December 20, 2007

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Today's Top Stories
Gene-mapping unlocks new generation of vaccines
States ignoring call to plan emergency vaccine distribution
Acambis takes aim at proof-of-concept vaccine trial
Human protective system disables HIV vaccines

Also Noted: Spotlight On... Analysts ponder Cervarix delay; Gates Foundation fuels malaria programs; Recall spurs CDC to urge deferral of Hib vaccine booster; researchers on track of future vaccine; and much more...

 

Welcome to the inaugural issue of FierceVaccines.  

Every week, a team of writers will examine the people, trends and research projects making news in the vaccine field. Drawing on reports from around the globe, our newsletter aims to provide authoritative insight on a fast-moving industry. Designed to appeal to industry insiders with a compelling and quick read, you'll get the latest analysis of the field and a look at the innovative technology that is revolutionizing the development and production of vaccines. And we'll offer original coverage, with interviews and profiles of the people on the cutting edge of the industry.

To accommodate the holiday schedule, we'll be taking a break after this inaugural issue and returning on a weekly schedule in early January. Everyone subscribing to one of our Life Sciences publications--FierceBiotech, FiercePharma and FierceBioResearcher--will get the first two issues of 2008. Anyone who wants to receive it after that will have to subscribe, which is free. We'd like to thank Covance, which is sponsoring FierceVaccines. And we'd love to hear any suggestions you may have for our new newsletter. - John Carroll, Editor-in-Chief



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Gene-mapping unlocks new generation of vaccines
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Researchers at Novartis have made significant headway using gene-mapping tools to develop new vaccines. Mapping the genes in bacterium that cause meningitis B fostered a development program for a new vaccine that has produced some convincing early data. Up to 90 percent of the 150 babies inoculated with the vaccine developed a strong level of defense against three strains of meningitis B. Novartis' vaccine chief--Rino Rappuoli (photo)--has blueprinted a mid-stage trial for the vaccine and says that it could hit the market as early as 2010. Wunderkind geneticist Craig Venter (photo), who helped crack the genetics of meningitis, calls the advance "incredibly exciting," adding that this could be a model approach that others in the vaccine business can follow as well.

Intercell and Merck, meanwhile, have been developing vaccines for staph infections that have been derived from their own gene-mapping projects. And GSK has early-stage programs for vaccines covering streptococcus and the bacterium that causes meningitis B. With the growing pressure to produce new therapies to replace the blockbusters losing patent protection, you can expect to see big pharma continuing to play a leading role here.

"Getting these hints from genetics isn't really close to producing a drug," says David Goldstein (pictured), a geneticist and director of Duke University's Center for Population Genomics and Pharmacogenetics. He and others say the human genome is helping scientists understand diseases better and should lead to new drugs down the road.

- read the article on gene mapping from The Wall Street Journal

Related Articles:
Venter's latest revelation could save the world. Report
Ventner team gets clearer picture of full genome. Report
Intercell touts early success of bacterial vaccine. Report

States ignoring call to plan emergency vaccine distribution
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After being urged for years to blueprint plans for distributing emergency vaccines and drugs to deal with a potential pandemic, 13 states still aren't ready, according to the Trust for America's Health. Seven states--Colorado, Connecticut, Florida, Massachusetts, according to the fifth annual report on pandemic preparedness from the Trust for Mississippi, North Dakota and Rhode Island--have also decided against buying antivirals from the country's strategic stockpile. The states that are doing the best job: Illinois, Kentucky, Nebraska, New Jersey, Pennsylvania, Tennessee and Virginia. The key concern, according to the report, is that an uneven response to a flu pandemic would make some regions of the country particularly vulnerable, adding to everyone's risk of a major outbreak. And there's widespread public distrust that local authorities are able to deal with any kind of natural disaster.

For now, the U.S. government is stockpiling the pre-pandemic vaccine. "It's a vaccine that would work against H5N1 as it is currently circulating," Jeff Levi, the executive director of the trust, tells FierceVaccines. "Unfortunately, the dosage required is very, very high to get the immune response you would want. Adjuvant experiments have reduced the dosage requirements and may help make the vaccine effective against different strains of the virus."

The threat of a bird flu pandemic has triggered a variety of programs to develop new flu vaccines that would be more effective at blocking an outbreak.

- see the release on their findings
- here's the report on pandemic preparedness

Related Articles:
HHS awards H5N1 contracts. Report
HHS issues contracts for pandemic vaccine research. Report


Acambis takes aim at proof-of-concept vaccine trial
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Taking aim at the leading cause of hospital-acquired diarrhea, Clostridium difficile, Acambis has completed its prep work for a proof-of-concept trial late next year. During Phase I testing involving about 200 subjects, the vaccine generated immune response to the two toxins that cause C. difficile-associated disease, which costs European and U.S. hospitals some $5 billion annually.

Since then, the company has developed new, better-stabilized formulations for the vaccine. One of these will be selected for use in the next trial. "We have previously shown that this vaccine can achieve seroconversion rates of up to 100 percent," says Dr. Michael Watson, head of R&D at Acambis. "We are focused on getting our vaccine to proof-of-concept as quickly as possible."

- read the report from ShareCast
- get more from Hemscott

Related Articles:
Sanofi buys into Acambis' West Nile vaccine program. Report
Acambis' universal vaccine begins human clinical trials. Report
Acambis shares plunge after U.S. nixes contract. Report
Acambis completes vaccine BLA. Report
Acambis researching single-shot solution to flu. Report


Human protective system disables HIV vaccines
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Scientists from the University of Missouri and Imperial College London have found evidence suggesting why vaccines directed against the virus that causes AIDS and many cancers don't work. In research spanning more than a decade, Gary Clark, associate professor of Obstetrics, Gynecology and Women's Health in the MU School of Medicine, and Anne Dell, an investigator at Imperial College London, found that HIV, aggressive cancer cells, H. pylori, and parasitic worms known as schistosomes carry the same carbohydrate sequences as many proteins produced in human sperm.

"It's our major Achilles heel," says Clark. "Reproduction is required for the survival of our species. Therefore we are 'hard-wired' to protect our sperm and eggs as well as our unborn babies from any type of immune response. Unfortunately, our results suggest that many pathogens and tumor cells also have integrated themselves into this protective system, thus enabling them to resist the human immune response."

- check out the release for more info


ALSO NOTED

TODAY'S SPOTLIGHT... Analysts ponder Cervarix delay
There's been a considerable number of post mortems on the FDA's decision to delay a decision on GlaxoSmithKlines's Cervarix, a cervical cancer vaccine that is already approved in Europe and has the capacity to become a blockbuster therapy in competition with Merck's Gardasil. Motley Fool's Brian Lawler is betting that the European Medicine Agency's green light indicates only a small hold-up for Cervarix. Glaxo added considerably to the uncertainty around the delay when it declined to spell out exactly what the regulators want to know. In the meantime, though, Gardasil has gained even more time to establish itself as the leader in the HPV vaccine race. Article

Editorial: The recent failure of Merck's experimental HIV vaccine was a major setback, writes Seth Berkley, CEO of the International AIDS Vaccine Initiative, but 2007 still big gains in the struggle to advance a new vaccine. With a renewed commitment, a vaccine that can rid the world of AIDS is a real possibility. And the $900 million a year being spent on the research effort is well worth the money. Report

> Fueled by a billion dollars in grant money from the Gates Foundation, researchers have been studying new vaccines that could halt the new surge of malaria around the world. Malaria kills a million people a year, mostly children. Report

> After Merck's recall last week of 1.2 million doses of Hib vaccine, the CDC is urging doctors to defer booster shots of the vaccine for infants aged 12 to 15 months. Report

> Medical researchers at Lund University are on the track of a possible future vaccine. The method they are using may also be of significance for other new vaccines. Release

> TechJournalSouth profiles Pique Therapeutics, which is developing new cancer vaccines. In a small Phase I trial, median survival times in non small cell lung cancer more than doubled. Story

> In a matter of days, New Jersey will become the first state in the country to require that all schoolchildren be given a flu shot, and the mandate has focused renewed attention on the controversy regarding thimerosal. Report

> A group of lawmakers including Senator Ted Kennedy introduced a package of bills that will help to ensure that adults have access to life-saving vaccines. These vaccines include the new vaccine against the virus that causes cervical cancer as well as vaccines against seasonal influenza, certain pneumonias, Hepatitis B, and shingles, among others. Report

> Bioniche Life Sciences snagged a 10 million government loan to manufacture a cattle vaccine to ward off E. coli. Report

> The UK is ordering 22.5 million doses of the bluetongue vaccine for farmers. Article

> Novavax announced favorable results from preclinical studies of its recombinant trivalent seasonal influenza virus-like particle vaccine. Report

> Maxygen has agreed to transfer a portfolio of preclinical dengue antigens to Sanofi Pasteur for use developing a second generation vaccine. Maxygen stands to gain up to $24.5 million in the deal. The dengue virus afflicts more than 50 million people worldwide. Report

> Genocea Biosciences, a vaccine discovery and development company, announced the license to 14 antigens to Chlamydia trachomatis discovered in the lab of Dr. Darren Higgins, Associate Professor of Microbiology and Molecular Genetics at Harvard Medical School and scientific founder of Genocea. Release

> The New York Times profiles Sanaria, a Maryland vaccines company that is taking a cue from Louis Pasteur in developing a new way to combat malaria. Article

> The National Research Council of Thailand has awarded special recognition to a study of an experimental vaccine for dengue fever. Report

> A virulent strain of flu virus has infected more than a thousand people in the U.S., killing at least 10 of them. Report

And Finally… Many adults should get a variety of protective adult vaccines, but many often forget the advice or find that their doctor doesn't carry them on hand. Article

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