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November 2006 Archives

November 30, 2006

Dynavax shares rocket on hepatitis B vaccine data

dynavaxSAN FRANCISCO (MarketWatch) -- Dynavax Technologies Corp. shares soared as much as 44% Wednesday to reach their highest level ever after the company said its experimental hepatitis B vaccine protected all of the patients it tested in a late-stage clinical trial.

Shares of the Berkeley, Calif.-based drugmaker (DVAX) were changing hands for $9.96 in afternoon trading, up $2.56 and off an earlier high of $10.66.

Dynavax said that after three doses, its Heplisav vaccine protected 100% of a "difficult-to-immunize" population of adults aged 40 to 70 years compared with GlaxoSmithKline PLC's (GSK) Engerix-B vaccine, which was found to protect 73.1% of such people. In those ranging from 56 to 70 years of age, Heplisav's rate of protection was similarily 100% vs. a 56.1% rate for Engerix-B.

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Rumors of Canada bird flu case false

bird flu TORONTO (Reuters) - Internet speculation over a potential human case of bird flu in the Canadian province of Quebec is untrue, health officials said on Wednesday.

"It's a false rumor," Dr. Patrick Dolce, head of infection control at the hospital in Rimouski, Quebec, told Reuters. "Everything is false; there is no patient, no nothing."

His remarks echoed those of Quebec Health Ministry spokeswoman Helene Gingras, who also said the rumors were "not true."

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Bird flu: S Korea slaughters dogs, cats, pigs, mice

south koreaBEIJING, Nov. 29 (Xinhuanet) -- South Korean quarantine officials in Iksan City on Tuesday began the slaughter of pigs and dogs although international health experts have questioned the necessity of killing non-poultry species to prevent the spread of bird flu.

But the officials insist the decision to slaughter pigs and dogs was not unusual and that the step has been taken in other countries without public knowledge.

Park Kyung-hee, an official at Iksan city hall, said Wednesday 426 pigs and four dogs have been killed along with 127,200 chickens and 6.8 million eggs.

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Federal Vaccination Plan Inadequate

vaccineA U.S. scientist is criticizing the effectiveness of a federal plan to vaccinate hospital healthcare workers against a threat of smallpox.

Temple University researchers who conducted the first metric analysis of the prophylactic health program say it fell short on several levels and raises questions about future preparedness.

In 2003, the Centers for Disease Control and Prevention asked each state to vaccinate at least 50 to 100 healthcare workers per hospital -- a number the government considered large enough to respond to a possible smallpox outbreak.

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Rich nations contribute $200 million for vaccine program

GAVINEW YORK - Some of the wealthy nations of the world are collectively donating $200 million to a project to fight diseases in poor countries.

The Global Alliance for Vaccines and Immunizations (GAVI), which has brought these nations together on a common platform, said Wednesday the fund will be used to help the poor countries around the world to receive vaccines that prevent diseases like rotavirus and pneumococcus in a timely manner.

The plan is to supply newly-licensed vaccines for preventable diseases to the developing nations avoiding the usual delay for these vaccines to reach these countries where these are required most.

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Govt to fund Gardasil vaccine

gardasil The World Today (interview)
Reporter: Gillian Bradford

ELEANOR HALL: After weeks of toing and froing, the Federal Government has announced it will now fund the cervical cancer vaccine, Gardasil, from next year.

Health Minister Tony Abbott initially said the vaccine couldn't be available until at least 2008, but under pressure from the Coalition's own backbench, the Prime Minister intervened to force a faster process.

The vaccine will be targeted at 12 and 13-year-old school girls and the Health Minister Tony Abbott says the Government has extracted the best price from the drug manufacturer after weeks of negotiation.

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November 29, 2006

Acambis requests meeting with US Health Department on smallpox vaccine

acambis LONDON (AFX) - Biotechnology company Acambis PLC confirmed that it has requested a meeting with the US Department of Health and Human Services (DHHS) to discuss its rationale for excluding Acambis from the ongoing Modified Vaccinia Ankara (MVA) procurement process.

Acambis is developing an investigational smallpox vaccine, ACAM2000.

DHHS determined that Acambis' technical proposal was no longer in the competitive range for award, and to-date, DHHS has not provided a specific reason for the decision.

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Italy - 27 percent of youth believe there's already AIDS vaccine

survey (AGI) - Rome, Nov 28 - 27pct of young people believe that there already is a vaccine against AIDS. 20pct are mistaken in how the HIV virus is spread. These figures were given by Prof. Fernando Aiuti, immunologist and Chairman of Anlaids, opening for the XX National Congress in Rome in the presence of Prof. Roberto Gallo, a world expert on the disease.

"There is no vaccine against AIDS, but there are some candidates which could become it, though it is not yet known which ones will work," he added. "Condoms should be placed in selling machines in high schools or nearby. Joints should not be allowed," added Prof. Aiuti, recalling data given by the Italian National Health Institute (ISS), which count one infection every two hours.

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AVAX tests metastatic melanoma vaccine

avaxPHILADELPHIA, Nov. 29 (UPI) -- U.S. firm AVAX Technologies said Wednesday it is cleared to launch a phase 3 study of its metastatic melanoma vaccine, M-Vax.

The trial will enroll as many as 387 patients with stage IV melanoma at sites in the United States, Europe and Australia. Patients will be randomized in a 2-1 ratio to receive either M-Vax or placebo.

The study will measure best overall anti-tumor response rate and the percentage of patients surviving two years, AVAX said.

Continue reading "AVAX tests metastatic melanoma vaccine" »

Bird Flu Vaccines Lose Their Strength

avian fluThe 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.)

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New information regarding Tamiflu

tamifluOTTAWA - Health Canada is informing Canadians of international reports of hallucinations and abnormal behaviour, including self harm, in patients taking the antiviral drug Tamiflu. These reports include children and teenagers, primarily from Japan. While the connection with the drug in these cases has not yet been proven, high fever or other complications of influenza can affect mental state, which in turn can lead to abnormal behaviour. Health Canada has not received any such reports in Canada and is continuing to actively monitor adverse events reported for Tamiflu.

As of November 11, 2006, there have been 84 reports of adverse events occurring in Canadian patients using Tamiflu, including 10 which reported a fatal outcome. A causal relationship has not been confirmed in these cases. There have been seven Canadian reports of psychiatric adverse events, suspected by those reporting the events, due to Tamiflu, most involving elderly patients. There have been no Canadian reports of abnormal behaviour or deaths involving children.

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November 27, 2006

ICT Completes Licensing Transaction for Cancer Vaccine Therapy Technology

cancer vaccineImmunoCellular Therapeutics, Ltd., which was formerly known as Optical Molecular Imaging, Inc. ("ICT"), announced today that it has entered into an exclusive, worldwide license agreement with Cedars-Sinai Medical Center covering Cedars-Sinai's technology for cellular therapies, including dendritic cell-based vaccines for brain tumors and other cancers, as well as other neurodegenerative disorders. The technology is covered by patent applications that have been filed in the United States.

Dendritic cell-based vaccines may bolster the body's natural tendency to defend itself against various forms of cancer. ICT's first product candidate will be a vaccine for treating malignant brain tumors. The high rate of mortality of patients diagnosed with brain cancers and in particular with glioblastoma multiforme (the most lethal form) is driving the scientific community to develop improved treatments to increase the survival time and enhance the quality of life of patients. More than 17,000 cases of glioblastoma are diagnosed each year in the United States. There currently is no satisfactory treatment and two-year survival rates are only in the range of 26%.

Continue reading "ICT Completes Licensing Transaction for Cancer Vaccine Therapy Technology" »

European Study Looks at Safety, Efficacy of Reformulated Live Attenuated Vaccine in Asthmatic Children

asthma kidThe authors note that inactivated, trivalent, injectable influenza vaccine (injectable vaccine) is the only formulation approved for use in high-risk children, owing in part to concerns that live attenuated influenza vaccine (given nasally) might worsen asthma symptoms in asthmatics. This paper reports the results of an efficacy and safety trial of a reformulated live attenuated vaccine (live vaccine).

Subjects were European children aged 6-17 years with asthma enrolled during the 2002-2003 influenza season. The study excluded children with many other chronic diseases and children who were immune compromised. For 15 days after vaccination (1:1 randomization to live or injectable vaccine), parents recorded daily asthma symptom scores and peak expiratory flow measurements. In addition, the parents recorded nocturnal symptoms and asthma medication use. After the 15 days of parental log completion, investigators contacted subjects weekly to determine if they required revisit for symptoms. Any subject who developed fever or upper or lower respiratory illness was seen for office visit and nasal swab for influenza culture. The subjects were also monitored for side effects and other unscheduled medical visits. The study enrolled 2229 subjects, with 1114 receiving live vaccine.

Continue reading "European Study Looks at Safety, Efficacy of Reformulated Live Attenuated Vaccine in Asthmatic Children" »

New worry: Too much flu vaccine

vaccine shotThis is the first time someone admits that there's too much flu shots manufactured. If you choose to believe everything that media, CDC and administration tell you, then I let you read the article. However, if you believe that too much manufactured vaccine shots means only one thing - mass pressure from media, doctors, administration to make sure that all this vaccine is used (i.e. paid by administrations or the customers, which means that the pharma giants will have their profits secured), then you can skip the article. It's up to you.

Two years ago, a manufacturing glitch led to shortages of flu vaccine in the United States, prompting long lines - and occasionally angry customers - at the few flu-shot clinics that were able to go off as scheduled.

This year, according to the Centers for Disease Control and Prevention, there's potential for a problem of a different sort - too many doses of the vaccine.

"It is quite a turnaround from 2004," said Richard McGarvey, spokesman for the Pennsylvania Department of Health. "And I think the concerns on the part of the CDC are legitimate."

Continue reading "New worry: Too much flu vaccine" »

South Korea confirms outbreak of H5N1 bird flu

bird fluSEOUL - South Korea said on Saturday a bird flu outbreak at a poultry farm was caused by the highly virulent H5N1 strain of the virus, in the country's first case for three years of the infection that can kill humans.

The Agriculture Ministry said earlier this week it suspected bird flu had killed 6,000 chickens at a farm in the southwest of the country that lies on a path for migratory birds.

"It is the H5N1 strain," a ministry official said by telephone on Saturday, after test results.

Continue reading "South Korea confirms outbreak of H5N1 bird flu" »

Taking a global shot

research in indiaWhile there is no doubt that biotechnology is unlocking a new vista for tackling various complex problems of world food security, human diseases, etc, it is the rapid progress being seen by India in order to emerge as a significant player in the global biotech arena that is drawing global attention. Early this month, it caught the attention of French biotech billionaire Alain Merieux —whose father Marcel Merieux was a former laboratory aide to Louis Pasteur—when his vaccine behemoth Merieux Alliance (2005 turnover: 1.128 billion Euros) acquired a majority stake in Hyderabad-based bio-pharmaceuti cals company Shantha Biotechnics. The Indian company specialises in the development and production of vaccines, therapeutic proteins and monoclonal antibodies.

In association with Shantha Biotechnics, the European company, which has a strong presence in preventive medicine, aims to develop a global strategy for managing the infectious diseases segment. Specifically, it will have access to the Indian company’s indigenous proprietary R&D and a branded product base in recombinants.

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November 25, 2006

Vaccination - The Hidden Truth

vaccination - the hidden truthThis is the shocking but extremely informative video documentary “Vaccination - The Hidden Truth” (1998) where fifteen people, including Dr. Viera Scheibner (a PhD researcher), five medical doctors, other researchers, reveal what is really going on in relation to illness and vaccines. Ironically, the important facts come from the orthodox medicine’s own peer-reviewed research. With so much government and medical promotion of vaccination for prevention of disease, the video is clearly devoted to presenting the other side of the issue that parents and others are not being told.

The result is a damning account of the ineffectiveness of vaccines and their often harmful effects. It declares that parents are not being told the truth by the media, the Health Department and the medical establishment, with a medical doctor, Dr. Mark Donohoe, confessing that “It is a problem for me that I am part of a profession that is systematically lying to people?”.

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Baxter signs Austrian flu vaccine contract

baxterBaxter has been contracted by the Austrian government to supply 16m doses of pre-pandemic influenza vaccine - enough to vaccinate the country's entire population.

Pandemic influenza occurs when a new virus emerges that is easily transmitted among humans and causes serious illness, which can result in a worldwide outbreak of disease, or pandemic.

Avian influenza, or bird flu, does not normally infect humans, but there have been several examples in the last few years of transmission to people, leading to fears of a strain with the potential to lead to a pandemic.

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November 23, 2006

South Korea suspects bird flu after thousands of chickens die

bird fluSEOUL : South Korea Thursday reported a possible bird flu outbreak after 6,000 chickens on one farm died in three days - the first suspected cases since the country declared itself free of the disease last December.

The agriculture ministry ordered the culling of the remaining 6,000 birds on the farm in the southern city of Iksan, a major centre for the country's poultry industry.

It sent an emergency supply of Tamiflu for 50 people and influenza vaccines for another 300.

Kim Chang-Seob, the ministry's chief veterinary officer, said the government received word of the outbreak Wednesday, and from the large number of deaths it suspected the virus may be a virulent strain.

Continue reading "South Korea suspects bird flu after thousands of chickens die" »

Vietnam lab says it has bird flu vaccine

chicken eggsHANOI - A Vietnamese laboratory said Thursday it managed to produce a bird flu vaccine for humans that has now to be validated by the Ministry of Health before a possible test.

Scientists at the Nha Trang Institute of Vaccines and Biological Products, in central Khanh Hoa province, had produced 5,000 doses of the vaccine against the deadly H5N1 virus, said its director, Dr Le Van Hiep.

"We produced the vaccine via a technology of transplant on chicken eggs. It was tested successfully on mice and roosters," he said.

Continue reading "Vietnam lab says it has bird flu vaccine" »

Bird flu vaccine ban to get rethink

avian flu virusBANGKOK - Vaccination of fowl against bird flu has been tabled for consideration again as part of the government's bird flu control policies amid warnings by experts about the country's lack of readiness to handle such a programme.

Agriculture and Cooperatives Minister Thira Sutabutra said yesterday the ministry would reconsider the pros and cons of using the vaccine in fowl as one of the counter-measures against bird flu at a meeting next week to be joined by experts from both state and private agencies.

If vaccine use proves beneficial and effective, the meeting's conclusions will then be forwarded to the government for a change in policy, he said.

Continue reading "Bird flu vaccine ban to get rethink" »

November 22, 2006

Cervical cancer vaccine's rival 'lasts longer'. Or so GSK claims.

GSKTHE cervical cancer vaccine being held out as an alternative to Gardasil may offer much longer-lasting protection, according to its maker.

Drug giant GlaxoSmithKline, which is trying to stop the Government agreeing to a vaccination program using only Gardasil, says its treatment, Cervarix, has the strength to protect women vaccinated at school until they turn 55.

Continue reading "Cervical cancer vaccine's rival 'lasts longer'. Or so GSK claims." »

Flu Vaccine Withdrawn on Strong Allergy

Gennady Onishchenko didn’t suffer from allergic response to Grippol, but the response of the patients made him recall a million doses of vaccine (courtesy ITAR/TASS)Federal Service on Consumer Rights Supervision has withdrawn six series of Grippol flu vaccine. Roughly a million doses are being recalled from circulation on 68 cases of strong allergic response in nine regions of Russia. In two regions, the authorities independently stopped vaccination. The loss of vaccine producer, federal-run Microgen, is estimated at $2 million.

Chief of Federal Service on Consumer Rights Supervision (Rospotrebnadzor), Gennady Onishchenko, announced yesterday the withdrawal of six series of Grippol vaccine on strong allergic response to the preparation. Sixty eight people in nine regions of Russia suffered from it as of yesterday. All victims had laryngeal edema, palpitation and breathing troubles.

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November 21, 2006

Experts call for better flu plans

stupid faceAnother news just hit all news agencies' websites. The only question that I have is how much did these experts get paid to voice their message that can lead to major fear and panic. How much did GSK and Roche pay? And why the normal influenza vaccines can be helpful against bird-flu virus?! What is the reason of this move? Do GSK and Roche need to flush their stock of vaccines because their expiration date is getting close, again?

Leading scientists say the UK government is failing to take advantage of scientific developments in the fight to prevent a flu pandemic.

A Royal Society and Academy of Medical Sciences report says more than one anti-viral drug should be stockpiled.

It warns the H5N1 virus can develop resistance to Tamiflu, and says the drug Relenza should also be stockpiled. 

Continue reading "Experts call for better flu plans" »

Vietnam completes bird flu vaccination in 2006

bird fluHANOI, Nov. 21 (Xinhua) -- Vietnam has vaccinated 163.4 million fowls in the second batch of bird flu vaccination, fundamentally finishing its two-phase vaccination plan for 2006, according to a local veterinary agency on Tuesday.

The second batch of vaccination, which is underway in 63 out of64 cities and provinces nationwide, is scheduled to be complete by late this month, said the Department of Animal Health under the country's Ministry of Agriculture and Rural Development.

Vietnam, to prevent reoccurrence of bird flu outbreaks, is intensifying fights against fowl smuggling, and monitoring poultry transport and trade.

Continue reading "Vietnam completes bird flu vaccination in 2006" »

ALK-Abello launches pollen allergy vaccine

alk-abelloHORSHOLM, Denmark, Nov. 20 (UPI) -- ALK-Abello said Monday it launched its tablet-based vaccine against grass pollen allergy, Grazax, in Germany.

"The launch of Grazax is the culmination of years of research and development at ALK-Abello," said Jens Bager, ALK-Abello's chief executive officer. "With this convenient tablet for home treatment, many more patients throughout Europe can be offered a treatment that targets the cause of their allergy, cuts the symptoms and improves their quality of life."

The company said it plans to introduce the vaccine in other, unspecified European markets.

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November 19, 2006

Common Misconceptions About the Flu

fluAnother article by Steven Woloshin, Lisa Schwartz and Gilbert Welch, a must read, as always.

Here we highlight a few common misconceptions that we hope will make you better informed this flu season.

36,000 Americans die of flu-related illnesses during a typical flu season

CLOSER LOOK: It is very hard to know how many people die from any given disease because there is often much uncertainty in determining the cause of death. This is particularly true for the flu. That's because it shares symptoms with so many other diseases, and because people most likely to die a flu-related death are also at high risk for many other causes of death. Read More: Research-Basics: Understanding How Big a Risk Is

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How Well Does the Vaccine Work in the Elderly?