German doctors boycot adjuvanted vaccines.

[Snowy Owl]

German doctors boycott Glaxo-Smith-Kline adjuvanted vaccines.

http://www.rp-online.de/public/artic...mstritten.html


Photo: RP


NRW-Ärzte boykottieren
Schweinegrippe-Impfung umstritten

OF JÜRGEN STICK - last updates: 01.10.2009 - 20:34 Duesseldorf (RP). In North-Rhine/Westphalia is to be probably begun on 26 October with the inoculation against the H1N1-Virus. When first are member of the health service such as physicians, practice coworker, care forces and receive policeman the vaccine. But many want to boycott the inoculation.
More to the topic
Pig flu: Employees must know that



Michael Blondin (large picture) is a general physician. In its practice in Neukirchen Vluyn he inoculates daily many patients against flu. Like the other family doctors in North-Rhine/Westphalia also he was asked by the health authorities whether he makes his practice available as base for at the end of of October inoculation beginning against pig flu. “We go through there not”, say the physician. “And of the coworkers in our practice also nobody can be inoculated.”
With its attitude Blondin does not stand alone. Thus the Krefelder work physician center, which cares for numerous enterprises and nursing facilities in the region, communicated its customer that it will not take part in the inoculation. It is not so far well-known “, which is contained in the vaccine.




Carrier materials are added to the vaccine, which well-known-prove strong side effects release, like local reactions, pain, inflammations and still worse inoculation damage ", so the leading lady doctor of the work physician center. Them become “, their coworkers and also otherwise nobody with the present vaccine inoculate themselves”, write them. Angelika Hauser, chairman of the association of physicians Hartmann federation in North-Rhine/Westphalia, confirms that many of its colleagues do not think anything from the vaccination campaign: “Many think that the illness is simply not so dangerous.”

RKI and WHO recommend inoculation

With their inoculation impfverweigerung the medical profession and practice member act against a recommendation of the Robert Koch Institute, which are responsible in Germany for the fight against infections, and the Paul Ehrlich institute, which control the permission of drugs. Also the World Health Organization expressed itself for an inoculation. A statement of the constant inoculation commission in Germany is expected for the next days.
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Pig flu: Thus the companies ensure forwards



It is considered as safe that first in a first wave as much as possible coworkers of the health service are to be inoculated with patient contact. But so far the disease symptoms run mildly let the inoculation readiness shrink: With 20 \ x0e648 announced cases in Germany there was so far only one death, with which the pig flu virus was along also H1N1. The number of the new infections per week decreased/went back from 3300 at the end of of July on 749 at the end of of Septembers.
In addition warnings of the “drug telegram” come. Its publisher Wolfgang Becker Brüser warns of amplifier materials (Adjuvantien), which are contained in the vaccine. These preparations were not tested extensively enough. Side effects like life-threatening immune reactions are not to be excluded. Becker Brüser: “We experience a full-scale test at the German population.” From the medical profession it received much agreement.
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A billion into the sand set?

“If physicians against an inoculation express themselves, that negative effects on the inoculation readiness of the population to have”, fear Susanne Glasmacher of the Robert Koch Institute in Berlin. Also Leonard Hansen, chairman of the under health insurance combination (KV) north Rhine, considers a failure of the vaccination campaign possible: “It is not to be excluded that we set a billion euros into the sand.”

The physicians would stand before splits between a Dramatisierung and a minimization of the pig flu. Canada, UK,

On the one hand the illness is most sticking on, on the other hand is so mild the symptoms that probably already many are gotten sick with the new influenza form, without knowing it. Nevertheless Hansen uses itself for an inoculation. “One must weigh use and risks against each other here.” The danger of side effects is not larger than with each other inoculation also. Finally it must be counted on the fact that the virus mutates.
Also the European Commission shows up anxiously: “Europe threatens a second flu wave with more deaths”, says commissioner Androulla Vassiliou in an interview. Humans would have to protect themselves against infections. So far according to data of the KV-Nordrhein 4000 family doctor practices explained themselves ready to support the inoculation in their practice. Michael Blondin does not belong to. He says: “For high-speed shots I am not available.”

[Emily]

Adjuvant White Paper, 2002

http://www.antigenics.com/whitepaper..._adjuvant.html
"The vaccine market is going to explode.

And when it does, it will be in large part due to the addition of a set of essential but unsung immunological tools called adjuvants. These immune enhancers will be vital components in making new vaccine types viable, making old ones more efficacious, and making those that are expensive to manufacture or in scarce supply go further.

A new generation of vaccines is being brought into being by giants like GlaxoSmithKline, Merck and Wyeth, says Garo Armen, PhD, CEO of New York City-based biotech Antigenics Inc. All three pharmaceutical houses are moving vaccines for a large number of indications containing Antigenics’ powerful new adjuvant, QS-21™, toward or through clinical trials. “With a successful assault on such major diseases as AIDS, most hepatitis forms, and herpes, the market for prophylactic vaccines could easily double by the end of this decade,” Armen says. “And the total size of the vaccine market theoretically could be as large as the entire pharmaceutical market is today, because most diseases can theoretically be treated with therapeutic vaccines, which harness the immune system to cure — rather than prevent — illnesses.”

Vaccinology has expanded beyond its traditional mainstays — attenuated or killed microorganisms — to the likes of recombinant proteins and glycoproteins, synthetic peptides, and conjugate vaccines, in which relatively nonimmunogenic, carbohydrate-based antigens are tethered to strongly immunogenic carrier proteins. But paradoxically, the new, pared down vaccines may become less intrinsically immunogenic, even as they become safer and more precisely targeted. This is because although they contain antigens that tell the immune system’s warriors and weaponry exactly what to attack, they may lack other components that kick the immune system’s logistical support machinery into higher gear.

Enter the adjuvant: a substance that, although not necessarily eliciting an immune response itself, improves the immune response to a co-administered antigen. Adjuvants can work in many ways: raising antibody titers, enhancing mucosal immune responses, or making better cell responses. Considering that a vaccine may spend close to 20 years in development, research and development (R&D) expenses dwarf other aspects of its cost structure. So an adjuvant doesn’t add much to the cost of a vaccine — but it can add immensely to its potency. Indeed, experimental vaccines often just won’t work without one.

Clinical immunologist and public health specialist Bob Edelman, MD, a professor of medicine and pediatrics at the University of Maryland, says an ideal adjuvant would open up new worlds of prevention and treatment: “It might make for an effective vaccine against malaria or HIV. We could stop with those two.” But his list also includes autoimmune diseases and a variety of cancers.

A superior adjuvant might also extend the benefits of existing vaccines to poor responders such as older or immunocompromised people. An adjuvant that rendered lower doses more effective, moreover, would allow for cheaper vaccines in cases in which the antigen is expensive to produce (a recombinant protein, for example). It could also stretch supplies in a hurry during an epidemic or after a bioterrorist incident. Dose sparing, as this property is called, is of increasing importance in the development of conjugate vaccines, in which difficult chemistry limits antigen dose size, especially when several antigens must be packed into a single shot.

Adjuvant activity has been found in numerous natural products through serendipity and trial and error. One of the very first papers on the subject was written in 1925 by a French researcher who learned he could enhance immunogenicity by injecting crude products such as tapioca or bread crumbs, and chemical substances such as lecithin or saponins (soap-like substances isolated from plants).

That early discovery presaged one of the most promising new adjuvants in the burgeoning arsenal of vaccinology. In 1986, biochemist Charlotte Kensil, PhD, now vice president for research operations and strategy at Antigenics, came to work for what was then Cambridge Biosciences, taking on the analysis of a complex saponin extract from the bark of Quillaja saponaria (a South American tree) with which the company hoped to adjuvant its vaccine for feline leukemia virus (FeLV). The extract was very effective, but toxic. Looking to purify out the toxicity using high-performance liquid chromatography (HPLC), Kensil identified 23 separate peaks, or components, and set about characterizing them. Several proved irrelevant, others toxic. The 21st HPLC peak, however, yielded a saponin that was both active and nontoxic.

This substance — actually a mixture of two compounds that co-exist in a relatively constant ratio and are virtually identical in both structure and activity — was christened QS-21 (Kensil is one of the two inventors on the patent); by 1990, it was in a successfully licensed FeLV vaccine in the United States and Europe. In a restructuring move about seven years ago, Cambridge Bioscience spun off Aquila Biopharmaceuticals, which retained the rights to QS-21. Long on intellectual property but short on cash, Aquila Biopharmaceuticals was in turn bought by Antigenics at the end of 2000.

Adjuvants on Trial

These days, the US Food and Drug Administration (FDA), rather than grant blanket approval for an adjuvant itself, reviews each vaccine-adjuvant combination as a separate package. The exception is alum, the only currently approved adjuvant per se. Alum — a generic term for salts of aluminum, chiefly aluminum hydroxide and aluminum phosphate — was first employed in 1926 and was effectively grandfathered in when the FDA first assumed new drug approval authority in 1938.

But Is Alum Worth Its Salt?

Oldest doesn’t always mean best, says cancer vaccine specialist Phil Livingston, MD, attending physician at Memorial Sloan-Kettering Cancer Center and professor of medicine at Cornell University’s medical school. In fact, he says, “as adjuvants go, alum’s the weakest.”

On the other hand, “Billions of doses of alum have been administered — not millions, billions — and it has a track record of being generally safe,” says the University of Maryland’s Edelman. “As a result of this long experience, we’ve grown to have a warm, fuzzy feeling about it, and it’s become the benchmark adjuvant against which all others are now tested.”

.......

Edelman cautions: “You’re going to find article after article saying that ‘this adjuvant causes a Th1 response in this animal, or a Th1 response in that animal.’ What they fail to go on to say is: ‘It hasn’t been put into man yet.’ The use of adjuvants is an empirical science, and you can learn only so much from preclinical studies. I’ve grown very skeptical because I’ve been burned so many times. It really comes down to clinical trials. If you want your vaccine to work in a human, you’d better get it into a human, quickly. Otherwise you’re going to spend a lot of time with animal studies and never be able to predict what it will do in people.”

In animals and humans, alum tends to skew things towards Th2, says infectious disease vaccinologist Tom Evans, MD, professor of medicine at the University of California, Davis. Evans has also worked with MF59, a squalene/water emulsion manufactured by Chiron that is in a licensed influenza vaccine in Italy. “MF59 gives you better responses than alum, but it’s very Th2-skewed,” Evans says...."

[Snowy Owl]

Fromatted by SusanC ar Flu Wiki

In North-Rhine/Westphalia is to be probably begun on 26 October with the inoculation against the H1N1-Virus. When first are member of the health service such as physicians, practice coworker, care forces and receive policeman the vaccine. But many want to boycott the inoculation.

Michael Blondin (large picture) is a general physician. In its practice in Neukirchen Vluyn he inoculates daily many patients against flu. Like the other family doctors in North-Rhine/Westphalia also he was asked by the health authorities whether he makes his practice available as base for at the end of of October inoculation beginning against pig flu. "We go through there not", say the physician. "And of the coworkers in our practice also nobody can be inoculated."

With its attitude Blondin does not stand alone. Thus the Krefelder work physician center, which cares for numerous enterprises and nursing facilities in the region, communicated its customer that it will not take part in the inoculation. It is not so far well-known ", which is contained in the vaccine.

Carrier materials are added to the vaccine, which well-known-prove strong side effects release, like local reactions, pain, inflammations and still worse inoculation damage ", so the leading lady doctor of the work physician center. Them become ", their coworkers and also otherwise nobody with the present vaccine inoculate themselves", write them. Angelika Hauser, chairman of the association of physicians Hartmann federation in North-Rhine/Westphalia, confirms that many of its colleagues do not think anything from the vaccination campaign: "Many think that the illness is simply not so dangerous."



It is considered as safe that first in a first wave as much as possible coworkers of the health service are to be inoculated with patient contact. But so far the disease symptoms run mildly let the inoculation readiness shrink: With 20 \ x0e648 announced cases in Germany there was so far only one death, with which the pig flu virus was along also H1N1. The number of the new infections per week decreased/went back from 3300 at the end of of July on 749 at the end of of Septembers.



In addition warnings of the "drug telegram" come. Its publisher Wolfgang Becker Brüser warns of amplifier materials (Adjuvantien), which are contained in the vaccine. These preparations were not tested extensively enough. Side effects like life-threatening immune reactions are not to be excluded. Becker Brüser: "We experience a full-scale test at the German population.
" From the medical profession it received much agreement.

more at http://newfluwiki2.com/diary/3987/ad...mmune-response

[Snowy Owl]

Please refer to

Adjuvants and Pathogenesis of Autoimmune Disease II - Inflammation and Immune Regulation

Snowy Owl

[Snowy Owl]

Bumping this