they stated, as fact, that they had data from (a) 64,600 DHHS vaccinees, (b) 590,400 DoD vaccinees, and (c) a total of approximately 665,000 personnel. They also stated, as fact, that a review of all VAERS reports submitted between December 2002 and March 2004 for those 665,000 personnel yielded no more than 95 reports involving headaches. Furthermore, they presented data (see Table 2 in [1]) indicating a rate of 14.3 headaches "with or without other symptoms" per 100,000 vaccinations; that rate is clearly derived from dividing 95 headaches by 665,000 vaccinations.

The risk-benefit ratios of vaccination are very important [2-4]. Public trust depends upon accurate reporting and interpretation of research data on adverse outcomes associated with vaccination, especially for programs associated with bioterrorism, such as the smallpox vaccination campaign conducted in the United States since 2002. It is also important that public trust be maintained with respect to adverse outcomes associated with vaccination among military service members, who may be required to accept mandatory vaccinations even without informed consent.

Issues also have been raised whether rates of adverse reports among military members or DoD employees have tended to be underreported [5-7]. A variety of ideas have been proposed to account for such underreporting, which even military health experts have admitted is possible [8]. The differing age and gender compositions of civilian and military populations have been cited, as well as general health and access to good medical care [6]. Many military personnel may not be available for reporting adverse events because of pre-deployment activities [9] or because of distant geographic location with minimal access to reporting channels.

Reports of adverse reactions associated with the smallpox vaccine in a number of scientific sources [8-12] were compared to the facts alleged by Sejvar et al [1]. In particular, the rates of reported headaches were considered as a function of source and type of adverse event reporting. Several important inconsistencies were observed. However, due to the selection of different adverse events for study, it was not possible to compare most of the studies except with respect to the symptom of headache. For example, using their mixture of 665,000 civilians and military personnel, Sejvar et al [1] considered headache, limb paresthesias, dizziness/vertigo, limb pain, meningitis, Bell's palsy, limb weakness, seizures, syncope/presyncope, encephalitis, tinnitus, Guillain-Barre syndrome, dysphagia, demyelinating disease, brachial neuritis, and stroke as adverse events, whereas Grabenstein & Winkenwerder [8] considered an almost completely different set of conditions: mild, generalized vaccinia, erythema multiforme, encephalitis, acute myopericarditis, eczema vaccinatum, progressive vaccinia, and death, as adverse events among 450,923 military personnel. Relevant smallpox vaccination studies that concerned myopericarditis [13] or folliculitis [14] were not considered here.

Type of adverse event (active versus passive) reporting

VAERS is a passive surveillance system used, in part, to help detect rates of rare but serious adverse reactions to vaccinations. However, some reports have involved active surveillance of adverse reactions to smallpox vaccine [8-10,12]. Using VAERS, Sejvar et al [1] identified 95 headaches as reported adverse events among 665,000 vaccinated individuals. Also using VAERS, Casey et al [11] identified at least 110 headache cases among 38,885 civilian recipients of smallpox vaccination. Using active surveillance of only 526 vaccinated personnel assigned to seven selected military organizations, Grabenstein & Winkenwerder [8] found 95 headaches as reported adverse events. Also using active surveillance of 680 civilian volunteers for a random single-blind trial, Frey et al [10] received reports of 294 headaches in the first six days after smallpox vaccination, with an unspecified number of new cases developing after six days (they reported the number of headaches after day 6 without indicating how many were new cases). With 936 mostly civilian subjects, Baggs et al [12] received 266 reports of headaches within 20 days of smallpox vaccination. In a study of 1,212 U.S. civilian DoD and military personnel who participated as first-time vaccinees (N = 439) or re-vaccinees (N = 773) in a trial of the use of electronic reporting of adverse events, Olmstead et al [9] received 317 reported incidences of headaches. Consistently, as noted in Table 1, passive event reporting systems yielded lower rates of headache as an adverse event than did active event reporting systems.

VAERS is a passive surveillance system used, in part, to help detect rates of rare but serious adverse reactions to vaccinations. However, some reports have involved active surveillance of adverse reactions to smallpox vaccine [8-10,12]. Using VAERS, Sejvar et al [1] identified 95 headaches as reported adverse events among 665,000 vaccinated individuals. Also using VAERS, Casey et al [11] identified at least 110 headache cases among 38,885 civilian recipients of smallpox vaccination. Using active surveillance of only 526 vaccinated personnel assigned to seven selected military organizations, Grabenstein & Winkenwerder [8] found 95 headaches as reported adverse events. Also using active surveillance of 680 civilian volunteers for a random single-blind trial, Frey et al [10] received reports of 294 headaches in the first six days after smallpox vaccination, with an unspecified number of new cases developing after six days (they reported the number of headaches after day 6 without indicating how many were new cases). With 936 mostly civilian subjects, Baggs et al [12] received 266 reports of headaches within 20 days of smallpox vaccination. In a study of 1,212 U.S. civilian DoD and military personnel who participated as first-time vaccinees (N = 439) or re-vaccinees (N = 773) in a trial of the use of electronic reporting of adverse events, Olmstead et al [9] received 317 reported incidences of headaches. Consistently, as noted in Table 1, passive event reporting systems yielded lower rates of headache as an adverse event than did active event reporting systems.

Source of adverse event (military versus civilian) reporting

Table 1 presents the percentage of headaches reported as adverse events following smallpox vaccinations as reported across both a variety of types of reporting (passive versus active), as discussed previously, and across a variety of samples (military versus civilian compositions). Within VAERS (passive) reports, Casey et al [11] found at least 110 headaches (0.28%) among 38,885 civilians in contrast to Sejvar et al [1] who found only 95 headaches (0.01%) reported among their mixture of 665,000 civilian and military personnel. Even if nearly all of the headaches reported by Sejvar et al [1] were military personnel related, the reporting rate in VAERS for headaches (< 0.02%) would have been much lower for military personnel than for civilian personnel as reported by Casey et al [11].

Within active adverse event reporting systems, Frey et al [10] found at least 44.2% of their civilian subjects reporting post smallpox vaccination headaches. In a sample of mostly civilian subjects, Baggs et al [12] had 28.4% of subjects reporting headaches. With a mix of DoD civilian and military personnel, Olmstead et al [9] found 26.2% of subjects reporting headaches. Using only military subjects, Grabenstein & Winkenwerder [8] found 18.1% reporting headaches after smallpox vaccination. In other words, the larger the military composition of the subjects, the lower was the rate of reported headaches as post-vaccination adverse events. The fact that all of Frey et al's [10] subjects were primary vaccinees may account for part of the difference between the samples, according to Sejvar et al [15].

Factual discrepancies or errors

The Committee on Smallpox Vaccination Program Implementation [16] reported that the national smallpox vaccination campaign had reached a cumulative total of 38,004 civilian smallpox vaccinations by July 25, 2003, with only 1,575 more civilian smallpox vaccinations over a year later, by July 31, 2004, for a total at that time of 39,579. Sejvar et al [15] reported 34,752 civilian smallpox vaccinations between January 24 and May 2, 2003. Casey et al [11] used 38,885 vaccinations as their baseline from January 24, 2003 to October 31, 2003, a number that matches closely with the Committee data [16]. Poland et al in a March 2003 report [17] indicated a total of 40,449 civilian smallpox vaccinations as of 13 February 2004 as well as a total of 730,580 military smallpox vaccinations as of 4 January 2005. However, Sejvar et al [1] reported 64,600 civilian smallpox vaccinations between December 16, 2002 and March 11, 2004, with apparently 24,151 additional smallpox vaccinations in less than four weeks between 14 February and 11 March 2004. While the time frame for civilian smallpox vaccinations was shorter in Sejvar et al [1] than that considered by the Committee [16], Sejvar et al [1] reported nearly 60% more civilian vaccinations that were otherwise officially reported, even though Dr. John Grabenstein co-authored at least two of the conflicting reports [1,17]. Sejvar et al [1] also reported considerably fewer military vaccinations than Poland et al [17], raising questions about the number of military vaccinations cited in Sejvar et al [1]. Furthermore, they added their 64,600 civilian vaccines to their 590,400 military vaccinees, obtaining a total of 665,000 vaccines, though their actual sum was short of 665,000 by exactly 10,000 subjects. Such errors are critical because they factored both 665,000 and 64,600 into their computations of incidence rates, as reported in their manuscript (see Table 2 in [1]), for not only headaches, but also for 18 other neurologic syndromes. It must be noted that both of the co-authors of the Sejvar et al [1] report who reviewed this comment admitted in their reviews that the 64,600 figure was incorrect and should have been approximately 40,000.

Furthermore, Sejvar et al [1] reported only 95 VAERS headache reports from among all 665,000 subjects, even though, using a far smaller data set including most of the same civilian subjects, Casey et al [11] had found at least 110 headaches reported as adverse events in VAERS. Sejvar et al [1] should have found at least as many headaches as Casey et al [11] because both their time frame and their number of civilian subjects were larger; in addition, they should have located many additional headache reports, given the percentage of headaches noted elsewhere by Olmstead et al [9] and by Grabenstein & Winkenwerder [8] among military personnel.

The scientific validity of the article by Sejvar et al [1] has probably been compromised by several errors. First, their estimate of 64,600 civilian vaccinations is much larger than the approximately 40,000 estimated from other sources concerning the 2002–2004 smallpox vaccination campaign [11,16,17], unless they were counting over 24,000 vaccinations provided that had not been officially reported along with those 40,000. Second, their addition of 64,600 civilian and 590,400 military vaccinees should have totalled to 655,000 rather than 665,000, unless there is an unexplained source of the additional 10,000 vaccinations. Third, of course, is that if the count of 64,600 civilians is incorrect, then the total should have been closer to 630,400 rather than 665,000. Fourth, it is not clear how Sejvar et al [1] counted only 95 headaches among VAERS reports for 665,000 subjects, when Casey et al [11], using the same civilian subjects but a total pool of subjects of less than 40,000, was able to identify a greater number (111) of headache reports in VAERS. Fifth, if their counting of VAERS headaches is incorrect and their total number of cases is incorrect, then their rates of a variety of adverse events are, by consequence, also incorrect. Essentially, such a large number of substantial errors or omissions can do little except to undermine the stated objective of Sejvar et al's [1] report, which was, as noted before, to "determine rates and describe the clinical features of neurologic events associated with smallpox vaccination," as well as raising questions about the factual validity of their conclusion that "During the 2002–2004 smallpox vaccination campaign, neurologic events were generally mild and self-limited, and no neurologic syndrome was identified at a rate above baseline estimates."

Given our observation that military samples, whether using active or passive reporting of adverse events following smallpox vaccination, tend to report fewer adverse events than civilian samples, their process of combining a relatively small civilian sample with a far larger military sample is also probably suspect in terms of generating accurate rates of adverse events, even if the numbers of civilian and military vaccines had been correct or were to be adjusted to correct values. The publishing of such uncorrected errors and weak methodologies by officials, most of whom are employed full-time by the U.S. government and/or the U.S. military, in pre-eminent medical journals, such as JAMA, does not contribute to public trust in the U.S. government's current approach to vaccination programs that were designed by public policy and law, at taxpayer expense, to support international efforts to counter the threat of bioterrorism. The scientific value of the research reported by Sejvar et al [1] has probably been compromised to such an extent that the article should either be retracted or the errors or omissions of fact and computation should be corrected throughout their report.

Despite logical protest by Grabenstein [6], Nass [5] appears to be correct in her assertion that military subjects have tended to underreport adverse events associated with smallpox vaccination, relative to civilian populations, as clearly shown in Table 1. Assuming that our assertions are valid with respect to smallpox vaccination within the U.S. military, underreporting of adverse symptoms associated with other controversial vaccinations, such as anthrax vaccination, is almost certain. Such underreporting has important implications for determining accurate risk-benefit ratios associated with vaccination [2-4]. Along with the types of errors presented here, uncertainty with respect to risk-benefit ratios weighs against making higher risk vaccinations mandatory, without informed consent, even for military service members, especially when there are legitimate research questions about adverse side effects of vaccination [3], including long-term effects [18]

Competing interests

Dr. Schumm is a retired colonel, U.S. Army Reserve, and will receive retirement pay from the Department of Defense from January 2011 at age 60. Dr. Schumm has served as an expert witness for the plaintiffs in the Doe v. Rumsfeld civil suit, in which he primarily reanalyzed data from former studies of anthrax vaccine. Otherwise, Dr. Schumm has no financial interests in this research. He is not employed by any agency of the U.S. Department of Defense or the U.S. government, although he is an unpaid volunteer with the U.S. government program for "Employer Support of the Guard and Reserve" that encourages employers and Reserve Component soldiers to cooperate, in accordance with U.S. law, in allowing such soldiers to leave and return to their civilian employment without penalty.

Authors' contributions

WRS is solely responsible for the content of this report. However, Dr. Meryl Nass and Lieutenant Colonel (Retired) John Richardson reviewed previous drafts of this report and suggested helpful improvements. As noted below, reviewers also provided helpful comments on previous drafts.


Appreciation is expressed to three reviewers for their helpful and insightful comments on the original draft of this manuscript.


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Pre-publication history

The pre-publication history for this paper can be accessed here:

School of Family Studies and Human Services, College of Human Ecology, Justin Hall, Kansas State University, 1700 Anderson Avenue, Manhattan, KS, USA 66506-1403

BMC Medicine 2006, 4:27 doi:10.1186/1741-7015-4-27

The electronic version of this article is the complete one and can be found online at:

Received 8 February 2006
Accepted 10 November 2006
Published 10 November 2006

© 2006 Schumm; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

November 17, 2006

VaxGen Wins Extension on Anthrax Vaccine

VaxGen Wins Extension on Anthrax Vaccine

By Renae Merle, Washington Post Staff Writer

VaxGen Inc., a California biotechnology firm, said yesterday that the government had given it more time to conduct human testing of its anthrax vaccine, postponing a decision on whether the program should be canceled.

The Food and Drug Administration threw the effort into doubt earlier this month after calling a halt to testing in response to questions about the drug's reliability. The decision put the company in potential violation of its contract with the Department of Health and Human Services, which required testing to begin Nov. 13.

VaxGen said HHS has decided to extend the company's deadline for resolving the issue until Dec. 18. At stake is a contract potentially worth $1 billion.

Meeting that deadline will be difficult. The company has yet to hold a formal telephone or in-person meeting with the FDA.

Those meetings should occur no later than the middle of December, said Lance Ignon, VaxGen's vice president of corporate affairs. "HHS, it appears, has provided the necessary time for us to meet with FDA to try to discuss our data and try to find a pathway forward," he said.

VaxGen's anthrax vaccine effort, already years behind schedule, is the largest component of the Bush administration's Project BioShield, a $5.6 billion effort to counter bioterrorism threats. The firm has run into several technical problems, including a previous failed human test, and has struggled to fund its research. The contract calls for the company to be paid after it delivers the vaccine -- which is supposed to be enough for 25 million people, roughly the population in the New York and Washington metropolitan areas combined.

The latest problem centers on the vaccine's stability or the rate at which it would deteriorate while stockpiled. VaxGen has said it was encouraged by the improvements it made to the vaccine's stability, but that FDA still had concerns.

November 16, 2006

Emergent Biosolutions Falls After IPO


Shares of the manufacturer of the only U.S.-approved anthrax vaccine declined in their first day of trading Wednesday.

Shares of Emergent BioSolutions Inc. closed at $11.70 on the New York Stock Exchange, down more than 6 percent from the initial offering price of $12.50, where the stock opened on Wednesday morning.

The company sold 5 million shares of its stock at a price below the expected range of $14 to $16 a share, set by underwriter JPMorgan Chase & Co.

Based in Gaithersburg, Md., Emergent makes the only Food and Drug Administration-approved anthrax vaccine, BioThrax. Its primary customer for the vaccine is the U.S. government, which relies on it to immunize troops.

The company also has three other biodefense drug candidates.

Unlike many drug developers that have come public this year in the United States, Emergent has actually been profitable, thanks to BioThrax. But in the first nine months of 2006, its revenue declined 24 percent to $65.8 million compared with the same period of 2005 as the number of doses it delivered to the U.S. government decreased after it fulfilled its orders earlier than required.

The company lost $3.3 million for the first three quarters of the year, compared earnings of $6.3 million for the same period of 2005, as growth in its expenses, especially in research and development, outpaced revenue.

November 15, 2006

Joint Pain in Gulf War Syndrome Appears Not To Be Inflammatory But Rather Neurological

Joint Pain in Gulf War Syndrome Appears Not To Be Inflammatory But Rather Neurological: Presented at ACR-ARHP
By Maggie Schwarz

WASHINGTON, DC -- November 15, 2006 -- Joint pain in veterans with Gulf War syndrome appears to be a stress response similar to fibromyalgia or chronic fatigue syndrome, rather than an inflammatory one, researchers reported here at the American College of Rheumatology - Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR-ARHP).

Frank Pessler, MD, PhD, research associate, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, and colleagues performed a histological examination of synovial biopsies from Gulf War veterans complaining of rheumatologic symptoms.

Gulf War syndrome is a dramatically symptomatic, incompletely explained illness described among US and British military personnel who returned from the First Gulf War (1990-1991). Some of its symptoms may reflect underlying immune dysfunction. Rheumatologic symptoms, including joint pain and stiffness, are reported frequently, yet whether synovitis is a cause of the articular complaints in these individuals has not been determined until now.

Dr. Pessler and colleagues hypothesized that exposure to a large number of immunizations or toxins might have triggered the joint inflammation associated with Gulf War syndrome.

The researchers obtained biopsies from 9 veterans with Gulf War syndrome, and obtained 7 specimens with sufficient tissue quality for analysis. Specimens from 11 patients with rheumatoid arthritis and 14 with osteoarthritis were used as controls.

Inflammatory changes were quantified using a synovitis score. Cell division and vascular density were also measured. Differences were also assessed using a composite inflammation score that consolidates results from immunohistochemical parameters into one value.

Microscopy revealed normal synovial tissue with changes consistent with healthy joints. Inflammatory cells (macrophages, T cells, CD20 B lymphocytes CD3, CD38 and CD68) were absent.

Mean synovitis score of 1.39 +/- 0.29 corresponded to absence of synovitis. Consistent with these results, inflammatory cell densities, cell division index, vascular density and inflammation score were lowest in Gulf War syndrome, intermediate in controls with osteoarthritis and highest in controls with rheumatoid arthritis.

The low numbers of inflammatory cells, which were occasionally seen, were similar to the background frequency expected in synovial biopsies from asymptomatic knee joints.

Dr. Pessler concluded that prevailing thinking on Gulf War syndrome that points to a neurological stress response rather than an inflammatory one appears to be correct.

[Presentation title: Absence of Inflammation in Synovial Biopsies Form Patients With "Gulf War Syndrome" and Joint Pain. Abstract 160]

Flu Vaccine increases risk for neurological disorder

by Michael Dorausch, DC news staff

It is important to be aware of the risks involved when considering taking any drug or vaccine or putting a drug or vaccine into a young ones body. A new study has revealed that the flu vaccine is associated with an increased risk of developing a debilitating neurological disorder known as Guillain-Barré syndrome.

The debilitating nerve destroying syndrome affects about one in 100,000 people each year. It results from the body's immune system attacking parts of the nervous system, causing weakness or tingling that can eventually lead to paralysis. Previous research had linked Guillain-Barré syndrome to the flu vaccine, but researchers continue to look for more connections between debilitating conditions and flu vaccines.

According to the National Institute of Neurological Disorders and Stroke, Guillain-Barré (ghee-yan bah-ray) syndrome is a disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the patient is almost totally paralyzed.

The research comes from the University of Toronto. Researchers studied residents in Ontario, where a flu vaccine immunization program was started in 2000. All Ontario residents 6 months or older received a FREE flu vaccine. Researchers looked into cases of hospitalization for Guillain-Barré syndrome from 1993 to 2004. They then researched who had received a flu vaccine and compared the individuals risk for the syndrome within two to seven weeks after vaccination up to twenty to forty-three weeks later. Researchers also compared the number of Guillain-Barré cases before and after the immunization program began in 2000.

Researchers discovered that Ontario residents were more likely to be hospitalized for Guillain-Barré syndrome in the two to seven weeks after being vaccinated than at forty-three weeks. It showed a small but increased risk for the disease after vaccination.

There has been a lot of discussion whether the flu vaccine is even effective in preventing the flu. Add to that, the risk of developing disabling nerve disorders, mercury toxicity (from shots containing thimerosal), as well as other side effects, and you may wonder we one would even subject themselves to the shot. One thing is for sure, the more people that get the flu shot, the more data researchers will have to determine what disorders and conditions are caused by the shot.

Senate to Take Up Biological Threats - Firms Could Get Funding Sooner

By Renae Merle, Washington Post Staff Writer

The Senate is moving to take up legislation as soon as this week revamping a struggling multibillion-dollar effort to counter bioterrorism threats with a national stockpile of new vaccines and other drugs.

The legislation creates a central authority within the Health and Human Services Department to manage the effort, sets aside an additional $1 billion for research and gives the federal government the flexibility to provide cash infusions to the small firms doing most of the work.

Supporters of the bill, which is more than a year in the making, are cautiously optimistic that it will pass. Sen. Harry M. Reid (D-Nev.), who is slated to take over as majority leader, listed it among his priorities for Congress's lame-duck session.

"From a policy standpoint, there is nobody shooting at it," said Sen. Richard Burr (R-N.C.), one of the bill's sponsors.

If passed, the legislation would have to be reconciled with the House version, which was passed in September. The initiative is intended to salvage the Bush administration's Project BioShield, a $5.6 billion program to counter biological and radioactive weapons.

The two-year effort has been marked by delays and operational problems. Some companies, for example, have floundered as they conducted research and testing because the bulk of government payments typically do not arrive until firms are ready to produce approved drugs.

Meanwhile, Project BioShield's most significant investment, a nearly $1 billion effort by VaxGen Inc. to develop an anthrax vaccine, is in limbo after the Food and Drug Administration refused to let the company conduct human tests and Health and Human Services threatened to end the company's contract.

Project BioShield "didn't work because a majority of the companies choose not to participate and the ones that did, they were not financed through the valley of death," Burr said.

The new legislation aims to correct those problems, but it still may face some questions. Sen. Patty Murray (D-Wash.), who said she supports the intent of the bill, nonetheless raised safety concerns.

"We need to debate compensating those who may suffer adversely from new vaccines or treatments and expand protections for high risk populations like children, pregnant women, and the elderly," Murray said in a statement.

Under the current proposal, the bill would create the Biomedical Advanced Research and Development Authority to oversee the effort. The bill also attempts to pump more government money into the private market sooner. Under current law, participating companies are not paid until they deliver the drugs, even though Health and Human Services has the authority to give companies a 10 percent prepayment, which would have to be repaid if the company failed to deliver the product. But the agency has never exercised that option.

The legislation would speed up the development cycle by allowing Health and Human Services to pay companies up to 5 percent of the value of their contract when they reach certain milestones, providing them with a welcome cash infusion. The Senate version would also allocate $1 billion over three years for research not funded by a Project BioShield contract or the National Institutes of Health. The House version of the legislation sets aside $160 million per year for two years.

"The federal government is now their venture capital partner," Burr said.

Lance Ignon, VaxGen's vice president for corporate affairs, applauded the notion of the government playing a larger role in sharing the financial risk. Under the current program, "we have all of the financial risk," he said.

The change would not be a "panacea" in VaxGen's case, he said, but could be helpful to the company and the industry in general.

"The success of our nation's bio-defense effort will rest in large measure on the ability to form true partnerships between government and industry based on mutual respect," Ignon said. That includes an "understanding of the almost inevitable setbacks one encounters in drug development."

Acambis crashes after US smallpox setback

By Stephen Foley in New York

Acambis, the vaccines manufacturer, has been dumped by the US government from a contract to supply smallpox vaccine that could have been worth up to $1bn (£555m).

The UK company was told that its proposal for a new, weakened vaccine was "no longer highly rated" on technical grounds. The unexpected announcement wiped almost 40 per cent from the share price.

Investors fear that without revenue from the contract, which would have part-subsidised Acambis's research and development work until the end of the decade and beyond, the loss-making company is more reliant than ever on signing licensing deals for its other products.

Gordon Cameron, chief executive, said he was seeking an urgent meeting with the US health department to find out why Acambis had been shut out of the smallpox contract. He was told the news late on Monday night."We are surprised that the US government would eliminate Acambis," he said. "We believe that our proposal would have met the requirements of the government, especially given our track record in
the biodefence field."

Acambis shares crashed 59.75p to 94.75p, falling back for the first time below their level on 11 September 2001, when the terrorist attacks on the US transformed the company's fortunes. Fears of a bioterrorist attack led the US government to ask Acambis to make a stockpile of smallpox vaccine from what had previously been a little used plant inside the company.

Acambis has since supplied almost 200 million doses of traditional smallpox vaccine and funnelled the cash into new projects, such as experimental vaccines against Japanese encephalitis and the West Nile virus. The US has been funding a race between Acambis and its Dutch rival, Bavarian Nordic, to develop a second, weakened smallpox vaccine for the elderly and people with weak immune systems, and it had previously been expected that the contract would be split between the two companies.

Acambis announced the outcome of a strategic review last week which promised its two smallpox vaccines would "provide significant revenues and cashflow to underpin the business while supporting the core non-biodefence pipeline".

The health department's decision to withdraw support for Acambis is a "significant slap in the face", according to Chris Redhead, analyst at Nomura Code.

Acambis, the vaccines manufacturer, has been dumped by the US government from a contract to supply smallpox vaccine that could have been worth up to $1bn (£555m).

The UK company was told that its proposal for a new, weakened vaccine was "no longer highly rated" on technical grounds. The unexpected announcement wiped almost 40 per cent from the share price.

Investors fear that without revenue from the contract, which would have part-subsidised Acambis's research and development work until the end of the decade and beyond, the loss-making company is more reliant than ever on signing licensing deals for its other products.

Gordon Cameron, chief executive, said he was seeking an urgent meeting with the US health department to find out why Acambis had been shut out of the smallpox contract. He was told the news late on Monday night."We are surprised that the US government would eliminate Acambis," he said. "We believe that our proposal would have met the requirements of the government, especially given our track record in
the biodefence field."

Acambis shares crashed 59.75p to 94.75p, falling back for the first time below their level on 11 September 2001, when the terrorist attacks on the US transformed the company's fortunes. Fears of a bioterrorist attack led the US government to ask Acambis to make a stockpile of smallpox vaccine from what had previously been a little used plant inside the company.

Acambis has since supplied almost 200 million doses of traditional smallpox vaccine and funnelled the cash into new projects, such as experimental vaccines against Japanese encephalitis and the West Nile virus. The US has been funding a race between Acambis and its Dutch rival, Bavarian Nordic, to develop a second, weakened smallpox vaccine for the elderly and people with weak immune systems, and it
had previously been expected that the contract would be split between the two companies.

Acambis announced the outcome of a strategic review last week which promised its two smallpox vaccines would "provide significant revenues and cashflow to underpin the business while supporting the core non-biodefence pipeline".

The health department's decision to withdraw support for Acambis is a "significant slap in the face", according to Chris Redhead, analyst at Nomura Code.

November 14, 2006

Bioterrorism Aftermath Could Top Nuclear Devastation

Global Security Newswire

The damage caused by biological weapons could top the devastation left by a nuclear weapon, a U.S. expert said yesterday at a bioterrorism conference in Scotland (see GSN, Nov. 10).

Terrorists are also more likely to obtain a biological weapon than a nuclear bomb, said Ronald Atlas, co-director of the Center for Deterrence of Biowarfare and Bioterrorism at the University of Louisville in Kentucky.

“When it comes to weapons of mass destruction, studies have shown that some biological weapons could equal or even exceed the damage caused by a nuclear weapon,” Atlas said.

“Anthrax is the proven agent, but focusing on anthrax may be short sighted. As biology advances, we are putting on the table much more problematic and sophisticated weapons. The fear is that the same technologies we are developing for human good may be used for fearful purposes,” he said (James Morgan, The Herald, Nov. 14).

From an earlier article from May '02, Village Voice,

Here are some excerpts from an article in New York paper the Village Voice, 10 May 2002

U.S. Military Proposes Illegal Bioweapons Research
by Russ Kick

According to documents unearthed by a nonprofit government watchdog, the United States military has proposed the development of biological weapons that would violate international treaties and federal law. In fact, they may have already developed some of these illegal, treaty-busting bioweapons.

Using the Freedom of Information Act, the Sunshine Project has recently pried loose some damning documents from the Marine Corps, which seems to be overseeing this area of research.

Exhibit A is a 1997 proposal from the Naval Research Laboratory to create genetically engineered bacteria and fungi that will corrode and degrade enemy matériel, such as roads, runways, vehicles, weapons, and fuel. The military scientists take great care to point out that the germs they want to create would be "nonlethal." But this doesn't matter. The international Biological and Toxin Weapons Convention treaty absolutely bans member nations from possessing or developing microbes, toxins, or any other biological agents for use in battle or other hostile situations. Yet the navy lab is advocating these super-bugs for blatantly offensive purposes, saying they will "degrade opposing forces' mobility, logistical support and equipment maintenance programs prior to or during military engagements." Likewise, the air force proposal is for bioweapons that would be used to attack enemy forces: "Catalysts can be developed to destroy whatever war matériel is desired. All [military] Services would have an interest."

Both proposals claim that the destructive germs wouldn't violate the biological weapons treaty. "That's completely false," says Edward Hammond, a co-founder of the Sunshine Project. He notes that the convention makes no distinction between bioweapons that target humans and those that take out equipment or other targets. "If the Biological and Toxin Weapons Convention was limited to humans, it would be disastrous. Weapons that target animals, like livestock, would be legal. Destroying crops would be legal." The military's proposed germ research would violate more than just international treaties.

"U.S. federal law explicitly states that biological weapons that attack matériel are illegal," Hammond says. "The penalty is life in federal prison. If they lifted a finger to do this research, they have violated the [Biological and Toxin Weapons] Convention and federal law."

Burr bill may be taken up in lame-duck session
If held, it will keep its support, adviser says

By Mary M. Shaffrey

Though Republicans still control the congressional agenda, they can't do much without widespread Democratic support.

And one of the big items expected to get consideration this week during the lame-duck session is a bill sponsored by Sen. Richard Burr, R-N.C., that would establish a new federal agency to combat bioterrorism - the Biomedical Advanced Research and Development Authority.

Senate Minority Leader Harry Reid of Nevada, who will be the majority leader come January, has said he would like to see bioterrorism and pandemic flu-related legislation taken up before Congress adjourns for the year.

Burr's bill, commonly referred to as BARDA, would create a new position within the Department of Health and Human Services that would be solely responsible for the oversight of vaccine production.

This individual, who would require Senate confirmation, would administer a billion-dollar fund for the next two years that would aid the development of vaccines.

Bob Kadlec, a bio-defense and public-health consultant, used to work for Burr. He said that Hurricane Katrina demonstrated the need to have one person in charge, and though the bill has many components, this is perhaps the most critical.

"This was something that (has been) left in flux," Kadlec said. "It's important to have one identifiable person in charge."

Brad Smith, a senior associate at the Center for BioSecurity at the University of Pittsburgh Medical Center, has followed the bill closely since Burr introduced it in 2005. He said that it would deal with the concerns of pharmaceutical-industry officials, who have complained that they did not have "a strong partnership" with the federal government as industry was developing vaccines.

But Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland, said that it's a bad idea to pass the bioterrorism bill now.

"It would be a mistake to pass this now in a lame-duck Congress. It would be the wrong approach. It needs a more thorough review," he said.

Passing the bill now is "like putting a Band-Aid on a mortal wound," said Greenberger, who recommended fixing existing pieces of legislation before trying to create something new.

BARDA has already passed the House of Representatives, by a voice vote before the October recess. The Senate version is attached to a pandemic-flu bill - also promoted by Burr - that needs to be reauthorized before Congress adjourns for the year.

It's not clear whether the House would take up the new version of the legislation, if it passes the Senate. The House is expected to take a recess on Wednesday and return in early December.

There's little motivation for many House Republicans to stick around for anything other than necessary appropriations bills - particularly those who lost in midterm elections.

Smith said that if the bioterrorism bill is not taken up this year, he expects it to be one of the first items discussed when Democrats take over in January.

"All along this has been a bipartisan issue," he said. "If for whatever reason it doesn't get done in time (this year), there will still be critical bipartisan support."

• Mary M. Shaffrey can be reached in Washington at 202-662-7672 or at

November 11, 2006

Universities becoming more involved in bioterrorism research

PHOENIX Arizona universities are becoming more involved in bioterrorism research while taking in tens of (m) millions of dollars in grants.

The Arizona Republic reports research is under way on nearly all six agents listed as the highest priority for national security.

Among them, anthrax, plague, smallpox and Ebola.

Arizona State University is announcing this week that it will join four other institutions in a 14 (m) million dollar federal grant to develop an antidote for the nerve agent sarin.

The federal government is spending more than one and a-half (b) billion dollars a year on research to improve prevention and detection of bioterrorism agents.

Information from: The Arizona Republic,

Anthrax Vaccine Supplier Moves Closer to Initial Public Offering
By Michael S. Rosenwald, Washington Post Staff Writer

A Gaithersburg drug company that makes most of its money selling the only federally approved vaccine against anthrax is in the final stages of preparing an initial public offering to raise up to $92 million.

Late last month, Emergent Biosolutions Inc. set the range of its offering at $14 to $16 a share. The company said it intends to use the money on its manufacturing facilities in Frederick and Michigan and to fund development of several products, according to documents filed with the Securities and Exchange Commission.

The company is tightly controlled by Fuad El-Hibri, its chairman and chief executive. El-Hibri, who lives in Potomac, has an extensive background in the telecommunications industry. He and his father have also had significant involvement with a British provider of anthrax vaccines. El-Hibri, who became a U.S. citizen in 1999, was born in Germany and grew up around Europe and the Middle East before attending Stanford and Yale universities.

El-Hibri controls 99.5 percent of the Emergent's outstanding stock. After going public, he will control 81.4 percent. In SEC documents, the company said El-Hibri "will continue to have substantial control over us after this offering, including through his ability to control the election of the members of our board of directors, and could delay or prevent a change of control."

Biotech analysts said Emergent could have a tough time with its initial public offering. Just two biotech companies -- Osiris Therapeutics, a Baltimore biotechnology firm working on stem-cell therapies, is one -- went public in the third quarter, and the market for IPOs in general has been spotty.

According to Thomson Financial, more companies have withdrawn IPOs this year than in any of the previous five years, indicating investors are skeptical of new company stock offerings despite the generally strong market for stocks. And venture capital-backed IPOs, traditionally the most prolific source of new company issues, fell significantly in the third quarter.

Companies that have managed to go public are in a broad range of industries, and those that have had the most success are in tried-and-true money-making or technologically hot industries. For example, locally, government contracting giant SAIC Inc. is up 33 percent since its Oct. 12 IPO. And Osiris Therapeutics is up 89 percent since its August IPO.

Emergent Biosolutions' effort to finish its IPO comes as federal health officials deal with a troubled $877.5 million contract for another anthrax vaccine, made by VaxGen Inc. VaxGen is supposed to provide 75 million doses for the national stockpile, but the Food and Drug Administration recently halted human testing of the California company's vaccine because of concerns about its potency, throwing the entire contract into doubt.

VaxGen's contract was awarded under the Project Bioshield initiative, which seeks to develop modern vaccines and drugs for chemical, biological, radiological or nuclear attacks. VaxGen's proposed anthrax vaccine, if successful, would require fewer doses over a shorter period of time to produce immunity than the older version made by Emergent.

Emergent has been urging Congress and federal health officials to buy more of its anthrax vaccine, called BioThrax, for the stockpile. The efforts are being aided by Louis W. Sullivan, who was health and human services secretary from 1989 to 1993, and Jerome M. Hauer, a former senior HHS official who oversaw public health emergency preparedness. Both men are on Emergent's board.

So far, the government has purchased 10 million doses.

In its SEC filings, Emergent said the government's efforts to stockpile a newer version "would limit, possibly significantly, the market for BioThrax." The company said it is in the early stages of developing a next-generation anthrax vaccine and products for other diseases and bioterrorism agents.

Emergent officials could not comment because the company is in a quiet period before its offering.

While the $5.6 billion Project Bioshield program is potentially the most lucrative outlet for BioThrax, Emergent also sells the vaccine to the Defense Department. Since 1998, the Defense Department has vaccinated 1.5 million people with more than 5.7 million doses, according to SEC documents. It is providing 1.5 million doses to the military through September 2007.

BioThrax has been controversial in the military. Some soldiers have complained of significant side effects and have refused to use the vaccine, leading to a court battle that temporarily stopped mandatory vaccinations. The government recently resumed mandatory vaccinations with BioThrax after the FDA said the vaccine was safe and effective.

John T. McCamant, editor of the Medical Technology Stock Letter, said Emergent's IPO could be particularly difficult because the only customer for bioterrorism products is the government.

"That's a tall trick because the money will come in lumps at best," he said.

Staff writer Terence O'Hara contributed to this report