See other World News Articles
Title: Swine Flu Shot in U.S. May Rely on Emergency Use of Additives
Source:
Bloomberg
URL Source: http://www.bloomberg.com/apps/news?pid=20601103&sid=a_xObcaSxF2o
Published: Jul 29, 2009
Author: By Tom Randall and Gary Matsumoto
Post Date: 2009-07-29 02:56:30 by TwentyTwelve
Keywords: Swine Flu, Vaccines, Weapons of Mass Destruction, Made-In-The Lab Flu
Views: 64
Comments: 6
Swine Flu Shot in U.S. May Rely on Emergency Use of Additives By Tom Randall and Gary Matsumoto July 29 (Bloomberg) -- Swine flu vaccine makers may rely on a U.S. emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic. The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. Health officials, meeting today at the U.S. Centers for Disease Control and Prevention in Atlanta, plan to discuss use of the additives, and may also recommend who should be first to receive the limited amount of vaccines drugmakers say they will begin delivering in October. The U.S. Health and Human Services Department declared a public health emergency over swine flu in April, and the Food and Drug Administration has the power to allow the use of unapproved medical products during such a crisis. The U.S. has been slow to approve the use of adjuvants because of safety concerns, and for fear of giving Americans an excuse to avoid getting the shots, said John Treanor, a University of Rochester researcher. “The question is, do you really feel comfortable throwing this new thing into the mix and do you really need to?” said Treanor, a professor of medicine, microbiology and immunology at the school in Rochester, New York. “I myself, if I had to do it, would really wrestle with that decision.” The CDC agreed to pay London-based Glaxo and Novartis, based in Basel, Switzerland, more than $415 million for adjuvants that could be added to the swine flu vaccines, according to a July 13 statement. Mice Studies A safety concern was raised in 2004 when researchers at the University of Florida in Gainesville reported that mice injected with oils used in the adjuvants developed conditions of the type that occur when the body’s immune system produces an excessive protective reaction. Similar reactions haven’t been seen in humans. MF59, made by Novartis, has been given to more than 40 million people, mostly adults, to prevent seasonal flu, according to the company. Glaxo’s adjuvant has proven safe and effective in clinical trials with 39,000 people, said Lisa Behrens, a spokeswoman for the company, in an e-mail. Glaxo will conduct more studies and continue to monitor safety after the vaccines are in use, she said. Under the U.S. health emergency, the FDA may authorize the use of unlicensed vaccines, according to Peper Long, an agency spokeswoman. The FDA convened an advisory committee July 23 to consider what trials are necessary for the vaccines’ approval. Advisory committees consist of medical experts who provide guidance to the agency. Race to Make Shots Swine flu’s full force may reach the U.S. earlier than the typical flu season, according to the CDC. Vaccine makers are racing to make shots by mid-October, when cases are expected to rise in the northern hemisphere, fueled by cooler temperatures and the return of pupils to close quarters of classrooms. The World Health Organization, based in Geneva, has said the H1N1 influenza, as the pandemic flu is known, is moving with “unprecedented speed.” The flu spread farther globally in less than six weeks than previous pandemics have in more than six months, the Geneva-based agency said on its Web site on July 17. Global health authorities have stopped counting the number of cases and the CDC says more than 1 million people Americans have been sickened by the virus. The vaccine makers have found it difficult to cultivate the quantities of virus needed for vaccine, as the strain yields 50 percent to 75 percent less antigen, the substance that induces immunity, compared with a typical seasonal flu strain, according to the WHO. The strain doesn’t grow well in eggs, the principal medium used by the industry, vaccine makers said. Mixing Oil, Water The adjuvants are mixes of oil and water that -- by stimulating the immune system -- offer a way to boost the body’s response to antigen. Adjuvants, whose effectiveness vary by flu strain, may boost the strength of the antigen as much as 10- fold, as was the case with a bird flu vaccine approved in Europe, said Treanor, of the University of Rochester. By adding an adjuvant the same amount of antigen can be used to treat more people, he said. “Until GlaxoSmithKline and Novartis can show me it won’t harm a rat or guinea pig, I think it’s a bad idea to give it to humans,” Vicky Debold, a registered nurse with a Ph.D. in public health, who is a member of the FDA’s advisory committee for reviewing vaccines, said July 27 in an interview. ‘Tremendously Well’ The U.S. never had to consider the risks of an adjuvant because regular flu vaccines were deemed to have “worked so tremendously well,” said Lone Simonsen, research director in the department of global health at George Washington University in Washington. “We have had a safe experience with the MF59-adjuvanted vaccine in Italy and Spain for many years now,” Simonsen said. “That experience we can lean on. That’s going to be the best data we have in time for using adjuvanted vaccines.” CSL Ltd., which has a $180 million order to supply bulk H1N1 antigen to the U.S. government, decided against boosting its vaccine with an adjuvant, preferring to use a formulation more closely resembling the seasonal flu shot, said Mary Sontrop general manager of the Melbourne-based company’s biotherapies unit. The U.S. has contracts with five companies to provide flu shots. Novartis, based in Basel, Switzerland, is responsible for 45 percent of the supply, while Sanofi will provide 26 percent and CSL will make 19 percent, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, in an interview last week. The remaining doses will be made by Glaxo and London-based drugmaker AstraZeneca Plc. To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net; Gary Matsumoto in New York at gmatsumoto@bloomberg.net. Last Updated: July 29, 2009 00:01 EDT
Post Comment Private Reply Ignore Thread
Top • Page Up • Full Thread • Page Down • Bottom/Latest
#1. To: All (#0)
Readying Americans for Dangerous, Mandatory Vaccinations Title: Swine Flu Vaccine of 1976- More Harm than Good? Mass flu vaccination would be madness Title: Drug groups to reap swine-flu billions Title: Swine flu vaccine a boon for Baxter Vaccine May Be More Dangerous Than Swine Flu Title: New flu resembles feared 1918 virus, study finds Baxter: Product contained live bird flu virus ‘Accidental’ Contamination Of Vaccine With Live Avian Flu Virus Virtually Impossible The Avian Swine Flu Strain Created in the Lab? On Purpose? Who Benefits?
www.whale.to/vaccines/mf59_h.html MF-59 Ingredients Contains squalene FLU SHOTS AND THE NEW ADJUVANTS: BEWARE! by Dr. Sherri Tenpenny, DO [NVIC] NIH Wants Toxic Adjuvant in Flu Vaccine (MF59) MF59TM is a sub-micron oil-in-water emulsion of a squalene, polyoxyethylene sorbitan monooleate (TweenTM 80) and sorbitan trioleate. Squalene is a natural organic compound originally obtained from shark liver oil and a biochemical precursor to steroids. The MF59 adjuvant was developed by Chiron Corp., a company acquired by Novartis. MF59 is approved in Europe and is found in several vaccines, such as an influenza vaccine manufactured by Novartis. It has also been licensed to other companies and is being actively tested in vaccine trials. Exploring Vaccines Vaccine A: The Covert Government Experiment That's Killing Our Soldiers and Why GIs Are Only the First Victims By Gary Matsumoto 1. Many new vaccines feature recombinant DNA. One piece of a deadly germ is inserted or spliced into other organisms, creating bio-engineered microbial molecules. To prompt the body to create antibodies to these recombinants, scientists have created deadly oil-based vaccine additives called adjuvants. Oil-based adjuvants cause extreme inflammation and animals injected with them always develop painful, incurable auto-immune diseases like multiple sclerosis, rheumatoid arthritis or systemic lupus. 2. Since Gulf War I, the military has been secretly putting an oil-based adjuvant called SQUALENE into certain experimental lots of military vaccines. Just like lab animals, thousands of soldiers given SQUALENE- laced vaccines have developed disabling auto-immune diseases. Independent researchers have found SQUALENE antibodies in these sick soldiers. In 2005, the military admitted that 1,200 military personnel who received anthrax vaccine before going to Iraq recently developed serious illnesses, including memory loss and chronic fatigue. 3. The military and federal health agencies have long kept their SQUALENE experiments on U.S. military troops secret because they know that oil-based adjuvants wreak havoc with immune function, causing the body to attack itself. Matsumoto documents how federal and military officials have often been caught lying about the SQUALENE in military vaccines. 4. Matsumoto warns that the National Institutes of Health has funded production of new vaccines for flu, human papilloma virus, malaria, HIV and herpes that also contain SQUALENE. The federal government has been running human clinical tests on these new commercial vaccines and test subjects have not been properly informed of the grave health dangers. Researchers have even found SQUALENE in some of the older vaccines containing tetanus and diphtheria toxoids. Should we wonder why auto-immune diseases like fibromyalgia and chronic fatigue are now rampant? 5. The Bush administration is funding development of new bio-warfare vaccines that will also contain oil- based SQUALENE adjuvants like MF59 or MPL. Because federal officials know that these vaccines may cause disability or death, legislation to protect vaccine makers from lawsuits is expected to be passed by Congress before the end of 2005.* If you become chronically ill from these vaccines, tough luck! Exploring Vaccines "Tri-Mix" or "Triple Mix" was the U.S. Army designation in the late 1980s for the squalene emulsion adjuvant now sold by Corixa under the commercial name Ribi Adjuvant System or RAS. Scientists at Fort Detrick began working with this emulsion "vehicle" in 1987 (NIH scientists had been working with squalene emulsions since the late 1970s). As I report in Chapter Three of my book, by 1989 - a year before Operations Desert Shield and Desert Storm - Army scientists believed they had succeeded in creating a new, faster-acting anthrax vaccine that induced the same amount of immunity in guinea pigs with one shot of the new vaccine as did three shots of the licensed vaccine. The new vaccine was formulated with Tri-Mix adjuvant as well as De-Tox and Syntex Adjuvant Formula I (which were emulsified in either squalene or its more stable, hydrogenated form, squalane). The chief pharmaceutical ingredient in the new vaccine was a more highly purified protective antigen (PA) protein, or fragments or "sub-units" of PA. In parallel research, Fort Detrick also constructed various "chimeras" - genetic engineered hybrid microbes that would biosynthesize protective antigen without any trace of the other two anthrax toxin proteins. Theoretically, this would make the new vaccine less "reactogenic" (less likely to induce unpleasant side effects), but it also made it weaker. Previous data from military scientists in both the United States and Britain had already shown that the immune system responded to a wide array of Bacillus anthracis components: all three toxin proteins (PA, LF and EF), to structures called "epitopes" found on the anthrax capsule, the surface of anthrax ve getative cells and the surface of spores. By design, all of these epitopes were missing from the new vaccine, which was less reactogenic but, predictably, less immunogenic. It required a new and more powerful adjuvant: one of the new generation oil emulsions. Around 1994, Fort Detrick concluded that the non-spore forming Delta Sterne variant of Bacillus anthracis made the most efficient platform for making recombinant protective antigen, now called rPA102. Protective antigen made from this system was emulsified principally with MF59 - an adjuvant made from squalene in water, but without a bacterial component. In 1998, the British scientists at the Center for Applied Microbiological Research at Porton Down adopted the formula for the U.S. "second generation" anthrax vaccine, but added the Ribi Adjuvant System (the old Triple-Mix adjuvant) instead of MF59. According to relatively recent briefings given by Col Arthur Friedlander (U.S. Army, ret.) to senior military officers, Fort Detrick has continued to study the effects of rPA102 when combined with Tri-Mix/RAS, Syntex Adjuvant Formula and MF59. Army scientists are still testing rPA102 with alum (the only vaccine adjuvant licensed in the U.S. for human use), Walter Reed Liposomes (made with cholesterol, and sometimes with squalene and monophosphoryl Lipid A), and QS-21. The NIH-approved clinical trials with rPA102 are with alum only. The anti-squalene antibodies in retired and active duty military personnel are evidence that the Army has been acquiring safety and efficacy data for the new vaccine, combined with squalene emulsion adjuvants, by ethically dubious means. All this, and a lot more, is recounted in the book in much greater detail. Please read the whole book, not just parts of it, to fully understand the basis of the very serious charge that the Department of Defense has been conducting covert medical experiments on troops to "fast track" its new anthrax vaccine. Gary Matsumoto www.vaccine-a.com/forum.html
www.infowars.com/baxter-p...ined-live-bird-flu-virus/ Baxter: Product contained live bird flu virus Helen Branswell The Canadian Press March 5, 2009 The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained live H5N1 avian flu viruses. featured stories Baxter: Product contained live bird flu virus The contamination incident, which is being investigated by the four European countries, came to light when the subcontractor in the Czech Republic inoculated ferrets with the product and they died. Ferrets shouldn’t die from exposure to human H3N2 flu viruses. And an official of the World Health Organization’s European operation said the body is closely monitoring the investigation into the events that took place at Baxter International’s research facility in Orth-Donau, Austria. “At this juncture we are confident in saying that public health and occupational risk is minimal at present,” medical officer Roberta Andraghetti said from Copenhagen, Denmark. “But what remains unanswered are the circumstances surrounding the incident in the Baxter facility in Orth-Donau.” The contaminated product, a mix of H3N2 seasonal flu viruses and unlabelled H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany. The contamination incident, which is being investigated by the four European countries, came to light when the subcontractor in the Czech Republic inoculated ferrets with the product and they died. Ferrets shouldn’t die from exposure to human H3N2 flu viruses. Public health authorities concerned about what has been described as a “serious error” on Baxter’s part have assumed the death of the ferrets meant the H5N1 virus in the product was live. But the company, Baxter International Inc., has been parsimonious about the amount of information it has released about the event. On Friday, the company’s director of global bioscience communications confirmed what scientists have suspected. “It was live,” Christopher Bona said in an email. The contaminated product, which Baxter calls “experimental virus material,” was made at the Orth-Donau research facility. Baxter makes its flu vaccine — including a human H5N1 vaccine for which a licence is expected shortly — at a facility in the Czech Republic. People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted. Accidental release of a mixture of live H5N1 and H3N2 viruses could have resulted in dire consequences. While H5N1 doesn’t easily infect people, H3N2 viruses do. If someone exposed to a mixture of the two had been simultaneously infected with both strains, he or she could have served as an incubator for a hybrid virus able to transmit easily to and among people. That mixing process, called reassortment, is one of two ways pandemic viruses are created. There is no suggestion that happened because of this accident, however. “We have no evidence of any reassortment, that any reassortment may have occurred,” said Andraghetti. “And we have no evidence of any increased transmissibility of the viruses that were involved in the experiment with the ferrets in the Czech Republic.” Baxter hasn’t shed much light — at least not publicly — on how the accident happened. Earlier this week Bona called the mistake the result of a combination of “just the process itself, (and) technical and human error in this procedure.” He said he couldn’t reveal more information because it would give away proprietary information about Baxter’s production process. Andraghetti said Friday the four investigating governments are co-operating closely with the WHO and the European Centre for Disease Control in Stockholm, Sweden. “We are in very close contact with Austrian authorities to understand what the circumstances of the incident in their laboratory were,” she said. “And the reason for us wishing to know what has happened is to prevent similar events in the future and to share lessons that can be learned from this event with others to prevent similar events. … This is very important.”
snardfarker.ning.com/group/flu Bio Watch : CDC: "Never-before-seen mixture of swine, human and avian viruses Outbreak"
Article completely ignores the bad results of sqalene in military vaccines. This is a Bloomberg whitewash of the dangers of adjuvents.
#2. To: All (#1)
#3. To: All (#2)
#4. To: TwentyTwelve (#3)
#5. To: TwentyTwelve (#0)
#6. To: TooConservative (#5)
Top • Page Up • Full Thread • Page Down • Bottom/Latest