Swine Flu Scare: It’s All about The
By Herb Newborg ~
Pandemic fears used as excuse to bypass safety and
efficacy testing of patented adjuvants
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
In 2005, the Department of Health and Human Services
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
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
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
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 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
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
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
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,
lymph-adenopathy, 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
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
10 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
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The above news is at:
COME ON, LET'S GO ~
By David Icke
First Deaths In Sweden From 'Swine Flu'
WGFT Editor: I immediately became badly
ill (just hours) after receiving two injections at a homeless
shelter in South Dakota, USA, in 2005; over the coming weeks
(lasting approx 3 months) I was fighting for my life. I recently
read some information which suggested that it could be
Squalene that caused the nearly lethal response. I was given
two injections at the same time (was I stupid or what - it just
seems strange to have to always be on guard). I was told one was
a T.B. test (probably true); and the other was a Tetanus jab
(that seemed strange - I hadn't just cut myself, which in the UK
is usually the reason for Tetanus jabs - if I had my time again
I would definitely say NO to that one). Either way, SQUALENE
does seem to be the cause of severe illness for approximately
400,000 U.S. military people who served in the Gulf War.