December 2006 Archives

sanofi

Let's see, Sanofi invests  €160 million last year, then produces 170 million influenza shots this year. The price of a single shot varies between $10 and $15 (according to CDC). Gross profit would make $1.7 billion, at least. 800% ROI? Not bad.  What was the key factor of this outcome? A fear. Consumers' fear.

Don't forget that some pharma companies were doubling the price (Some Suppliers Jack Up Flu Vaccine Price, The Washington Post, Oct.14, 2006). And now there's a huge surplus of influenza vaccines stocked in clinics. Will we see another warning about some new virus, dangerous and deadly, for sure?

Sanofi pasteur, the vaccines business of the sanofi-aventis Group (NYSE: SNY; EURONEXT: SAN), announced that it completed production of more than 170 million doses of influenza vaccine in 2006. Sanofi pasteur confirmed its leadership as one of the world’s largest manufacturers of seasonal influenza vaccine, supplying a very significant portion of the estimated global production of about 350 million doses.

As the global influenza vaccine leader, Sanofi pasteur has been steadily increasing its manufacturing capacity. Since 2003, capacity has increased by more than 40% in line with the company’s commitment to serve a central role in the fight against a disease that causes between three and five million cases of severe illness and between 300,000 and 500,000 estimated deaths every year around the world according to the Word Health Organization. In addition, sanofi pasteur’s leadership position in developing and producing influenza vaccines places the company at the forefront of readiness against the threat of pandemic influenza. The company is committed to producing as many doses of sanofi pasteur’s most advanced vaccine in the shortest possible timeframe, should a pandemic be declared by the world’s health authorities.

Doctors Suggest Infants Get Rotavirus Vaccine

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vaccination and profitsAnother vaccine for newborns and infants? Sounds like a plan. A plan to fulfill another plan. Such as Pfizer's plan to increases the global vaccine sales to 30+ billion USD by 2015.

I can only hope that vaccinations won't be made obligatory worldwide. Though this hope may die by the time 2015 will arrive.

KANSAS CITY, Mo. -- Doctors said rotavirus is a contagious, gastrointestinal illness that is especially dangerous to infants.

Experts at Children's Mercy Hospital are encouraging parents to make sure their babies receive a new rotavirus vaccine as part of their immunization schedule.

Rotavirus is a common childhood illness, characterized by fever, vomiting and watery diarrhea. It can cause severe dehydration in infants and toddlers.

Crucell signs vaccine production deal with Merck

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crucell AMSTERDAM, Dec 27 (Reuters) - Dutch biotechnology firm Crucell (CRCL.AS, CRXL.O) said on Wednesday it has signed a cross-licensing agreement with U.S. drugmaker Merck (MRK.N) on its vaccine production technology.

"This agreement will make it possible to speed up the delivery of our malaria and TB vaccines to the people in need, and makes it realistic to do so on the mass scale required," Jaap Goudsmit, chief scientific officer at Crucell, said in a statement.

© Reuters 2006

BioVeris licenses vaccine patent

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bioveris corpVaccine and medical test maker BioVeris Corp. said Tuesday it licensed a Baxter Healthcare Corp. meningitis vaccine for use in a combination vaccine that would require fewer injections per doctor visit.

Under the deal, BioVeris will receive nonexclusive, worldwide patent rights to the development, testing or use of the Neisseria meningitidis group C vaccine.

BioVeris did not disclose financial terms of the deal, but said it paid a license issue fee and may also make future payments for patent costs, milestone fees related to clinical trials and regulatory approvals.

2006 Could Be Called the Year of the Vaccine

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vaccine2006 was a very big year when it came to health news. New drug approvals, new vaccines, health scares that never quite made it and health scares that keep coming back for more. They were all part of the big year in health news in 2006.

2006 could easily be named the year of the vaccine. Several new shots hit the market: the first shingles vaccine, a whooping cough, or pertussis vaccine, for adults and a new, safer rotavirus vaccine to prevent the common diarrheal illness in children.

The biggest news, perhaps, surrounded the cervical cancer vaccine. It's approved for pre-teen girls to prevent HPV--human papilloma virus--the sexually transmitted virus that triggers cervical cancer.

Prostate cancer vaccine linked to longer survival

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Prostate cancer vaccineA study has found that men with advanced, often untreatable prostate cancer who received a therapeutic cancer vaccine went on to survive longer than those receiving a placebo.
Study findings showed the vaccine group lived up to an average of four-and-a-half months longer and had a greater than three-fold increase in survival at 36 months when compared to patients in the placebo group.

The study is published in the Journal of Clinical Oncology.

The double-blind, placebo-controlled phase III clinical trial was conducted to test the efficacy of the vaccine, called sipuleucel-T, in delaying disease progression and prolonging survival in patients with asymptomatic metastatic hormone refractory prostate cancer (HRPC).

Uganda launches HIV vaccine trials for babies

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clinical trialsUganda has screened and vaccinated at least a quarter of the 50 babies needed for vaccine trial focused on prevention of HIV transmission from mother to child during breastfeeding.

The first baby in the vaccine trials was enrolled in October and by last week 14 of them had received either the vaccine or placebo saline solution (for control) while 16 have been screened to participate. 

The study is in its phase I, randomised double blind — where the researchers will not know which babies receive the vaccine or the placebo solution, while 40 babies will randomly receive the vaccine and 10 the placebo.

The molecular mechanism of a diabetes vaccine revealed

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diabetesA team of researchers led by Irun Cohen of the Weizmann Institute of Science Immunology Department has revealed the molecular mechanism of a vaccine for type 1 diabetes.

The new findings should help amplify the effectiveness of the vaccine, which is currently in advanced stages of clinical trials.

Several years ago, Cohen and colleagues developed a vaccine that arrests the progression of type 1 diabetes in laboratory animals. They had discovered that a particular protein called HSP60, or even only a small particular fragment of it – the peptide designated p277 – is able to shut down the autoimmune response causing this disorder. The vaccine is currently being tested in clinical trials in Europe and the United States, but its precise mechanism has until now been unknown.

Flu vaccine makes man paralyzed

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vaccine shotHealth technician Hamit Öztürk has been paralyzed due to thenflu vaccine. Öztürk stayed at the hospital for 15 days. He was saved by cleansing of his blood from antigens. Öztürk got the flu shot in the corporate office of the government doctor of the ministry of health on November 21.

Then his health started to get worse. It was thought that he had muscle aches in an examination in Ankara Numune Hospital. Then he could not move any of his organs, even his eyelids. It was detected that Öztürk's nervous and immunity system broke down due to the side effect observed in 1 per thousand with the flu vaccination.

source - Sabah.com 

Childhood vaccine against heart disease planned

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Dr. Vijay KakkarLondon - Professor Vijay Kakkar has the gentle demeanour of a man into whose hands you would happily entrust your heart, should disease and circumstance require it. And you would be wise to do so. For the professor is a world-renowned vascular surgeon and research scientist whose career has spanned more than 40 years.

Now, approaching his 70th birthday, he is embarking on his most ambitious project yet a vaccine against heart disease that can be administered in childhood and he is confident he will achieve it before the decade is out.

By 2008, he and his team also hope to have developed a cheap, reliable urine test to identify those at high risk of heart disease.

Bird Flu Infects Three Family Members In Egypt

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bird fluA family cluster infection of bird flu has been identified in Garbiya, about 55 miles north of Cairo, Egypt, say officials from the World Health Organization (WHO). Two infected people had been slaughtering ducks prior to becoming infected, say WHO officials.

Official confirmation conflicts with the WHO version. A spokesman for the Egyptian Health Ministry said only two patients had been infected with H5N1, the virulent bird fly virus strain.

Authorities say birds in the immediate vicinity of the infections are being culled as a precautionary measure. They added that all humans in the area who have been handling poultry are being checked.

Which is More Dangerous to Your Health—the Flu or the FDA?

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tamifluby John W. Whitehead, Rutherford.com

The flu season is here once again. During the last flu season, doctors reportedly wrote more prescriptions for the drug Tamiflu than any other flu treatment. But after recent reports about the Food and Drug Administration’s reluctance to issue a warning about certain possible dangers of using Tamiflu, one has to wonder which is more dangerous—the flu or the FDA?

First approved by the FDA in 1999, Tamiflu was touted as a drug that could significantly reduce the length and severity of influenza. These claims even prompted the U.S. government to purchase 20 million doses of Tamiflu—at a cost of $2 billion—in the event that a bird flu pandemic occurred. The Pentagon followed, paying a whopping $58 million in July 2005 for treatments of U.S. troops around the world.  

rice plantationsPurpose of review: Plant pollens are the most common cause of seasonal allergic disease. The number of patients undergoing treatment for allergies to the pollen of Japanese cedar (major antigens: Cry j 1 and Cry j 2) has increased steadily each year. Integration of an effective, safe and inexpensive clinical program would be greatly improved by addressing deficiencies in systemically delivered immunotherapy.

Recent findings: We have demonstrated that feeding mice transgenic rice seeds accumulating the T-cell epitope peptides of Cry j 1 and Cry j 2 before systemic challenge with total protein of cedar pollen inhibits the development of allergen-specific IgE, IgG and CD4+ T-cell proliferative responses. The levels of allergen-specific CD4+ T-cell-derived allergy-associated T-helper 2 cytokine of IL-4, IL-5, and IL-13 and histamine release in serum were also significantly decreased. Moreover, clinical symptoms were inhibited in an experimental sneezing-mouse model.

1918 pandemic could kill 62 million today

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vaccineAre you wondering who might have called for this research, as I am? What is the real purpose of this number - 62 million dead people? I think, this number is in the news for a simple reason. Fear. Put fear in us. When this pandemic will come (not if, but when), the solution will be a vaccine shot.

BOSTON, Dec. 22 (UPI) -- U.S. and Australian researchers have re-analyzed data from 27 countries on the 1918 pandemic and estimate a similar pandemic might kill 62 million today.

Based on 2004 population data, the researchers at the Harvard School of Public Health and the University of Queensland in Australia say if a similarly virulent strain of flu virus were to strike today approximately 96 percent of deaths would occur in developing countries.

Bush signes ligeislationBAKERSFIELD - President Bush has signed legislation providing $40 million towards developing a Valley Fever vaccine.

The grant would triple the amount of money that has been raised over the past decade to develop a vaccine.

Valley Fever occurs naturally in Kern County and is contracted by breathing in a fungus found in soil.

Last year, nearly 1,600 cases were diagnosed in Kern County, but according to the Health Department, there could be a lot more considering about 60 percent of the people who have it also have no symptoms.

The next step could be funding through the appropriation of a new bill or the U.S. Department of Health and Human Services could make the funds available.

via 17KGET

HMSA has Vials of Unused Flu Vaccine

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vaccine and profitsAs expected, now it appears that there's too much of influenza vaccine shots. Surprise? Not really. Despite mass media attacks on the consumer to push these rather useless shots and secure profits of pharma corporations, the customers are not in a hurry to get an injection against flu. Who knows, maybe we are a bit less ignorant and more resistant to panic news than it was expected. 

HAWAII - This year you won't see long lines at makeshift vaccination clinics.  What you will see at health insurer HMSA are vials and vials of unused flu vaccine.

"It appears that the demand based on the estimates that everyone provided to us just didn't arrive," said Sr. Vice President Cliff Cisco.

The past two years, demand exceeded supply so much that the shortage left some going without a shot. So everyone, doctors and health insurance companies, increased their orders.

Anthrax Vaccine Contract Voided, Thwarting Administration

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VaxGenBy Renae Merle, Washington Post

Federal health officials yesterday scuttled the largest piece of the Bush administration's two-year program to counter bioterrorism, canceling an $877.5 million contract with VaxGen to develop an anthrax vaccine after the company missed a deadline to begin human testing.

The decision, delivered in a one-page letter, ends a troubled effort by the small California firm that has come to symbolize the failures of the government's ambitious $5.6 billion Project BioShield. The termination occurred on the same day President Bush signed legislation attempting to salvage the program by reorganizing its management and pumping more money into firms doing the work.

Critics question safety of vaccine additives

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anthrax vaccineA persistent criticism from opponents of the Pentagon’s anthrax vaccination program is the charge that defense officials purposely put squalene in some vaccine lots to boost troops’ immune responses and increase the length of time vaccine stocks would remain effective.

The Pentagon and the vaccine’s manufacturer have repeatedly denied those charges, but opponents continue to question whether the fatlike substance may have played a role in illnesses developed by some troops who got anthrax shots during the 1991 Persian Gulf War and in the early stages of the Pentagon’s mandatory anthrax vaccine program in the late 1990s.

Researchers making progress to create men's HPV vaccine

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HPV virusby Michael N. Westley

A vaccine that prevents the spread of the human papillomavirus (HPV) has been approved for women and promises to decrease the risk of cervical cancer.

But in the face of such an exciting announcement, one question remains: What about the guys?

Of course, men don't have cervixes, but they do contract and spread HPV, which can cause genital warts and in some cases, rectal cancer. Research also has shown that men are excellent carriers of the strain of HPV that causes cancer in women without developing any symptoms themselves.

The good news is that a vaccine for men may not be too far away, according to a Utah researcher.

VaxGenBRISBANE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Pink Sheets: VXGN.PK) announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.

China to test new AIDS vaccine on humans

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vaccineBEIJING, Dec. 18 (Xinhua) -- China is seeking volunteers to participate in its second clinic trial of a new AIDS vaccine early next year, a leading Chinese scientist said recently.

The center is looking for men and women to participate in the trials which will take place in Beijing, said Shao Yiming, chief expert for the National Center for AIDS/STD Control and Prevention.

He revealed the plan at a conference on Sino-U.S. AIDS vaccine research and development held on Sunday without indicating how many participants will be involved in the trial.

pevion biotechBERN, Switzerland, Dec. 18, 2006 – Pevion Biotech announced the start of phase I clinical testing of its virosome-based hepatitis C virus (HCV) vaccine. The therapeutic HCV vaccine is based on Pevion Biotech`s proprietary PeviPROTM and PeviTERTM technologies and will be tested for its safety and immunogenicity.

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPROTM and PeviTERTM platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech’s HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTERTM) together with a supportive helper T cell response (PeviPROTM). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.
bird flu London – 'Daronrix', Glaxo's bird-flu vaccine, will hold a pride of place in the annals of preventive medicine, to be the first experimental bird-flu vaccine to receive certification by the European Medicines Agency, for its use in protecting people in the event of a bird-flu pandemic.

This first generation vaccine can be used only after the WHO or the European Union officially declares a pandemic.

A second –generation vaccine has also been conceived by the same company, Glaxo, and work is underway to study the effects of the vaccine in combating the H5N1 virus strain. The product is slated to go in for approval in the subsequent weeks. This second generation vaccine is intended to strengthen the immune system, as a preventive measure against an imminent pandemic.

House Votes Down Cervical Cancer Vaccine

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senateLegislation that would urge young girls to receive a vaccine to fight cervical cancer hit a red light. The bill passed easily in the senate, but did not pass in the state house.

Concerns about the vaccine's long-term effects hindered the bill's ability to gain enough support with lawmakers.

However, the Food and Drug Administration did approve the vaccination for use in girls as young as nine years old.

source - WLNS 

vaccine developmentBy Ed Susman SAN ANTONIO, TX -- December 15, 2006 -- A experimental breast cancer vaccine appeared to offer protection against recurrences but failed to achieve statistical significance after 2 years of treatment, doctors reported here at the 29th San Antonio Breast Cancer Symposium (SABCS).

"Recurrence rates reached 8.3% among the 101 women who received the vaccine and 16% among the 85 women who acted as controls in the trial," said Col. George Peoples, a surgeon at Brooke Army Medical Center, Fort Sam Houston, Texas.

Despite the nearly 50% reduction in recurrence, the small numbers of women in the trial resulted in a statistical value that is above the cutoff generally recognized as being significant.

vaccinationBy Anai Rhoads Ford

Recently, the Washington post printed an article about vaccine waivers that could jeopardise your parental rights:

"The American Academy of Pediatrics recommends that doctors ask parents who refuse to vaccinate their children to sign a waiver indicating they are aware of the risks of refusal."

Note: Despite that vaccines have been linked to asthma, autism, diabetes, and sudden infant death syndrome, the author implies that parents are being overly theatrical about the shots.

Temporary ban on tetanus vaccination

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tetanus vaccineKozhikode, INDIA - Tetanus vaccination has been temporarily suspended following the death of Rupisha (15), daughter of Rajan of Kuttiyadi. A temporarily ban was put on the vaccine of Mumbai based Afkin Company which is suspected to be the cause of death of the girl. The health department ordered to suspend the vaccine used in the Vattoli sector.

Though the authorities stated that the death was not due to the tetanus vaccine, suspicion arose after temporarily suspending it. The sample of the medicine used for the tetanus injection at the Vattoli High School has been sent for analysis to the National Virology Institute at Hasoli in Himachal Pradesh. The decision to ban the injection temporarily was taken since it takes at least one month to get the report.

source - Keral Online 

First atherosclerosis vaccine: time for the count-down

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EVGNThe first vaccine against atherosclerosis is not far away in the future, according to Jan Nilsson, professor of Experimental Cardiology at Lunds Universitet in Malmö (Sweden) and EVGN member.

Human clinical trials are likely to begin at the end of next year: they will be aimed at verifying the safety of a preparation, still under investigation in a laboratory model, made of antibodies obtained against selected fragments of oxidized Low Density Lipoproteins, or oxLDLs. LDLs are the major component of the “bad cholesterol”: their accumulation in the arterial wall causes inflammation and is a key factor in the onset of atherosclerosis.

Intercell AGVienna (Austria), December 12, 2006 - Intercell AG (VSE, "ICLL") announced   today that it has completed a Phase II trial for its therapeutic Hepatitis C vaccine (IC41), where the vaccine was applied in combination with the standard Hepatitis C therapy (pegylated Interferon and Ribavirin - PegIFN- RBV) to patients infected with genotype 1. In the study, the vaccine  administration was bound to the schedule of the first patient trial  concluded in 2004 where route and frequency was still sub-optimal as  compared to the improved induction of pivotal T cells achieved in recently  concluded optimization trial.

In the current clinical trial, chronically infected Hepatitis C patients receiving standard therapy with PegIFN-RBV were enrolled in Germany, Austria and in the UK. 22 patients who had an early response at week 12 to standard therapy received vaccinations with IC41 as an add-on to standard therapy during the second half of their treatment (week 28 to 48). 

cytogenixHOUSTON--(BUSINESS WIRE)--CytoGenix (OTCBB:CYGX) has demonstrated that a synDNA™ vaccine against human immunodeficiency virus (HIV) has activity in monkeys. The study, conducted by Drs. Yin Chen and Frédéric Kendirgi at CytoGenix in collaboration with Lauren Hirao and Dr. David Weiner of the University of Pennsylvania, demonstrated that rhesus monkeys injected with a synDNA™ HIV vaccine mounted a significant cellular immune response. The study involved monkeys treated with a synDNA™ vaccine targeting two key viral proteins (gag and env) with interleukin-15 as an adjuvant.

"This observation, the first evidence of activity for a synDNA™ vaccine in non-human primates, is encouraging in that it shows that the synDNA™ vaccine is as effective as the DNA plasmid-based vaccine expressing the same antigen. The advantages of using DNA vaccines can be significantly extended using synDNA™ constructs and warrants further study to determine if the response is sufficient to protect against HIV infection,” stated David B. Weiner, Ph.D., an expert in DNA vaccination and a Professor of Pathology and Laboratory Medicine at the University of Pennsylvania School of Medicine.

Vaccination foes needling doctors

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vaccineCEDAR HILLS — Kara Davis is a staunch believer that you shouldn't give cocktails to babies, especially if a newborn is injected with one in the arm or foot before ever leaving the hospital.

But while Davis and a growing population of like-minded parents share their concerns out loud and on the Internet, others, including a majority of hospital doctors, say those "cocktails" — also known as vaccines — are crucial to saving lives.

Davis, 53, although not an expert, recently persuaded her son not to allow his newborn to receive a hepatitis B vaccine, which is normally administered within the baby's first 48 hours. Davis did allow her six children to be vaccinated when they were young, but that was before she started doing research that generated her ill feelings toward the common shots.

Large-scale HIV vaccine trials to start in SA

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HIV in Africa South Africa's first large-scale HIV vaccine efficacy trial will start next year at five clinical sites around the country.

Representatives from the HIV Vaccine Trials Network and the SA Aids Vaccine Initiative remained tight-lipped on details of the number of subjects and the locations of the trial sites, saying an announcement would be made in January.

But principal investigator at the Desmond Tutu HIV Centre at UCT, Linda-Gail Bekker, said the trials would test the efficacy of a subtype B HIV vaccine on South Africa's predominantly subtype C sufferers.

Each HIV-infected region of the world tends to have a predominant genetic subtype of the virus.

novartis Dec. 11 (Bloomberg) -- Novartis AG and Sanofi-Aventis SA are among drugmakers searching for new weapons against influenza viruses that evade protection from existing vaccines.

Each year, a new strain of the flu virus circles the globe and kills as many as a half million people annually worldwide. As the virus changes annually into forms that can circumvent the human immune system, scientists are seeking the first universal vaccine against the flu.

To defeat the flu, doctors will need new vaccines with unprecedented power, said Albert Osterhaus, the head of virology at Erasmus University in Rotterdam. Such a vaccine should be able to protect against many strains at once, including the avian form arising in Asia that threatens to become a pandemic deadly to tens of millions of people.

Vaccines for all H5N1 flu strains crucial

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H5N1 virusSINGAPORE, Dec 11 (Reuters) - The H5N1 bird flu virus has undergone many changes since making its first known jump into humans in 1997 and vaccines must be manufactured to fight its major strains, experts said on Monday.

While the virus remains largely a bird disease and does not infect people easily, the scientists at a conference on avian flu and other infectious diseases in Singapore warned against any complacency.

"What's worrying is there were more (human) cases in 2006 than 2004 and 2005. The problem is still with us," Robert Webster of the St Jude Children's Research Hospital in the United States told Reuters on the sidelines of the conference.

EU team develops new Alzheimer's vaccine from Austria

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affiris gmbhA recently approved project of the sixth EU Framework Programme – MimoVax – is focussing on a new target for an Alzheimer's vaccine. The project, coordinated by the Austrian company Affiris GmbH, centres on the use of immune reactions to combat previously overlooked forms of the beta-amyloid that cause Alzheimer's disease. It is being run by seven partner organisations from three countries and has received an exceptionally positive response from Brussels – as well as Euro 2.4 million in financial support.

The signing of the contract yesterday signalled the start of the active
phase of the EU MimoVax project. The project is part of the sixth EU
Framework Programme and is seeking to develop an Alzheimer's vaccine that targets specific types of beta-amyloid, the causative agent of Alzheimer's disease. 

A Campaign to Get a Disease Some Respect

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pneumonia vaccineOrin S. Levine may be heading for trouble with the Disney people.

At lectures, Dr. Levine, a pneumonia expert, uses a homemade slide that illustrates his predicament — Nemo, the little lost movie clownfish, next to the words “Finding Pneumo.”

Pneumonia is the biggest killer of the world’s children. It kills two million a year, more than AIDS, malaria and measles combined. It carries off many adult AIDS victims in poor countries and, even in rich ones, is the final shove through the gates of death for many of the elderly and sick.

If an avian flu pandemic emerges, pneumonia will stroll its killing fields, finishing off the wounded.

Yet it gets no respect.

In need of influenza vaccine?

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vaccinationIf you believe that you definately need an influenza vaccine, if you think that you can be protected by taking this shot, please read the article A Shot of Fear. It's worth every second of the time you will spend reading it.

Coley amends vaccine licence agreement with GlaxoSmithKline

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Coley Pharmaceutical GroupLONDON (AFX) - Coley Pharmaceutical Group Inc said it has amended some of its exclusive licences with GlaxoSmithKline for the use of Coley''s VaxImmune vaccine in the development of vaccines for infectious diseases.

This means that the US company can enter into non-exclusive VaxImmune agreements with other vaccine developers, but will see it taking a 17.4 mln usd reduction in potential milestone payments.

The amendments do not affect the GSK''s agreement with Coley on the use of VaxImmune in the development of cancer vaccines.

source - AFX 

‘WHO did not provide the required vaccine’

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WHOKARACHI - The officials of WHO had not supplied the required quantity of P3 vaccines due to which two more cases of polio in the province had resulted, said Sindh Secretary Health Dr Naushad Shiekh while speaking at the closing ceremony of a training workshop organised by the UNICEF and EPI Sindh Thursday.

He said that another case of polio had been registered in Kashmore and that he would ask the WHO authorities to transfer the officials responsible for the negligence.

He said that the P1 virus had been curbed in the area while P3 had migrated from Balochistan to Sindh. He appreciated this workshop and stressed the need for more such events.

source - Daily Times 

Jury still out on vaccines

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bird fluBANGKOK, 8 December (IRIN) - International pharmaceutical companies are racing to prepare, and obtain regulatory approval for, a vaccine to protect humans against avian influenza, but scientists do not know whether the vaccines under development would be able to protect people from a potential pandemic influenza strain, if it eventually emerges.

At present, 27 human clinical trials of vaccines against several different strains of avian influenza are under way by more than a dozen western drug companies, and so far, they have resulted in some immune response in those vaccinated.

However, the vaccines now in development are based on strains of the lethal H5N1 virus that have circulated in Vietnam, Indonesia and Turkey and influenzas are fast mutating viruses, so it is unclear whether vaccines developed from old strains will offer any protection against new strains.

Researchers trial diabetes vaccine

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diabetes vaccineThe trial of the vaccine has been launched this morning at the University of Melbourne, and the researchers say if all goes well it could be as significant as the recently approved vaccine for cervical cancer.

In Melbourne, Samantha Donovan reports.

SAMANTHA DONOVAN: Type 1 diabetes is the least common form of the disease. Only 10-15 per cent of people with diabetes have it. It's marked by an inability of the pancreas to produce insulin, because the cells that make insulin have been destroyed by the body's own immune system. That's usually triggered by something like a viral infection, which leads the immune system to destroy the cells. The insulin must be replaced by daily injections.

Unlike type 2 diabetes, which can be caused by poor diet and lack of exercise, the cause of type 1 diabetes isn't fully understood. But researchers say there's a strong family link.

Anti-Cervical Cancer Vaccine To Appear In Russia Next Year

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gardasilMerck & Co Company has developed a unique quadruple vaccine for preventing cervical cancer, which is expected to appear in Russia next year.
      
The vaccine is called "Gardasil" and is recommended for women aged between 9 and 26 as a preventive measure for malignant growths in womb neck, caused by human papilloma virus of types 6, 11, 16 and 18.
      
Gardasil is not a therapeutic agent, it is designed only for prevention, and thus the most effective way of application for this vaccine is vaccination of girls before they start their sexual life.

The Ethics and Politics of Compulsory HPV Vaccination

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HPV VaccinationJames Colgrove, Ph.D., M.P.H.

On September 12, 2006, 3 months after the Food and Drug Administrationlicensed a vaccine against human papillomavirus (HPV), Michiganlawmakers became the first in the United States to propose thatvaccination be compulsory for girls entering sixth grade. Parentswho objected would be able to opt out of the requirement underthe same provisions that apply to other vaccinations. The billpassed the state senate by an overwhelming margin a week laterand awaits consideration by the house. Other states are likelyto follow Michigan's lead.

The development of Gardasil, Merck's HPV vaccine, is of majorpublic health importance. The vaccine protects against fourstrains of HPV, the most common sexually transmitted diseasein the United States, including the two strains that cause mostcases of cervical cancer. More than 6 million people in thiscountry become infected with HPV every year, and nearly 10,000 women are diagnosed with cervical cancer. Because the vaccinehas the greatest benefit when it is given before a person becomessexually active, the Advisory Committee on Immunization Practicesof the Centers for Disease Control and Prevention recommendedthat it be given routinely to girls at 11 or 12 years of age;it is not yet approved for use in boys. The committee took noposition on whether vaccination should be required by law; suchpolicy decisions are made by individual states.

Panacea takes stake in Cambridge's new vaccine biz

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panacea biotecIndian pharma firm Panacea Biotec has taken a 10 percent stake in UK-based vaccine maker Cambridge Biostability (CBL) for £1.9m (€1.4m) under a new joint venture deal signed between the two companies.

This investment in gives Panacea more insight into CBL's stable liquid vaccine technology – which allows it to make vaccines stable without refrigeration –, its ongoing development and application in other vaccines and fields.

Panacea has also entered into an agreement to in-license Cambridge's technology for pentavalent and other vaccines used in the treatment of diphtheria, tetanus, whooping cough, hepatitis B and a virulent form of influenza.

Allergy Therapeutics says vaccine passes study

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allergy therapeutics LONDON, Dec 7 (Reuters) - Biotech group Allergy Therapeutics Plc <AGY.L> said on Thursday a Phase IIa study of its orally delivered hay fever vaccine showed it to be safe and effective.

The company said it was now confident that it can go ahead and develop the vaccine, which could be the first ever oral alternative to existing injectable treatments.

"These results provide the first indication that we have the technology to deliver a painless, injection-free potentially curative allergy treatment," Chief Executive Keith Carter said.

Analysts at Bridgewell -- which has a buy rating on the stock -- said that the statement was "good news that could uniquely position the drug against its competitors".

© Reuters 2006

Vaccination proof required to register beginning fall 2007

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stop!University of South Alabama - Beginning next fall all students must have proof of measles, mumps and rubella (MMR) vaccinations to attend the University.

"The student health center will be tracking it, and we will be holding up registration for those who have not provided verification," Beverly Kellen, practice director of Student Health, said.

In a step toward this new requirement, international students were required to submit MMR documentation as well as tuberculosis skin testing results this fall semester.

Vice President of Academic Affairs Patsy Covey said she believes the newly required immunizations are "more than justified."

When to use bird flu vaccine a "tricky issue"

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vaccination By Darren Schuettler BANGKOK (Reuters) - A vaccine against the killer H5N1 bird flu virus could be licensed for human use in a year, but when to use it is becoming a "tricky issue," a senior World Health Organization official said on Wednesday.

Drug companies are racing to find a cure for the avian influenza virus which has killed 154 people since 2003 and fanned fears of a global human pandemic. At least a dozen manufacturers have clinical trials underway or planned.

"We can expect that a year from now there would be vaccines against H5N1 influenza strains that would be licensed for human use," Marie-Paule Kieny, head of the WHO's Initiative for Vaccine Research, told reporters on the final day of a WHO vaccine conference in Bangkok.

Is it flu or malaria? New disease test has answer

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malaria WASHINGTON (Reuters) - A new diagnostic tool called a gene chip can tell with a single test if a patient has malaria, Ebola, influenza or a bacterial infection, researchers said on Wednesday.

The so-called GreeneChip can quickly diagnose infectious diseases caused by viruses, bacteria, fungi or parasites, using tissue, blood, urine and stool, the international team of researchers report in the journal Emerging Infectious Diseases.

So when a patient comes in with flu-like symptoms, such as fever, a sore throat, a cough and muscle aches, a doctor armed with such a chip can quickly tell if it is a dangerous strain of flu or a relatively harmless virus.

hepalifeBOSTON -- Independent Third-Party Analysis by World's Leading Provider of Integrated Preclinical Support Services Confirms HepaLife’s PBS-1 Cells Are Free from Exogenous Agents, Bacteria and Fungi

HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) today announced confirmation that the Company’s patented ‘PBS-1’ cells, under development for avian influenza vaccines, are free of pathogens, diseases, bacteria, and potentially harmful viruses. Pathogen-free cells are critical for the rapid development of novel, cell-culture based vaccine production to help protect against the spread of influenza viruses among humans, including potentially the high pathogenicity H5N1 avian flu virus.

Flu vaccination while pregnant does not help baby

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pregnant woman NEW YORK (Reuters Health) - Influenza vaccination for pregnant women expecting to deliver during influenza season does not seem to reduce the occurrence of respiratory illness in their newborn infant, new research suggests.

Influenza vaccination is currently recommended for children between 6 and 23 months of age. Vaccination in younger children has proven unsuccessful because the vaccine does not stimulate much of an immune response at that age, according to the report in the Archives of Pediatrics and Adolescent Medicine.

One solution to provide protection to these young infants might be to vaccinate the mother in hopes that protective antibodies would be passed to the developing baby while still in the womb. Whether this strategy actually helps prevent respiratory disease in the child is unclear.

dynavaxDynavax Technologies Corporation (Nasdaq: DVAX) announced today positive results from a Phase 2 trial comparing two different vaccination schedules of HEPLISAV, its hepatitis B virus (HBV) vaccine. The primary endpoint is comparative seroprotection after the second dose.

The data was reported today in a poster at the Canadian Immunization Conference in Winnipeg, Manitoba, Canada by Dr. Scott A. Halperin, Professor of Pediatrics and Microbiology and Immunology at Dalhousie University and Head of Pediatric Infectious Disease at the Halifax-based IWK Health Center.

Yellow Fever Vaccine: Adverse Events Appear Rare but Real

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mosquitoA highly effective live attenuated vaccine, developed more than 60 years ago from the 17D strain of yellow fever (YF) virus, has been a key tool in controlling this disease. The vaccine is given as part of national childhood immunization programs in some endemic areas, and many countries require travelers to provide proof of YF vaccination on entry. Three recent papers report adverse events following YF vaccination.

Researchers in the U.S. report 4 patients (63 and older) with multiple organ-system failure after vaccination with 17D-204 YF. Three died. Researchers found vaccine-related YF virus in the plasma and cerebrospinal fluid of 1 patient and YF antigen in the liver tissue of another. Convalescent sera (available for 2 patients) showed unusually high levels of antibodies.

ProMetic, Novartis to develop vaccine purification product

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novartisDec 4 (Reuters) - ProMetic Life Sciences Inc. (PLI.TO: Quote, Profile , Research) said its UK unit has entered into an agreement with Novartis (NVS.N: Quote, Profile , Research) to develop a synthetic-ligand affinity adsorbent for the purification of protein vaccines.

ProMetic will receive funding from Novartis to screen its chemical combinatorial libraries for ligands suitable for the purification of a new vaccine product developed by Novartis and currently undergoing clinical trials, it added. (Reporting by Sweta Singh in Bangalore)

© Reuters 2006

WHO launches new drive for malaria vaccine by 2015

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WHO BANGKOK (Reuters) - The World Health Organization launched a new global effort on Monday to find a vaccine against malaria, which infects up to 500 million people each year, and the donors to pay for it.

The Malaria Vaccine Technology Roadmap aims to develop and license a first generation vaccine by 2015 against the mosquito-borne disease which kills more than one million people a year, mainly African children.

"The Roadmap marks the first concerted global attempt at mapping out a shared plan of action for making a preventive malaria vaccine reality," Marie-Paule Kieny, a top WHO official, said on the sidelines of a vaccine conference in Bangkok.

Fury over mercury vaccine for Scots

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fluarixCHILDREN and pregnant women in Scotland are being given a flu vaccination that has poisonous mercury.

Two years ago, the UK Government announced the withdrawal of mercury-based thiomersal vaccinations after they were linked to autism.

But Scottish Health Minister Andy Kerr last week confirmed it is still being used in flu vaccines north of the Border.

In reply to a question from the SSP's Carolyn Leckie, Kerr said: "In this year's flu programme, there is only one vaccine (Fluarix) which contains thiomersal and could be offered to pregnant women and children."

bird fluJAKARTA, Dec. 2 (Xinhua) -- The world's poultry industry suffered approximately 2 billion U.S. dollars in losses due to the bird flu epidemic in the period of September 2005 to September 2006, an Indonesian official was quoted Saturday as saying.

"The global poultry industry has suffered direct losses of 2 billion dollars due to lower prices. This is equal to 14 percent of the total value of world trade," National Avian Influenza Control Commission chairman Bayu Krisnamurthi said, as quoted by major newspaper The Jakarta Post.

Apart from the direct financial losses, Bayu said, indirect losses had also been severe, including lower incomes for poultry breeders, lower poultry consumption and lower nutritional intake as a result of people's unwillingness to consume poultry products.

Bird flu vaccine leaves 10 Canadians dead

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tamiflu Two weeks ago, international warnings were posted of adverse reactions to the medication among children and youth. Health Canada didn't issue a public update about the flu drug until Wednesday.
Health Canada's bulletin said that since February 2000, 84 Canadians have had adverse reactions after taking the drug, including 10 who died and seven adults who reported "psychiatric adverse events."

This year alone there was 13 reported reactions to the drug including 3 women aged 95, 88 and 81 that died. Tamiflu is used to treat the flu and combat the H5N1 avian flu virus.

Health Canada spokesman Alastair Sinclair says there is no reason for Canadians to be worried.

source - Digital Journal 

viraxA small Australian biotech company has secured the help of the world's leading miners to fund clinical trials of its Aids vaccine in South Africa.

In the first programme of its kind, Virax, which is listed on the Australian stock exchange and plans to float on Aim next year, has set up a non-profit organisation for corporate donors with operations and interests in South Africa and other neighbouring countries, and whose workforces are affected by the disease.

Eight companies including Rio Tinto and BHP Billiton will fund the trials, expected to cost between $5m and $6m.

There are more than six million people with HIV/Aids in the country. The incidence of the disease varies - in KwaZulu-Natal, for example, up to 35% of the population is HIV positive, and 41% of those in the penal system have the virus.

Perth professor in HIV vaccine bid

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Simon MalalA Perth researcher playing a key role in the fight against HIV-AIDS says there could be a breakthrough in vaccines within 10 years.

Professor Simon Mallal leads a team of 42 scientists at a collaborative research centre in Perth who have already notched up a breakthrough in HIV-AIDS research.

In 2002, the team discovered that a person's genetics will determine how they will react to HIV and how they should be treated.

meningitisCANADA - Health officials in Toronto are issuing a warning to patrons of a particular bar after one customer died of meningitis C a few days after visiting the bar. The deceased, whose identity has not been revealed was a 23 year old man who present at the gay Crews & Tango Bar, at 508 Church St., on Nov. 17 and 18. Toronto Public Health is concerned that he might have spread the infection to any of the estimated 300 to 500 other customers present through sharing drinks, cigarettes or kissing.

Although his identity remains in the dark, a friend told the Toronto Times on condition of anonymity that the gay man was originally from St. Lucia. His relatives were immediately informed and offered vaccination. In fact, Toronto Public Health announced in a press conference that any patron of the bar who was present on those two days can – and must – get a free vaccine at the 519 Church Street Community Center between 3 and 7 pm today.

Why scientists are still years from a vaccine

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research The unique nature of HIV has hampered the search for an Aids vaccine and it remains a distant prospect, the world's leading experts say.

When American politicians announced the discovery of HIV in 1984, they predicted that a vaccine and a cure for Aids would be available within five years. It turned out to be a hopelessly optimistic assessment as the immense technical and scientific difficulties unfolded.

Nevertheless, the discovery of the virus led to important developments. The first was a blood test to determine whether someone was HIV positive. A global research effort into the genetics and biology of HIV led to a deeper understanding of the virus's modus operandi. This pointed to ways of sabotaging viral replication in infected patients.

russiaRUSSIA, December 1 (Itar-Tass) - Prosecutors in Russia's Stavropol territory opened a criminal case over the facts of allergic complications in children who have been inoculated against the flu.

Medical assistance has been rendered in the region to more than 70 children since the beginning of mass vaccination. Of those, 32 children were hospitalized with edemata, rash, palpitation and tachypnea, a regional prosecutor told.

In several cases reported in the regional center, the allergic reaction proved so severe that the children had to be taken to an intensive therapy ward.