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August 5, 2009
The U. S. government has paid pharmaceutical companies $7.9 billion* since 2004 to develop the capacity to mass vaccine the entire U.S. population by 2011. Under the perceived threat of H1N1, these plans have been accelerated to include the use of a non FDA approved chemical adjuvant suspected of causing Gulf War Syndrome, circumventing the FDA approval process for this potentially life threatening chemical.
In 2005, the Department of Health and Human Services (HHS) published a plan with two specific goals that relate to vaccines. The first goal was to have in place by 2011 domestic production capacity sufficient to supply vaccine to the entire U.S. population within six months of the onset of a pandemic. The second goal was to stockpile enough doses of vaccine to inoculate 20 million people as soon as possible after the onset of a pandemic.
As of September 15, 2008, HHS had yet to determine how best to build and develop the capacity to create the hundreds of millions of doses necessary for such an ambitious undertaking. Three options were identified which could possibly achieve the stated goal by 2011:
Continue to fund and expand funding for the egg-based vaccine antigen production currently utilized in the production of seasonal flu vaccine (viruses are grown in hens’ eggs). Toward this end, HHS has budgeted $600 million to offer capital subsidies to manufacturers to build egg-based production facilities in addition to $176 million already awarded.
Continue to fund and expand funding for cell-based vaccine antigen production (for example, viruses grown in the kidneys of dogs) widely used to manufacture vaccine against polio, chicken pox, measles, mumps, and rubella. To date, HHS has obligated $1.3 billion to promote the development of new cell-based influenza vaccines.
Fund next generation vaccine manufacturing, based on the use of recombinant-DNA technology. Recombinant vaccines are made by splicing antigen producing genes into the DNA of another organism (pigs, monkeys, birds, insects, etc.) The modified organisms then reproduce to provide bulk quantities of antigen. Recombinant techniques are already in use to make vaccines against hepatitis B and human papillomavirus.
All three scenarios had major drawbacks.
Using egg-based vaccine antigen to provide the quantities necessary to vaccinate all 300 million Americans with 2 doses each would require massive infrastructure build up. Despite the $176 million already awarded to manufactures, additional funds would be needed and FDA approvals (not expected until 2011) are necessary in order to even begin to approach the desired number of vaccine doses. It is estimated that the two companies awarded egg-based funding combined could produce only 125 million doses, even after the infrastructure upgrades, and not until 2011.
Using cell-based antigen to provide the quantities necessary to vaccinate all 300 million Americans with 2 doses each would also require massive infrastructure build up. A plant could produce 25 million pandemic-influenza doses at 90 micrograms per dose. It would take about nineteen plants with that capacity to produce 475 million doses. If the cost of construction, bringing the plant online, and obtaining the FDA’s approval averaged $400 million per plant, the total cost of the expanded capacity would be $7.6 billion. If each plant cost $600 million, the total would be $11.4 billion. This capacity would not be available until 2011-2012.
Next generation or recombinant-DNA is not an attractive option, as most recombinant influenza vaccines have not yet advanced past early-stage clinical trials. These vaccines could be 10 years or more away from the market. HHS has yet to fund their development for use against influenza, in part because it has chosen to build on the decades of experience in using cell culture to produce other vaccines. However, HHS plans to award contracts worth $155 million for the development of next-generation vaccines in the near future.
So where does the capacity to mass vaccinate the entire population stand after our $7.9 billion investment?
We currently have a stockpile of 22.5 million doses of the H5N1 antigen for the feared Avian flu pandemic that never materialized. The cost to maintain this stockpile for just two circulating strains of H5N1 is about $2.2 billion annually. Influenza vaccine typically expires after two years; 15 million doses have expired or will expire soon.
In addition, we have stockpiled 268 million doses of what appears to be the wildcard in the whole equation. This is what is known as an adjuvant. An adjuvant is a chemical that can be added to vaccines to reduce the amount of active ingredient (antigen) needed per dose of vaccine by “turbo-charging” the immune system response in the recipient. This could potentially stretch the supply, providing six times as many doses from the same quantity of antigen.
This would solve many, if not all of the issues regarding capacity to mass vaccinate the entire population. Instead of investing in building additional plants and hiring workers to produce antigen, the funds could be used to purchase proprietary, patented chemical adjuvants.
The only problem is: these chemicals are not FDA approved. They have not been FDA safety tested. We have no idea if they are safe and in fact have every reason to suspect that they are not.
Despite this fact, the U.S. has already purchased at least 312 million doses of two proprietary, patented adjuvants: MF59 from Novartis and ASO3 from GSK. These purchases took place despite the fact that neither chemical has been FDA approved for use in a vaccine. The manufacturers have not yet even obtained FDA approval for Phase I clinical trials in the U.S., the first step toward approval of any new drug, vaccine or adjuvant.
On average, it takes a little over a decade for a drug to move from preclinical development to the marketplace. Before a vaccine enters human testing, the developer conducts laboratory (in vitro) and laboratory animal (in vivo) testing to determine whether the product will be safe enough for researchers to proceed to clinical trials.
The developer must obtain the FDA’s approval to begin clinical trials through the submission of an investigational new drug, or IND, application. Clinical trials typically have three phases. Phase I focuses on the vaccine’s safety and generally involves fewer than 100 human subjects. The purpose of Phase II, which typically involves several hundred subjects, is to expand Phase I safety data and identify whether and at what dose the vaccine elicits a protective immune response. Phase III typically involves thousands of people and is used to document effectiveness and develop additional safety data (notably concerning the incidence and severity of side effects) required for licensing. Clinical trials generally last five to seven years. If all three phases of the clinical development are successful, the developer may submit a biologics license application, or BLA, to the FDA for review. If the FDA approves the application, the developer launches the new vaccine, a process that includes training its sales force and increasing production capabilities to meet the anticipated demand.
It appears that the U.S. is prepared to skip all of the normally required safety and efficacy procedures and allow for the massive testing of this novel adjuvant on at least 25% of the 12,000 Americans serving as paid clinical trial participants in tests of the new H1N1 vaccine, despite documented U.S. government warnings that adjuvanted vaccines can induce more pronounced side effects than ordinary vaccines, a definite downside because vaccines, unlike most other pharmaceuticals, are given to healthy people.
To date, the Food and Drug Administration has never approved an adjuvanted vaccine for influenza. Other adjuvanted vaccines currently licensed for use in the United States—against diphtheria, tetanus, hepatitis A, and hepatitis B—are made with aluminum. But aluminum adjuvants do not reduce the amount of antigen needed by enough to substantially increase the amount of vaccine that would be available during a pandemic.
The FDA has not approved a human vaccine containing a new type of adjuvant in many years, as all other types of adjuvants have thus far produced too many side effects to meet the FDA’s standards.
The reason introducing this chemical without the required safety and efficacy testing is so objectionable is that both of these proprietary adjuvants contain squalene.
Oil-based vaccination adjuvants like squalene have been proved to generate concentrated, unremitting immune responses over long periods of time according to a 2000 article in The American Journal of Pathology.
A 2000 study published in the American Journal of Pathology demonstrated a single injection of the adjuvant squalene into rats triggered “chronic, immune-mediated joint-specific inflammation,” also known as rheumatoid arthritis. The researchers concluded the study raised questions about the role of adjuvants in chronic inflammatory diseases.
What happens when Squalene is injected into humans?
Your immune system recognizes squalene as an oil molecule native to your body. It is found throughout your nervous system and brain. In fact, you can consume squalene in olive oil and not only will your immune system recognize it, you will also reap the benefits of its antioxidant properties.
The difference between “good” and “bad” squalene is the route by which it enters your body. Injection is an abnormal route of entry which incites your immune system to attack all the squalene in your body, not just the vaccine adjuvant.
Your immune system will attempt to destroy the molecule wherever it finds it, including in places where it occurs naturally, and where it is vital to the health of your nervous system, according to award-winning investigative journalist Gary Matsumoto, who explains there is a “close match between the squalene-induced diseases in animals and those observed in humans injected with this oil: rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus.”
“There are now data in more than two dozen peer-reviewed scientific papers, from ten different laboratories in the US, Europe, Asia and Australia, documenting that squalene-based adjuvants can induce autoimmune diseases in animals…observed in mice, rats, guinea pigs and rabbits. Sweden’s Karolinska Institute has demonstrated that squalene alone can induce the animal version of rheumatoid arthritis. The Polish Academy of Sciences has shown that in animals, squalene alone can produce catastrophic injury to the nervous system and the brain. The University of Florida Medical School has shown that in animals, squalene alone can induce production of antibodies specifically associated with systemic lupus erythematosus,” writes Matsumoto.
We got our first hint at the dangers of these proprietary adjuvants when they were secretly tested on soldiers during the Gulf War.
Gulf War veterans with Gulf War Syndrome (GWS) received anthrax vaccines which contained squalene. MF59 (the Novartis squalene adjuvant) was an unapproved ingredient in experimental anthrax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets according to data published in the February 2000 and August 2002 issues of Experimental and Molecular Pathology.
The Department of Defense made every attempt to deny that squalene was indeed an added contaminant in the anthrax vaccine administered to Persian Gulf war military personnel – deployed and non-deployed – as well as participants in the more recent Anthrax Vaccine Immunization Program (AVIP).
However, the FDA discovered the presence of squalene in certain lots of AVIP product. A test was developed to detect anti-squalene antibodies in GWS patients, and a clear link was established between the contaminated product and all the GWS sufferers who had been injected with the vaccine containing squalene.
The Pentagon never told Congress about the more than 20,000 hospitalizations involving troops who took the anthrax vaccine from 1998 through 2000, despite repeated promises that such cases would be publicly disclosed. Instead, generals and Defense Department officials claimed that fewer than 100 people were hospitalized or became seriously ill after receiving the shot, according to an investigation by the Daily Press of Newport News.
A study conducted at Tulane Medical School and published in the February 2000 issue of Experimental Molecular Pathology included these stunning statistics:
“ … the substantial majority (95%) of overtly ill deployed GWS patients had antibodies to squalene. All (100%) GWS patients immunized for service in Desert Shield/Desert Storm who did not deploy, but had the same signs and symptoms as those who did deploy, had antibodies to squalene.
In contrast, none (0%) of the deployed Persian Gulf veterans not showing signs and symptoms of GWS have antibodies to squalene. Neither patients with idiopathic autoimmune disease nor healthy controls had detectable serum antibodies to squalene. The majority of symptomatic GWS patients had serum antibodies to squalene.”
According to Dr. Viera Scheibner, Ph.D., a former principle research scientist for the government of Australia:
“… this adjuvant [squalene] contributed to the cascade of reactions called “Gulf War Syndrome,” documented in the soldiers involved in the Gulf War.
The symptoms they developed included arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS (amyotrophic lateral sclerosis), Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhoea, night sweats and low-grade fevers.”
Clearly bypassing the FDA requirements for safety testing of these new adjuvants and the vaccines which contain them puts the entire population at risk for serious, possibly life threatening side effects, particularly any of the 12,000 trial paid trial participants (6,000 children) who are unfortunate enough to be randomized into the adjuvant containing groups.
Still, on July 23, 2009, the FDA announced, “Currently, no U.S. licensed vaccine contains the adjuvants MF-59 or ASO3. It is expected that a novel influenza A (H1N1) vaccine manufactured using the same process as U.S. licensed seasonal inactivated influenza vaccine but administered with MF-59 or ASO3 will be authorized for emergency use only.”
And that, “Two of the manufacturers (Novartis and GSK) have proprietary oil-in-water adjuvants (MF-59 and ASO3, respectively) which have been evaluated in a number of clinical studies including studies with influenza vaccines. These manufacturers will include an evaluation of the utility of the adjuvant for dose sparing and enhanced immunogenicity in their clinical studies. While there may be exceptions, in general, studies which include an adjuvanted arm(s) to evaluate dose sparing and enhanced immunogenicity may be conducted concurrently in the adult and pediatric age groups in order to have timely immunogenicity results to guide pediatric dose recommendations.”
The same document indicates that vaccines containing the un-approved adjuvants will be given to 100 children 6 months to 3 years old, 100 children 3 years old to 8 years, 100 individuals 18 to 64 years old and 100 individuals 65 and older in each of the multiple clinical trials. In addition, 700 individuals in each trial will be given non-adjuvanted vaccine.
Since the government has recruited 12,000 paid “volunteers” for the trials, it would be possible that as many as 10 trials could be conducted simultaneously.
Oddly, 60% of the world’s confirmed cases have occurred in people age 18 or younger, yet this age group (between 8 and 18) have been excluded from the clinical trials, with the results for this age group to be extrapolated from the other study data.
Given the fact the U.S. currently owns 268 million doses of the non-approved, non FDA tested adjuvant, the vaccines that contain this novel chemical will likely be found to be completely safe in these industry run trials. Unfortunately, the effects on the soldiers that experienced injury sometimes appeared long after the planned duration of the current trials.
*$5.6 billion in funding occurred in 2006 alone. The $5.6 billion spent for vaccine development in 2006 is 100 times the $515 million the FDA spent in 2006 for all FDA activity related to drug safety and efficacy for the entire drug industry including: pre and post approval testing, approval and regulation of over-the-counter and prescription drugs, biological therapeutics and generic drugs and personal care products such as fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens, monitor the more than 10,000 drugs on the market to be sure they continue to meet the highest standards, monitor TV, radio, and print drug ads to ensure they are truthful and balanced and provide health professionals and consumers information to use drugs appropriately and safely.